VAERS USA Data - updated from latest file from vaers.hhs.gov


Date run: 2022-11-28 - Total deaths 8413

Dates range:2020-01-01 00:00:00 to 2022-09-09 00:00:00
VAERS_ID RECVDATE STATE AGE_YRS SYMPTOM_TEXT
1636388 2433858 2022-09-08 KY 81.00 Patient was Covid positive 7/14/22 and expired 8/29/22.
1636366 2433836 2022-09-08 KY 54.00 Covid + 8-31-22; to er with shortness of breath, chest pain, muscle aches . H/o CHF. He reported he had + home test for covid. WBC high 26.3 and placed on remdesivir. lethargic abd pain but no n/v. no pneumonia on initial cxr. placed in icu 9/1 and troponin increased on 9/2/22 Intubated for stabilization Levophed due to hypotension. Air vac contacted for emergent transfer but code blue was called three times and in spite of ROSC at one time, efforts were not successful in reviving the patient and he expired 9/2/22.
1636355 2433825 2022-09-08 92.00 MODERNA COVID VACCINE #3 GIVEN 11/30/21, LOT #027H21B; pt had a positive COVID test in the nursing home; DNR; pt not in respiratory distress during course of illness; appetite decreased over time; taking only sips of liquid, and unable to swallow medication the day he passed in the nursing home
1636347 2433817 2022-09-08 MI 77.00 The patient has a history of a fall with progressive quadraparesis, a sacral decubitis ulcer, and PEG tube. He presented to the emergency department on 8/22/22 with hypoxia and was tachypneic. He tested positive for COVID on 8/22/22. The patient was made hospice on 8/27/22 and deceased on 8/30/22.
1636322 2433792 2022-09-08 79.00 MODERNA COVID VACCINE #3 GIVEN 1/27/22, LOT #016J21A-2A; pt had a positive COVID test 1/27/22; DNR/DNI; pt passed away.
1636268 2433736 2022-09-08 81.00 pt had a positive COVID test on 1/18/22 at SNF) where he was residing. From our records, pt passed away at home on 2/11/22.
1636263 2433731 2022-09-08 KY 60.00 tested + covid 8-14-22; to er with shortness of breath, had covid 19 sepsis pneumonia, anemia , thrombocytopenia, hypokalemia and elevated lfts. H/o metastatic breast cancer. and ITP. admitted for remdesivir, decadron vitamins electrolyte replacement . Required intubation and developed acute kidney injury and etabolic acidosis and contined to decline. 8/19/22 had bleeding issues and it was decided to place her on comfort measures and expired 8-19-22
1636208 2433672 2022-09-08 MI 78.00 79y.o. male who presents with altered mental status. Patient is a poor historian, majority of history is taken from wife over the phone. Patient tested positive for covid on August 12, 2022 at his nursing home. Patient has advanced dementia, not conversational at baseline. He was living with his wife at home until August 1, 2022 when he moved into a nursing home. A few weeks ago, he started having poor oral intake and worsening confusion. In the EC, temp 102 degF, blood pressure 168/104, heart rate 134, respiratory rate 36, pulse ox 89% on 6L nasal canula. Labs significant for sodium 162, creatinine 3.07, troponin 0.11, WBC 19.6. COVID test positive. Patient found to be in acute hypoxic respiratory failure due to covid, MSSA bacteremia, VTE, AKI and hypernatremia. Family including wife and daughter, decided to transition patient to hospice care. Patient assessed and unresponsive to verbal and tactile stimuli, pulseless, respirations and heartsounds absent. Pupils dilated, fixed, and unresponsive to light. Date and time of death pronounced on 8/31/22 at 1600.
1636201 2433664 2022-09-08 MI 67.00 68y.o. female with PMH pertinent for seronegative RA on chronic prednisone recent COVID PNA presented for worsening SOB. In the ER, patient was hypoxic requiring HFNC 100% FiO2/50 L and a nonrebreather maintaining SPO2 in the early 90s. Significant increase in work of breathing. Patient was intubated. On 8/28, the patient developed resp distress. Patient had a needle decompression and then chest tube placement for right sided tension pneumothorax. Patient was unable to be weaned off ventilator and on 9/5 had a drop in SpO2 with increased WOB. Patient required multiple pressors for hemodynamic instability. Patient transitioned to comfort care, and passed peacefully that evening.
1635733 2431127 2022-09-07 KY 68.00 + covid 7/21/2022; admitted 7/23/22 altered mental status, had mild confusion after AAA repair 7/6/22 but worsened the last few days prior to admission . covid infusion? 7/22. Pneumonia. given roephin, azithromycin, decadron and later vancomycin and zosyn. CT showed indeterminate age infarct & chronic small vessel ischemic disease tPA not recommended, had carotid artery disease. Statins held due to transaminitis. transfered to ICU d/t acute resp failure s/p cardiac arrest apparently on 7/25/22 and he had ROSC, placed on ventilator, levophed. AKI, AGMA, did not improve and expired 7/30/22
1635605 2430996 2022-09-07 MI 86.00 87y.o. male known to our office for management of CLL/SLL who completed 6 cycles of RminiCHOP on 7/27/2022. Pt was admitted to hospital on 8/3/2022 for SOB, cough, and subjective fevers. Pt was found to be covid19 positive in the ED. CXR with infiltrate vs atelectasis in right midlung and bilateral bases. CTA Chest PE protocol 8/4 negative for PE, showed multifocal areas of consolidation. Pt was started on empiric vanoc/cefepime on admit. ID and pulmonology were consulted. Vanco stopped. Pt remained on Cefepime x 7 days total, completed on 8/10/22. Pt was also treated with remdesivir 8/5/2022-8/8/22, and started on Decadon 6mg daily x 10 days. Pt will complete last two days as OP, course will complete on 8/13/22. Pt will also remain on PPI ppx x 1 week at discharge. Pt was neutropenic on admit. He received Neulasta on 7/27/2022, Granix started on admission due to persistent neutropenia and acute infection. Discontinued Granix 8/5 given ANC >1.0. Patient was able to be weaned back to room air on 8/11/22. PT/OT evaluated patient and recommended SAR at discharge. Patient's wife was very adamant that patient was discharged home with home care. Patient became very weak during hospitalization and requires two person assist to stand. His wife remained insistent patient be discharged to her care. Exception made to have wife come to hospital while patient in isolation so she was able to visualize patient and better understand recommendations for SAR. Wife submitted written documentation that she understands the risks of being patient home and prefers patient be discharged to her care with home care. Patient has two son's that are also available to help patient as needed. After long deliberation with patient's wife, will agreed to have patient discharged with home skilled nursing, PT, and OT. Patient's wife is an RN and was well educated on the risk she is taking on by bringing patient home. Patient will follow up in our office in 2 weeks after he is cleared from COVID 19 isolation.
1635624 2431015 2022-09-07 MI 60.00 61y.o. female patient, with a past medical history of heart failure, hypothyroidism, malignant ascites, history of endometrial carcinoma peritoneal metastasis, coronary artery disease with NSTEMI history currently being treated at gynecological oncologist. Patient presented to the EC for evaluation for ongoing abdominal pain, nausea, a diarrhea that became intolerable beginning the night of 5/21. Patient attempted use of oral antiemetics without success, patient was unable to eat or drink. Her abdominal pain also became unmanageable at home, thus her presentation for urgent evaluation. She states she was having bowl urgency with soft stool, but denies any blood in bowel movements or urine. Patient denies fevers, chills, body aches, cough, chest pain/pressure/heaviness/palpitations, shortness of breath. Patient had a peritoneal drain placed on 4/15 which became infected, patient was treated for peritonitis related to enterococcus faecalis with IV antibiotics and discharged on PO linezolid. Patient was again recently admitted and discharged 5/17 - 5/20 for abdominal pain and leakage from old aspira drain site. On 5/18 a paracentesis was attempted but due to trace amounts of fluid, the procedure could not be completed. Patient had initiated chemotherapy with docetaxel, carboplatin and Avastin, and was hospitalized recently for carboplatin desensitization. During the course of hospitalization, paracentesis took place, and the patient had started to experience a new onset left-sided abdominal pain. CT scan abdomen and pelvis was acquired, which unfortunately was suggestive of further progression of disease, especially within the liver. Plan was to change treatment to gemcitabine and Avastin, with incorporation of Piqray. The patient, recently initiated treatment with gemcitabine and Avastin, and received a treatment on 7/26/2022, in addition to undergoing a round of paracentesis. The patient thereafter developed symptoms of nausea vomiting, and abdominal pain. Patient presented to EC on 8/5 for evaluation of abd pain, chills, SOB, leg swelling, nausea, and vomiting. Patient is positive for COVID currently in isolation. Patient had paracentesis yesterday. Overall patient statess she feels about the same, denies any chest pain pressure. Patient is currently on 3L NC and stable. 1. Nausea vomiting and abdominal pain and COVID -As delineated above, the patient presents with concerns regarding abdominal pain, nausea and vomiting, status post paracentesis, -Overall symptoms have improved with conservative measures. -Continue adequate pain control, and antiemetics at this time. -Currently in isolation for COVID, rec'd dose 1 of remdesivir this afternoon. -Did c/o severe itching w/o rash. Ordered hydralazine -HGB 8.7 Plts 153 -Patient anxious and uncomfortable. States she feels confused, talking to herself, having auditory and visual hallucinations. Consulted Dr for acute delirium -Patient states abd discomfort. Paracentesis ordered -WBC 14.2 ID following -Creat 1.17, IV hydration, nephro consulted -Denies any changes in shortness of breath. -Increase in ALK phos and LFT's. Associated with remdesivir -HGB 7.3 down 1g. Plts 353, stable. R/O hemolysis -Creat improved 1.03 from 1.17. -Appreciate psych's recs, positive for delirium, avoid benzo use. Seroquel 12.5 3 times daily for anxiety management. -Plan for paracentesis today -ID cleared patient for discharge -appreciate nephs recommendations. IV lasix 40mg bid, added albumin 25% 25 g TID x 5 days. Avoid large volume paracentesis, rec's once a week. -Appreciate medicine rec's - continue with supportive measures, IV antiemetics -Patient is not eligible for treatment and prognosis remains very poor. Our recommendation is to transition to comfort measures only and move forward with hospice. -Had extensive discussion with husband and patient. -Inquired regarding home hospice. Reviewed philosophy of hospice and palliative care. Patient and husband agreeable to home hospice at this time. -Placed stat hospice/palliative care/care management consult. -Will discharge home pending planning and coordination of care. -Had extensive discussion with family this morning. Overall prognosis is very poor. Patient is no longer eligible for treatment at this time. Husband was agreeable to hospice yesterday but had hesitations going home hospice due to the inability for the patient to receive as needed paracentesis. Patient overall status continues to significantly decline. At this time it is my opinion she is not eligible for ambulance transfer home for hospice. Patient was changed to no DNAR yesterday. Patient will remain inpatient until she passes. -comfort measures only Patient seems to be actively dying, moaning continue Robinul Dilaudid Ativan. 2. Metastatic endometrial carcinoma: High-grade serous: Poorly differentiated: Initially FIGO 3AT3AN0M0: Current progression of disease with peritoneal carcinomatosis: Bilateral pleural effusions: -Diagnosed with high-grade serous carcinoma of endometrium: high grade serous carcinoma of the endometrium FIGO IIIa (pT3aN0M0) s/p TAH-BSO, SLND and chemotherapy with Carbo/Taxol at Karmanos, patient follows Dr GynOnc. -High-grade poorly differentiated endometrial carcinoma initially stage Ia status post surgery March 10, 2021, subsequently got 6 cycles of carboplatinum and Taxol last cycle in August 2021 within 6 months had recurrence of pain in January and February CT showed progression and effusion. She started on lenvatinib however significant progression. Molecular testing has been done with Caris, no actionable mutation. Tumor mutation burden is 3 mismatch repair stable, PD-L1 negative. She has rare mutation RECQL4 which is not actionable at this time. -Progression of disease with peritoneal carcinomatosis and malignant ascites diagnosed 02/2022, currently on Keytruda and Lenvima. -Patient was started on carboplatinum along with docetaxel and Avastin weekly regimen. CT scan after completion of 2 cycles, was suggestive of progression of disease. -Status post initiation of gemcitabine, Avastin, with possible incorporation of Piqray. -The patient is currently modest of the first cycle, status post day 1 and 8 of treatments, with subsequent treatments to be resumed upon resolution of acute events. -Patient has not started piqray due to frequent hospitalizations. Now patient is terminal. Actively dying. 8/7 -Patient feeling tired today, denies fevers, and remains on 3L NC. -Some slight nausea but able to tolerate fluid and nutritional intake. -Will continue remdesivir dose 2/5 -Spoke with patient husband, updated plan of care 8/8 -Patient continues to remain stable on 3L NC. -Will complete remdesivir -CBC cmp reviewed. Remains stable 8/9 -Patient anxious and uncomfortable. States she feels confused, talking to herself, having auditory and visual hallucinations. Consulted Dr for acute delirium -Patient states abd discomfort. Paracentesis ordered -WBC 14.2 ID following -Creat 1.17, IV hydration, nephro consulted -Denies any changes in shortness of breath. 8/10 -Patient remains anxious and uncomfortable, has medications for anxiety -Denies and changes in respiratory status, stable on 3L NC -HGB 7.3 down 1g. Plts 353, stable. R/O hemolysis -Creat improved 1.03 from 1.17. -Appreciate psych's recs, positive for delirium, avoid benzo use. Seroquel 12.5 3 times daily for anxiety management. -Plan for paracentesis today -ID cleared patient for discharge -appreciate nephs recommendations. IV lasix 40mg bid, added albumin 25% 25 g TID x 5 days. Avoid large volume paracentesis, rec's once a week. -Appreciate medicine rec's 8/11 -Patient remains delirious, difficulty concentrating, falls asleep easily. -RRT'd this afternoon for respiratory distress, was found w/o her oxygen on. Husband updated. Patient transferred to progressive care. -HGB <7, 1 unit PRBC's given -Paracentesis today 8/12 -Patient doing much better since transferring to progressive care. -Patient states SOB has significantly improved -States she does not feel ready to go home. -CBC stable, HGB 9.2, Plts 339 8/13 -Patient seen and evaluated this AM, discussed with RN at bedside -Continue supportive measures 8/14 -Patient reports feeling nauseated this AM, IV antiemetics in place -Awaiting thoracentesis 8/15 - s/p thora. abd hard, plan paracentesis. - D/w ID. Dr Cannot get her off isolation , as per COVID policy yet. - Otherwise she feels better. 8/16 -Per ID, isolation for 20 days, today is day 14. -Family able to visit at bedside -Acute respiratory failure, on BiPAP earlier short amount of time, with AMS. Hypercarbia, refused BiPAP. -S/P paracentesis today 2L -Cardiac w/u this am abnormal Trops, BNP 1051. -2D echo EF 25%, new -Attempted left thoracentesis, fluid is loculated, attempt radiology -S/P right throa 8/14 700 cc -CBC stable HGB 10.0, plts 346 8/17 -Had extensive discussion with husband and patient. -Inquired regarding home hospice. Reviewed philosophy of hospice and palliative care. Patient and husband agreeable to home hospice at this time. -Placed stat hospice/palliative care/care management consult. -Will discharge home pending planning and coordination of care. -Thoracentesis done today 8/18 -Had extensive discussion with family this morning. Overall prognosis is very poor. Patient is no longer eligible for treatment at this time. Husband was agreeable to hospice yesterday but had hesitations going home hospice due to the inability for the patient to receive as needed paracentesis. Patient overall status continues to significantly decline. At this time it is my opinion she is not eligible for ambulance transfer home for hospice. Patient was changed to no DNAR yesterday. Patient will remain inpatient until she passes. -comfort measures only 8/20 Very weak fatigued, actively dying, Spent some time with the family. All family around the patient. Patient is moaning, actively dying. Continue Ativan, Dilaudid. Robinul. Discussed with the nurse. Actively dying. Date and time of death pronounced on 8/20/2022 at 2105.
1635637 2431030 2022-09-07 MI 83.00 84y.o. female with PMH of A fib ( not on ACs , DM, HTN, CHF, GERD, OA, Hyperthyroidism and others , who presented to the hospital due to altered mental status . Patient unable to provide any history , so most of the history was obtained from available medical records, per EMR , Patient was first noted to have altered mental status around 11 PM on 8/6. Patient's last known well time being around 7 PM on 8/6. The patient's grandson states that he fed the patient at 7 PM, and around 11 PM he found the patient altered. Grandson reported that she was not speaking with him, and was twitching. The patient was noted to have blood sugars in the 40s and 50s with EMS. She was brought here, in ER , head CT showed no acute hemorrhage , CTA showed occlusion of the right middle cerebral artery in the mid M1 segment, amenable to mechanical thrombectomy. Patient was not a candidate for tPA. IR was consulted and evaluated the patient. They recommended cerebral angiogram with thrombectomy and she underwent thrombectomy of the M1 segment of right MCA thrombus and was admitted in the ICU for further care . She also had acute hypoxic resp failure, her COVID swab was positive . She was seen by neurology , ID ,neurosurgery , cardiology and pulmonary and endocrinology here . Her stroke was worsening , neurosurgery evaluated the patient and started on Keppra , she remained unresponsive , resp status got worse, she was given remdesivir and IV steroids here , overall very poor prognosis , no sings of neurological recovery. D/w family, they agreed to comfort care, hospice and palliative care was consulted. She was appropriate for inpatient hospice care And she was expired on 8/16/2022 at 3:30 am
1635717 2431111 2022-09-07 91.00 pt had a positive COVID test on 2/14/22 in a nursing home; only sx were mild sinus drainage; pt in hospice care; passed away in the nursing home
1635729 2431123 2022-09-07 84.00 2/6 - 2/7/22 pt in Hospital with sx of cough, congestion, poor oral intake, SOB, weakness, AMS, nausea, body aches; positive COVID test, acute renal failure; DNR/DNI; family decided to transition pt to hospice; dc'd to home where pt passed away
1635745 2431139 2022-09-07 85.00 pt died in the home with hospice after being brought to ED via EMS for SOB, AMS; when EMS got to the home, pt unresponsive with BS of 27; treated for low BS; found to be positive for COVID; DNR; wife decided to take him home with hospice
1635757 2431151 2022-09-07 89.00 EMS brought pt to ED at local hospital after a fall during the night and upper respiratory gurgling sounds; low O2 saturation; found to be positive for COVID; pneumonia; DNR; family took pt home with hospice from the ED; pt passed away in the home
1635759 2431153 2022-09-07 CA 84.00 VAERS REPORT WRITE-UP FOR MY MOTHER, KILLED BY MODERNA ON 08/15/22 On August 15, 2022, my Mother died from a sudden cardiac event while vacationing. She visits every August for 2-3 weeks. SHE HAD NO HEART ISSUES. NO UNDERLYING BLOOD PRESSURE OR CARDIAC EVENTS IN HER ENTIRE LIFE. She did not have one single underlying major medical condition. No cancer, no autoimmune issues, no asthma, no lung problems. Perfect weight. Active until the day she died both physically and mentally. Walked up to 3 miles a day, read every night before she went to sleep and played bridge weekly her entire adult life. Her mind was sharp as a tack, and she never even had a bout with depression. She lived a stress-free life by enjoying sports, her friends, volunteering at the local community center and participating in her grandchildren?s lives. She was not taking any prescription medications. She traveled often. She had NO PROBLEMS while on vacation. She was active every single day. On Monday, August 15th her sister heard her wake up at 6 am to use the bathroom, and when she went to tell her coffee was ready at 8 am she had passed. In under two hours. For no reason. LIKE SOMEONE TURNED OFF THE LIGHTSWITCH TO HER HEART. The ONE PROBLEM SHE DID HAVE was FOUR SHOTS OF MODERNA MRNA COVID-19 VACCINE. THE ONLY COMMON DENOMINATOR. THE LAST BOOSTER WAS 4/26/21. FOUR SHOTS WITHIN FIFTEEN MONTHS of a toxic pharmaceutical put in a 125 lb. body killed her. Moderna has THREE TIMES the amount of lipid nanoparticles than the other bioweapon Pfizer. She was told to take those shots by her government up and down the line. Using all sorts of scare tactics. From the County Public Health Director to Health and Human Services Secretary. MY MOM DID NOT LIVE IN FEAR. BUT SHE BELIEVED IN FOLLOWING THE RULES. DO AS YOU ARE TOLD BY THE POWERS THAT BE. THAT IS THE WAY SHE WAS RAISED AND NOW THE WAY SHE DIED TOO. HER SHOT HISTORY: 01/27/21: #-029L20A 02/24/21: #011A21A 11/12/21: #032F21A 04/26/22: #056A22A HERE ARE THE LINKS TO THE CORRESPONDING DEATH REPORTS IN VAERS FOR THESE EXACT TOXIC BATCH #?S. YOU NEED TO RECALL THESE TOXIC BATCHES AND NOTIFY THE PUBLIC ACCORDINGLY. #029L20A: #011A21A #032F21A #056A22A MY MOTHER DIED ON 8/15/22. MEDICAL MURDER. CLEAR AS DAY. ?THERE WILL BE JUSTICE. PRESERVE YOUR DOCUMENTS.?
1635771 2431165 2022-09-07 75.00 pt to hospital 1/11/22; positive for COVID; treated with dexamethasone and empiric ABX; O2 supplementation; AHRF; during hospitalization, CXR showed some improvement; pt dc'd to home on 2/2/22 with home O2; pt passed away in the home on 2/5/22
1635828 2431222 2022-09-07 TX 79.00 Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. rec' Pfizer-BioNTech on 1/26/21, 2/20/21, and 11/02/21. Admitted 8/12 2/2 for pelvic mass and bil hydronephrosis c/b AKI on CKD. Found to have a UTI. Tested Covid + on 8/17. Bilateral nephrostomy tubes placed in IR on 8/19, in PACU placed on bipap. Resp status cont'd to decline requiring transfer to ICU for emergent intubation on 8/31 c/b fungemia and distributive sepsis w/shock. Paracentesis removed pus-like fluid. Transitioned to comfort care. Tx'd w/micafungin, meropenem, vancomycin, cefepime, ceftriaxone, metronidazole, zosyn, remdesivir, and decadron. Expired 09/02/2022.
1635830 2431224 2022-09-07 TX 83.00 Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Rec'd Pfizer-BioNTech on 8/12/21, and 8/31/21. Presented to ED from hospice care 8/27/22 w/weakness and increased hand tremors. In ED noted to be in afib with RVR c/b elevated WBC, hypotensive and CXR showed PNA. Admitted to ICU. Initially Covid+ on 8/11/22 and remained + on 8/28/22. Cont'd to decline, w/worsening resp failure. Transitioned to comfort care/hospice care. Expired on 8/31/22. Tx'd w/zosyn and vancomycin.
1635908 2431303 2022-09-07 KY 85.00 tested + 1/26/22 , admitted 3/10/22 and was placed on hydration , antibiotics. Worsening resp status and continued to deteriorate and due to very grim prognosis was placed on comfort measures and passed 3/14/22. DX were post covid condition, acute and chronic resp failure, pneumonia and sepsis
1635239 2429606 2022-09-06 90.00 pt had a positive COVID test on 1/4/22 at Health Care; pt passed away at home on 2/8/22; no medical records
1635192 2429558 2022-09-06 66.00 pt had a positive COVID test on 2/3/22; pt died at home; no medical records
1635169 2429388 2022-09-06 75.00 Narrative: Patient had received a covid vaccine EUA (J&J) on 4/1/2021. On 8/23/2022 patient was admitted to hospital 8/19/2022 for COVID+ symptoms. Pt was determined to be COVID +. Pt died on 8/24/2022 at hospital. No information available if Covid treatment medications were given. Covid vaccine EUA (J&J) failure. --Location of Death--Medical Center Primary Medical Diagnosis: Ileostomy Status(ICD-10-CM Z93.2) COVID Infection
1634079 2427576 2022-09-02 TN 82.00 Meets vital records criteria. COVID listed as COD on death certificate. DIDI COD: ASCVD, DMII, Possible COVID19. The decedent was discovered unresponsive in bed 10/11/21. Pt medical hx: hypertension, diabetes, and a kidney transplant 10 years ago. Pt's daughter had tested positive for COVID the day before and the decedent had been coughing more than usual prior to her death.
1633905 2427363 2022-09-02 This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Die from the vax) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 2021 The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication provided. No treatment information mentioned. Reporter mentioned 2 friends in their 40s who died after the vaccine. Both were healthy, one was forced to take it or would lose their job. Company comment: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced unexpected, medically significant Death, which occurred at an unknown time with regards to vaccination with mRNA-1273. No further information was provided. The cause of death is unknown, and no autopsy result was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced unexpected, medically significant Death, which occurred at an unknown time with regards to vaccination with mRNA-1273. No further information was provided. The cause of death is unknown, and no autopsy result was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reported Cause(s) of Death: Unknown cause of death.
1634028 2427522 2022-09-02 KY 78.00 270202; 79 y.o.; 7/1/1943; Admit Date: 7/25/2022; Discharge Date: 7/26/22; Principal Dx/ Final Dx: Closed 2-part intertrochanteric fracture of proximal end of right femur; Relevant Inpt Dx: Principal Problem: Closed 2-part intertrochanteric fracture of proximal end of right femur; Active Problems: Primary hypertension; COVID-19 virus infection; Stage 4 chronic kidney disease; Mixed hyperlipidemia; Diabetes mellitus; Chronic anemia; HPI: Hospital Course: This 79 year old man was admitted with hip fracture. He was taken to OR and had surgical repair by orthopedics. He became hypoxic and suffered a cardiac arrest. They were not able to resuscitate him. TOD1919 Consults: IP CONSULT TO ORTHOPEDIC; Signed: MD; 8/4/2022; 2:47 PM.
1634051 2427548 2022-09-02 TN 90.00 The patient presented to hospital, l on 06/29/2022 and was found to have Covid-19 PNA. The patient did not improve and was enrolled in hospice care on 07/01/2022. The patient expired on 07/05/2022.
1634059 2427556 2022-09-02 TN 91.00 The patient was brought to Medical Center on 02/18/2022 by her daughter for worsening confusion, generalized weakness, and new urinary incontinence and was refusing to eat/drink, or walk. The patient tested positive for Covid-19 on 01/19/2022. CT abdomen pelvis on 02/18/2022 showed moderate bilateral pleural effusion with overlying atelectasis/consolidation. Due to the patient's multiple comorbidities, palliative care was consulted, and decided that the patient would be discharged home on hospice care. The patient was discharged on 02/25/2022. The patient expired on 03/08/2022.
1634063 2427560 2022-09-02 TN 90.00 The patient presented to the ED with c/o SOB and was diagnosed with Covid-19 6 days prior to admission. The patient was admitted for Covid-19 Was placed on bronchodilators and duo nebs. The patient was treated with dexamethasone and remdesivir. She developed left-sided weakness during hospitalization and hypertension urgency. MRI showed a subacute infarct, several grouped early subacute lacunar infarcts of the right basal ganglia extending to the pericallosal parietal white matter. The patient was transferred on 02/08/2022. The patient expired at facility on 02/13/2022.
1634069 2427566 2022-09-02 TN 61.00 The patient presented to hospital on 02/09/2022 with a worsening SOB. The patient stated progressively worsening chest congestion, cough, SOB, chills, and body aches. In the ED the patient was placed on 15 L nonrebreather. The patient was admitted to the hospital for Covid-19 PNA, acute hypoxic respiratory failure, and pancytopeia/microcyticanemia. The patient was treated with dexamethasone and remdesivir. The patient expired on 02/22/2022.
1634087 2427584 2022-09-02 MI 78.00 Discharge Provider: MD Primary Care Physician at Discharge: MD Admission Date: 8/14/2022 PRESENTING PROBLEM: Hyponatremia [E87.1] Sepsis (HCC) [A41.9] Severe sepsis (HCC) [A41.9, R65.20] AKI (acute kidney injury) (HCC) [N17.9] COVID-19 virus test result unknown [Z20.822] HOSPITAL COURSE: This is a 78 y.o. patient with a past medical history significant for Hepatocellular carcinoma, enrolled in a study; HTN, NICM, DM, persistent Afib, CAD, OSA, who presented to the ED with symptoms of fever, n/v and diarrhea, weakness and shortness of breath. In the ED he was afebrile. His lactic acid was elevated at 5.4, he received 4L IVF bolus in the ED. Blood cultures x 2 and UA obtained, and pt was treated with IV zosyn. Patient was admitted to the oncology service for further workup and treatment of sepsis with fevers. During this admission, patient's initial infectious work up was negative though given persistent fevers, ID was consulted and ultimately ordered a Karius test 8/17/22 which was positive for EBV, CMV so patient was treated for viremia with gancyclovir though 8/27/22. ID also felt patient had HLH, so that work up was initiated. Dr. and ID did conclude patient developed checkpoint inhibitor (treatment) induced HLH given criteria met including but not limited to fevers, pancytopenia, BMBx on 8/24/22 with Hemophagocytosis, IL2 >29,000 and liver bx 8/26/22 consistent with HLH. Patient was started on dex 10mg IV BID and then increased to 20mg IV BID which was suspected to have lead to encephalopathy and nightly dilerium. Patient began to show progressive liver injury. Immunology was consulted and was not convinced patient had HLH but did recommend IVIG BID started 8/26 and Anakinra TID, started 8/27 and cyclosporin started 8/29. Unfortunately, patient continued to have liver failure and progressive decline. Given no improvement in HLH, patient determined he did not want further care; however, he was deemed by then incompetent to make medical decisions and his daughter/DPOA was activated. Patient/family decided to proceed with sign on plans for hospice. In the meantime, while awaiting hospice placement, he was made comfort care overnight last night. He passed aware today with daughters, partner and Hospice at bedside. Patient was seen per nursing request as patient had expired. Upon evaluation, patient was unresponsive with daughters at bedside. Patient's pupils were fixed and nonreactive to light. Patient was without heart or lung sounds upon ascultation. Patient was without pulses x4 extremities. Patient was pronounced as having expired today, 09/01/2022, at 1058. Attending was notified.
1634117 2427617 2022-09-02 59.00 Meets vital records criteria: Cardiovascular disease, recent COVID-19. Pt was discovered in a state of decomposition by law enforcement conducting a welfare check requested by a family member on the afternoon of 11/13/21. Record shows pt was fully vaccinated
1634122 2427623 2022-09-02 TN 61.00 The patient tested positive for Covid-19 on 01/25/2022. The patient expired on 02/01/2022. No record of hospitalization.
1634168 2427669 2022-09-02 75.00 MODERNA COVID VACCINE #3 GIVEN 9/11/21, LOT #020F21A; pt to ED with generalized body aches; states he ran out of pain medication 2 days prior to coming; found to be positive for COVID; not hypoxic; admitted with Atrial Fibrillation with RVR, treated with medication; pt had acute metabolic encephalopathy secondary to COVID; this resolved and pt was recovering well from COVID; pt experienced asystolic cardiac arrest and passed away in the hospital
1634182 2427688 2022-09-02 62.00 pt passed away at home; post-mortem COVID test was positive
1634209 2427901 2022-09-02 51.00 pt passed away at home; she had a positive COVID test on 1/27/22 from Lab.
1634106 2427605 2022-09-02 MI 77.00 Discharge Provider: MD Primary Care Physician at Discharge: PA-C Admission Date: 8/28/2022 PRESENTING PROBLEM: Acute on chronic respiratory failure with hypercapnia (HCC) [J96.22] Acute on chronic respiratory failure with hypoxia and hypercapnia (HCC) [J96.21, J96.22] HOSPITAL COURSE: Patient is a 77-year-old male with a history of significant comorbid conditions including end-stage chronic obstructive pulmonary disease, systolic congestive heart failure, chronic kidney disease as well as chronic respiratory failure with hypoxia and hypercapnia. Patient was admitted to the hospital on August 28, 2022 for acute on chronic respiratory failure with hypoxia and hypercarbia in the setting of COVID-19 infection complicated by chronic obstructive pulmonary disease and congestive heart failure. Patient was also noted to have acute kidney injury superimposed on chronic kidney disease. The patient was admitted to the intensive care unit for treatment of respiratory failure with BiPAP. Patient's hospital course was complicated by agitation, delirium and cardiac arrhythmia. The patient struggled with the use of BiPAP which seemed to make him more agitated. With the patient's condition failed to improve, patient's family elected to transition patient into comfort and hospice care. This decision was made August 31, 2022. Patient was placed into comfort care order set with family at bedside. Patient expired peacefully today September 1, 2022 at 11:09 p.m.. Family was at bedside and present. Message sent primary care provider for notification.
1633616 2426534 2022-09-01 64.00 1/18/22 pt had a positive COVID test; 2/8 - 2/17/22 pt in hospital for COVID; dc'd to home on O2; 2/21/22 pt to ED with worsening SOB; transferred to another hospital; developed worsening respiratory failure; Vapotherm dependent; pneumothorax; CT placed; CT became dislodged and pt's respiratory status worsened; CT reinserted and pt transferred to another hospital; arrived on Vapotherm; eventually required intubation; pt okay with short time frame for intubation; does not want CPR or tracheostomy; placed on steroids; condition worsened; pt transitioned to comfort measures; was extubated and passed away in the hospital
1633607 2426525 2022-09-01 KY 83.00 He had been weedeating a few days before and fell and broke humerus a few days before coming to ER for weakness and another fall. He had appt with ortho apparently. He lost balance and slid into the floor and was brought in due to this fall and weakness and had elevated cpk due to fall and laying in the floor. He incidentally tested + for covid in ER. Admitted 7-17-22. He developed resp distress and had Upper GI bleed felt to be Mallory Weiss tear and expired 7-26-22 and it was felt that he had complications from the covid. Tx rem D and decadron
1633311 2426200 2022-09-01 This spontaneous report received from a consumer via social media (J&J Corporate) via a company representative concerned a female of unspecified age and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death after vaccination. It was unknown if autopsy was performed or not. Reporter stated "So frustrated with the loss of my sister after taking J&J". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). Sender's Comments: V0: 20220853278-covid-19 vaccine ad26.cov2.s-Loss of sister. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH.
1633546 2426464 2022-09-01 TN 75.00 COVID-related death, breakthrough case
1633550 2426468 2022-09-01 66.00 9/24/21 pt brought to ED via EMS after being found unresponsive by pt's husband; pt in cardiac arrest; CPR/ACLS performed; ROSC 2 x while en route to hospital; experienced cardiac arrest again in ED; CPR/ACLS performed for greater than 1 hour; still had asystole/PEA rhythm; 9/17/21 pt had a positive COVID test; pt then had a previous admission to the hospital with COVID pneumonia, UTI, and acute on chronic renal failure; was dc'd to home 4 days later
1633558 2426476 2022-09-01 93.00 10/25/21 pt had a positive COVID test from nursing home where he stays, 10/28/21 pt to ED via EMS for AMS and O2 saturation 46% on RA; placed on NRB; DNR; pt had a second positive COVID test in ED; COVID pneumonia; Dexamethasone, Remdesivir; pt eventually succumbed to COVID PNA, became obtunded and hypotensive; he passed away in the hospital
1633572 2426490 2022-09-01 75.00 PFIZER COVID VACCINE #3 GIVEN 12/9/21, LOT #FJ8751; 4/29/22 pt had a positive COVID test; 5/15/22 pt brought to ED via EMS with AMS; coughing; admitted to Hospital with a positive COVID test in ED; oncologist consulted; suffered acute GI bleed, likely aspiration into lungs; O2 sats immediately dropped to 74%; placed on NRB; pt non-responsive with congested breathing; wife decided to transition pt to GIP hospice services for comfort measures; pt passed away the following day
1633577 2426495 2022-09-01 82.00 PFIZER COVID VACCINE #3 GIVEN 10/26/2021, LOT #FF2590; pt had a positive COVID test on 1/19/22; 1/23/22 pt brought to ED with SOB, slurred speech, AMS; test revealed no evidence of CVA; positive for COVID; Pneumonia due to COVID; pt's condition worsened throughout hospital stay; DNR; pt passed away in the hospital
1633579 2426497 2022-09-01 85.00 2/18/22 pt brought to ED with cough, SOB, increasing edema bilateral LE; positive for Flu AB and COVID; admitted; started on Lovenox and O2 supplementation; CXR showed large pleural effusion and signs of CHF; Albuterol Inhaler, Lasix, ABX; pt passed away in the hospital
1633594 2426512 2022-09-01 88.00 pt brought to ED via Ambulance from home with c/o AMS x 3 days; lethargy, no BM x 1 wk, thinks may have UTI; admitted with metabolic encephalopathy, sepsis, UTI; found to be positive for COVID; COVID protocols initiated (specific protocol not listed in medical records); DNR; ABX; pt's condition deteriorated and she passed away in the hospital
1633670 2426590 2022-09-01 82.00 pt admitted to hospital with SOB; pneumonia; positive for COVID; septic shock and sepsis; AHRF; transferred to ICU; pt's condition worsened requiring intubation; ABX given; condition continued to deteriorate; transitioned to in-patient hospice care where she passed away
1633608 2426526 2022-09-01 KY 78.00 hospitalized for COVID 19 on 7-11-2022
1633639 2426559 2022-09-01 KY 80.00 to ER with syncope and found in the floor, generalized weakness, h/o neck mass she had declined intervention for in the past. found to be + covid . Admitted 7-22-22 dehydration, weakness, hypotension. Developed afib RVR, hematemesis( not a surgical candidate due to comorbidities), acute kidney injury, Covid pneumonia. Treated with rocephin, doxy, remdesivir and also decadron. Had reduced cardiac EF. Patient was DNR status and expired 8-3-22
1633680 2426600 2022-09-01 78.00 2/3/22 pt had a positive COVID test; was admitted to hospital with COVID pneumonia; took 2 days of Remdesivir, then stopped due to spike in LFT; given dexamethasone; dc'd to home on 2/11/22 with O2 via NC; 2/17/22 pt to ED for worsening SOB and AMS; positive for COVID still; O2 saturation 50%; placed on BiPAP; sent to PCU; worsening condition; worsening renal function; family transitioned pt to comfort care; he passed away in the hospital
1633690 2426610 2022-09-01 65.00 MODERNA COVID VACCINE #3 GIVEN 8/23/21, LOT #003B21A; 2/4 - 2/15/22 pt in hospital and treated for COVID pneumonia; dc'd home with 4L O2 via NC; 2/19/22 pt to ED; still positive for COVID; requiring 7L O2 via NC with O2 saturation 80%; eventually placed on Vapotherm; CXR showed multifocal pneumonia; ABX, Albuterol, Vitamins C & D, zinc, steroids; transferred to ICU; eventually requiring intubation; multiorganism pneumonia; ABX and antifungals given; developed shock, treated with vasopressors; renal function worsened requiring CRRT; condition worsened more; pt lost pulse; code called; CPR, shocks, medications with improvement; pt passed away in the hospital
1633701 2426622 2022-09-01 NJ 49.00 Mother reports he got his vaccine, he reported that he didn't do that good. He complained of tiredness. He just didn't feel right, and that something wasn't right with him. He felt like his stamina was down, he was very athletic and felt that he was not doing his normal routine. He went to work as usual, that morning he told his mother that "they want to kill us all". He went to work, thought that he was going to be OK. He came home for lunch, he ate lunch and went to work and then he came back within 5 minutes and said that he did not feel good. He collapsed on the floor and she called 9-1-1, they resuscitated him and taken to the hospital and he died. He did not have any history of heart disease prior to the vaccine. He had routine blood work and had no issues other than some high blood pressure. In January of 2021 he did have COVID which did not require hospitalization and recovered at home without any issues. They had cough, exhaustion and fatigue. He recovered fully and was back to his baseline and back to work without any problems prior to the vaccine. He saw the doctor for his COVID who told him he was OK to go back to work. He was a very active, athletic and ran in all the marathons and eat healthy foods.
1633713 2426634 2022-09-01 88.00 pt sent from hospital ED for pneumonia due to COVID; Initially in ED pt c/o headache, myalgias, dizziness, diarrhea, cough with increasing SOB; 84% O2 saturation on RA; placed on NRB with O2 saturation at 92%; pt positive for COVID; UTI; given Decadron and ABX; eventually required Vapotherm and NRB due to worsening respiratory status; pt's condition deteriorated and she was transitioned to comfort measures; she passed away in the hospital
1633725 2426646 2022-09-01 68.00 pt brought to ED via EMS with lethargy, chills, and poor oral intake by several days; (recently admitted to hospital with seizures; dc'd to home); prior to arrival to ED pt had a seizure (witnessed); CT brain/head did not show evidence of acute hemorrhage, mass or mid-line shift; found to be positive for COVID; dexamethasone; severe AKI and medications adjusted; experienced bradycardia to PEA arrest; CPR and medications given per ACLS protocol; pt unable to be revived
1633746 2426667 2022-09-01 59.00 pt to ED with c/o nausea and vomiting; found to be positive for COVID; CT suspicious for necrotizing PNA; O2 supplementation; PEG tube placed; underwent palliative radiation; pt worsened; severe respiratory distress; Atrial Fibrillation with RVR; DNR/DNI; transitioned to comfort care and passed away in the hospital
1632832 2425065 2022-08-31 TN 68.00 The patient had a PMH of severe COPD s/p R lung transplant (2016), CKD 4, BK virus nephropathy, Stage III melanoma with Lymph node metastasis presented to a local ED following a ground-level fall on 2/17/2022 with left-sided weakness. MRI did not show any clear evidence of an acute infarct. Found to have C3-4 disc herniation with pre-existing spinal canal stenosis, s/p ACDF with neurosurgery on 2/25/22. On 3/2/2022 the patient was found to have Covid-19 and treated with Dexamethasone and Remdesivir. The patient then tested positive for C. diff 3/7/2022 and received PO vanc. On 3/11/22 the patient became acutely hypoxic and was transferred to MICU and initiation on therapeutic anticoagulation for suspicion of PE. The patient required intubation. On 3/13 CRRT was initiated and had 2 L taken off with improvement in his oxygenation. The patient continued to decline and was made DNR/DNI and expired on 3/17/2022.
1632839 2425072 2022-08-31 TN 75.00 The patient was admitted to Health and Rehab from home with a history of generalized weakness, inability to walk and inability of his family to care for him. The patient had a history of carcinoma of the prostate and was treated with antiandrogen drugs. The patient was admitted for palliative care. The patient tested positive for Covid 19 on 2/14/22. The patient expired on 3/2/2022.
1632908 2425146 2022-08-31 TN 82.00 The patient presented to Healthcare Center on 02/02/2022 post hospitalization from 01/23/22-02/2/22 where the patient was admitted for hypoxia d/t Covid-19 PNA. He required intensive care unit for levophed, vapotherm and bipap and was treated with dexamethasone and tozolizumab. CHF was treated with lasix. The patient and wife stated the the patient would be a DNR. The patient expired at the facility on 02/7/22.
1632826 2425059 2022-08-31 TN 63.00 The patient was admitted to a HCF on 02/24/2022 with end-stage alcoholic cirrhosis, hepatic encephalopathy, AKI on CKD, severe thrombocytopenia, acute anemia, and acute on chronic subdural hematoma. The patient tested positive for COVID 19 on 2/24/22. During the hospital course the patient intermittently required vasopressor support, and blood products, and was found not to be a candidate for dialysis. The patient decided to proceed with DNR code status. On 3/20/2022 he quickly decompensated, had AMS, and a CT head revealed small areas of subarachnoid hemorrhage. The family wished to proceed with comfort measures. The patient expired on 3/20/2022.
1632817 2425050 2022-08-31 TN 58.00 The patient was on hospice with Hospice care for Cirrhosis of the Liver. The patient tested positive for Covid/-19 on 08/12/2021 at Healthcare and was diagnosed with Covid PNA and hypoxia. The patient was transferred to Hospice care. The patient expired on 8/18/2021.
1632904 2425142 2022-08-31 TN 64.00 Presented on 8/13 with worsening severe abdominal pain, peritoneal signs, CT concerning for perforated bowel. Taken for exploratory lap which showed walled off abscess with perforated sigmoid colon and necrotic small bowel. Performed partial small bowel resection and end colostomy. The next day the patient had an aspiration event leading to desaturations to the mid 70s. Proceeded with increasing oxygen requirements requiring intubation. Became increasingly hypotensive and started on levophed, vasopressin and epinephrine. COVID test returned +. Pulmonary consulted and started patient on dexamethsone, remdesivir and flolan. Improved some with respiratory status but unable to be extubated with inability to follow commands. On 8/24 patient remained stable and scheduled for trach and PEG, however became increasingly tachycardic and hypotensive requiring increased pressors. CT of chest negative for PE but showed moderate pneumoperitoneum with pneumatosis and gas suggesting bowel perforation and ischemia/necrosis. Due to instability preventing further surgery family requested comfort care.
1632889 2425125 2022-08-31 TN 81.00 Arrived from a residential facility on 8/10 with anemia and worsening repiratory failure. Previous hospitalization 7/27-8/5 for covid pneumonia. Started IV antibiotics and consulted nephrology for dialysis. Patient was too hypotensive for first dialysis attempt. Midodrine was intitiated with fluid resuscitation. Next day tolerated dialysis but could not pull any fluid. Started cardizem drip due to worsening RVR. Unable to tolerate dialysis consistently and became encephalopathic and nonverbal after first full session. POA involved in care being given and requested comfort care.
1632922 2425160 2022-08-31 TN 88.00 The patient with dementia, history of DVT status post IVC filter on Coumadin, hypertension fell at assisted living found to have acute left intertrochanteric hip fracture. Family requested no surgery with comfort measures only. The patient became resident. The patient expired at facility on 03/15/2022. The patient did test positive for Covid-19 on 01/13/2022. The patient was asymptomatic.
1632967 2425206 2022-08-31 60.00 DO Last attending ? Treatment team Cardiopulmonary arrest Clinical impression Cardiac Arrest Chief complaint ED Provider Notes DO (Physician) ? Emergency Medicine (F) - 60 y.o. Note Creation:8/1/2022 Encounter Date:7/27/2022 History Chief Complaint Patient presents with ? Cardiac Arrest The patient is a 60 y.o. female with hx of cervical CA, chronic anemia, COPD, GERD, and MRSA colonization who presents to the ED for evaluation of cardiac arrest that began around 8am. Pt was eating breakfast at 0745. She is currently staying at facility s/p surgery for right ankle open trimalleolar fracture on 7/11. She tested positive for covid-19 at that time. Staff states that they came back at 0809 and began chest compressions. She was asystole with EMS and they got ROSC for a few seconds, but she returned to asystole. EMS also reports that they had a palpable pulse en route but lost it before arriving to this department. Pt was shocked x1. She was intubated 6'0 22 at the lip per EMS. Her glucose was 145 in this department. Time of Death called 0913. The history is provided by the EMS personnel, medical records and the nursing home. The history is limited by the condition of the patient. Past Medical History: Diagnosis Date ? Cancer cervical ? Chronic anemia 07/11/2022 ? Chronic constipation ? Chronic diarrhea ? Colitis 12/05/2020 ? Colon polyp ? COPD (chronic obstructive pulmonary disease) ? GERD (gastroesophageal reflux disease) 01/13/2011 ? MRSA nasal colonization 07/01/2022 Past Surgical History: Procedure Laterality Date ? ENDOSCOPY, COLON, DIAGNOSTIC ? HX CLOSED REDUCTION N/A 7/11/2022 ANKLE, EXTERNAL FIXATOR performed by MD at MC MAIN OR ? HX COLONOSCOPY N/A 12/9/2020 COLONOSCOPY /C POLYPECTOMY VIA SNARE(HOT) performed by MD ? HX CONE BIOPSY/CONIZATION (LASER ABLATION), CERVIX ? HX EGJ N/A 12/7/2020 EGD /C BIOPSY performed by MD ? HX EGJ N/A 7/14/2022 EGD /C ARGON PLASMA COAGULATION performed by MD ? HX KNEE ARTHROSCOPY ? HX TONSILLECTOMY ? LUMBAR PUNCTURE - FLUID TO LAB N/A 12/18/2020 LUMBAR PUNCTURE - DIAGNOSTIC performed by MD ? PR UPPER GI ENDOSCOPY,EXAM Family History Problem Relation Age of Onset ? Heart Disease Mother ? Cancer Mother lung (smoker) ? Colon Cancer Father ? Cancer Father colon, stomach ? Stomach Cancer Father Social History Tobacco Use ? Smoking status: Current Every Day Smoker Packs/day: 1.00 Years: 30.00 Pack years: 30.00 Types: Cigarettes ? Smokeless tobacco: Never Used Vaping Use ? Vaping Use: Never used Substance Use Topics ? Alcohol use: No ? Drug use: No Patient is a tobacco user, and I have offered a counseling referral. No LMP recorded. Patient is postmenopausal. Allergies Allergen Reactions ? Doxycycline Nausea Only ? Penicillins Rash Has tolerated rocephin in the past and during admission in 7/2022 Current Outpatient Medications on File Prior to Encounter Medication Sig ? sucralfate (CARAFATE) 1 gram tablet Take 1 Tablet by mouth Before meals and at bedtime. ? tiotropium (SPIRIVA) 18 mcg inhalation cap Take 1 Capsule by inhalation Once Daily. ? [EXPIRED] senna (SENOKOT) 8.6 mg tablet Take 1 Tablet by mouth Once Daily for 3 days. ? pantoprazole (PROTONIX) 40 mg DR tablet Take 1 Tablet by mouth Twice a day. ? gabapentin (NEURONTIN) 100 mg capsule Take 1 Capsule by mouth Once Daily. ? HYDROcodone-acetaminophen (NORCO) 5-325 mg per tablet Take 1 Tablet by mouth Every 6 hours. ? lactulose (CHRONULAC) 20 gram/30 mL solution Take 30 mL by mouth Three times a day. ? metoprolol (LOPRESSOR) 25 mg tablet Take 1 Tablet by mouth Twice a day for 30 days. ? ipratropium-albuteroL (DUO-NEB) 0.5 mg-3 mg(2.5 mg base)/3 mL nebulizer solution Take 3 mL by nebulization Every 4 hours. Indications: bronchi muscle spasm resulting from COPD ? budesonide-glycopyr-formoterol (BREZTRI AEROSPHERE) 160-9-4.8 mcg/actuation HFAA Take 160 mcg by inhalation Twice a day. ? roflumilast (DALIRESP) 250 mcg tablet Take 1 Tablet by mouth Once Daily. ? umeclidinium-vilanteroL (ANORO ELLIPTA) 62.5-25 mcg/actuation DsDv Take 1 Puff by inhalation Daily. ? albuterol (VENTOLIN HFA) 90 mcg/Actuation inhaler Take 1 Puff by inhalation Every 4 hours as needed (shortness of breath, wheezing). ? sodium chloride 1 gram tablet Take 1 Tablet by mouth Three times a day with meals for 30 days. ? leg brace (ANKLE BRACE) Misc 1 Device Daily as needed. ? RT OXYGEN PER DELIVERY DEVICE 2 L/min by Nasal Cannula route RT Continuous. Indications: COPD ? cetirizine (ZYRTEC) 10 mg tablet Take 10 mg by mouth Daily. ? esomeprazole (NEXIUM) 40 mg capsule Take 1 Cap by mouth Daily. ? metoclopramide HCl (REGLAN) 10 mg tablet Take 1 Tab by mouth Twice a day. Review of Systems Review of Systems Unable to perform ROS: Acuity of condition Constitutional: Negative for fever. Eyes: Negative for redness. Cardiovascular: Negative for leg swelling. Skin: Negative for pallor and rash. Neurological: Negative for facial asymmetry. Hematological: Negative for adenopathy. Does not bruise/bleed easily. Physical Exam ED Triage Vitals BP BP Manual or Automatic? Patient Position BP Location Heart Rate (Monitor) -- -- -- -- -- Pulse Pulse Source Resp Temp Temp src -- -- -- -- -- SpO2 SPO2 Location O2 Delivery O2 Device O2 Flow Rate (l/min) -- -- -- -- -- FIO2 (%) Pain Intensity 1 Exacerbated By Relieved By Quality -- -- -- -- -- Duration -- Physical Exam Vitals and nursing note reviewed. Constitutional: General: She is in acute distress. Appearance: She is well-developed. She is ill-appearing and toxic-appearing. Comments: ACLS protocol in place, compressions going on arrival. Pupils fixed round 5+ non reactive. Pale appearance. Cool to touch. HENT: Head: Normocephalic and atraumatic. Eyes: Comments: Pupils fixed. Neck: Vascular: No JVD. Trachea: No tracheal deviation. Pulmonary: Effort: No respiratory distress. Breath sounds: No stridor. No wheezing, rhonchi or rales. Abdominal: General: Bowel sounds are normal. There is no distension. Palpations: Abdomen is soft. Tenderness: There is no abdominal tenderness. There is no guarding or rebound. Comments: Soft non distended. No ecchymosis. Musculoskeletal: General: No tenderness. Skin: General: Skin is warm. Capillary Refill: Capillary refill takes less than 2 seconds. Coloration: Skin is pale. Neurological: Mental Status: She is unresponsive. Coordination: Coordination normal. Comments: gcs 3T MDM Treatment: Procedures Medications EPINEPHrine injection (1 mg Intravenous Given 7/27/22 0910) magnesium sulfate injection ( Intravenous Canceled Entry 7/27/22 0911) sodium bicarbonate injection (50 mEq Intravenous Given 7/27/22 0907) atropine injection (1 mg Intravenous Given 7/27/22 0912) Results for orders placed or performed during the hospital encounter of 07/27/22 SARS-CoV-2, QL, PCR (Rapid) Specimen: Throat Result Value Ref Range SARS-CoV-2 RNA Detected (A) Rapid Tox Screen, Urine Result Value Ref Range CANNABINOID NEGATIVE Cutoff: 50 ng/mL PHENCYCLIDINE NEGATIVE Cutoff: 25 ng/mL COCAINE NEGATIVE Cutoff: 300 ng/mL OPIATES POSITIVE (A) Cutoff: 300 ng/mL FENTANYL NEGATIVE Cutoff: 200 ng/mL BUPRENORPHINE NEGATIVE Cutoff: 5 ng/mL AMPHETAMINES NEGATIVE Cutoff: 1000 ng/mL BENZODIAZEPINE NEGATIVE Cutoff: 200 ng/mL METHADONE NEGATIVE Cutoff: 300 ng/mL BARBITURATES NEGATIVE Cutoff: 200 ng/mL OXYCODONE NEGATIVE Cutoff: 300 ng/mL PROPOXYPHENE NEGATIVE Cutoff: 300 ng/mL D-Dimer, QT Result Value Ref Range D-DIMER 2,483 (HH) 151 - 318 ng/mL Troponin I Result Value Ref Range TROPONIN I 0.14 (A) 0.00 - 0.02 ng/mL Fingerstick Glucose Result Value Ref Range GLUCOSE FINGERSTICK 145 (H) 70 - 110 mg/dL RT Blood Gas, Venous Result Value Ref Range PH,VENOUS 7.01 (LL) 7.32 - 7.42 PCO2,VENOUS 77 (HH) 41 - 51 mm[Hg] PO2, VENOUS 18 (LL) 28 - 48 mm[Hg] HCO3 13 mmol/L BASE EXCESS -13 mmol/L O2 SATURATION 11 % DRAW SITE Other O2 DEVICE 1 Ambu FIO2 100.0 % RT Potassium Result Value Ref Range RESP K 5.0 3.5 - 5.0 meq/L RT Sodium Result Value Ref Range RESP NA 137.00 130.00 - 150.00 meq/L RT Ionized Calcium Result Value Ref Range RESP IONIZED CALCIUM 1.23 1.10 - 1.35 meq/L RT Lactic Acid Result Value Ref Range RESP LACTIC ACID 14.9 (HH) 0.5 - 2.2 mmol/L Results XR Portable Chest (Final result) Result time 07/27/22 10:03:41 Final result Narrative: Medical Center Radiology PROCEDURE DATE: 07/27/2022 ORDERING PHYS: EXAM: Portable chest x-ray CLINICAL INDICATION:Cardiac arrest TECHNIQUE:Portable AP view of the chest COMPARISON: 07/18/2022 FINDINGS:The endotracheal tube terminates 5 cm above the carina. There is enlargement cardiomediastinal silhouette. There are patchy bilateral airspace opacities, similar to comparison exam. No pneumothorax or definite pleural effusion. IMPRESSION: No pneumothorax. Similar appearance of patchy bilateral airspace disease. Endotracheal tube appropriately positioned. THIS IS AN ELECTRONICALLY VERIFIED REPORT 7/27/2022 10:00 AM: MD MD DD: 07/27/2022 TD: 07/27/2022 Radiology Page 1 of 1 COPY Plan: RECHECK: Time of Death 0913 MDM Number of Diagnoses or Management Options Cardiopulmonary arrest Diagnosis management comments: Family made aware. And coroner notified. Amount and/or Complexity of Data Reviewed Clinical lab tests: ordered and reviewed Tests in the radiology: ordered and reviewed Tests in the medicine section: ordered and reviewed Discussion of test results with the performing providers: yes Decide to obtain previous medical records or to obtain history from someone other than the patient: yes Obtain history from someone other than the patient: yes Review and summarize past medical records: yes Discuss the patient with other providers: yes Independent visualization of images, tracings, or specimens: yes Risk of Complications, Morbidity, and/or Mortality Presenting problems: moderate Diagnostic procedures: moderate Management options: moderate Patient Progress Patient progress: stable DIFFERENTIAL DIAGNOSIS Differential Diagnosis: The following diagnoses were considered in the evaluation of this patient: cardiac arrest, sepsis, MI, PE, CVA, metabolic derangement, electrolyte disturbance and other acute pathologies. . Progress Note: deceased. family made aware. Coroner made aware. ED Prescriptions None Final diagnoses: Cardiopulmonary arrest ED Disposition ED Disposition Deceased Condition Stable Comment --
1632982 2425221 2022-08-31 FL 61.00 Hospitalization: 6/2/2022 admitted; 8/14/2022 discharged. Presentation to the ED: initially admitted for severe necrotizing fasciitis of her right groin, presenting with complaints of fever chills nausea and vomiting. COVID-19 + date: 07/05/2022. Treatment: treated with IV steroids. Was not given Remdesivir d/t acute renal failure. Discharge to: patient was discharged to hospice on 8/12/2022 and later became deceased (8/14/2022).
1632998 2425237 2022-08-31 MI 76.00 Patient with 3 Moderna COVID vaccines who admitted with COVID PNA who subsequently died. Receiving dialysis but had worsening neurological status including seizures and was unable to tolerate hemodialysis. Family changes status to DNR and patient admitted to hospice status and died on 08/31/22.
1633099 2425340 2022-08-31 49.00 Physician Discharge Summary Patient ID: Age: 50 y.o. Admit Date: 7/14/2022 2:57 AM Discharge Date: 7/17/2022 Unit: 4A109/4A109A Discharge Diagnosis: Principal Problem: Pneumonia due to COVID-19 virus Active Problems: Hypernatremia Elevated troponin Hyperlipidemia AKI (acute kidney injury) Hypothyroidism Chronic respiratory failure with hypoxia Hospital Course: 50yo female presented to ED from home with respiratory distress r/t COVID 19. Has significant past medical history, including L sided paralysis due to previous CVA. She has PEG tube and is on 4L NC PTA. Was also hypotensive and in renal failure w/hypernatremia Continue to decompensate, was intubated and admitted to COVID ICU. Nephrology and Pulm/CCM consulted. Despite full care, she continue to have hemodynamic instability and decompensation. Also developed R UE and LLE loss of pulses and was started on Heparin gtt. Multiple discussions regarding goals of care initiated. Given her overall poor health/debility, family chose to purse comfort/withdrawal of care. This was initiated per protocol and patient expired at 06:42 today. Consults: IP CONSULT TO PULMONOLOGY IP CONSULT TO NEPHROLOGY IP CONSULT TO SOCIAL WORK IP CONSULT TO SEPSIS NURSE NAVIGATOR IP CONSULT TO DIETARY IP CONSULT TO DIETARY IP CONSULT TO SOCIAL WORK IP CONSULT TO WOUND CARE IP CONSULT TO SOCIAL WORK IP CONSULT TO VASCULAR SURGERY Significant Diagnostic Studies: COVID +, Na 156, Cr 2.1 at admission Disposition: Funeral home of family's choice Discharge Condition: deceased
1632659 2424209 2022-08-30 KY 75.00 date of death 05-03-22 His PUI forms note he was asx for covid at time of his + test 07-24-2021
1632343 2423809 2022-08-30 SC DIED; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 23-DEC-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-DEC-2021, 2 days after vaccination, the patient died. On 25-DEC-2021, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220846104.; Sender's Comments: V0:20220848257-covid-19 vaccine ad26.cov2.s-Died. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
1632511 2424057 2022-08-30 82.00 2/7/22 patient had a positive COVID test in the nursing home where she stays, she was having weakness, generalized edema, cough, SOB; DNR; given Lasix IV; patient passed away in the nursing home on 2/10/22.
1632520 2424066 2022-08-30 78.00 PFIZER COVID VACCINE #3 GIVEN 9/28/21, LOT #FF2587; 1/27/22 pt had a hospital admission Hospital in from a facility with AMS, hepatic encephalopathy, thrombocytopenia, ascites; functional decline; 2/10/22 tested positive for COVID while in the hospital; required IV morphine for worsening dyspnea; dc'd to Hospice, where she passed away
1632536 2424084 2022-08-30 85.00 PFIZER COVID VACCINE #3 GIVEN 9/23/21, LOT #FC3182; 3/2/22 pt had a positive COVID test from a health care facility; 3/7/22 pt started requiring O2 supplementation at home, ordered by PCP (name unknown); 3/10/22 pt seen in cardiac clinic, told to return to hospital d/t worsening hypoxia; started on steroids and dc'd to home on Decadron 3/15/22; 3/17/22 pt to hospital again with O2 desaturation during the night; requiring 35L @70%; admitted ICU with AHRF; DNR/DNI; transitioned to BiPAP; O2 saturation continued to fall; pt made comfort care and passed away in the hospital
1632576 2424124 2022-08-30 KY 67.00 Patient deceased 02-02-2022. Covid pneumonia, respiratory failure, and cardiac asystole.
1632602 2424152 2022-08-30 KY 72.00 Deceased on 2/28/22 Per notes in she was admitted thru ER where she presented with dyspnea and had AFIB RVR. She had flu B prior to admission. Admitted 1-30-22 . Covid pneumonia. was to be given Rem D decadron, rocephin azithromycin. Converted to NSR .
1632637 2424187 2022-08-30 KY 75.00 Date of death 02/18/2022; hosp notes covid 19; stemi; acute resp failure, intubated in ER , pneumonia; admit 2-4-22
1632650 2424200 2022-08-30 69.00 Pt had a positive COVID test at Medical Center on 1/18/22; to ED on 1/25/22 with generalized weakness, nausea, vomiting, cough in the setting of COVID 19; dc'd to home with Dexamethasone; pt passed away at home on 2/1/22
1632623 2424173 2022-08-30 KY 92.00 Date of death 2/28/22. Admitted 2/7/22 with acute ischemic stroke. Tested negative for Covid 2/7/22 and 2/9/22 and + 2/11/22.
1632669 2424220 2022-08-30 WI 48.00 Per Record: This patient was admitted to hospital on 8/11/2022 with 1 week of worsening of symptoms. Per record: Patient tested positive for COVID-19 on 8/5/2022 and was symptomatic of SOB, fever, chills, and increased anxiety since then. Per record this patient was Hypoxic on arrival with SpO2 78% on RA, improved to 96% on 6L O2 NC. Prior to the onset of symptoms patient had missed multiple dialysis sessions. Per record, this patient was emergently dialyzed upon admission; shortness of breath worsened with hypoxia that was non-responsive to BiPAP. Patient was intubated while in the ICU and also had an NSTEMI. After extubating patient has had periods of waxing and waning leukocytosis, and has also had multiple dialysis sessions. Ferritin 1117, procal 0.61. CXR shows fluid overload, R basilar opacity c/f atelectasis vs PNA. Patient was counseled about mortality benefits with steroids in COVID-related hypoxia, however she consistently declines this therapy. Per record, patient was afebrile, RR 22, 96% on 6L O2. No remdesivir per nephrology as patient is on hemodialysis. Per record, Pt was intubated on 08/12/2022 for acute hypoxic respiratory failure. Pt was noted to have rising troponin and evaluated by cardiology team with echocardiogram and plan was for an outpatient stress test. Patient received hemodialysis sessions as per nephrology recommendations. Pt was extubated on 0814/2022 and transitioned to bipap therapy. Pt was transferred to the floor on 08/20/2022 from the ICU. Code team was called just before 3:00 am. Upon arrival patient was sitting in the chair, unresponsive, with emergency protocol ongoing. Per record, this patient was noted to be in asystole initially and then was in V fib briefly for which patient was shocked and given 300m g IV amiodarone. Blood glucose level was greater than 200 gm/dl. Patient had significant yellowish secretions coming out of mouth and nose during ongoing CPR. Was intubated after placing NG tube during CPR. After approximately 18 minutes of CPR, there was no ROSC. Pt was pronounced dead on 8/25/22.
1632707 2424258 2022-08-30 84.00 PFIZER COVID VACCINE #3 GIVE 1/6/22, LOT #330258D; 12/23/21 pt admitted to hospital with increasing generalized weakness, mild cough, and falls at home throughout the week; 12/25/22 pt c/o epigastric pain; TTR amyloidosis, was to receive treatment once discharged; Echocardiogram revealed left ventricular ejection fraction of 40% with grade II diastolic dysfunction; pt experienced increase in confusion and hallucinations; potassium levels had dropped; uric acid levels were high; medications given; 1/20/22 pt requiring more O2 supplementation; found to be positive for COVID; Infectious Disease consulted; pt had a cardiac arrest the next day and passed away in the hospital
1632721 2424272 2022-08-30 79.00 9/9/21 pt brought to ED and admitted with severe FTT over the past 9 months; noncompliant with doctor's follow ups; refused to see a dr in the past; admitted; found to be positive for COVID; severe dysphagia; 50 pound weight loss in 2 months; pt not requiring O2 supplement; found to have right peritonsillar mass; bx done; squamous cell carcinoma posterior pharyngeal wall and hypopharynx; not a candidate for surgery; PEG tube placed; dc'd from hospital to facility; records show pt passed away at home on 11/21/21
1632728 2424279 2022-08-30 KY 90.00 deceased on 5-6-22, tested + covid 2-22
1632729 2424280 2022-08-30 68.00 1/17/22 pt admitted to Hospital; found to be positive for COVID; pt having SOB; refused dialysis; does want to be treated for dyspnea; on continuous O2 supplementation; poor oral intake; requested hospice care; 1/18/22 admitted to Hospice with ESRD; pt passed away at the facility.
1632752 2424343 2022-08-30 KY 63.00 she had covid 8/2021. Had fall 1/2022
1632760 2424351 2022-08-30 KY 70.00 deceased on 02/20/2022: had covid 12/2021 and was admitted after a fall 2/13/22 with closed fx of nasal bone, sepsis, jaundice, anemia in setting of myeloproliferative disorder. placed on comfort measures and discharged 2-16-22 to hospice
1632787 2424378 2022-08-30 KS 48.00 Eleven months after first dose of COVID 19 vaccine, she also had second dose and booster, patient was diagnosed with pancreatic cancer. Her sister was diagnosed with breast cancer 8 months after she had her first dose of COVID 19 vaccine. Both are BRCA 2 pathogenic mutation positive. Patient died on Aug. 1, 2022.
1632671 2424222 2022-08-30 69.00 2/25/22 patient brought to ED by wife in car with CP, SOB, diaphoresis; became unresponsive in parking lot with cardiac arrest; CPR/ACLS with ROSC; patient in ED experienced another cardiac arrest; CPR/ACLS performed with success; to cath. lab; showed occlusion of proximal RCA with sluggish coronary flow through collaterals; experienced cardiogenic shock; intra-aortic balloon pump placed; found to be positive for COVID (no mention of treatment for COVID in medical records); 2/28/22 MRI of brain showed global ischemia; grim prognosis; patient transitioned to comfort measures; patient extubated and he passed away in the hospital.
1631992 2422747 2022-08-29 66.00 11/30/21 pt brought to ED via EMS; pt in respiratory distress with O2 saturations in 60s% on RA; fever and chills x 1 wk; EMS administered Solu-medrol and DuoNeb; pt admitted to ICU; found to be positive for COVID; COVID pneumonia; given Decadron and Tocalizumab; alternating between BiPAP and Vapotherm; pt's O2 needs increased requiring intubation; developed progress hypotension; given Levophed; concern of pulmonary embolism; developed changes in QRS complex eventually widening and pt with asystole; pt expired in the hospital
1632045 2422804 2022-08-29 TN 72.00 The patient arrived at Hospital via EMS with CPR in progress. The patient was found in asystole upon arrival. The patient was intubated and was given Epi x 5, and bicarb x 1. The patient was recently discharged from the hospital on 3L O2, and COVID positive. The patient expired with a cause of death: cardiopulmonary arrest.
1632010 2422767 2022-08-29 TN 87.00 COVID-related death, breakthrough case
1632009 2422765 2022-08-29 75.00 2/4/22 pt brought to ED with generalized weakness, difficulty with ADLs after a fall on 1/24/22;( was evaluated at Hospital then sent to another hospital on 1/27/22, multiple fractured ribs and lumbar vertebrae; was dc'd to home after refusing to go to rehab); continues to c/o of pain; on pain medications; CXR showed pleural effusion/hemothorax and multiple rib fractures; developed fever while in the hospital; given ABX; 2/9/22 COVID test was positive; DNR/DNI; poor oral intake; condition worsened; comfort measures put in place and was GIP on hospice care where she passed away
1631998 2422754 2022-08-29 100.00 PFIZER COVID VACCINE #3 GIVEN 10/1/21, LOT #30145BA; 2/11/22 pt brought to ED with hemoptysis and SOB; was on hospice for CHF; pt had a positive COVID test on 1/30/22; DNR/DNI; pt in hospital became tachycardic and tachypneic; comfort measures put in place and pt expired in the hospital
1631945 2422699 2022-08-29 59.00 MODERNA COVID VACCINE #3 GIVEN 11/8/21, LOT # 076C21A; pt had a positive COVID test and was hospitalized at a local health care facility on 2/5/22; dc'd to home (date not in medical records); 2/26/22 pt back to ED with increasing SOB, nausea, vomiting, generalized weakness; placed on NRB for hypoxia; hypotensive; DNR/DNI; given Rocephin; Sinus Tachycardia with right bundle branch block; pt became unresponsive prior to a test with agonal respirations; pt made comfortable and she passed away in the hospital
1631970 2422725 2022-08-29 74.00 1/11/22 to ED with generalized weakness, fatigue, abdominal pain x 3 days; AKI; UTI; started on ABX; CT showed lung bases with pneumonia; found to be positive for COVID; hypotensive; O2 supplementation; dexamethasone; worsening condition; ICU; required intubation; went into shock and required renal replacement therapy; condition continued to worsen; family decided to withdraw care and concentrate on comfort measures; palliatively extubated and pt passed away in the hospital
1631960 2422714 2022-08-29 69.00 2/17/22 pt sent to hospital from another facility after CVA; c/o abdominal pain and hypokalemia; pt bedbound; watery stools; dehydrated; ileus; found to be positive for COVID; given Decadron; started on O2 supplementation; developed Bacteremia from Staphylococcus aureus; respiratory status worsened requiring BiPAP; no improvement; pt was DNR; pt passed away in the hospital
1631957 2422711 2022-08-29 94.00 pt to hospital with c/o dyspnea x 2 days; placed on NRB with O2 saturation on NRB 84%; found to be positive for COVID; started on steroids, ABX and fluids; septic shock; required intubation; pneumonia; AHRF; hypotension; AKI; no improvements; pt's condition worsened; family decided on palliative extubation; pt passed away in the hospital
1631953 2422707 2022-08-29 62.00 2/19/22 EMS called to pt's house; pt in severe respiratory distress, found on the floor with gurgling respirations; pt became unresponsive; intubated and bagged; pt never lost pulse; bradycardic; had outpatient CT yesterday with pneumonia dx; started on ABX; found to be positive for COVID; experienced pneumothorax in hospital, chest tube placed; ICU; no improvement; family decided upon palliative extubation; pt passed away in the hospital
1632059 2422818 2022-08-29 TN 65.00 The patient was brought to the local hospital on 02/21/2022 via EMS d/t being found unresponsive. The patient is a residential facility patient who was found to be covid positive and was a DNI/DNR with limited interventions. The patient expired on 02/21/2022.
1632053 2422812 2022-08-29 TN 83.00 The patient presented to Hospital ED on 01/31/2022 with c/o SOB, and tested positive for COVID 19 5 days prior. The patient also c/o nonproductive cough, fever, chills, HA, and myalgia. The patient was admitted to the hospital with PNA d/t SARS-Coronavirus. Chest X-ray showed interval development of patchy bilateral mixed density, predominately interstitial infiltrates. On 2/1/22 code was called to the patient's room. The patient received chest compressions and was noted to be in V. Fib on monitors. The patient received one shock. The patient received 3 rounds of Epi, 2 amps of bicarb, and 2 G of calcium gluconate. The patient's family member requested the patient be made comfort care. Patient expired.
1632083 2422842 2022-08-29 77.00 MODERNA COVID VACCINE GIVEN 12/29/21, LOT #066H21A; patient in and out of hospital and rehab since September 2021; January 2022 another hospitalization with DX of sepsis and UTI; no hospitalization records received in records from nursing home; 2/10/22 patient had a positive COVID test in rehab facility. Patient's condition continued to worsen with loss of appetite, vomiting and weight loss; patient passed away in the Nursing Home.
1632061 2422820 2022-08-29 TN 79.00 The patient arrived at Medical Center on 09/23/2021 for AMS x 1 week, and a temp of 102. In the ED, covid positive, cxray indicated both diffuse interstitial and airspace infiltrates. CT scan of the thorax without contrast confirmed at least moderate possible severe diffuse ground-glass and interstitial infiltrates consistent with COVID. US of RLE showed chronic occluded distal vessels with collateral follow. Patient sent to dialysis, his blood pressure was running low and was lethargic and weak, Oxygen saturations dropped. Patient then had a rapid response, he was unresponsive with an unobtainable blood pressure. He then went into a PEA cardiac arrest. Patient expired on 9/24/2021.
1632093 2422853 2022-08-29 TN 65.00 The patient presented to the Medical Center on 02/17/2022 with SOB. She was diagnosed with Covid-19 1 month prior. Over the past two weeks, the patient has had worsening body aches, fevers, generalized weakness, SOB, cough, HA, and nausea. She was given multiple courses of antibiotics and steroids by her PCP. On arrival at the ED, the patient's oxygen was 89% on RA. CT Regulatory AUthority study showed moderate bilateral PNA, left worse than right. The patient was given IV fluids and antibiotics in the ED. The patient was admitted to the hospital. During her hospitalization, oxygen requirements continued to trend up. The patient was transferred to the ICU on 03/04/2022 for worsening hypoxemia. The patient decided on DNR. The patient remained on vapotherm and nonrebreather. The patient transitioned to comfort care. The patient expired on 03/06/2022.
1632105 2422865 2022-08-29 TN 51.00 The patient presented to Hospital on 02/20/2022 in cardiac arrest. Pre-arrival treatment included CPR, Oxygen, intubation, defibrillated, and epi. ROSC was achieved prior to arrival. The patient's hospital course was complicated by aspiration PNA and Covid. The patient worsened throughout the ICU course. Palliative care was consulted on 02/23/2022. The patient was transitioned to comfort care on 02/26/2022. The patient expired on 02/27/2022.
1632106 2422866 2022-08-29 86.00 1/12/22 pt to ED after a week of cough, fever, chills, decrease in appetite, SOB; SOB worsening when came to ED; O2 supplementation; positive for COVID; CXR showed diffuse bilateral infiltrates, right > left; cardiomegaly; admitted; given Decadron, Remdesivir; AKI on CKD; DNR/DNI; pt's condition worsened; oxygenation worsened; comfort measures instituted; pt passed away in the hospital
1632118 2422878 2022-08-29 TN 67.00 The patient was transferred to the Hospital on 03/05/2022 for a higher level of care from the Medical Center. He had a recent COVID infection, became SOB, and was diagnosed with bilateral PNA and sepsis. CTA of chest was obtained d/t elevated D dimer which was negative for pulmonary embolus or aortic dissection. Had significant interval worsening in the appearance of the lungs with increased infiltrates superimposed on chronic emphysema with areas of nodular consolidation, bronchial wall thickening, and trace bilateral pleural effusions and atelectasis. The patient's hgb was low and received 2 units of PRBC. On the floor, the patient was treated with Rocephin in addition to DuoNeb breathing treatments. The patient had a complicated course requiring oral intubation and mechanical vent when he failed Bipap. He could not be weaned from vent, and underwent chest tube placement for left-side pneumo. The patient was taken off sedation but remained unresponsive. The patient had profound encephalopathy. The patient expired on 04/01/2022.
1632121 2422881 2022-08-29 57.00 12/31/21 pt had a positive COVID test; sx - SOB, fever, weakness, O2 saturation 89-90% on RA; 1/7/22 to ED with increasing SOB; CXR showed atelectasis; CT chest negative for pulmonary embolism, bandlike infiltrate left lower lung lobe, ground-glass densities right upper lung lobe; sent home with inhaler and Tessalon; 1/11/22 increase in weakness and continued cough, fever, headache; back to ED; PCP (name not included in records) had called in prednisone and ABX the week before; COVID pneumonia and respiratory failure; given Dexamethasone and empiric doxycycline; pt's respiratory status continued to worsen; Vapotherm; 1/21/22 emergent code blue called; ACLS/CPR done; asystole; continued with ACLS/CPR without any success; pt passed away in the hospital
1632124 2422884 2022-08-29 TN 91.00 The patient was admitted to the hospital with diarrhea after recently taking antibiotics for otitis media. infectious workup unremarkable. Ultimately amoxicillin was restarted for otitis media. The patient was noted to be oxygen requiring during the hospital stay and felt to be volume overloaded following lV fluid resuscitation and was diuresis not requiring oxygen at the time of discharge. The patient was discharged to a Health care facility. The patient tested positive for COVID-19 on 01/26/2022. The patient expired on 02/23/2022.
1632132 2422892 2022-08-29 TX 37.00 Pfizer-BioNTech COVID-19 Vaccine EUA Rec'd Pfizer-BioNTech COVID Vaccine on 3/3/21 and 3/28/21. Admitted 8/12/22 @ 37wk gestation for tx of sickle cell pain crisis w/IVF and pain relief. ED labs - Tbili 3.2, Alk phos 172, AST 80, Hgb 11.2, Hematocrit 31.1, SARS-CoV-2 detected, CXR revealing Increased interstitial markings bilaterally. 8/13/22 clinical course c/b nonreassuring FHR strip, acute mental status changese and hypoxia. Underwent Cesarean 2/2 IUFD, DIC/abruption noted. Rec'd 4u pRBC, u1 FFP, 1u Plts. Transferred to ICU intubated. POD #1 c/b resp failure & liver shock. Postop course c/b worsening resp status w/sickle cell crisis, acute hypox resp fail. severe Covid PNA, asp PNA, AKI, leukocytosis, transaminitis, reactive hyperglycemia and thrombocytopenia. Pulmonary status cont to decline; VV ecmo started w/improvement in sats. Severe ARDS w/refractory hypoxia present; trach place 8/23/22. 8/25/22 PEA arrest c/b multiorgan failure. On 8/25/22 overall condition determined to be terminal and irreversible. Status changed to DNAR and transitioned to comfort care. Tx'd w/decadron, , zosyn,cefepime, clindamycin, azithroycin, flagyl and remdesivir. Expired 8/26/22.
1632141 2422901 2022-08-29 TX 74.00 Moderna COVID-19 Vaccine EUA Rec'd Moderna COVID Vaccine on 3/12/21 and 4/09/21. Presented to ED 8/14/22 from facility via EMS. Decreasing mental status since contracting covid. EMS reported she was unresponsive in a wheelchair on arrival w/no radial pulse and cold to the touch. EMS reported 141 glucose and HR 38-42. In ED she was hypotensive, bradycardic with HR in 30s Admited for septic shock and AMS 2/2 UTI and Covid. Rec'd atropine x2, warming initiated, ivg, intubated, and central line, iv abx started. Course c/b seizure, possible anoxic brain inj and poor prognosis. Transitioned to comfort care. Exp 8/22. Tx'd w/zosyn, meroperum and vanc.
1632163 2422924 2022-08-29 KY 43.00 I am not sure if anyone ever reported this potential AE and while my brother had numerous comorbidities he was also quite young (44) to die in his sleep and was on no other prescription medications at the time of his death. The coroner's report stated that: atherosclerotic and had hypertensive heart disease, cardiomegaly with left ventricular dilation and obesity--this coupled with his lack of medical care was most likely the cause of his death. I am estimating the time of his J&J Covid vaccination to be around May 2021 although I do have have his records to verify.
1632070 2422829 2022-08-29 TN 83.00 The patient was admitted to Regional Health System on 02/07/2022 for SOB. The patient was diagnosed with Covid-19 and progressively required more oxygen. The patient gradually declined with mental status and respiratory drive. The family decided to transition the patient to comfort care only and admit the patient to general inpatient hospice. The patient expired at the facility on 02/18/2022.
1631585 2422258 2022-08-27 TX Die; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Die". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Patient died in the first day of trials. One died instantly. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200047905 Same reporter, event, drug, different patient;; Reported Cause(s) of Death: die
1631468 2422136 2022-08-27 died two weeks later from ITP; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNE THROMBOCYTOPENIA (death, medically significant), outcome "fatal", described as "died two weeks later from ITP". The patient date of death was unknown. Reported cause of death: "Immune thrombocytopenia". It was not reported if an autopsy was performed. Clinical Course:Female Reporter stated that she would like to be vaccinated with Pfizers Covid 19 vaccines but she was concerned because she has ITP Idiopathic thrombocytopenic purpura that she developed during her third pregnancy in 2002 and continued on until 2015 She states she has been in remission and her platelet counts have been within normal range for the last 5 years. She stated that she had Covid last year in Aug and did well . She stated that she was nervous because a Doctor in withheld took the vaccine and died two weeks later from ITP and he was healthy prior. She stated that she has been staying home and wearing a mask and waiting for more research but she has not seen any new information yet. Her hematologist relayed that getting any vaccine would be a risk for worsening ITP They suggested that she get the first shot and see how it goes and then wait 3 months to get the second shot Also relays that she has autoimmune disorder Hashimotos. She would like to know if there is any information or new data that would help her to know what her risks are when getting the Pfizer Covid 19 vaccine with ITP. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Immune thrombocytopenia
1631582 2422255 2022-08-27 TX die; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "die". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Patient died in the first day of trials. One died instantly. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200047905 Same reporter, event, drug, different patient;; Reported Cause(s) of Death: die
1631583 2422256 2022-08-27 TX Die; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Die". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: it was reported patient died in the first day of trials. One died instantly. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200047905 Same reporter, event, drug, different patient;; Reported Cause(s) of Death: Die
1631584 2422257 2022-08-27 TX Die; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Die". The patient date of death was unknown. Reported cause of death: "Die". It was not reported if an autopsy was performed. Clinical course: it was reported patient died in the first day of trials. One died instantly. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200047905 Same reporter, event, drug, different patient;; Reported Cause(s) of Death: Die
1631726 2422405 2022-08-27 TX Die; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Die". The patient date of death was unknown. Reported cause of death: "Die". It was not reported if an autopsy was performed. Clinical course: it was reported patient died in the first day of trials. One died instantly. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201082234 Same reporter, event, drug, different patient;US-PFIZER INC-202201082235 Same reporter, event, drug, different patient;US-PFIZER INC-202201082233 Same reporter, event, drug, different patient;US-PFIZER INC-202201082236 Same reporter, event, drug, different patient;; Reported Cause(s) of Death: Die
1631746 2422426 2022-08-27 My now deceased Dr from [Place withheld] became my patient after having an ischemic stroke post 2nd shot of Pfizer; My now deceased Dr from [Place withheld] became my patient after having an ischemic stroke post 2nd shot of Pfizer; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: DEATH (death), outcome "fatal", ISCHAEMIC STROKE (medically significant), outcome "unknown" and all described as "My now deceased Dr from [Place withheld] became my patient after having an ischemic stroke post 2nd shot of Pfizer". The date and cause of death for the patient were unknown. Clinical course: It was reported that in the course of duties as a vendor working for Pfizer, a comment was observed which can be constituted as a reportable event relating to a side effect at 11:09 on 23Aug2022: Event: Death following ischemic stroke. It was reported that the deceased had became patient after having an ischemic stroke post 2nd shot of Pfizer. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: My now deceased Dr from [Place withheld] became my patient after having an ischemic stroke post 2nd shot of Pfizer
1631803 2430918 2022-08-27 76.00 Narrative: 76yo male died in hospice care with Medical Diagnosis: Other Frontotemporal Dementia on 7/8/2022. Pt had received a covid J&J vaccine EUA on 4/28/2021. Likely this death is not related to the vaccine given hospice care at end of life and lont time between date of vaccine and date of death.
1631809 2433490 2022-08-27 75.00 Narrative: 74 yo male patient died on 8/3/2022 at home in full hospice care. Pt with feeding tube dislodged, abdominal pain, & cramping also with complications with bradycardia and decreased respirations when hospice care was initiated. Pt had received a covid EUA vaccine (J&J) on 5/13/2021. Death does not appear to be related to this vaccine given pt's age, in hospice care & long length of time between date of death & date patient received the vaccine. Patient did not receive the vaccine at this facility. He got vaccine from community pharmacy.
1630915 2420954 2022-08-26 MI 83.00 Patient with 3 COVID vaccinations who admitted with COVID pneumonia. Symptoms worsened, patient and family declined advancing care to ventilator. Patient subsequently died.
1630908 2420947 2022-08-26 MI 93.00 Pt to ED 8/12 for dyspnea and congestion. Pt sinus tach upon arrival, rhonchi bilaterally with labored respirations, pt is a/ox2. Pt COVID+ 8/12. 8/13 rx to initiate remdesivir, to continue cefepime and azithromycin. 8/14 pt remains confused oriented x2 name and place only, when asked if in pain says no. 8/15 pt A&OX2, tube feeding started. 8/18 Pt in no apparent distress. IV infusing and IV site is intact. Tube feeding infusing without residual. 8/21 pt had spit up all over gown, there was left sided facial drooping noted. Patient was agonal breathing and unresponsive, chest compressions started immediately. The patient was pronounced at 0637.
1630851 2420890 2022-08-26 46.00 Three months after receiving the second dose of the Covid 19 vaccine, he began complaining of chest tightness and also had difficulty catching his breath after participating in strenuous activity. He initially believed he was experiencing Exercise-induced asthma, which he had experienced in the past. He was prescribed an Albuterol Sulfate HFA inhaler. He believed he felt some relief while using the inhaler; however, at some point, it was no longer helping.
1630844 2420883 2022-08-26 TN 73.00 Covid Vaccine x 3. Tested positive for Covid on 7/7/22. Admitted to Medical Center on 7/21/2022 and expired on 8/24/22.
1630837 2420876 2022-08-26 TN 91.00 Covid vaccine x 3. Positive covid on 8/10/2022. Admitted to the Medical Center on 08/18/22. DC'd home on 8/21/22. Readmitted on 8/21/2022 and expired on 8/24/22.
1630833 2420872 2022-08-26 74.00 Patient was admitted to Hospice Care 02/2/2022 for COVID 19. The patient expired on 02/28/2022.
1630808 2420846 2022-08-26 TN 61.00 Covid vaccine x 2. Tested positive for covid on 8/25/2022. Expired at Medical Center on 8/25/2022.
1630647 2420076 2022-08-25 88.00 MODERNA COVID #3 VACCINE GIVEN 11/5/21, LOT #047C21A; pt lives in a residential facility; pt had a positive COVID test on 1/17/22 at the facility; pt's condition worsened; DNR; pt passed away in the residential facility
1630567 2419993 2022-08-25 TN 71.00 COVID-related death, breakthrough case
1630614 2420043 2022-08-25 TN 81.00 COVID-related death, breakthrough case
1630627 2420056 2022-08-25 69.00 PFIZER COVID VACCINE #3 GIVEN 11/3/21, LOT #FD0809; pt had a positive COVID test on 1/22/22; increased confusion; CXR negative; pt's condition continued to decline; pt in local Hospice where he passed away.
1630642 2420071 2022-08-25 90.00 pt to hospital with SOB, malaise, poor oral intake, myalgias x 3 days; positive test for COVID in hospital; Decadron; worsening confusion; AF with RVR, treated with medication; multiorgan failure; DNR; pt passed away in the hospital
1630674 2420103 2022-08-25 65.00 MODERNA COVID #3 VACCINE GIVEN 11/5/21, LOT #058F21A; 2/16/22 EMS brought pt to ED, unresponsive, BG 44 - treated low blood sugar; NRB; hypotensive; positive for COVID; admitted; Remdesivir, ABX, steroids, bronchodilators; condition worsened requiring intubation; condition continued to worsen; status changed to DNR, comfort measures; pt extubated and passed away in the hospital
1630697 2420126 2022-08-25 71.00 MODERNA COVID VACCINE #3 GIVEN 11/11/2021, LOT #939904; 2/22/22 pt had a positive COVID test at Hospital in and was admitted with COVID pneumonia; stayed in hospital x 4 days, then dc'd to home with prednisone Dosepak and doxycycline; since he's been home his sx have worsened; nausea, vomiting, dyspnea, fatigue, dizziness, fever, cough; 3/10/22 admitted to Hospital; CXR shows bilateral pneumonia; CT of abdomen shows cirrhosis, splenomegaly; given ABX; worsening respiratory status requiring ICU and intubation; 3/27/22 extubated; respiratory status worsened; pt on maximum Vapotherm; status changed to DNR and comfort care since he wasn't improving; pt passed away in the hospital
1630706 2420135 2022-08-25 MO 82.00 The patient, my father, told me he had been having various symptoms and felt unwell for months, which he associated with the initial Moderna experimental COVID-19 gene therapy injections in March and April of 2021. After the booster dose of Pfizer's experimental COVID-19 gene therapy injection at a routine physical in December 2021, at which he was said to be in good condition for his age, he began to have digestive problems including incontinent diarrhea. He began to have pain in his "guts," to the point he could not lie on his back and sleep became difficult and later nearly impossible. He lost significant weight. Various tests were done. Doctors began to suspect a pancreatic cyst after an MRI. After a PET scan, they then suspected pancreatic cancer. After a biopsy, they finally diagnosed pancreatic cancer in June 2022. The tumor was believed to be inoperable. Chemo and radiation were not advised because of his age and severely weakened condition after months of poor digestion, severe pain, and little sleep. Hospice care was advised. Once palliative pain relief was finally prescribed he was able to eat and sleep. However, after only a few weeks of improved symptoms, he deteriorated rapidly and died July 14, 2022. While he may have had pancreatic cancer developing for a long time before the experimental injections, I am reporting this as a potential adverse event from said injections because of its rapid progression from January-July 2022. I have read about concerns that the injections impair the immune system in various ways, including negative impact on toll-like receptors and killer T cells. Thus, I am interested in the possibility that his own immune system was keeping the pancreatic tumor in check until such time as the injections damaged his immune system. I feel it is important for his case to be in VAERS in case enough other rapidly progressing cancers are reported to rise to the level of a safety signal that should be investigated, since this is the purpose of VAERS. In addition to the booster dose of Pfizer listed above, he received two doses of Moderna on 03/05/21 (Lot 011A21A) and 04/02/21 (Lot 044A21A). My understanding is that there is little to no data on the safety of mixing the different experimental COVID-19 gene therapy injections. Thus his case may also be of value in investigating outcomes following use of mixed products.
1630303 2419314 2022-08-24 77.00 1/21/22 pt to hospital for left foot wound with plans for I&D in next few days; given ABX; amputated 1st metatarsal of left foot; 2/7/22 pt had audible crackles and wheezes; breathing heavily; CXR showed pulmonary edema and pneumonia; 2/8/22 pt had a positive COVID test; increase in O2 need; placed on Vapotherm; family changed pt status to DNR; poor respiratory status; pt became bradycardic and expired in the hospital
1630117 2419000 2022-08-24 DEATH; This spontaneous report received from a consumer through a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died and cause of death was not reported. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220833399-covid-19 vaccine ad26.cov2.s-Death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
1630124 2419008 2022-08-24 died due to blood clots from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (died due to blood clots from the vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (died due to blood clots from the vaccine) (seriousness criteria death and medically significant). The reported cause of death was died due to blood clots from the vaccine. It is unknown if an autopsy was performed. No concomitant medication information provided. The reporter also reported that there were females who died due to blood clots from the vaccine. No treatment medication information provided. Company comment: This spontaneous case concerns a female patient of unknown age, with no medical history information provided, who experienced the unexpected serious (fatal) AESI of thrombosis. The event occurred on an unknown date after a dose of mRNA-1273. The reported stated there were females who died due to blood clots from the vaccine. Very limited information was provided. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age, with no medical history information provided, who experienced the unexpected serious (fatal) AESI of thrombosis. The event occurred on an unknown date after a dose of mRNA-1273. The reported stated there were females who died due to blood clots from the vaccine. Very limited information was provided. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: died due to blood clots from the vaccine
1630233 2419243 2022-08-24 OK 62.00 Tumorigenesis of Diffuse Large B cell Non-Hodgkin's Lymphoma. Initial diagnosis in September 2021 after suffering from unusual pain in mid-section. Scans showed widespread lymphoma. Underwent rounds of chemo and radiation. Received Covid-19 booster shot on November 9, 2021 at urging of medical doctors in order to continue chemotherapy and "qualify" for other treatments. Getting a booster Covid-19 shot was not negotiable if she wanted to continue being treated. Subsequent scans showed a remarkable increase and spread of the disease from scans just prior to receiving Moderna booster. Deceased on March 13, 2022.
1630250 2419260 2022-08-24 TN 86.00 The patient was brought back to Hospital on 02/26/2022. The patient previously had a 30-day admission at the facility for PNA, acute diastolic heart failure, and was found to have COVID towards the end of her hospitalization. She was brought back to the facility for respiratory failure, hypotension, and lethargy. In the ED the patient was found to be septic and have a new PNA. The family agreed to perform only comfort measures. The patient expired on 02/27/2022.
1630262 2419272 2022-08-24 84.00 pt lives at nursing home; positive COVID test on 1/13/22; given IVFs; over several days pt became more lethargic, non-responsive, with tachypnea, fever; given Vitamin C, Pepcid; was seen by NP; supplemental O2, Depomedrol, Dexamethasone, Azithromax; DNR, comfort measures only; pt found not breathing and no pulse; expired in the nursing home
1630257 2419267 2022-08-24 TN 79.00 The patient presented to Hospital on 02/19/2022 with rectal bleeding. She was recently admitted at another hospital for 10 days after a fall at home and complicated by PNA, severe encephalopathy, NSTEMI, atrial fib. In the ED, the patient tested positive for COVID. Other lab abnormalities in the ED included lactic acidosis. The patient was placed on Bipap. Chest x-ray showed low lung volumes. The patient was hypotensive. The patient was admitted to the ICU. The patient's daughter elected to proceed with comfort care. The patient expired on 02/23/2022.
1630318 2419329 2022-08-24 81.00 1/8/22 pt admitted to Hospital with SOB, CP, O2 saturation 56% on RA; found to be positive for COVID; given Baricitinib, Dexamethasone; A Fib with RVR, treated with medication; respiratory decline; intubated; blood culture positive for MRSA; given ABX; tracheostomy and PICC line placed; 2/15/22 pt admitted to Hospital; 2/17/22 moderate amount of blood in tracheostomy; bronchoscopy performed, no source of bleeding found; respiratory distress; agonal; pulse lost; CPR and ACLS with medications; intubated orally; removed large blood clot from tracheostomy; tracheostomy tube removed; 29 minutes of CPR; family opted to stop CPR and pt expired in the hospital
1630357 2419369 2022-08-24 FL 75.00 Hospitalization: Admitted 8/14/22, discharged 8/22/22 Presentation to the ED: Shortness of breath. elevated white blood cell count. COVID-19 + date: 08/14/22 Treatment: Patient was admitted from the ED to the ICU. He had a productive cough. Patient was treated for lung cancer, COPD, and cardiovascular problems. He was prescribed vancomycin, but was not given COVID prophalyxis. Discharge: deceased on 08/22/2022.
1630379 2419393 2022-08-24 KY 50.00 Patient admitted 01/13/22 and tested + for covid. Expired 02/03/2022 . Had complicated course, developed acute tubular necrosis, required feeding tube. Developed covid pneumonia.
1630382 2419397 2022-08-24 MI 42.00 Discharge Provider: MD Primary Care Physician at Discharge: MD Admission Date: 8/5/2022 PRESENTING PROBLEM: Pleural effusion [J90] Other ascites [R18.8] Pleural effusion, right [J90] Acute respiratory failure with hypoxia (HCC) [J96.01] Hypoxia [R09.02] Shock (HCC) [R57.9] HOSPITAL COURSE: The patient is a 43 y.o. female with a PMH of anxiety, anemia, and rectal cancer. Patient presented to the ED for generalized upper abdominal pain and fulliness. She has metastasis of her rectal cancer and has had multiple rounds of chemothreapy and abdominal perineal resection with end colostomy. She ended up with bacterial peritonitis, septic and cardiogenic shock requiring pressors in the ICU. CT revealed large right pleural effusion, a mild amount of ascites, and no evidence of mechanical bowel obstruction. IR drained 2.2L of yellow-colored ascites drained form her abdomen which has grown GNR, GPR, GPC, and yeast for which infectious disease was concerned was 2/2 to a bowel perforation. She was started on broad spectrum antibiotics. On echo, it showed a pericardial effusion and cardiology was consulted and recommended diuresis and re-evaluation on ech in 48 hours pending further clinical stabilization. She was incidentally covid 19 positive without symptoms and severe chronic protein calorie malnutrition. It was later discovered that she had an active intraperitoneal hemorrhage and peritoneal drain was placed. Prognosis was poor. Hospice care was consulted and eventually, transitioned out of the ICU to IM service where she would await a hospice facility that could take her with covid 19 infection. While awaiting isolation, the patient declined further and passed on 8/22/2022 suddenly. She was discharged deceased and the family was offered condolences.
1630493 2435969 2022-08-24 80.00 Narrative: 79 yo patient died at home on Aug 3,2022@13:05. Circumstances of pt's death not available. Pt had the following medical problems per chart: PROBLEM LAST MOD PROVIDER Contents of stool - finding 03/31/2022 (ICD-10-CM R19.5) Indigestion ICD-10-CM K30) 01/05/2022 Imaging of lung abnormal 01/05/2022 (ICD-10-CM R93.89) Contusion of right ankle 01/05/2022 (ICD-10-CM S90.01XA) Solitary nodule of lung 10/19/2021 (ICD-10-CM R91.1) Systolic heart failure 09/24/2021 (ICD-10-CM 150.22) Finding of oxygen saturation 09/17/2021 (ICD-10-CM Z99.81) Tachycardia (ICD-10-CM R00.0) 09/17/2021 Abnormal breath sounds 09/17/2021 (ICD-10-CM R06.89) Ambulatory ECG abnormal 09/17/2021 (ICD-10-CM-R94.31) Arachnodactyly (ICD-10-CM 09/17/2021 M89/8X0) Cardiac defibrillator in situ 0/28/2021 (ICD-10-CM X95.810) Dr outside provider-placed icd Bilateral localized swelling of lower limbs) ICD-10-CM R60.0) Under care of multiple providers (ICD-10-CM Z75.8) Lower urinary tract symptoms 12/10/2020 (ICD-10-CM N39.8) Disorder of eye (ICD-10-CM 08/20/2020) Pain in bilateral legs 08/20/2020 (ICD-10-CM M79.606) Macrocytic anemia (ICD-10-CM 12/03/2020 D64.89) 1. Lab report 2. Lab report Herpes zoster (ICD-10-CM B02.9) 04/30/2020 Sweating attack (ICD-10-CM 02/27/2020 L74.9) Bilateral inguinal hernia 08/08/2019 (ICD-10-CM K40.20) Long-term current use of antiplatelet drug (07/13/2019 ICD-10-CM M79.605) Nocturia (ICD-10-CM R35.1) 07/12/2019 Atrophy of muscle of left thigh (ICD-10-CM M62.552) Groin mass (ICD-10-CM R22.2) 04/25/2019 Iliotibial band friction syndrome) 12/17/2018 (ICD-10-CM M76.30) Corn of toe (ICD-10-CM L8.) 09/06/2018 Impacted cerumen in right ear (09/06/2018) (ICD-10-CM H61.21) Long-term current use of opiate analgesic drug 09/06/2018 (ICD-10-CM Z79.891) Fine tremor (ICD-10-CM R25.1) 08/22/2018 Right foot drop (ICD-10-CM 06/04/2018 M21.371) Lumbar spondylolisthesis 06/04/2018) ICD-10-CM M43/16) Hyperlipidemia (ICD-10-CM-E78/5) 06/04/2018 Fatigue (ICD-10-CM R53.83) 04/17/2018 Decreased vitamin D (ICD-10-CM 04/17/2018 55.9 Hypercalcemia (ICD-10-CM E83.52) 04/16/2018 Low vitamin d25 on lab report History of myocardial infarction 11/15/2017 (ICD-10-CM I25.2) History of coronary artery bypass grafting (ICD-10-CM Z95.1) Atrial fibrillation (ICD-10-CM 11/15/2017) H/O: anticoagulant therapy 11/15/2017 Cough (ICD-10-CM R05.) 10/14/2017 Rhinitis (ICD-10-CM-J31.0) 10/14/2017 Immunization status (ICD-10-CM 10/04/2017 Z23.) Dyspnea on exertion (ICD-10-CM 10/04/2017 R06/09) Multiple joint pain (ICD-10-CM 10/04/2017 M25.50) Left foot drop (ICD-10-CM 05/13/2017 M21.372) Iliotibial band friction syndrome of right knee 05/13/2017 (ICD-10-CM M76.31) Inguinal pain (ICD-10-CM R10.30) 02/10/2017 Pain in right hip joint 01/05/2017 (ICD-10-CM M25.551) Essential hypertension (ICD-10-CM 02/29/2016 I10.) Chronic long term disease management required 02/29/2016 (ICD-10-CM Z79.899) Hip pain (ICD-10-CM M25.552) 01/28/2016 Thigh pain (ICD-10-CM M79.652) 01/28/2016 Admits alcohol use (ICD-10-CM 12/09/2015 F10.988) Heart sounds abnormal (ICD-9-CM 07/20/2015 785.3) Tendinitis of hip (ICD-9-CM 07/20/2015 727.09) Cardiomyopathy (ICD-10-CM I42.9) 02/29/2016 Echo report with ef = 40-45% Esophageal dysphagia (ICD-10-CM 06/01/2021 R13.19) Alcohol intake above recommended sensible limits 11/20/2014 (ICD-9-CM 305.00) Chronic airway obstruction, Not elsewhere 04/17/2018 Classified (ICD-10-CM J44.9) Cardiomyopathy (ICD-10-CM I42.9) 12/09/2015 Tobacco Use Disorder (ICD-10-CM 12/09/2015 Z72.0) Positive PPD (ICD-9-Cm 795.5), Onset 00/00/1967 05/15/2001 Pt had received a covid vaccine (J&J) EUA on 3/18/2021. Likely this death is not related to the vaccine given the long length of time between date of death & date received vaccine.
1629925 2418353 2022-08-23 TN 61.00 The patient presented to Medical Center on 02/04/2022 with c/o SOB. The patient uses home O2 at 4 Liters. On arrival at ED, oxygen saturation was in the 80s. The patient was placed on a nonrebreather. CT showed multifocal PNA in both lungs, and improved infiltrates of the soft tissue encasing bilateral structures of the pulmonary artery. The patient was admitted to Med Surg floor. The patient then tested positive for Covid-19 and was treated with Covid-19 protocol. The patient's condition declined and he was transferred to the ICU and intubated. The patient developed multiorgan failure and septic shock. The patients condition did not improve with aggressive interventions including pressor support and antibiotic therapy. The family transitioned patient to comfort measures. The patient expired on 02/22/2022.
1629805 2418230 2022-08-23 TN 68.00 Covid vaccine x 2 in 2021. Tested positive for Covid on 8/15/2022. Admitted to the Medical Center on 8/15/2022. Expired on 8/20/2022 while still hospitalized.
1629818 2418243 2022-08-23 SC 79.00 Decedent was given Paxlovid on 08/08/2022 after being diagnosed with COVID19
1629826 2418251 2022-08-23 70.00 pt brought to Hospital 1/24/22 with AMS, progressive weakness, FTT; positive COVID test; O2 saturations WNL on RA; sinus tachycardia and HTN; urinary retention and hematuria; cystoscopy with bx done, no malignancy; UTI, treated with ABX; PEG tube placed due to inability to swallow; DNR/DNI; dc'd to home on hospice 2/11/22 (hospice name not in medical record) where she passed away
1629868 2418293 2022-08-23 KY 91.00 Patient expired 03/09/2022; He was tranferred to facility 03-08-2022 with Covid Pneumonia per notes and resp failure
1629906 2418334 2022-08-23 TN 72.00 Patient was initially admitted to Medical Center on 02/04/2022for ortho surgery for ongoing issues with a left hip wound. On 01/17/2022 she tested positive for COVID and went to Facility for treatment and was transferred to medical center for ongoing concerns of her left hip wound. She had surgery on 2/7 for debridement of the left hip. Postop she required vasopressor support. She became obtunded and required intubation on 2/9/22. On 2/11 she required a CT PE scan for concern of pulmonary embolism, the scan did not show a PE. She also had an active GI bleed. She was seen by ID and was started on Zosyn and Zyvox and evaluated for CKD IV. Her renal function continued to decline and was started on CRRT. She was weaned from sedation and continued to be very minimally responsive. EEG showed no electrical activity indicative of global cerebral dysfunction. On 02/17/2022 the patient was transitioned to comfort care measures, was extubated and expired on 02/17.
1629919 2418347 2022-08-23 TN 72.00 The patient was brought to Hospital on 02/16/2022 for AMS. The patient quickly became hypercarbic, profoundly hypoxic and found to have COVID PNA. The patient was intubated and had a prolonged course of ventilator support and was able to be extubated and was maintained on nasal cannula. The patient's mental status did not improve and the patient had a sudden onset of hypotension, hypoxia and worsened mental status. The family elected to make the patient DNR comfort and focus on comfort measures. The patient expired on 03/15/2022.
1629759 2418172 2022-08-23 Starting the day after his 2nd shot, my husband was in the hospital many times for different things over the next ten months, eventually passing on November 19Nov2021.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization. The following information was reported: DEATH (death, medically significant) with onset 19Nov2021, outcome "fatal", described as "Starting the day after his 2nd shot, my husband was in the hospital many times for different things over the next ten months, eventually passing on November 19Nov2021.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. The patient date of death was 19Nov2021. The reported cause of death was unknown. It was not reported if an autopsy was performed. Additional information: Starting the day after his 2nd shot, the patient was in the hospital many times for different things over the next ten months, eventually passing on 19Nov2021. The patient was in the reporter's health plan. The patient was in relatively good health before the shots. He was tested for Covid every time he was admitted, and the test was always negative. The reporter gave permission to examine all of the patient's medical records. The reporter mentioned that if there are statistics on 'death after shots' the reporter would be interested. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Starting the day after his 2nd shot, my husband, was in the hospital, many times for different things over the next ten months, eventually passing on 19Nov2021
1629928 2418356 2022-08-23 KY 68.00 deceased 03/06/2022; + covid 02/22/2022
1629946 2418374 2022-08-23 79.00 PFIZER COVID VACCINE #3 GIVEN 10/22/21, LOT #FE3590; pt brought to ED via EMS for AMS and worsening SOB; positive for COVID; placed on 4L O2 via NC; admitted with pneumonia due to COVID; given Decadron, remdesivir, vitamins, ABX; sepsis; respiratory failure; admitted to ICU on NRB mask; eventually able to go to 2 L O2 via NC and off of mask; stable enough to be dc'd to nursing home with SN orders and PT orders where she passed away.
1629957 2418386 2022-08-23 55.00 1/18/22 pt had a positive COVID test at Hospital; was brought from Nursing and Rehab; admitted with AMS; full code status; required intubation; hypotensive; started on sepsis bundle IVFs and empiric ABX; required ICU with AHRF; metabolic encephalopathy; 2/8/22 was dc'd back to facility from hospital; 3/1/22 pt found unresponsive; CPR started; EMS called and took over CPR once they got there without success; pt expired in the facility.
1629969 2418398 2022-08-23 86.00 PFIZER COVID VACCINE #3 GIVEN 11/17/21, LOT #FF2590; pt brought to ED via EMS from Center; with "abnormal labs and hypotension"; DNR; admitted; UTI and pneumonia; given ABX; septic shock; BiPAP; positive COVID test on 6/10/22; severe respiratory failure; family transitioned pt to hospice care in the hospital; when BiPAP removed pt passed away
1629977 2418406 2022-08-23 85.00 pt lives in Unknown, Quality Center for Rehab and Healing; 3/3/22 pt had a positive COVID test in the center; O2 via NC; pt found unresponsive on 3/12/22, pt expired
1629943 2418371 2022-08-23 TX 72.00 Pfizer-BioNTech COVID-19 Vaccine. Rec'd Pfizer-BioNTech COVID Vaccines on 2/9/2021 and 3/2/2021. Admitted to Hospital for N/V w/recent COVID/PNA (7/18/22), now w/post COVID PNA, c/b hypoxic resp fail, admitted to ICU w/HF O2. Increased WOB, cont'd to desaturate, less responsive, intubated 8/8. Transferred 2/2 concern for CMV reactivation. P/F ratio <300 tx'd per ARDS recommendations including lung protective ventilation, permissive hypercapnia, proning, paralyzed, conservative strategy of fluid management & Medduri protocol. Started on Baracitinib for COVID-19. BPs cont to fall despite multiple therapies. Transitioned to DNR-COT. Tx'd w/meropenem, vanc, ganciclovir, cresemba, baricitinib and decadron. Exp. 8/18/22
1629465 2417313 2022-08-22 TN 71.00 Patient brought to Regional Medical Center on 11/05/2021 for c/o falls, generalized weakness, and back pain. In the ED the patient had increased work of breathing. The patient was placed on BiPAP. CXR showed left lower lobe that was consistent with PNA. His Covid-19 test was positive. EKG revealed sinus tachycardia with nonspecific changes. The patient was given Decadron. The patient was given vancomycin and cefepime. Patient was admitted to the ICU and required intubation. Patient self-extubated on 11/7, required CPR 2-3 min and re-intubated. Patient again self extubated but was able to be maintained on BiPap and went to 2LNC. Patient improved with course of dexamethasone and baricitinib. He developed worsening mental status and on 11/25 required reintubation. Patient also developed shock again requiring vasopressor support. Palliative care was consulted and the patient was transitioned to comfort measures. The patient expired on 11/30/2021.
1629344 2417191 2022-08-22 TN 91.00 Patient presented to hospital on 06/12/2022 with c/o SOB. Patient was placed on BiPAP via EMS. On arrival to ED patient was intubated for continued hypoxia and distress. CXR showed hyperdensity in left lung. EKG showed atrial flutter with QTc 523. Patient was admitted to the ICU. Patient tested positive for Covid-19. Patient was started on antibiotics and steroids. Patient ultimately went into PEA arrest and full ACLS protocol was initiated. Patient expired on 06/12/2022.
1629348 2417195 2022-08-22 TN 86.00 Patient was a resident of a facility. Patient was admitted for rehabilitation d/t lack of coordination. Patient tested positive for Covid-19 on 02/11/2022 and was placed in isolation. Patient expired at facility on 02/24/2022.
1629377 2417224 2022-08-22 TN 65.00 Patient presented to the hospital in respiratory arrest. Patient's household had tested positive for Covid-19. Patient had a hx of Lung Ca. In ED CXR showed left lung interstitial infiltrate's. Patient was placed on mechanical ventilation. Patient's COVID test was positive. D dimer was more than 20, CRP of 75.90. Patient was admitted to ICU. Nephrology was consulted for severe acute kidney injury, cardiology followed for elevated troponins. Patient was on steroids, antibiotic therapy for PNA, patient deteriorated requiring low dose levophed. He continued to deteriorate and had 3 episodes of cardiopulmonary arrest. Patients family wanted to withdraw care. He expired on 01/18/2022.
1629453 2417301 2022-08-22 TN 67.00 Patient was a resident of a facility. Patient had hx of thoracic spinal mass and not being able to walk. Patient tested positive for Covid-19 at the facility on 02/08/2022. CXR obtained at the facility came back clear. On 02/17/2022 patient c/o SOB with exertion and positional changes. Patient expired at facility on 02/22/2022.
1629512 2417361 2022-08-22 TN 58.00 Patient was admitted to a facility on 01/18/2022 for acute hypoxemic respiratory failure 2/2 to Covid-19, acute toxic metabolic encephalopathy, acute kidney injury, dehydration and polypharmacy, severe sepsis secondary to COVID 19, transaminitis and hyperbilirubinemia. While in the hospital the patient received Decadron, and respiratory status continued to worsen to need to be placed on Bipap, and could not be weaned off. The patient was made comfort care and passed on 01/22/2022.
1629477 2417326 2022-08-22 TN 72.00 Patient with h/o CAD, vertebrobasilar insufficiency, recent hospitalization for COVID PNA admitted to hospital on 02/20/2022 with inferior STEMI. The patient was at rehab and acutely lost consciousness, was intubated on arrival to ED and found to have inferior STEMI. The patient was taken to VUMC cath lab and had POBA to totally occluded RCA, also severe disease in LAD. Post procedure the patient continued to be hypotensive requiring pressors and hypoxemic. On 02/28 patient was noted to be more hypoxemic. He was placed on OptiFlow. On 03/01 the patient went into PEA arrest. CPR was initiated immediately, and underwent multiple rounds of CPR during ROSC was obtained multiple times, however, his rhythm continued to degrade into PEA arrest. Patient expired on 03/01/2022
1629620 2433333 2022-08-22 76.00 Narrative: 76yo male patient died on 7/6/2022 of unknown cause. Pt was last known to have transfered to community nursing facility on 6/14/2022 per medical chart note on 6/14/22 to medical facility. Pt with the following problem list: PROBLEM LAST PROVIDER Seen by palliative care medicine service (03/10/2022) (ICD-10-CM Z51.5) Critical illness myopathy 02/25/2022 (ICD-10-CM G72.81) Hyperlipidemia (ICD-10-CM E78.5) 12/15/2016 Cardiomyopathy (ICD-10-CM I42.9) 12/07/2016 Chronic atrial fibrillation 08/10/2016 (ICD-10-CM I48.1) Diabetic neuropathy (ICD-10-CM 06/02/2016 E11.40) Type 2 diabetes mellitus 11/30/2015 (ICD-10-CM E11.65) Male hypogonadism (ICD-10-CM 11/30/2015 E29.1) Chronic post-traumatic stress disorder (11/03/2015) (ICD-10-CM F43.12) Degeneration of lumbar intervertebral disc (11/02/2015) (ICD-10-CM M51.36) Iron deficiency anemia (ICD-10-CM 03/28/2018 D50.9) Congestive heart failure 12/19/2015 (ICD-10-CM I50.42) Spinal stenosis of lumbar region 06/13/2019 (ICD-10-CM M48.062) Osteoarthrosis, unspecified whether generalized 11/27/2017 or localized, involving lower leg (ICD-10-CM M17.9) Major Depressive Disorder, Recurrent Episode, 05/03/2016 Moderate Degree (ICD-10-CM F33.1) Coronary Atherosclerosis (unspecified type 01/14/2016 vessel, native or graft) (ICD-10-CM I44.0) (ICD-10-CM E66.9); Obesity 11/30/2015 (ICD-10-CM I25.10); Coronary artery disease 12/19/2015 (ICD-10-CM N18.3); Chronic kidney disease 12/15/2016 (ICD-9-CM V45.81); Postsurgical Aortocoronary 10/19/2011 Bypass Status (ICD-9-CM V45.81) (ICD-10-CM G47.30); Sleep apnea 12/15/2016) Essential Hypertension (ICD-10-CM 11/30/2015 I10) Gout (ICD-10-CM M10.9), Onset 02/15/2019 00/00/1992 Diverticulosis, colon (ICD-9-CM 562.10), Onset 02/16/1996 00/00/1992 Acute myocardial infarction, of other inferior 02/16/1996 wall, initial episode of care (ICD-9-CM 410.41), Onset 00/00/1992 Pt had received a covid vaccine on 5/26/2021 (Covid Vaccine EUA J&J). Death appears unrelated to patient's death given pt's age, medical problem list & long length of time between death & date covid vaccine was given.
1629508 2417357 2022-08-22 TN 64.00 Patient presented to the hospital on 12/29/2021 with weakness, fatigue, and cough. Chest Xray was significant for cardiomegaly with interval enlargement. CT of abdomen, pelvis and thorax with contrast significant for pulmonary emboli involving the left upper lobe and right lower lobe along with cardiomegaly consistent with right heart dysfunction, colonic diverticulosis and fecal impaction. Rapid Covid-19 was positive. Patient was admitted to hospital. Patient had significant change in her mental status and had breakthrough seizures. CT showed new bilateral cerebral infarcts. Patient continued to deteriorate and required intubation, and required Levophed. The patient expired on 01/09/2022.
1629498 2417347 2022-08-22 TN 76.00 Patient brought to the local Medical Center via EMS for a code stroke. Patient had a hx of recently being diagnosed with Covid-19 with poor oral intake and fatigue. EMS intubated patient. CT scan did not show acute stroke, no stroke per neurology. Patient's EKG was performed had ST elevations in leads V23 and V4 with some reciprocal changes in the inferior leads. Patients troponin came back significantly elevated. Patient was hypotensive. Central line was placed. Patient was admitted to ICU for NSTEMI, hypotension, AMS, acute renal failure, acute resp failure. Patient showed profound hypotension, concern for having blood loss, 4 units PRBC provided, another 1 L bolus IV fluid given, and patient was maxed on Levophed, and then started vasopressin and epinephrine. Arterial line placed which demonstrated a value of 34/20. Patient expired on 09/17/2021.
1629277 2416940 2022-08-21 TX 60.00 Patient is deceased. Patient's wife called pharmacy on 8/21/2022 to report adverse events from covid vaccine. She states that patient got congestion, cough, trouble breathing the night he got the vaccine on 8/27/2021. A couple of days later patient saw physician and was prescribed medication. Over the next week patient continued to be sick and disoriented and was eventually taken to a hospital via ambulance on 9/7/2021. Patient then passed away on 9/25/2021.
1629133 2416750 2022-08-20 We just had an otherwise healthy family friend drop dead "suddenly" a few weeks ago; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. A 48-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "We just had an otherwise healthy family friend drop dead "suddenly" a few weeks ago". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: drop dead "suddenly"
1628840 2415917 2022-08-19 TN 78.00 Patient was admitted to Hospital on 01/18/2022 with acute on chronic abdominal pain and high output ileostomy causing dehydration with acute kidney injury. CT showed mild enterocolitis. Acute kidney injury initially resolved with IV fluids. Nephrology was consulted d/t worsening. She incidentally had Covid-19. Patient continued to decline in spite of supportive treatment. Patient and family agreed for hospice and transitioned to comfort measures only. The patient expired on 01/31/2022.
1628520 2415570 2022-08-19 contract the virus / COVID-19; passed away; This serious spontaneous report was reported to Amgen on 10/AUG/2022 by a consumer from a commercial program and involves a female patient (sister) who passed away [PT: death], contracted the virus/COVID-19 [PT: COVID-19] while receiving Enbrel. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. The patient's co-suspect medication included COVID-19 Vaccine. The patient began Enbrel on an unknown date. On an unknown date, the patient contracted the Coronavirus disease 2019 (COVID-19) after receiving the vaccine while concurrently taking Enbrel. Shortly after on an unknown date in OCT/2021, the patient had passed away. The cause of death was unknown. It was unknown if an autopsy was done. No treatment information was received. The outcome of the event COVID-19 was reported as unknown. Action taken with Enbrel was reported as unknown for the event COVID-19. The causal relationship between the events death, COVID-19 and Enbrel was not provided by the consumer. Follow up has been requested. Amgen comment: This safety report does not necessarily reflect a conclusion by Amgen that etanercept, caused or contributed to the adverse event reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product. ENBREL is under agreement with Amgen.; Reported Cause(s) of Death: Unknown cause of death
1628552 2415602 2022-08-19 NY DEATH; BLEEDING THROUGH NOSE; This spontaneous report received from a consumer concerned multiple patients of unspecified age, gender, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patients experienced bleeding through nose and then later died. On an unspecified date, the patients died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patients died of death on an unspecified date, and the outcome of bleeding through nose was not reported. This report was serious (Death).; Sender's Comments: V0- 20220830199-covid-19 vaccine ad26.cov2.s -Death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
1628558 2415608 2022-08-19 GA 68.00 Patient passed away 2 hours post vaccine administration; This spontaneous case was reported by a nurse and describes the occurrence of DEATH (Patient passed away 2 hours post vaccine administration) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011B22A) for COVID-19 vaccination. The patient's past medical history included COVID-19 (Patient was hospitalized.) in February 2022. Concurrent medical conditions included Drug allergy (Allergic to Niacin), Drug allergy (Allergic to Imitrex), Diabetes, Chronic heart failure, Hypothyroidism and Colon cancer. Concomitant products included METOPROLOL, INSULIN ASPART (NOVOLOG), MEMANTINE HYDROCHLORIDE (NAMENDA), ASPIRIN [ACETYLSALICYLIC ACID], DONEPEZIL HYDROCHLORIDE (ARICEPT), PANCREATIN (CREON), ROSUVASTATIN CALCIUM (CRESTOR), FENOFIBRATE, LEVOTHYROXINE SODIUM (SYNTHROID), QUETIAPINE FUMARATE (SEROQUEL), SERTRALINE HYDROCHLORIDE (ZOLOFT) and VALPROATE SEMISODIUM (DEPAKOTE) for an unknown indication. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 18-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 03-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. Death occurred on 03-Aug-2022 The patient died on 03-Aug-2022. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient received first and second boosters on 18-Jan-2022 and 03-Aug-2022 respectively. Patient was monitored for 15 minutes after administration and had no reactions. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. The event did not cause patient to seek medical care. No treatment information was provided. Company Comment: This fatal spontaneous case concerns a 70-year-old female patient with medical history of Covid-19 on February 2022, Drug allergy (to Niacin and to Imitrex), Diabetes, Chronic heart failure, Hypothyroidism and Colon cancer, Concomitant products included METOPROLOL, INSULIN, MEMANTINE, ACETYLSALICYLIC ACID, DONEPEZIL, PANCREATIN, ROSUVASTATIN, FENOFIBRATE, LEVOTHYROXINE, QUETIAPINE, SERTRALINE and VALPROATE who experienced the unexpected (seriousness criteria death and medically significant) event of death the same day of the 4th. dose of Moderna Covid 19 vaccine. Also, there were more than 35 days between first two doses, Inappropriate schedule of vaccine administration was noted in this case. The reported cause of death is unknown. It is unknown if an autopsy was performed The medical history, age and concomitant medications are confounders for the event death. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-628582, MOD-2022-628590 (Patient Link).; Sender's Comments: This fatal spontaneous case concerns a 70-year-old female patient with medical history of Covid-19 on February 2022, Drug allergy (to Niacin and to Imitrex), Diabetes, Chronic heart failure, Hypothyroidism and Colon cancer, Concomitant products included METOPROLOL, INSULIN, MEMANTINE, ACETYLSALICYLIC ACID, DONEPEZIL, PANCREATIN, ROSUVASTATIN, FENOFIBRATE, LEVOTHYROXINE, QUETIAPINE, SERTRALINE and VALPROATE who experienced the unexpected (seriousness criteria death and medically significant) event of death the same day of the 4th. dose of Moderna Covid 19 vaccine. Also, there were more than 35 days between first two doses, Inappropriate schedule of vaccine administration was noted in this case. The reported cause of death is unknown. It is unknown if an autopsy was performed The medical history, age and concomitant medications are confounders for the event death. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of Death
1628728 2415804 2022-08-19 71.00 PFIZER COVID VACCINE #3 GIVEN 11/12/21, LOT #FF2593; 1/8/22 pt had a positive COVID test at Medical Center and was given monoclonal antibodies; 1/27/22 pt to ED and admitted with fever, fatigue, SOB, cough, nausea and vomiting; ARDS; given Decadron, Baricitinib, empiric ABX, O2 supplement; worsening hypoxemia; toggled between BiPAP and Vapotherm; respiratory status continued to worsen; transferred to ICU; intubated RLE DVT, anticoagulation therapy until a GI bleed, then placed IVC filter; pt's condition did not improve, worsened; family decided to withdraw all life support and pt expired in the hospital
1628748 2415824 2022-08-19 82.00 PFIZER COVID VACCINE #3 GIVEN 12/29/21, LOT #FJ8757; 1/4/22 pt had a positive COVID test from Urgent Care; 1/9 - 1/19/22 pt had a hospitalization (name of hosp unknown) with COVID pneumonia; 2/7 - 2/26/22 pt brought to hospital again with increasing weakness, falling, and poor oral intake; CXR showed improvements, still with bilateral interstitial and patchy alveolar opacities; AKI; pt had a seizure in the hospital; found to have HSV-2 meningitis; treated with Acyclovir; seizure medications given for seizures; poor prognosis; transitioned to comfort care; dc'd to Life Care Center on hospice; pt expired in the Life Care Center
1628830 2415906 2022-08-19 TN 77.00 Patient brought to Healthcare Hospital on 01/06/2022 for SOB. In the ED the patient tested positive for Covid-19 and Influenza and was admitted to the hospital. CT of Head was negative for acute abnormalities, sinusitis, and mastoiditis. Patient completed Remdesivir for 5 days. Patient was discharged on hospice and expired on 01/21/2022.
1628834 2415911 2022-08-19 TN 84.00 Patient presented to Regional Medical Center on 02/18/2022 with SOB, and AMS. Patient was recently admitted at alternate Medical Center 02/04-02/07/22 with heart failure exacerbation and COVID PNA. At the time the patient was treated with dexamethasone, remdesivir and diuresis. In the ED at local Regional hospital, chest x-ray showed bilateral interstitial opacities consistent with pulmonary edema and bilateral PNA. The patient met sepsis criteria with hypotension and lactic acidosis. He was started on azithromycin and cefepime. Initially the patient required Opti Flow. Blood cultures grew staph, vancomycin was added but it ended being MSSA. Ultimately, the patient was discharged to hospice services on 02/27/2022 and expired on 03/01/2022.
1628862 2415939 2022-08-19 TN 69.00 Patient presented to Hospital on 01/08/2022 with an unwitnessed cardiac arrest onset just PTA. EMS reports that the patient was found unresponsive, pulseless V-tach. EMS gave patient 2 rounds of Epinephrine and 1 round of sodium bicarbonate en route to the ED, at which point the patient went into asystole. CPR was continued upon EMS arrival to the ED. Multiple rounds of ACLS were continued. Eventually a very bradycardic pulse was obtained and despite giving atropine, patient became asystole again. Patient had been resuscitated for over an hour and time of death was called. To note, patient tested positive for Covid-19 on 01/03/2022.
1628852 2415929 2022-08-19 TN 99.00 The patient was hospitalized in February 2022 d/t a fall at home, and urinary tract infection. She tested positive for Covid-19 during rehab stay and was returned to the hospital. She required assistance with eating and was non ambulatory and was placed in a nursing facility. She developed SOB with saturation in 70s on 03/09/2022 and was hospitalized again. She continued to decline and has required high flow oxygen and bipap. The family ultimately chose comfort focused care with Hospice Patient expired on 03/17/2022.
1628858 2415935 2022-08-19 74.00 MODERNA COVID #3 GIVEN 11/2/21, LOT #076C21A; 2/2/22 pt to ED from a SNF with AMS and apnea; in PSVT, treated with medication; acute encephalopathy; admitted to ICU; positive for COVID; COVID pneumonia; ABX; BiPAP; status changed to DNR; pt expired the following day
1628871 2415948 2022-08-19 TN 46.00 Patient presented to local hospital on 02/15/2022 with significant SOB from a skilled nursing facility where she tested positive for Covid-19. Patient has had persistent nonproductive cough. Initially on arrival patient was on 6LNC but continued to complain of SOB and went into respiratory distress requiring intubation. Patient had multifocal PNA and was intubated throughout admission. 03/01/2022 was terminally extubated and expired shortly after.
1628898 2415975 2022-08-19 73.00 1/30/22 pt had a positive COVID test; was hospitalized for SOB, dyspnea at rest, COVID pneumonia and hypoxia; O2 via NC; transferred to Medical Center on 1/31/22; DNR/DNI; given Remdesivir and Dexamethasone; hypotensive; AKI; increased O2 needs; Vapotherm then BiPAP; given Baricitinib; pt had worsening lethargy; possible aspiration; given ABX; pt's condition worsened and she expired in the hospital
1628932 2416134 2022-08-19 WI 97.00 8/5/2022: Presented to ED after fall x2, unable to stand after second fall at facility where he lives. No other contributing symptoms noted at the time. A pelvic x-ray is normal. Head CT reassuring. No signs of a stroke or definitive weakness. He has A. fib on his EKG. He has mild renal insufficiency. BNP noted to be elevated but nothing to suspect florid congestive heart failure. At this point it is unclear why he is weak. 8/9/2022 transitioned to Hospice with a terminal diagnosis of covid 19 virus infection. Evaluation revealed hypoxia and covid 19 infection. His hospital course was complicated by worsening dementia, atrial fibrillation with RAPID VENTRICULAR RESPONSE and an episode of presyncope. Passed away on 8/11/2022 Submitter does not have access to further medical records or information on hospital course. If further information is needed, please contact Hospital
1628977 2416285 2022-08-19 WA 74.00 Patient received Pfizer COVID vaccine on 2/17/21 (out of state), 3/10/21 (out of state), and 9/8/21. Patient was initially diagnosed with COVID in May 2022 and had been hospitalized at an outside hospital several times since then. He had persistent acute on chronic hypoxic respiratory failure of unclear etiology in the setting of persistent COVID-positive testing. On 8/13/22, patient admitted to our inpatient facility CCU with acute on chronic hypoxic respiratory failure due to long COVID-19 and pulmonary fibrosis. Patient expired on 8/17/22.
1628257 2414738 2022-08-18 56.00 2/1/22 pt tested positive for COVID and was hospitalized; prolonged mechanical ventilation; tracheostomy; PEG tube; dc'd to LTCF; 5/17/22 back to hospital Rehabilitation Unit; past 2 days with increasing SOB; admitted to hospital 6/5/22; BiPAP; ICU; Pulmonary Edema and possible pneumonia; Bumex started; required intubation; condition worsened; failed ventilation weaning; finally passed weaning and extubated; plans to place tracheostomy; pt labored on BiPAP; family transitioned pt to comfort care/hospice and she died in the hospital
1628225 2414706 2022-08-18 75.00 9/19/21 pt to ED with SOB, fevers, cough x 3-4 days; family member with COVID; pt tested positive for COVID; O2; dexamethasone, ABX; pt rapidly deteriorated; DNR; pt passed away due to COVID pneumonia
1628237 2414718 2022-08-18 74.00 11/28/21 pt tested positive for COVID and was hospitalized, dc'd to home 12/1/21; pt had increasing SOB and was readmitted to hospital on 12/2/21; CTA of the chest showed evolved PNA due to COVID; transferred to ICU; dexamethasone, Vitamins C & D, zinc, ABX; BiPAP; pt's condition worsened requiring intubation; grim diagnosis; transitioned to comfort care and passed away in the hospital
1628210 2414690 2022-08-18 86.00 6/11/22 pt to ED with malaise, fatigue, cough, fever, SOB for past 8 days; admitted; found to be positive for COVID; ABX, dexamethasone, Remdesivir; BiPAP/Vapotherm; DNR/DNI; AKI; hypotensive and bradycardic; pt passed away in the hospital
1628342 2414823 2022-08-18 60.00 5/23/22 pt to ED with weakness, SOB; had been seen earlier by oncologist and pt found to be hypoxic; sent to ED; found to be positive for COVID; CXR showed bilateral COVID pneumonia; steroids, Remdesivir; worsening oxygenation; transferred to ICU; ABX; condition worsened over time; DNR; transitioned to comfort care; pt passed away in the hospital
1628275 2414756 2022-08-18 45.00 PFIZER COVID VACCINE #3 GIVEN 8/24/21, LOT #FD8778; pt had a positive COVID test; 10/5/21 pt admitted to hospital with progressive dyspnea and left sided chest pain, no radiation; given O2, Decadron, ABX, DVT left subclavian vein; O2 requirements increased; given Remdesivir, baricitinib; CXR showed worsening bilateral infiltrates; placed on Optiflow; transferred to ICU; required NRB in addition to maximum Optiflow; condition worsened; hypotensive; significant hypoxia with movement; comfort measures instituted; suffered cardiopulmonary arrest and passed away in the hospital
1628286 2414767 2022-08-18 67.00 1/31/22 pt had a positive COVID test 2/16/22 pt admitted to the hospital; worsening SOB past 3 days; checked O2 saturation at home and reports it was in the 60s; O2 supplementation; CXR showed bilateral PNA; given decadron, ABX; pt's condition worsened; transitioned to comfort care and he passed away in the hospital
1628360 2414841 2022-08-18 83.00 MODERNA COVID VACCINE #3 GIVEN 10/21/21, LOT #007C21B; pt lives in nursing home; 1/4/22 positive for COVID; no sx; O2 saturation 93-94% on RA; over time increase in lethargy; given Rocephin; condition continued to worsen; pt found expired in the facility
1628365 2414846 2022-08-18 74.00 PFIZER COVID VACCINE #3 GIVEN 12/3/21, LOT #FK5127; 6/6/22 pt had a positive COVID test from Clinic; 6/12/22 pt to ED with increasing SOB; hypoxia; hypercapnea; intubated and on ventilator; sedated; CXR showed moderate right lower lobe infiltrates with small right pleural effusion; able to be weaned from ventilator after several days; extubated; on O2 via NC; encephalopathic; worsening respiratory acidosis; placed on BiPAP; DNI; family refuses PEG and tracheostomy for pt; on multiple ABX; transitioned to comfort care and inpatient hospice; pt passed away in the hospital.
1628403 2414884 2022-08-18 78.00 MODERNA COVID VACCINE #3 GIVEN 11/12/21, LOT #065F21A; 1/25/22 pt to ED from Rehab for acute on chronic AMS, Nausea, vomiting, diarrhea, RUQ abdominal pain; admitted; 1/26/22 pt had a positive COVID test; not hypoxic; acute on chronic pancreatitis; suffers from depression in the nursing home; dehydrated; pt did not make improvements while in the hospital; DNR; transitioned to comfort measures; passed away in the hospital
1628409 2414890 2022-08-18 WI 84.00 Adverse event note: Per web report received stating the patient presented on 7/23/2022 with generalized weakness. Patient with close exposure to COVID-19, her husband was recently positive. Vague symptom onset, approximately 7/21/2022 which included generalized fatigue/weakness, cough, shortness of breath worse with exertion, headache. PCR on admission 7/23 positive. ER work-up revealing elevated CRP, fibrinogen, D-dimer. Difficulty with IV access unable to obtain CTA chest, nuclear medicine lung scan and obtained with intermediate probability PE. Patient had been on Eliquis previously without tachycardia and maintaining room air oxygen saturations. ID consulted for management given COVID-19. Patient stated improvement but reports ongoing dry cough and some fatigue. Denies fever/chills, chest pain, abdominal pain, nausea, vomiting, diarrhea, rash, joint pai n. Denies recent travel. Vaccinated against COVID-19 with Pfizer x3, last immunization 11/2021 Per report, this patient was hemo-dynamically stable and saturating well on room air. Patient was admitted given acute viral infection and weakness. The patient had a hospital course of 11 days. Her initial hospitalization focused on conservative management of COVID-19 infection. Patient had no indication for specific treatment, she was supported and remained on room air. However, she was weak and worked with PT/OT. Therapy sessions were notably limited by patient's subjective dizziness. Orthostatic vitals revealed severe and ongoing orthostatic hypotension. Patient noted to be on both metoprolol and diltiazem, and per note, numerous adjustments made to assist with symptoms. Electrophysiologist was contacted as well for support. Despite adjustments to patient's AV nodal agents, her orthostasis persisted. She was trialed on increased salt tabs, midodrine, and Florinef at different times. Despite these interventions, her symptoms and orthostasis persisted. Per note, her chronic dysphagia worsened throughout her hospitalization. Patient was unable to complete repeat video swallow studies given ongoing dizziness. Per note, later in hospital course, patient was found having difficulty with already modified dysphagia diet. Patient aspirated and developed likely aspiration pneumonia. Infectious disease contacted; patient finished a course of cefepime. Clinically, she continued to deteriorate with poor oral intake and ongoing weakness. Palliative care consulted. Family meeting occurred on 8/5/2022 with patient, husband, daughter, son on phone. After thorough discussion of progression of patient's chronic conditions without notable improvement over the course of hospital stay, family made shared decision to pursue home hospice. Patient was planning for transition to home hospice on 8/6/2022. On the evening of 8/5/2022, patient had another aspiration event leading to severe respiratory distress with hypoxemia. A rapid response was called as patient was having agonal/irregular breathing. Attempts were made to provide patient with supplemental oxygen and bedside cares. Patient was DNR/DNI. Family was contacted and ultimately decision made to make patient comfortable. Patient passed away on 8/5/2022 at 6:22 PM.
1628412 2414893 2022-08-18 72.00 2/9/22 pt to ED with c/o CP, SOB, weakness, lethargy, cough, nausea, dry heaves; given Decadron, ABX in ED; rapid COVID test negative but PCR was positive; CT chest showed findings comparable to COVID pneumonia; Vapotherm; declining O2 saturations; transferred to ICU; intubated; sedated; became hypotensive; PEA; multiple rounds of CPR, shock and medications without success; pt passed away in the hospital
1628501 2416877 2022-08-18 10.00 Patient received COVID-19 vaccine on 8/12/22 at 1428. At approximately 0350 on 8/13, patient had a code white event that included hypotension, bradycardia, and subsequent pulselessness with wide complex rhythm. Patient was resuscitated and transferred to the PICU, but ultimately passed away on 8/15 after another code white event.
1627686 2413424 2022-08-17 29.00 2/21/22 was taken to the Medical Center in cardiac arrest, CPR, intubated; found to be positive for COVID; 2/22/22 pt was transferred to a different Medical Center for higher level of care; hypotensive, vasopressors and chest tube placed; concern about anoxic brain injury; dexamethasone, ABX, vitamins C & D, zinc, thiamine; DNR; pt expired in the hospital
1627611 2413349 2022-08-17 TN 77.00 Patient with PMH of HTN, HLD, CAD post CABG, Lymphoma currently undergoing chemotherapy, DVT on chronic anticoagulation with Xarelto, type 2 diabetes, BPH and GERD presented to Hospital on 09/25/2021 c/o myalgias, malaise, congestion, productive cough and SOB. He also reported blood in urine. In ED patient oxygen saturation at 92% on RA, but dropped to 78% when ambulating. He was also noted to be tachycardia. Labs showed elevated d dimer, chest x-ray showed small right pleural effusion, EKG showed sinus tachycardia with ST-T wave abnormality, Chest CTA showed no evidence of pulmonary embolism, moderate volume right pleural effusion and patchy confluent groundglass areas of opacification in both lungs. COVID -19 test was positive. Patient received a dose Decadron and admitted for further management. The patient completed Remdesivir, developed progressive oxygenation failure with ARDS and was transferred to ICU on 10/08/2021. The patient was intubated for ARDS and managed with low tidal volume ventilation. This was complicated by septic shock due to VAP with Klebsiella nd Pseudomonoas. Family elected to transition to comfort care. Patient expired on 10/20/2021.
1627615 2413353 2022-08-17 TN 80.00 Patient presented to local Medical Center on 08/29/2021 with acute hypoxic respiratory failure d/t COVID-19. Patient was febrile, complaining of abdominal pain. KUB was unremarkable. Chest x-ray showing PNA consistent with Covid-19. Patient received Remdesivir, Dexamethasone, Rocephin, and Zithromax. Patient progressively deteriorated and placed on BiPAP on 09/01/2021. Patient expired on 09/05/2021.
1627678 2413416 2022-08-17 74.00 PFIZER COVID VACCINE #3 GIVEN 10/14/21, LOT #FH8020; 1/29 - 2/7/22 pt hospitalized with COVID; was on supplemental O2; dc'd to home on RA with 10 day supply of Omnicef and Dexamethasone; 2/9/22 back to hospital with increasing SOB and fatigue; home health nurse encouraged pt to come to ED if SOB worsened; O2 supplementation; PO2 45 on RA, ABG; CXR worse when compared to the ones done on 2/1 and 2/5/22; givO2 needs continued to increase requiring Vapotherm and eventually BiPAP; family chose comfort care for pt since she was not improving; pt expired in the hospital
1627724 2413463 2022-08-17 TX 65.00 Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Rec'd Moderna vaccine on 1/21/21, 2/13/21 and 8/18/21. Covid + at home on 7/14/22 - Tx'd w/paxlovid, doxycycline, and decadron w/o improvement. Presented to ED 8/2/21 tachypneic, hypooxic, and hypertensive. Admitted for acute resp fail w/hypoxia and hypercapnia. Glucose 222, BUN 99, Cr 3.13, CO2 16, Cal 7.1, CRP 156.8, Procal 0.50, INR 1.6, WBC 14.1, Hgb 8.6, Plt 112, CXR - bil PNA, COVID+ swab. BC x2 and UC pending. Pt was admitted to ICU and required intubation and prognosis cont'd to worsen. Transitioned to comfort care, expired on 8/9/22. Tx'd w/decadron, cefepime, and vancomycin.
1627727 2413466 2022-08-17 80.00 PFIZER COVID VACCINE #3 GIVEN 10/12/21, LOT #30155BA; 1/21-2/6/22 pt hospitalized for COVID, dc'd to home on O2; 2/10/22 pt back to hospital after experiencing epigastric pain and worsening SOB the night before while on CPAP; pt took himself off of CPAP and went onto O2 via NC; dry cough; found to have a right pneumothorax; chest tube placed; ABX; respiratory status continued to worsen; pt's family opted for comfort care; pt passed away in the hospital
1627762 2413501 2022-08-17 81.00 2/22/22 pt with a positive COVID test, treated with Azithromycin and steroids by PCP outpatient; 3/3/22 pt to hospital with increasing SOB, hypoxia, ARF; transferred to ICU; O2 supplementation eventually requiring intubation; CXR showed lung volume diminished and multifocal pulmonary infiltrates, right > left; remdesivir, decadron, albuterol, AKI; condition worsened significantly; pt transitioned to DNR and pt expired in the hospital
1627799 2413538 2022-08-17 47.00 1/19/22 positive COVID test at a HCF; increasing SOB, fatigue, cough; 1/29/22 pt to hospital; CXR showed possible pulmonary edema or atypical infection; 69% O2 saturation on RA; AHRF; O2 supplementation; Dexamethasone, Remdesivir, Rocephin; transferred to ICU; AKI; intubated; respiratory status worsened; multiorgan failure; code blue called; multiple rounds of CPR; asystole; pt passed away in the hospital
1626895 2412267 2022-08-16 TN 76.00 Covid vaccine x 3. tested positive for Covid on 7/26/2022. Expired on 7/29/2022.
1626802 2412039 2022-08-16 fell over and died of heart attack; fell over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 27-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "fell over and died of heart attack"; FALL (non-serious), outcome "unknown", described as "fell over". The patient date of death was unknown. Reported cause of death: "fell over and died of heart attack". It was not reported if an autopsy was performed. Clinical course: the reporter reported that I just heard on the news today that the doctor (not clarified) who was 27 years old a doctor in the prime of her life running a Triathlon nothing wrong with her she just fell over and died of heart attack. She had two Pfizer shots and a booster. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: fell over and died of heart attack
1626872 2412242 2022-08-16 TN 84.00 Patient presented to ED on 02/06/2022 with SOB. Patient required 100% nonrebreather, and continued to be tachypneic, and hypotensive. Patient was placed on BiPAP and was barely able to maintain oxygen saturation 91-92% with 100% FiO2. Patient was given fluid resuscitation and placed on dopamine drip. She was given IV Rocephin and Iv cipro after blood cultures collected. Patients daughter decided for the patient to be comfort care only. Dopamine drip was discontinued, was placed on 100% nonrebreather and was given morphine 2mg IV every hour. Patient was found to be Covid positive. Patient expired in ED on 02/06/2022.
1626877 2412247 2022-08-16 TN 77.00 Patient went to Medical for fever and trouble breathing for COVID symptoms. Workup at hospital revealed sepsis and bilateral PNA. Despite aggressive care, including intubation patient continued to decline. Patients family decided to extubate and focus on comfort measures with hospice. Patient was then admitted to Hospice services on 03/30/2022. Patient expired on 04/01/2022.
1626878 2412248 2022-08-16 KY 60.00 Admitted to the hospital with COVID-19
1626887 2412259 2022-08-16 76.00 MODERNA COVID VACCINE #3 GIVEN 12/7/21, OT #064H21A; pt had a positive COVID test on 2/14/22 and was hospitalized for COVID, increasing SOB and cough from 2/14 - 2/22; dc'd to home; 3/7/22 pt back to ED with SOB, pain in ribs and back; admitted; O2 saturation in the 90s on RA; placed on O2 for comfort; CXR is concerning for pneumonia, possible pulmonary edema; given ABX; borderline hypotension; DVT in right femoral vein; started on heparin drip; later dc'd heparin and vascular surgery placed IVF filter; pt's renal condition worsened; put on dialysis; condition continued to worsen; transitioned to comfort care and pt expired in the hospital
1626894 2412266 2022-08-16 TN 66.00 Patient was transferred to Medical Center ICU on 02/17/2022 for further evaluation of lower GI bleed. Patient initially presented to Hospital on 01/27/2022 with COVID, patient was started on steroids, remdesivir, baricitinib, broad-spectrum antibiotics, and was intubated on 02/05/2022, and extubated on 02/15/2022. Patient was placed on a full dose anticoagulation for subsegmental PE diagnosed on 01/30/2022 but repeat CT PE study was negative on 2/9/2022. Patient started having maroon bowel movement, GI was consulted, and recommended patient transfer to higher level of care. Upon arrival patients ABG showed PCO2 was in range of 70, normal PH. Code status was changed to DNR d/t poor prognosis, and ultimately changed to Comfort care. Patient expired on 03/02/2022.
1627065 2412456 2022-08-16 TN 69.00 Patient presented to hospital on 01/09/2022 with weakness and was obtunded. Patient was found to be hypotensive and was treated for acute hypoxic/hypercapnic respiratory failure secondary to COVID 19 with PNA and subsequently had ARDS. Patient did required ventilator support and family did decide on comfort care and was extubated. Patient expired on 02/12/2022.
1626903 2412276 2022-08-16 TN 93.00 Patient brought to hospital on 03/02/2022 because of progressively increasing weakness, cough, sore throat, difficulty swallowing, poor oral intake, lower abdominal pain. In ED labs showed UTI and COVID Positive. Chest XRAY showed decrease in size of left side pleural effusion. Patient was admitted to hospital for Covid-19 infection, acute UTI, dehydration, vaginal candidiasis, generalized weakness, delirium. Patient was placed on vancomycin, and budesonide. With patients continued decline, family transitioned patient to comfort care. Patient expired on 03/05/2022.
1626905 2412278 2022-08-16 85.00 PFIZER COVID #3 VACCINE GIVEN 9/30/21, LOT #FE3592; pt had a positive COVID test on 1/24/22 at the clinic; saw PCP and was given Molnupipavr x 5 days; SOB worsened along with cough; pt to ED 2/1/22; O2 supplement placed; continued to worsen; ABX given; transferred to ICU in critical condition; placed on BiPAP; pulmonary fibrotic changes and multifocal infiltrates notes on CXR; intubated; sedated; ventilated; tube feedings; corticosteroids; failed weaning (O2) trial; DNR; Severe COVID pneumonia; pt passed away in the hospital
1626934 2412310 2022-08-16 TN 87.00 Patient was a resident of a HCF. Patient had a history of Covid-19; tested positive on 01/20/2022. Family felt she had recovered from illness. On 02/20/2022 patient was being seen and in significant distress. The patient became increasingly dyspneic. Family was at the bedside and requested that nothing aggressive be done, including xrays. Patient expired on 02/20/2022.
1626943 2412320 2022-08-16 TN 73.00 Patient was diagnosed with Covid-19 on 02/09/2022. He drove himself to ED and collapsed in the parking lot and was found down, he was taken to ED and CPR initiated, and he was intubated. Patient was found to have Lacunar Infarct, Pulmonary edema, Afib with RVR. Patient was admitted to hospital services. Family eventually elected DNR/Comfort Care. Patient was extubated. Patient was transferred to Hospice. Patient was unresponsive and actively dying. Patient expired on 03/18/2022.
1627124 2412520 2022-08-16 IL 81.00 Patient received moderna vaccine on 2/5/21, 3/9/21, and 12/13/21. Presented to ER on 7/26/22. Found to be COVID positive 8/5/22. She was initially admitted to HospitalF on 7/26 with confusion, UTI, and hyperglycemia. This was associated with decreased appetite and reported functional decline with worsening dementia over the past few months. Urine culture was positive for pan-susceptible E. Coli. She completed a course of Ceftriaxone. Throughout her admission, blood glucose was labile; significantly elevated, punctuated by periods of lows. Patient was pending discharge to facility but pre-placement COVID screening resulted as positive on 8/5, delaying transfer. In the morning of 8/7, her blood glucose was noted to be significantly elevated and chemistry panel was obtained. This demonstrated anion gap of 31, CO2 of 7 and blood glucose of 633. She had a large amount of acetone in her serum. She was noted to be encephalopathic. Findings consistent with DKA. She was transferred to from 5100 to ICU with intensivist consultation. Kept NPO, started broad-spectrum antibiotics for possible sepsis, sepsis protocol initiated, chest x-ray showed no infiltrate on 08/07, UA did not show evidence of infection on 08/07, blood cultures and urine culture are negative so far. Patient is out of DKA on 08/08/2022, bridged with long-acting, but patient is not eating even though awake, also remained noncommunicative later on, patient has severe dementia history and poor functional status, daughter and son continued to wish against tube feeding, goal of care discussion initiated with family and family members opted for hospice care. Patient will be discharged to facility with the hospice care. Discharged on 8/10/22. Passed away on 8/12/22
1627138 2412676 2022-08-16 TN 83.00 Case vaccinated with moderna x 2 in 2021. Tested positive for Covid 19 on 08/02/2022. Admitted to Medical Center on 8/14/2022 and expired on 08/15/2022 while still hospitalized.
1626550 2411218 2022-08-15 82.00 PFIZER COVID VACCINE #3 GIVEN 11/29/21, LOT # FD0809; pt had a previous hospitalization from 12/1-12/3/21 for a positive COVID test on 12/1/21 and COVID pneumonia; dc'd to home on 12/3/21; 12/4/21 pt brought back to ED after being found unresponsive in home; testing showed large left brain stroke due to carotid artery occlusion; in extremis with status epilepticus; treated with medication but continued to have seizures; admitted to hospital with end of life care; transitioned to comfort care and passed away in the hospital
1626466 2411132 2022-08-15 77.00 6/16/22 pt had a positive COVID test at Care Center; 6/19/22 pt brought to ED with dyspnea; O2 saturations in the 80s on RA; placed on O2 supplement; admitted; CXR showed moderate bilateral multifocal opacities and pleural effusions; A Fibrillation; dexamethasone; pneumothorax, chest tube placed; suffered cardiac arrest; CPR; transferred to CCU; treated with medications; ABX started for suspected sepsis; family decided to withdraw care; comfort care; pt expired in the hospital.
1626468 2411134 2022-08-15 TN 65.00 Patient with a PMH of Copd with oxygen at home. ESRD on HD, and tobacco use. He presented to Medical Center on 02/21/2022 with complaints of progressive dyspnea on exertion eventually leading to dyspnea at rest. Patient stated sleeping in tripod position. Patient admitted to hospital for respiratory failure, Covid-19 and ESRD. Chest X-ray revealed bilateral pleural effusions with marked interval increase in large left pleural effusion, left lung atelectasis with bilateral airspace disease. Patient had ST changes on EKG, and elevated troponin. Patient expired on 03/09/2022.
1626473 2411139 2022-08-15 TN 64.00 Patient presented to local hospital on 09/04/2021 with c/o SOB and weakness; with a PMH significant for Leukemia, CAD, Type 2 DM, HTN, HLD. Patient was diagnosed with COVID one week prior to hospitalization. Also c/o fevers, diarrhea, nausea, and decreased oral intake, SOB with nonproductive cough. In the ED patient was placed on oxygen and given IV fluids. CXR showed patchy bilateral infiltrate's. EKG showed sinus rhythm without acute ischemic changes. Patient also received Decadron in ED. Patient was admitted to hospital. Patient was intubated on 09/12/2021 and expired on 09/18/2021.
1626477 2411143 2022-08-15 TN 89.00 The patient presented to local Medical Center on 03/05/2022 with a known history of recent COVID diagnosis, hypertension, Addison's disease, factor V, CAD, CKD. He presented to ED with c/o AMS. Per EMS, the patient had bilateral lower extremity edema, O2 was 89% on RA, and temp of 102.2, and tachycardia. Portable CXR showed coarsened interstitial lung markings, and CT of the head without contrast showed chronic small vessel ischemic changes, but no acute abnormalities. CT of abdomen and pelvis with contrast that showed ground glass abnormalities. The patient expired at the facility on 03/05/2022.
1626493 2411160 2022-08-15 TN 86.00 Patient arrived to local Healthcare via EMS from home with difficulty breathing. Room air sat was 65% with productive cough. Patient was given steroid and placed on nasal cannula. Patient had a history of Covid 19 in January 2022. CTA of chest revealed large bilateral pleural effusion, right greater than left with compression atelectasis of bilateral lower, upper and middle lobes. Patient was admitted to hospital services and transitioned to comfort measures. Patient expired on 03/07/2022.
1626561 2411229 2022-08-15 73.00 pt admitted to hospital with SOB, generalized weakness, chills; found to be positive for COVID; hypoxic with O2 saturations in the 70s; given O2 supplement; dexamethasone, Tocalizumab; respiratory status worsened; transferred to ICU; placed on sedation; BiPAP and Vapotherm; became BiPAP dependent; poor oral intake; DNR; transitioned to comfort measures and passed away in the hospital
1626583 2411251 2022-08-15 74.00 PFIZER COVID VACCINE #3 GIVEN 11/15/21, LOT #FH8028; pt brought to ED via EMS with worsening SOB; O2 saturation 60% on RA; placed on CPAP; was able to switch to O2 via NC eventually; found to be positive for COVID; admitted to hospital; given Decadron, Remdesivir, Baricitinib, Vitamin C, Zinc; ABX; bilateral pneumonia secondary to COVID-19; Atrial Fibrillation with RVR; DNR; experienced respiratory failure and passed away in the hospital
1626598 2411266 2022-08-15 69.00 10/12/21 pt had a positive COVID test; 11/3-12/7/21 pt had a hospitalization for melena; 12/18/21 pt to ED after being transferred from outside hospital (name unknown) due to hypotension, bilateral swelling and redness, concerning for possible cellulitis; INR from outside hospital was 6; started on Levophed; transferred to alternate hospital for further care; admitted to hospital; shock, hypotension, rule out sepsis, likely related to volume overload, pt has not missed HD; outside hospital called and stated blood cultures growing gram positive cocci; started on ABX; pt became progressively agitated and c/o diffuse all over pain; unable to localize; given low dose oxycodone with pain improvement; rapid progression of hypotension; treated with vasopressors; transitioned to comfort care; pt expired in the hospital
1626602 2411270 2022-08-15 77.00 10/9/21 pt had a positive COVID test; 10/10-10/12/21 hospitalized for COVID pneumonia and splenic infaction; dc'd to home; 10/22/21 pt back to ED with worsening SOB; generalized weakness; admitted; CXR showed bilateral interstitial infiltrate; NRB; A Fib with RVR, treated with medication; hypotensive; treated with medication; acute renal failure; AHRF and severe acute respiratory distress syndrome secondary to COVID; mechanical ventilation; condition continued to worsened; cardiac arrest; pt expired in the hospital
1626569 2411237 2022-08-15 TN 77.00 COVID-related death / breakthrough case
1625719 2409791 2022-08-12 FL 84.00 Hospitalization for COVID symptoms on dates 7/1/22-7/2/22. Passed away on 7/2/2022 with DNR. Treated with no COVID-related medications. Primarily treated for infection.
1625821 2409907 2022-08-12 51.00 MODERNA COVID #3 VACCINE GIVEN 11/28/21, LOT #018F21A; 4/1/22 pt had a positive COVID test at Medical Center; was admitted to hospital with confusion, enterococcal bactremia; persistent encephalopathy; was dc'd to Hospice with uncontrolled pain and agitation, not alert enough to swallow; pt passed away in the hospice facility
1625789 2409872 2022-08-12 80.00 PFIZER COVID VACCINE #3 GIVEN 8/24/21, LOT #FC3184; pt had a positive COVID test on 1/28/22; admitted from 1/30-2/4/22 for COVID pneumonia; admitted to 2/14/ - 2/18/22 for Klebsiella Pneumonia; sent home on O2; back on 3/6/22 with AHRF; worsening right malignant pleural effusion; increasing SOB; placed on NRB initially then able to wean to NC; ABX; DNI/DNR; pt's condition worsened and he passed away in the hospital
1625793 2409876 2022-08-12 86.00 Patient had a positive COVID test on 10/10/21; Patient passed away in the SNF due to COVID (limited medical records).
1625805 2409889 2022-08-12 77.00 1/22/22 pt had a positive COVID test; 1/28/22 pt to ED with AMS (previous dx of delirium, hyperthyroidism and UTI; currently unable to take much by mouth including medications; pt remained in ED until 2/2/22 due to COVID surge; transferred to ICU; dx with UTI, anemia with signs of bleeding; on O2 via NC without respiratory sx; sepsis, delirium, acute renal failure; ABX; DNR; pt became unresponsive, asystole, pt expired in the hospital
1625782 2409864 2022-08-12 64.00 PFIZER COVID VACCINE #3 GIVEN 9/17/21, LOT #FF2588; 2/6/22 pt had a positive COVID test from Pharmacy; required a hospitalization (dates unknown) for COVID, treated and dc'd to home with O2 supplementation, steroids, Paxlovid; 2/23/22 pt admitted to Hospital with AHRD, Acute Renal Failure; septic shock, bilateral pneumonia, pulmonary embolus; rapid respiratory response occurred and pt required intubation; pt's condition continued to worsen; transitioned to comfort care; pt expired in the hospital
1625826 2409914 2022-08-12 MI 63.00 Patient with 2 Moderna COVID vaccinations who admitted and subsequently died of COVID complications. Provider H+P: " HPI: The patient is a 64 YO female patient with a past medical history of CLL and Covid pneumonia. She has developed acute respiratory failure 2/2 post covid pulmonary fibrossis. She had been hospitalized wit end stage pulmonary fibrosis developed after Covid pneumonia. Her symptoms progressed to the point that the patient elected for hospice care The hospice service was asked to evaluate the patient for uncontrolled tachypnea The hospice team reviewed the above case and determined that inpatient admission to the hospice service was required to gain control of the patients symptoms prior to any possible discharge." Patient died on hospice services on 08/10/22.
1625922 2410025 2022-08-12 74.00 MODERNA COVID VACCINE #3 GIVEN 11/3/21, LOT #006D21A; 2/16/22 pt had a positive COVID test; EMS brought pt to ED 2/19/22 with increase in weakness, SOB, decreased appetite; O2 saturation 50-60% on RA; COVID pneumonia; O2 supplementation; admitted to ICU; given Remdesivir, Baricitinib, Vitamins, Steroids, DNR; transitioned to comfort care and pt expired in the hospital
1625930 2410034 2022-08-12 65.00 8/31/21 pt had a positive COVID test at Hospital; was treated with dexamethasone, remdesivir; transferred; admitted with acute on chronic hypoxic respiratory failure; MICU; placed on ABX and BiPAP; shock; Atrial Fibrillation with RVR; acute renal failure; family transitioned pt to comfort care and pt expired in the hospital
1625948 2410056 2022-08-12 74.00 pt had a positive COVID test 9/19/21; after hospitalizations for pulmonary problems related to COVID dx, pt presents to ED on 11/20/21 with dyspnea, hypoxia, confusion; lives in a SNF; worsening respiratory status; placed on NRB; A Fib with RVR; Long COVID dx; steroids, bronchodilators, mucolytics; progressive acute on chronic renal insufficiency with cardio renal syndrome; transitioned to comfort care and passed away in the hospital
1625916 2410019 2022-08-12 91.00 MODERNA COVID VACCINE #3 GIVEN 11/17/21, LOT #018F21A; 1/18/22 pt had a positive COVID test at facility where she lives; limited medical records; pt did not have any respiratory problems; pt passed away in the facility
1625075 2408489 2022-08-11 WI 79.00 Notes received from Medical Center. Patient was recently discharged from the hospital to a skilled living facility brought into ED because of hypoglycemia. Per EMS, the patient's roommate at the facility noticed that the patient was not acting right. Per note the staff at the skilled living facility checked the patient's blood sugar and it was low. They called EMS and on EMS arrival blood sugar was 27. EMS gave D10. At that time patient was minimally responsive but woke up very quickly according to EMS. EMS did note patient to have transient hypotension and hypoxia. Per report the patient denied any fever, vomiting, diarrhea, pain. Patient had dialysis and stated she does not make urine. CT of chest noted bibasilar atelectasis without other focal consolidation and shows not frank infiltrate, shows evidence of fibrosis and edema. Per Note the patient met the criteria for sepsis. PCR positive for COVID 19: New leukocytosis with elevated LFT's and pro calcitonin and lactate. Cr shows mixed interstitial opacities. Patient was not hypoxic during exam. But received a dose of dexamethasone in ED. Received a dose of vancomycin and cefepime in ED. Labs were ordered to trend. Note stated inflammatory markers were elevated mostly from COVID. Patient was admitted to the medical floor. Patient denied any complains and stated she was feeling better. Per 2nd note, the patient's lactic acid was high due to persistent hypoglycemia, chronic renal failure, and hypoxemia. Due to renal failure, the patient was not a great candidate to receive IV fluids. The patient was given gentle fluids. Patient was also given multiple doses of amp of dextrose 50. Per note, the patient went into respiratory failure and patient and family declined any heroic efforts or intubation. Note stated Patient was a DNR and Do not intubate. Per note, patient died comfortable on 7/31/2022 at 22:37. Health Department does not have any further information on this patient.
1624961 2408370 2022-08-11 TN 85.00 Chronically ill patient resident of Rehab tested positive for Covid-19 on 01/17/2022 at facility. Patient expired on 01/30/2022.
1624964 2408373 2022-08-11 80.00 11/29/21 pt to ED from Hospice with worsening dyspnea; EMS transported pt; in ED found to be hypoxic with O2 sats in 70s, positive for COVID, hypertensive, acute on chronic kidney injury, pulmonary edema, pleural effusion, emphysema, extensive atherosclerotic disease; pt intubated and transferred to MICU; given dexamethasone; found to have brachial DVT, started on Heparin; pt has had several hospitalizations in pas for pulmonary edema and renal failure; family decided to have pt extubated and DNR/DNI with comfort measures; moved to PCU where he expired
1624995 2408406 2022-08-11 81.00 2/22/22 pt to ED with increasing SOB; pt tested positive 2/21/22 for COVID with a home test; wife with COVID; pt tested positive in ED for COVID; c/o fever, cough, chills, fatigue; given Remdesivir, Baricitinib, Decadron, ABX; during hospital stay pt's condition worsened; required intubation with mechanical ventilation; pt had sudden bradycardia event; medication administered; family decided on no CPR; cardiac arrest; pt expired in the hospital
1625042 2408455 2022-08-11 71.00 MODERNA COVID VACCINE #3 GIVEN 11/2/21, LOT #071F21A; pt had a positive COVID test on 2/17/22 at Medical Center; dc'd to Hospice where he passed away; pt terminally ill due to COPD;
1625060 2408474 2022-08-11 88.00 MODERNA COVID VACCINE #3 GIVEN 12/8/21, LOT #030H21B; pt brought to ED via EMS with unresponsiveness and hypotension; tested positive for COVID on 6/7/22 at SNF; diarrhea; 6/12/22 pt tested positive again for COVID in ED; given ABX; sepsis due to COVID or colitis; renal failure; pt's condition worsened; DNR/DNI; transitioned to comfort care; pt expired in the hospital
1625142 2408557 2022-08-11 73.00 pt was in the hospital for COVID pneumonia from 1/29 - 2/19/22; 2/20/22 pt had a positive COVID test; pt dc'd to rehab; while in rehab, pt had nausea, vomiting, diarrhea, and hypotension; 2/21/22 taken back to hospital; admitted with sepsis, AHRF; placed on mechanical ventilation; A Fib with rapid ventricular response; vasopressors for shock; respiratory culture grew mold, treated with medication; tube feedings; family decided to withdraw support and pursue comfort measures; pt passed away in the hospital
1625085 2408499 2022-08-11 TN 70.00 Patient brought to Hospital via EMS on 02/17/2022 for SOB. CT of thorax showed large right effusion, lung metastasis, bone metastasis, supraclavicular and left axillary lymphadenopathy. Patient had a known hx of Prostate cancer, Parkinson's, dementia, and Peg Tube. Chest tube was placed in ED and drained 1 L of bloody fluid. Arterial blood gas showed PO2 88 and sats 98% on RA. Patient was also COVID positive. Patient had leukocytosis with left shift, tachypneic in the 30s. Patient was started on Zosyn and Vancomycin. Patient was tachycardia in the 100s. Patient expired on 02/23/2022.
1625122 2408537 2022-08-11 81.00 pt had a positive COVID test on 1/14/22 in nursing home where she stays; placed on isolation; ABX; comfort measures only; on O2; pneumonia; pt passed away in the nursing home
1625161 2408576 2022-08-11 PA 52.00 Patient admitted to LTACH with increasing oxygen requirements. Tested positive for COVID. Patient developed cardiopulmonary arrest. ROSC was unable to be obtained. Patient CTB
1625224 2408640 2022-08-11 77.00 pt to ED with generalized weakness, increasing SOB, abdominal pain, body aches, fever, nausea; found to be positive for influenza B and COVID; AKI; given Tamiflu, ABX, IV fluids, Heparin; DNR/DNI; experienced ventricular tachycardia with varying arrhythmias; quickly became unresponsive; comfort care; pt passed away in the hospital
1625354 2408968 2022-08-11 CA 58.00 Death on May 21, 2022. Patient, was a scientist/professor, an active and healthy man. To avoid covid, he had two Moderna vaccines and one booster shot from Pfizer. The Vaccination dates were as follows: Two two Moderna vaccines: The date:June 21,2021 , lot #:025C21A The second vaccine shot was on The Date: July 19,2021 , lot #: 045B21A The third booster is Pfizer. The date: March 31,2022 , the lot #?FK9896 After the booster shot, two days later on April 2nd 2022, patient traveled from place to place for a business trip. On April 8 he started to feel an upset stomach. It was difficult to keep down food and water. He felt so tired and weak throughout his stay in country. He developed a bloated stomach. On April 28, he returned home from country, extremely jaundiced. On April 29, he went to health center to check up and had a blood test. The diagnosis showed he had high levels of bilirubin and something was triggering his liver dysfunction, though there was not much general cirrhosis. On May 5th evening, he went to Emergency hospital for his stomach bloating and difficulty breathing. On May 11 he was transferred to medical center for liver transplant evaluation. On May 21 2022 he passed away. The main cause was his weakened immune system as he had a fungal lung infections with the underlying sudden liver failure.
1624946 2408355 2022-08-11 77.00 1/23/22 pt had a positive COVID test at Medical Center; given IV ABX and steroids; also had Pulmonary Embolus; dc'd to SNF on 1/28/22; comfort care measures only; pt found deceased in nursing home
1624218 2407101 2022-08-10 74.00 3/16/22 pt to ED via EMS; pt unresponsive; hypoxic with O2 saturation in 80s%; intubated; pt had a positive COVID test 1/23/22 per family and had been treated; pt became bradycardic and hypotensive; resuscitated; CT of head showed no acute abnormalities; CXR showed bilateral infiltrates; given IV ABX; Atrial Fibrillation treated with medication; pt suffered another PEA arrest; ROSC achieved after 8 mins of CPR; pt then hypertensive and tachycardic; family decided no more CPR; pt expired in the hospital
1624215 2407098 2022-08-10 TX 90.00 Pfizer BIO-NTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Received Pfizer BIO-NTech vaccine on 2/13/21, 3/06/21 and 12/03/21. Presented to ED 7/30 c/o fatigue x3days. In ED, fever of 100.4, spO2 91% on R and RR 26 and hypotensive. Admitted for Covid PNA w/acute resp failure and AKI. Cr was 1.41, lactic 0.7. Required High Flow oxygen as well as bipap to maintain oxygenation. He had an acute decline overnight on 8/3 and was transitioned to DNR/DNI. Expired on 8/3/22. Treated w/azithromycin, ceftriaxone, vancyomycin, aztreonam, levofloxacin, remdesivir, tocilizumab, and decadron.
1624217 2407100 2022-08-10 TX 78.00 Pfizer-BioNTech COVID-19 Vaccine EUA. Rec'd Pfizer-BioNTech COVID-19 Vaccine on 1/22/2021 and 3/3/2021. Presented to ER on 7/15 w/low grade fever, chills, runny nose, sore throat, chest tightness, and SOB, Covid+. Admitted for Covid PNA. CXR w/Cardiomegaly and improving patchy bilateral pleural effusions. CT of the chest Volume overload. Transferred to ICU for worsening hypoxia. Continuous BiPAP support, but no improvement and remained hypoxemic and encephalopathic. Transitioned to DNR. Expired 8/4/2022. Pt received cefepime, vancomycin, metronidazole, dexamethasone.
1624221 2407104 2022-08-10 TX 75.00 Pfizer-BioNTech COVID-19 Vaccine EUA Rec'd Pfizer-BioNTech COVID-19 Vaccine on 2/4/2021 and 2/25/2021. Transferred arrived with worsening hypercalcemia and acute hypoxic resp fail requiring BiPAP. Intubated and NG tube placed. Failed weaning trials. Had an A-fib with RVR event and hypotension. Transitioned to DNR/COT on 7/28. Continued on full vent support and became febrile. Pt expired 8/4/2022. Tx'd w/cefepime, vancomycin, meropenem, metronidazole, and dexamethasone.
1624171 2407053 2022-08-10 TN 78.00 Brought to ED on 8/3 from skilled nursing facility for altered mental status and Covid +. Had been admitted to Medical Center in July with septic shock, cholangitis requiring ERCP/biliary stenting and bacteremia. There was concern for Cholangiocarcinoma but unable to peform EUS and was to f/u OP. He was then sent to facility. On arrival to ED he was hypotensive. Labs- creatinine 1.4, alk phos 976, AST 224 and ALT 224. WBC s elveated at 26. Hemoglobin 8.7. Had UTI with blood cultures positive for kebsiella. Underwent CT of thorax , abdomen and pelvis showing cholelithiasis with gallbadder distentions concerning for cholecystitis. Biliary stent appeared in good position with dilatation concerning for cholangitis. General surgery consulted. After discussion with wife she decided to transition to comfort care. Palliative care and hospice were consulted. Comfort measures were initiated .
1624165 2407047 2022-08-10 TN 51.00 Presented to ED on 7/19 for respiratory distress. COVID + in February, 2 weeks before admission and on admission. On Chemo therapy since December 2021. Admitted on Vapotherm to maintain O2 level. 7/28 critical care consulted and patient was intubated for acute onset chronic hypoxic respiratory failure. Sputum culture on 7/22 showed pulmonary aspergillus. Treated with cresemba for funagal infection and broad spectrum antibiotics and COVID treatment. Became infected with pseudomonas which was treated with cefepime. Developed right-sided tension pneumothorax which was relieved by chest tube placed to wall suction.Final sputum culture showed extended spectrum cephalosporin resistant pseudomomas aerginosa. Pressor requirments included norepinephrine, epinephrine, vasopressin to maintain mean arterial pressure greater than 65. Ventilator settings increased to 100% FiO2. Cefepime changed to meropenum on 8/4, however patinet was in multi organ failure from septic shock. Changed from full code to intubate only. Due to continued deterioration family decided on comfort care on 8/4.
1624147 2407017 2022-08-10 died a week after getting the Pfizer shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), 1 week after the suspect product(s) administration, outcome "fatal", described as "died a week after getting the Pfizer shot". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: died a week after getting the Pfizer shot
1624220 2407103 2022-08-10 TX 85.00 Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Rec'd Moderna vaccine on 1/28/21 and 2/25/21. Recently dx'd w/covid 19 w/delirium on dementia, encephalopathy, and completed paxlovid. Upon assessment pt was with shallow breaths, cold extremities, and weak thready pulse. Nonrebreather mask was placed on pt, and during further examination became unresponsive resulting in a code and CPR. Intubated and transferred to ICU where he expired within minutes. Pt expired on 8/3. Tx'd with azithromycin, vancomycin, and zosyn, ceftriaxone, and paxlovid.
1624198 2407081 2022-08-10 68.00 pt became unresponsive/unconscious at home; family called EMS and started CPR; EMS arrived and took over CPR, ACLS protocol, intubated pt; family stated pt had been positive for COVID on 9/14/21 and had become more congested with dyspnea that day; EKG showed PEA then asystole; brought to ED with continued CPR; pt expired in the ED (Medical Center)
1624223 2407106 2022-08-10 TX 75.00 Pfizer BIO-NTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Rec'd Pfizer BIO-NTech vaccine on 9/1/21 and 9/22/21. Recent admission 7/16/22 for acute hypoxemic resp fail 2/2 covid-19 c/b acute encephalopathy, severe COPD and CKD3. Tmax 101.7, RR mid 20s, satting mid to high 90s on 4L. CBC and CMP wnl, Cr 1.44. Lactate and Procal wnl. Trop/BNP wnl. CXR negative D/c'd 7/20 and readmitted 7/20. EMS reported pt noted with SPO2 87% on room air, placed on 4L with resultant SPO2 100%. VS on arrival significant for RR 24, SPO2 91% on RA; BUN 32, Cr 1.44, K+ 5.3, PCO2 28, Ph 7.46, WBC 9.3, UA (-) for UTI; CXR with increased interstitial markings likely scarring at lung bases but no acute process. Transitioned to hospice. Expired 8/1/22. Tx'd w/decadron and cefepime over entire stay.
1624450 2407335 2022-08-10 52.00 6/16/22 EMS found pt down and unresponsive in house with a broken air conditioner, brought to ED; unsure how long she had been there; 6/14/22 pt had a positive COVID test from Walkin Clinic; intubated by EMS; admitted; rectal temp 107F; imaging showed COVID pneumonia and diffuse cerebral and cerebellum edema with effacement of sulci and basilar cisterns; experienced PEA; ACLS with ROSC achieved briefly before pt repeatedly had PEA; ACLS x4 with additional vasopressors added; pt transitioned to DNR and passed away in the hospital
1624478 2407364 2022-08-10 74.00 MODERNA COVID VACCINE #3 GIVEN /3/21, LOT #048F21A; pt to ED with SOB; found to be positive for COVID; CXR showed viral and atypical pneumonia; given IV steroids, anticoagulants, remdesivir; intubated with mechanical ventilation; ABX; pt's condition continued to worsen; transitioned to comfort measures; he passed away in the hospital
1624466 2407352 2022-08-10 67.00 pt to ED with dyspnea; found to be positive for COVID; Pulmonary Edema; admitted; given IV steroids and O2 supplementation; increase in anxiety; more hypoxic; placed on NRB; pt's condition worsened; suffered respiratory arrest requiring intubation; transferred to ICU with vasopressors; CTA of head/neck showed multifocal stenosis of intracranial arteries; critically ill; pt passed away in the hospital
1624224 2407107 2022-08-10 TX 70.00 Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Rec'd Moderna vaccine on 2/25/21, 3/24/21 and 11/26/21. Recent admit 7/24-26/22 for acute on chronic systolic HF, bacterial and crytogenic PNA, Covid (+ on 7/23), COPD exacerbation and CKD3. Readmitted on 8/1 for acute on chronic respiratory failure with hypoxia and PNA. Subsequently decompensated - transferred to ICU, intubated and placed on pressors. Developed rapidly worsening refractory pressor dependent shock and multi-system organ failure. Transitioned to comfort care. Expired 8/5. Tx'd with meropenem, cefepime, methylprednisolone, and nystatin.
1624421 2407306 2022-08-10 80.00 MODERNA COVID VACCINE # 3 GIVEN 8/31/21, LOT #058E21A; pt to ED with increasing SOB; O2 saturation between 83 - 85% on RA; found to be positive for COVID; COVID pneumonia with hypoxia; O2 supplement; given dexamethasone, budesonide, and breathing treatments; pt's O2 needs increased; increased lethargy and poor po intake; DNR/DNI; pt transitioned to comfort measures only and passed away in the hospital
1624308 2407191 2022-08-10 94.00 Presented to ED 7/2/2022 with increasing weakness, poor appetite, congestion. Antibiotic therapy with IV zosyn, zithromax. Defer IV steroids as patient with no hypoxia. Admitted to Memorial hospital. Previously admitted to the hospital 6/22/2022. Febrile illness was noted without an infectious process identified. He was sent to rehab but has not been participating in rehab. He is increasingly weak and fatigued. Transferred to Hospice on 7/3/2022 and died there on 7/8/2022. Cause of death is listed as Pneumonia due to Covid-19. Submitter does not have access to full medical record. If further information is needed, please contact hospital and hospice records.
1623382 2405709 2022-08-09 70.00 PFIZER COVID VACCINE #3 GIVEN 10/2/21, LOT #FF8839; pt to ED and noted to be positive for COVID; NSTEMI; given ABX; required mechanical ventilatory support; metabolic encephalopathy with sepsis, COVID pneumonia, AKI; pt's condition worsened; unable to wean from O2; family decided to transition pt to comfort care, inpatient hospice care where she passed away
1623086 2405373 2022-08-09 DIED; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, it was reported that. "Facts I know a nurse an plenty of ppl fully vaxed that's died regardless....so... On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This report was associated with product quality complaint: 90000245172.; Sender's Comments: V0-20220809549-covid-19 vaccine ad26.cov2.s-Died. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
1623168 2405460 2022-08-09 NY Died; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. An 83-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Died
1623322 2405646 2022-08-09 83.00 3/2/22 pt brought to ED from outpatient Hemodialysis Unit with episode of GI bleed; pt reports x 2 days; transferred for further evaluation; found to have a positive COVID test in ED, asymptomatic, placed in isolation; have record of first positive COVID test being 12/29/21 at Hospital; during the March hospitalization, pt experienced Atrial Fibrillation and was treated with medication; found to have a non-functioning Perm-A-Cath, replacement performed; elevated WBC, given ABX; pt coded x 3 rounds, asystole after pulse check; meds also given without success; pt passed away in the hospital
1623329 2405653 2022-08-09 75.00 pt had a positive COVID test on 8/17/21 at Medical Center; pt to ED on 8/31/21 with hypoxia, AMS, tachycardia; O2 sats 62% on RA; AHRF secondary to COVID; had a second positive COVID test on 8/31/21; placed on NRB mask; DNR/DNI; septic, given ABX; death appeared imminent; placed in hospice care where pt passed away
1623369 2405695 2022-08-09 84.00 Per medical record, patient had a positive COVID test on 1/11/22 while patient was in nursing home. Patient was nauseated; placed on ABX and Zofran; patient passed away in the nursing home.
1623342 2405667 2022-08-09 70.00 9/15/21 pt had a positive COVID test; 9/17/21 pt to ED with COVID pneumonia; had another positive COVID test in ED; respiratory status worsened requiring CPAP; transferred to ICU; given Dexamethasone, Remdesivir, Lovenox, ABX; pt's condition worsened requiring intubation and vasopressors, high ventilation support; renal function worsened; dc'd Remdesivir and biologic agents; transitioned to comfort care; extubated and pt passed away in the hospital
1623386 2405713 2022-08-09 TN 88.00 COVID-related death, breakthrough case
1623390 2405717 2022-08-09 70.00 limited medical records received on pt; pt had tested positive for COVID on 9/28/21;10/28/21 pt to ED and was DOA; no other medical information received
1623413 2405740 2022-08-09 85.00 pt lives in a nursing home; was dx with a positive COVID test on 1/29/22; placed in isolation; DNR; on O2 via NC; given Dexamethasone, ABX, Guaifenisen; pt found deceased in the nursing home
1623570 2405899 2022-08-09 MT 68.00 Patient hospitalized with COVID while vaccinated. Expired: 08/09/2022.
1623578 2405907 2022-08-09 WI 75.00 Per web report received from hospital. Patient with no significant past medical history, presented to the ED via ambulance for evaluation of altered mental status. The patient was somewhat of a poor historian. She was oriented to person and place. She recalled she went to a store for shopping. Patient did not know what happened next. She stated she was feeling fine and did not want to stay in the hospital. She was unsure why she is currently in the ED. Patient denied any headache, fever, or chills. Denied any chest pain, palpitations, nausea, vomiting, abdominal pain, diarrhea, or dysuria. Per ED documentation, patient was found with altered mental status in shopping center parking lot. Patient was brought via EMS to hospital for further evaluation. Record noted that patient's diagnosis of altered mental status/acute metabolic encephalopathy of unclear etiology. Hospital notes stated this could be related to COVID-19 infection. CT scan of the head was negative for any acute intracranial process. No focal signs of acute stroke. COVID treatment was instituted, and the patient was monitored for changes in mentation. Hospital note stated primary diagnosis of COVID-19 infection, symptomatic. Not hypoxemic. Chest x-ray showed mild right upper lobe pneumonitis. Note stated Labs showed lymphopenia and laboratory orders for inflammatory markers ordered. Patient was started on Decadron 6 mg daily due to symptoms and monitor. Oxygen supplementation was ordered p.r.n. Speech evaluation was ordered due to concern for aspiration. Additional diagnosis of hypothyroidism, untreated. Hospital not stated that it is unclear if this is contributing to her altered mental status. The patient was started on Synthroid. Hospital notes stated addition diagnosis of Bacteriuria, due to probable acute urinary tract infection present on admission. Patient was started on IV Ceftriaxone and follow up on urine culture ordered. Additionally, patient had a normal anion gap metabolic acidosis, hypokalemia, Hypomagnesemia, of which supplemental potassium and magnesium and IV fluids for hydration and acute kidney injury were given and BMP monitored. Hospital note stated abnormal LFTs. LFTs on admission with slightly elevated AST; could be from COVID 19 infection. Patient was monitored for deep venous thrombosis and was put on prophylaxis Heparin. Additional note stated the patient declined and patient transferred to Hospice and died on 1/10/2022 from complications of acute on chronic respiratory failure and covid pneumonia at 12:02 with family present.
1622636 2404394 2022-08-08 MI 64.00 Pt had been SOB for about an hour at the nursing home before being sent to ED. Pt became increasingly hypoxic and required BiPAP and was hypotensive. She was found to be COVID positive and was in lactic acidosis. Pt also had an NSTEMI.
1622520 2404276 2022-08-08 TN 73.00 Admitted on 7/21 with shortness of breath. Placed on Vapotherm in the ED and found bilateral confluent nodular consolidative pulmonary opacities on CT scan. Had a positive home COVID test on 7/18. Started on decadron and doxycycline and sent to critical care. Started remdesivir. ID was consulted and started on ceftaroline and zyvox due to concerns of superimposed bacterial infection with MRSA. On 7/24 family decided to make patient DNR. Switched from zyvox to daptomycin then to oxacillin also. Weaned patient down to 3L via nasal cannula. On 7/26 patient pulled our NG tube partially and aspirated. Desatted and required BiPAP and place on levophed for BP support. Family decided to move to comfort care.
1622587 2404345 2022-08-08 TN 46.00 Patient with hx of fibromuscular dysplasia and CVAs presented on 06/13/2022 with abdominal pain, vomiting, AKI, lactic acidosis and progressive shock, found to be COVID positive. Admitted and started on broad spectrum ABX, stress dose steroids. Patient started to develop severe back/abdomen pain and had CTA of chest and abdomen that was negative for PE. On 06/14/2022 had PEA arrest with prolonged CPR after ROSC was transferred to alternate hospital. On transfer patient was in profound chock, on three vasopressors, intubated, acidemic, anuric, profound lactic acidosis, rising AST and ALT and was unresponsive. ECHO showed global HK with EF 25%, troponin rising post arrest to 1.4. CXR showed bilateral infiltrate's in lower lobes. Patient expired on 06/14/2022.
1622599 2404357 2022-08-08 TN 75.00 Patient presented to Hospital by his family for worsening lethargy, SOB, and fatigue. Patient was admitted with acute on chronic combined CHF. Patient initially admitted to ICU for BiPAP. CT PE showing signs of pulmonary edema, pericardial effusion, and pleural effusion. CT head negative. EKG negative for acute ST/T ischemic wave changes. Patient was admitted to hospital services for further management and evaluation of acute hypoxic respiratory failure to acute on chronic combined systolic and diastolic CHF. Patient then tested positive for Covid 19 on 01/03/2022 and expired on 01/04/2022.
1622606 2404364 2022-08-08 TN 50.00 Patient admitted to Hospice for Malignant Neoplasm of Pancreas. Patient had shown progressive decline since hospital admission (Hospital) for Respiratory failure and COVID 19. Patient was sent to ER on 01/26/2022 after a MVA. CXR revealed sternal FX and right sided anterior rib fractures. Patient had increasingly encephalopathic during his admission and was oriented to person only. On 02/02/2022 patient became hypoxic with SPO2 in the 70s. Patient was placed on 15L oxymask with improvement. COVID 19 was positive. Family elected to transition to comfort care. Patient expired on 02/02/2022.
1622613 2404371 2022-08-08 TN 89.00 Patient was a resident of a Health Center. Patient tested positive for Covid-19 on 02/04/2022 at facility. Ordering provider: Dr. Patient expired on 02/11/2022.
1622628 2404386 2022-08-08 74.00 pt had a positive COVID test on 1/16/22 and was hospitalized, (name of hospital not in records) for COVID pneumonia; 1/27/22 pt to ED via EMS with increasing SOB; DNI; pt had a positive COVID test in ED; pt placed on face mask ventilation; given IV steroids and bronchodilators; admitted to ICU; end stage COPD; worsening respiratory distress; family decided on comfort measures for pt and inpatient hospice on 2/6/22; pt passed away in the hospital
1622522 2404278 2022-08-08 AR 13.00 Patient died on 03/03/2022, death was not considered COVID related.
1622667 2404427 2022-08-08 79.00 EMS brought pt to ED with increasing SOB; O2 saturation in 70s%; was found on the floor in house by EMS; may have been there x 2days; placed on NRB; rhabdomyolysis; diarrhea; found to be positive for COVID; intubated in ED and central line placed for vasopressor treatment; Decadron; AHRF; multiorgan failure; transferred to ICU; suffered PEA arrest; code called; ROSC achieved; family transitioned pt to DNR and pt passed away in the hospital
1622730 2404490 2022-08-08 TN 89.00 Patient resident of Home. Patient tested positive for Covid 19 at facility on 11/25/2021. On 11/29/2021 patient required 5lNC for oxygen support, was lethargic, with 0ML of UOP. Patient expired on 11/29/2021.
1622746 2404506 2022-08-08 TN 91.00 Patient with a hx of COPD and CHF presented to Medical Center on 12/31/2021 with SOB. In the ED patient was placed on BiPAP. Patient was started on Lasix for volume overload, procalcitonin was elevated, started on empiric meropenem. Patient tested positive for COVID 19 on 01/05/2022. Patient remained in hospital for isolation until 01/17/2022 and discharge to skilled nursing facility with possible hospice. Patient then admitted to Health Center with acute and chronic respiratory failure, acute on chronic systolic heart failure, COPE, CKD IV. Patient expired at facility on 01/28/2022.
1622767 2404527 2022-08-08 TN 46.00 Patient with a PMH of chronic bronchitis, morbid obesity, epilepsy, and T2DM. Patient presented to Hospital on 01/26/2022 with c/o a cold and cough, chest tightness, post-tussive emesis, and HA. In the ED patient tested positive for Covid-19. Patient was triaged and discharged home. Patient was sent home with albuterol inhaler. Patient expired at home on 01/30/2022.
1622822 2404582 2022-08-08 KY 93.00 Received Pfizer vaccines 02/23/2021, 03/16/2021, and 12/03/2021. 6/13/2022 - patient presented to the ED c/o weakness, cough, chest congestion and fever. Patient reports being exposed a few days prior to COVID-19. 6/14/2022 - received acetaminophen 1000 mg, dexamethasone sodium phosphate 10 mg, labetalol HCL 10 mg x 2 doses, bebtelovimab 175 mg from Hospital. 6/14/2022 - discharged home 7/23/2022 - patient expired at home
1622721 2404481 2022-08-08 TN 87.00 Patient with Hx of Ovarian cancer on chemotherapy, recurrent atrial flutter, , HTN, COPD, recent Covid PNA presented to with weakness and fatigue, with a recent hospitalization for COVID PNA. In ED patient afebrile, hemodynamically stable, soft BP, elevated Cr, mild hyponatremia, mild hyperkalemia, mild leukocytosis, troponin negative, BNP elevated, normal lactate. CXR no significant interval change in bibasilar opacities and probable small left pleural effusion. Patient was admitted for orthostatic hypotension/AKI. CXR later revealed moderate bilateral pleural effusions with overlying bibasilar airspace disease, atelectasis/PNA. Cardiomegaly and pulmonary vascular congestion consistent with CHF. Patient was treated with Cefepime and pulmonary toilet, desaturation requiring oxygen support. Patient expired on 02/24/2022.
1622924 2404684 2022-08-08 KY 74.00 Received Pfizer COVID vaccines 02/10/2021 & 03/03/2021. 07/20/2022 - Admitted to Critical Care @ local hospital. Tested positive for COVID. 07/22/2022 - Discharged home with hospice. 07/24/2022 - Patient expired
1622245 2403953 2022-08-06 This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Caller mentioned that her brother and sister took the Pfizer Vaccine shot and are both dead now and his best friend". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: No, medical inquiry was not forwarded. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202201034250 Same drug, same event, different patient; US-PFIZER INC-202201034251 Same drug, same event, different patient; Reported Cause(s) of Death: Caller mentioned that her brother and sister took the Pfizer Vaccine shot.
1622193 2403899 2022-08-06 brother and sister took the Pfizer Vaccine shot and are both dead now; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). This case refers to reporters sister. A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "brother and sister took the Pfizer Vaccine shot and are both dead now". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: Caller mentioned that her brother and sister took the Pfizer Vaccine shot and are both dead now and his best friend. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200036809 Same drug, same event, different patient;; Reported Cause(s) of Death: brother and sister took the Pfizer Vaccine shot and are both dead now
1622194 2403900 2022-08-06 This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "dead". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: Caller mentioned that her brother and sister took the Pfizer Vaccine shot and are both dead now and his best friend. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-PV202200036809 Same drug, same event, different patient; Reported Cause(s) of Death: dead.
1622250 2403958 2022-08-06 FL give this shot to people knowing that it kills them; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "give this shot to people knowing that it kills them". The date and cause of death for the patient were unknown. It was not reported that is unknown if an autopsy was performed. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200037222 same reporter/suspect drug/event, different patient;US-PFIZER INC-PV202200037221 same reporter/suspect drug/event, different patient;; Reported Cause(s) of Death: give this shot to people knowing that it kills them
1622249 2403957 2022-08-06 FL Your so-called vaccine which is not a vaccine has killed my brother and my sister; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "Your so-called vaccine which is not a vaccine has killed my brother and my sister". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200037221 same reporter/suspect drug/event, different patient;US-PFIZER INC-PV202200037223 same reporter/suspect drug/event, different patient;; Reported Cause(s) of Death: Your so-called vaccine which is not a vaccine has killed my brother and my sister
1621666 2402872 2022-08-05 61.00 pt on CPAP/BiPAP at home for COPD; pt to ED via EMS for increasing SOB; O2 saturation 75% on CPAP; tachycardia; tachpneic; respiratory distress; tested positive for COVID; given remdesivir and steroids; respiratory status worsened requiring intubation; pneumothorax; asystole, no pulse; ACLS performed; pt passed away in the hospital
1621268 2402313 2022-08-05 DIED; This spontaneous report received from a consumer via social media a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date in May/2022 (Three months ago), the patient died from an unknown cause of death and it was reported as "My brother died on Johnson and Johnson shot 3 month ago". It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220806378-covid-19 vaccine ad26.cov2.s- Died. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
1621494 2402543 2022-08-05 blood clots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant; death), outcome "fatal", described as "blood clots". The patient date of death was unknown. Reported cause of death: "blood clots". Clinical course: why Pfizer have the covid-19 vaccine and Paxlovid which are approved under an EUA at the same time. When will the FDA-approved vaccine labeled as "Comirnaty" be available. Will the Pfizer-BioNTech COVID-19 Vaccine product distributed under an EUA still be useable since the FDA has approved for Comirnaty. why Pfizer have the covid-19 vaccine and Paxlovid which are approved under an EUA at the same time. Caller is consumer that is asking "How can Pfizer have 2 EUA approved products Paxlovid, and Pfizer COVID 19 vaccine, that treat the same thing at the same time is there a loop hole here". Reporter stated that his wife's grandfather died of blood clots from a COVID vaccine. Reporter mentioned that many Conspiracy Theories during call and frustration with the system. Transmitting A/E information. Is there any information on the study that states people who received the vaccine had restructured DNA in their liver or Kidney cells, Does the MRNA shot alter the DNA of those that have been given it. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: blood clots
1621550 2402600 2022-08-05 CA 69.00 SLE; Death; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 69-year-old male patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 2, single (Lot number: EP7534) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Enlarged Prostrate" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Arm Left), administration date: 20Feb2021, when the patient was 69-year-old, for Covid-19 Immunization. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (hospitalization, disability, life threatening) with onset 17Mar2021, outcome "not recovered", described as "SLE"; DEATH (death), outcome "fatal". The patient was hospitalized for systemic lupus erythematosus (hospitalization duration: 60 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Nov2021) unknown. Therapeutic measures were taken as a result of death, systemic lupus erythematosus. The date and cause of death for the patient were unknown. Patient had not received any other vaccine in four weeks. Patient not had covid prior vaccination and was tested to covid post vaccination. Treatment of events was reported as multiple. Patient had no known allergies. The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Reported Cause(s) of Death: unknown cause of death
1621619 2402824 2022-08-05 TN 73.00 COVID-related death, breakthrough case
1621624 2402830 2022-08-05 OK 78.00 Patient tested positive for COVID 8/1/2022 after receiving two vaccines and one booster
1621638 2402844 2022-08-05 KY Patient contracted COVID despite being vaccinated
1621646 2402852 2022-08-05 81.00 1/20/22 pt brought to ED with increasing SOB; positive COVID test; (pt also had a positive COVID test on 1/12/22); COVID pneumonia; O2 supplementation; dexamethasone; AKI - IV fluids; pt was made a DNR/DNI, comfort measures; transferred to an inpatient hospice bed, where she passed away
1621658 2402864 2022-08-05 73.00 MODERNA COVID VACCINE #3 GIVEN 11/8/21, LOT #076C21A; 2/13/22 pt brought to ED with AMS; unresponsive, tachypnea, tachycardia; was intubated; pt had a positive COVID test on 2/12/22 at nursing home, but rapid COVID test was negative on admission; septic shock; metabolic and respiratory acidosis; given ABX, antivirals; experience cardiac arrest twice; pt expired after second cardiac arrest
1621663 2402869 2022-08-05 KY 56.00 Patient diagnosed with COVID 7/29/22
1621700 2402906 2022-08-05 79.00 MODERNA COVID VACCINE #3 GIVEN 11/16/21, LOT #065F21A); pt in nursing home; positive COVID test on 2/3/22; given dexamethasone; O2 ; pt passed away in the nursing home
1621748 2402954 2022-08-05 86.00 PFIZER COVID VACCINE #3 GIVEN 9/23/21, LOT #30145BA; limited medical records received on pt; 2/22/22 pt to ED via EMS after hitting head during a fall; pt became unresponsive en route to hospital; intubated in ED; CT head showed right basal ganglia hemorrhage and right occipital hematoma; hypertensive bleed; CT chest showed bilateral pneumonia; positive COVID test; pt transferred to ICU; 5 days later pt passed away in the hospital
1621755 2402961 2022-08-05 MI 55.00 7/20--8/2 57-year-old male, presented from Hospital with hypotension and shortness of breath. He entered Hospital for a "liver workup" and paracentesis. When he got hypotensive, he was transferred to facility. He also had 9000 cc ascitic fluid removed initially. He is COVID positive and is partially vaccinated. He is an ex-cigarette smoker with multiple comorbidities. His hemoglobin and sodium were low as was his CO2 and magnesium. His creatinine was elevated. The patient was treated initially with his usual medications including intravenous fluids, electrolytes, and he was started on Flagyl and vancomycin as well as Levophed for an initial low blood pressure. His low magnesium was replaced and he had positive MRSA in his nasal swab and was started on mupirocin. At this time, COVID isolation was removed. On 07/23, there was evidence of acute hypoxic respiratory failure and fluid overload. Hypotension with possible sepsis from urinary tract infection was noted. It is obvious he had decompensated cirrhosis with ascites and later required a second paracentesis. His hemoglobin initially dropped. He had evidence of bilateral pulmonary edema with a rising BNP and MRSA was in the respiratory culture. He was continued on Flagyl and Vancomycin, and electrolytes were replaced as needed. INR was as high as 2.9 and again, magnesium was low and had to be replaced. BNP went up to 836 and metabolic acidosis was noted as well as portal hypertension earlier, requiring Blakemore tube. Creatinine started to rise. Metabolic acidosis was present and he continued to deteriorate and hospice was inquired. His mentation was very poor and there was a question of anisocoria. A CT of the head was ordered, but he continued to deteriorate and on 08/01/2022, he was discharged to inpatient hospice. Upon hourly rounding patient assessed and unresponsive to verbal and tactile stimuli, pulseless, respirations and heartsounds absent. Pupils dilated, fixed, and unresponsive to light. Date and time of death pronounced on 8/2/22 at 0545.
1621780 2402987 2022-08-05 77.00 2/7/22 pt admitted to hospital in respiratory failure due to COVID pneumonia; positive COVID test on 1/28/22; limited medical records received; O2 supplementation; pt became more lethargic; condition worsened; transitioned to comfort care; hospice where he expired
1621796 2403003 2022-08-05 84.00 1/26/22 pt admitted to hosp with AMS and weakness; planned to dc to SNF on 1/31/22, but was found to be COVID positive; given dexamethasone, remdesivir; O2 supplementation; dc'd to SNF on 2/10/22; back to ED on 3/5/22 with increased confusion and urinary incontinence x 2 days; on baseline of O2 3 LPM via NC; increased O2 to 6 LPM via NC; admitted with acute bilateral pneumonia, acute respiratory failure; given IV fluids and ABX; condition worsened; placed on BiPAP; pt pulling BiPAP off requiring restraints; family made pt a DNR and then transitioed to comfort care; pt expired in the hospital
1621797 2403004 2022-08-05 MI 80.00 Patient with 3 COVID vaccines who admitted with positive COVID test. Hypoxic during stay. Patient died on 08/01/22. Provider d/c note: "81 YO F with hx CAD, PAF on eliquis, TAVR, who presented with facial swelling x1 day, 1 month of increasing generalized weakness and falls, poor appetite, and 1-2 weeks of cough (diagnosed with COVID on 7/17) was found to have parotid/right tonsillar/left hilar mass in setting of symptomatic COVID with hypoxic respiratory failure. Thoracentesis performed demonstrated exudative fluid with cytology preliminary showing NSCLC. EBUS recommended; however, cancelled due to increasing oxygen requirements without overt clear etiology. Thought of latter due to post obstructive pneumonia complicated by fluid overload in setting of HFpEF. Given suspected stage IV cancer with worsening quality of life, patient and family elected to transition to comfort measures, and patient passed at 6:41 this morning. "
1621847 2403056 2022-08-05 WI 87.00 Patient received the first dose of the Pfizer COVID vaccine on a Wednesday afternoon, and was monitored afterward. Nothing unusual was noted. Thursday patient had an unrelated doctor visit and septic arthritis in shoulder was assessed. Patient was baseline. Friday morning patient passed away unexpectedly.
1621872 2403081 2022-08-05 80.00 MODERNA COVID VACCINE #3 GIVEN 12/3/21, LOT #060H21A; pt had a positive COVID test on 1/26/22 from Walgreens in Cordova, TN; went to ED that day; was on RA and doing ok so he was dc'd to home; 2/12/22 pt back to ED via EMS with AMS and increasing SOB; O2 supplementation; CXR showed COVID; given ABX; in renal failure; DNI; admitted; dexamethasone; rapidly worsened; transitioned to GIP hospice; pt passed away in hospital
1621892 2403101 2022-08-05 58.00 1/27/22 pt had a positive COVID test from physicians office; 1/29/22 pt to ED via EMS with weakness, N/V; on RA; N/V treated with medication; dc'd to home; pt expired at home
1621907 2403117 2022-08-05 72.00 MODERNA COVID VACCINE #3 GIVEN 11/10/21, LOT #058F21A; Pt to ED via EMS with AMS and minimally responsive; O2 saturation 60% on RA; intubated on mechanical ventilation; admitted to ICU; septic shock; AHRF; ABX, steroids, remdesivir; family decided to withdraw care and pursue comfort measures; pt expired in the hospital
1621844 2403053 2022-08-05 77.00 PFIZER COVID VACCINE #3 GIVEN 8/30/21, LOT #FE3592; pt had a positive COVID test on 1/14/22 from medical facility; was being followed by a doctor; pt is immunosuppressed; 1/22/22 pt to ED; tested positive for COVID; pt has been having more dyspnea, weakness, and cough since COVID dx; hypoxic; O2 supplementation; given ABX, steroids; multifocal pneumonia; required intubation with mechanical ventilation; septic shock; poor prognosis; DNR; family chose to withdraw care and move to comfort measures; pt passed in the hospital
1620957 2401285 2022-08-04 81.00 pt had a recent hospitalization on 10/8/21 for COVID Pneumonia and respiratory failure; was positive for COVID on 10/8/21; was sent to Hospice; pt progressively declined; DNR; comfort measures only; pt found deceased in hospice facility
1620944 2401272 2022-08-04 78.00 MODERNA COVID VACCINE #3 GIVEN 11/2/21, LOT #071F; pt in Health and Rehab in city; 1/17/22 pt tested positive for COVID; placed in isolation room; given Dexamethasone, Vitamins C, D and zinc, Regen-COV; O2 supplementation; pt was found deceased in the rehab center
1620914 2401242 2022-08-04 76.00 MODERNA COVID #3 VACCINE GIVEN 10/28/21, LOT #076C21A; pt had a positive COVID test at Dialysis on 2/7/22; 2/8/22 pt brought to ED with increasing SOB; hypoxic; O2 supplementation; Remdesivir and Decadron; worsening respiratory status requiring BiPAP; pt was made a DNR; pt became unresponsive on dialysis and hypotensive; transitioned to comfort measures; pt expired in the hospital
1620931 2401259 2022-08-04 79.00 PFIZER COVID VACCINE #3 GIVEN 11/9/21, LOT #FE3590; 3/9/22 pt brought to ED via EMS for dyspnea, cough, weakness; saw PCP (Dr.) 3/8/22 with same sx; XRAYS done showing effusion right lobe; no other tx; O2 saturation 84% in ED on RA; positive for COVID; respiratory status worsened requiring intubation; became unresponsive and no pulse at one point, CPR given, code called; grave condition; pt appears to have GI bleed after NG Tube placed; septic; COVID pneumonia; given IV fluids, ABX, blood; transitioned to comfort measures only; extubated and pt passed away in the hospital
1621046 2401374 2022-08-04 77.00 9/22/21 pt brought to ED via EMS in cardiac arrest; CPR; intubated; shocked 4x; pt had fallen day before coming to ED and had hit his head;( also pt had been in hospital 10 days prior with COVID; positive COVID test on 9/12/21; was dc'd from hospital 5 days before coming to ED); family made pt DNR if he became pulseless again; pt coded and passed away in the ED
1620974 2401302 2022-08-04 80.00 MODERNA COVID VACCINE #3 GIVEN 10/25/21, LOT #012F21A; Patient had a hospital admission on 9/8/21 and was diagnosed positive for COVID; did not require O2 and no sx of COVID; Patient was weak with impulsive behavior and metabolic encephalopathy; out of isolation on 9/18/21; Patient was unable to tolerate oral intake; DNR; family with COVID and unable to care for Patient at home; requested inpatient hospice; Patient transferred to inpatient hospice where he expired.
1620936 2401264 2022-08-04 81.00 pt previously admitted to Medical Center on 8/23/21 with sepsis and respiratory failure; pneumonia; was given ABX, steroids and nebulizer tx; COVID test at that time was negative ; echocardiogram showed EF of 63%; esophagitis with esophageal ulcers; PE right main artery; 9/3/21 was transferred to Regional Medical Center for IVC filter; on O2 supplement; IVC filter placed; on 9/6/21 pt tested positive for COVID; pt's condition worsened and he was placed on comfort measures; he passed away in the hospital
1621050 2401378 2022-08-04 87.00 pt admitted to hosp with acute respiratory failure; found to be positive for COVID; COVID pneumonia; given remdesivir; O2 supplementation; hypoxia worsened; CXR showed worsening pneumonia; transferred to ICU; required intubation; condition worsened; pt was made a DNR and extubated; pt expired in the hospital
1621068 2401398 2022-08-04 86.00 2/2/22 pt had a positive COVID test; saw PCP and O2 saturation was 70% on RA; transferred to ED via EMS; increasing SOB, hypoxia, cough, dizziness, CP in ED; admitted; CXR showed bilateral pneumonia; on NRB; given ABX, Remdesivir, Dexamethasone; worsening respiratory status; pt requested comfort care only; pt expired in the hospital
1621060 2401389 2022-08-04 87.00 pt had a positive COVID test on 9/24/21; was weak and had increasing SOB; 9/30/21 pt went to hosp; O2 saturation 70%; placed on O2; pt's condition did not improve; 10/5/21 dc'd to hospice facility with terminal dx; DNR; pt passed away in hospice
1621117 2401447 2022-08-04 83.00 PFIZER COVID VACCINE #3 GIVE 9/14/21, LOT #FF2589; pt had a positive COVID test on 1/21/22 and was seen in the ED, dc'd to home; 1/25/22 back to ED with increasing SOB, nausea, productive cough; admitted; COVID pneumonia; given dexamethasone, remdesivir, baricitinib; O2 supplementation - NRB; DNR/DNI; transitioned to comfort care and she expired in the hospital
1621122 2401452 2022-08-04 WA 95.00 95 year old female, COD listed as 'terminal cerebral vascular accident event on comfort care', received recent booster dose 06/17/2022. previously had COVID in December 2021 1. Time from vaccination to onset: 12 days 2. Symptoms: weakness, pnemonia, stroke, unable to ambulate 3. Treatment: comfort care measures 4. Outcomes and recovery: died of 'terminal cerebral vascular accident event on comfort care; 07/02/2022
1620557 2400420 2022-08-03 74.00 PFIZER COVID #3 VACCINE GIVEN 10/27/21, LOT # IS NOT AVAILABLE; 3/14/22 pt sent to hospital after cardiac arrest; suffered anoxic brain injury; found to be positive for COVID; sepsis; transferred to ICU; suffered another cardiac arrest and pt expired in the hospital
1620305 2400153 2022-08-03 GA 2 other people/they died/They couldn't make to the hospital on time because the blood clot reach to their heart, they took the Pfizer vaccine as well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CORONARY ARTERY THROMBOSIS (death, medically significant), outcome "fatal", described as "2 other people/they died/They couldn't make to the hospital on time because the blood clot reach to their heart, they took the Pfizer vaccine as well". The patient date of death was unknown. Reported cause of death: "2 other people/they died/They couldn't make to the hospital on time because the blood clot reach to their heart, they took the Pfizer vaccine as well". It was not reported if an autopsy was performed. Clinical course:- Consumer stated that "Last year in Mar and Apr. she took the Pfizer vaccine (Captured as Unspecified), she took the first shot in Mar and 3 weeks later in Apr, in Oct of last year she developed a blood clot and she was hospitalized, she had to have emergency surgeries because blood clot was trying to get into her heart, she never went to the doctor, she was 59 years old(not confirmed further, hence, not captured in tab) right now and she was about to go 60 years old, never had a history of blood clot until she got the Pfizer vaccine. She was seeing 2 doctors for this problem, one with the heart doctor and one was a lungs doctor and when she went to the hospital, she was walking and she collapsed, and somebody find her almost died or whatever. She didn't want to go to the hospital but she collapsed again and then when they assisted that she needs to get into the ambulance and go to the hospital. He did a test scan of her head right, there was no problem. They did one of her heart and it says her heart was slightly enlarged in one of the side where as she had to go to the surgery, before they make a decision they did a scan of her lung, both lung. She never smoked a day in her life before up the blood clots were found. Consumer told that this vaccine did this blood clot to her. Right now, she doesn't have a history, her family doesn't have a history to the Pfizer vaccine, no problem. I am the one, alright I had to be hospitalized for about 2 to 3 days, they let me go and then I have to be on blood thinners so, I was supposed to be on blood thinners since last Oct and doctor made the decision to take me off, not take me off but to completely take me off but he says stop taking it for about a month or so. I went to another country, again almost died because the blood clot came back or whatever and I was told when I came back I was told and I went to the doctor and he did the blood work, the blood clot came back. She was complaining that I have to be on the blood thinners for the rest of my life because of your vaccine, the rest of my life. Apology is not accepted because you know what because I have 2 other people that I used to catch the bus with to go with the [state name] because I am retired now, they died. They couldn't make to the hospital on time because the blood clot reach to their heart, they took the Pfizer vaccine as well (Further not clarified). They didn't make it but I did but I don't think it was right and I will sue you guys because this is horrible, you know I have to be on expensive medications for the rest of my life and I was a healthy person, I was healthy and now I have to be on blood thinner Eliquis, do you know how much that cost? "She was in the hospital and almost died. Must be on Eliquis for the rest of her life. Doctor took her off Eliquis for one month and she almost died again when the blood clots came back. Must be on Eliquis for the rest of her life. When she called the first time, she was on vacation at the time and didn't have her vaccination card with her. ave her the lot number from the Eliquis medicine that she on now the first time she called. She must get this filled every 60 days. and she has insurance, and it is still 150 something dollars. Without insurance its 400 something dollars. Needs glasses when she was reading the LOT number because she was old. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: 2 other people/they died/They couldn't make to the hospital on time because the blood clot reach to their heart, they took the Pfizer vaccine as well
1620306 2400154 2022-08-03 GA 2 other people /They couldnt make to the hospital on time because the blood clot reach to their heart, they took the Pfizer vaccine as well; The initial case previously was missing the following minimum criteria: [Unspecified product]. Upon receipt of follow-up information on 29Jul2022, this case now contains all required information to be considered valid. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CORONARY ARTERY THROMBOSIS (death, medically significant), outcome "fatal", described as "2 other people /They couldnt make to the hospital on time because the blood clot reach to their heart, they took the Pfizer vaccine as well". The patient date of death was unknown. Reported cause of death: "2 other people /They couldnt make to the hospital on time because the blood clot reach to their heart, they took the Pfizer vaccine as well (Further not clarified)". It was not reported if an autopsy was performed. Clinical course: 2 other people that I used to catch the bus with, they died. They couldn't make to the hospital on time because the blood clot reach to their heart, they took the Pfizer vaccine as well. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201004865 same reporter/drug/event, different patient;; Reported Cause(s) of Death: 2 other people /They couldnt make to the hospital on time because the blood clot reach to their heart, they took the Pfizer vaccine as well (Further not clarified)
1620352 2400200 2022-08-03 AZ 54.00 This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) via COVID-19 Adverse Event Self-Reporting Solution. A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jul2022 at 14:00 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years, in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Cirrhosis of Liver" (unspecified if ongoing), notes: Other medical history: Cirrhosis of Liver. There was no known drug allergies. Concomitant medication(s) included: CIPROFLOXACIN; FUROSIMIDE. Vaccination history included: BNT162b2 (Vaccine Brand: Pfizer, Dose Number: 1, Vaccine Administration Date: 02Jul2022, Vaccine Administration Time: 01:00PM, Batch/lot number: Unknown, Unable to locate or read the details, Location of Injection: Arm Right), administration date: 02Jul2022, when the patient was 54-year-old, for COVID-19 Immunization. The following information was reported: DEATH (death, hospitalization) with onset 23Jul2022 at 22:00, outcome "fatal", described as "Died 36 hours later". The patient was hospitalized for death (hospitalization duration: 1 day(s)). The event "died 36 hours later" required emergency room visit. Therapeutic measures were taken as a result of death. Details were as follows: the patient died on 23Jul2022, at 10:00 pm. This resulted in a day of hospitalization. Treatment included ventilator/life support. The was no noted Covid prior vaccination, and the patient was not Covid tested post vaccination. The patient date of death was 25Jul2022. The reported cause of death was unknown. It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Reported Cause(s) of Death: Died 36 hours later.
1620441 2400303 2022-08-03 TX 78.00 Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna vaccine on 1/29/21, 2/26/21, 8/19/21, and 4/1/22. Presented to outside ER c/o progressive confusion since Covid infection 6/19/22. Vaccinated 4x, last booster 4/1/22. DX'd w/Covid 6/28/22, rec'd Paxlovid x 5/days. Normal head CT and CXR with multifocal PNA. Transferred to the ICU 7/6 for worsening mental status. Intubated failed attempts at extubation. Refractory shock w/worsening P/F ratios requiring max doses of multiple vasopressors c/b encephalopathy. Transitioned to DNR/AND. Patient treated with Paxlovid, Merrem, bactrim, micafungin, cefepime, and vancomycin. Expired 7/28/22.
1620500 2400362 2022-08-03 65.00 MODERNA COVID VACCINE #3 GIVEN 9/29/21, LOT #014F21A; 3/9/22 pt transferred to this hosp from outside hospital (name not known) intubated due to hypoxemia; ARF,; hyperkalemia; pt had a positive COVID test 1/23/22; pt still positive for COVID on 3/9/22; critically ill; no improvement; worsened condition; developed A Fib and was treated with medication; pt made a DNR and comfort care; pt expired in the hospital
1620572 2400435 2022-08-03 82.00 pt was in the local Hospital 2 days prior to coming to ED for COVID pneumonia; pt had a positive COVID test on 1/13/22 and 1/25/22; family refused rehab for pt after hospitalization; 2/9/22 pt saw PCP and was found to be extremely weak, dehydrated and malnourished; sent to ED; CXR showed multifocal pneumonia; admitted; AKI; given IV fluids, ABX; G tube placed; pt developed HCAP and sepsis; hypoxia worsened; family did not want "life support tubes"; pt expired due to respiratory failure secondary to bacterial pneumonia
1620582 2400445 2022-08-03 80.00 MODERNA COVID #3 VACCINE GIVEN 10/25/21,LOT # 011F21A; pt had a positive COVID test on 2/17/22 from Fast Pace Clinic in Lafayette, TN; 2/24/22 pt to ED with increasing SOB and productive cough; admitted; hypoxic; BiPAP; dexamethasone and ABX given; COVID pneumonia with ARDS; pt had a sudden cardiopulmonary arrest; ACLS protocol given; return of pulse 5 times; continued to have cardiopulmonary arrest; family decided to discontinue CPR and pt expired in the hospital
1620602 2400465 2022-08-03 75.00 8/17/21 pt had a cholecystecomy; pt back to hospital on 8/25/21 with increasing SOB, cough, poor appetite; family members positive for COVID; pt's COVID test came back positive; hypotensive; O2 supplement; remdesivir, dexamethasone, IV fluids; pt's condition worsened; transitioned to comfort care and sent home on hospice; pt passed away at home
1620623 2400486 2022-08-03 92.00 pt had been in a facility and experiencing HTN and electrolyte abnormalities; began to experience hallucinations; SpO2 was in the 60s% despite O2 supplementation at 7LPM via FM; pt had a positive COVID test on 2/7/22; DNR; transitioned to comfort care with a hospice referral; pt expired in hospice
1620632 2400495 2022-08-03 69.00 pt was found in his home by police, unresponsive with two bottles of empty medication beside him on the floor; nasotracheally intubated for respiratory failure; hypotensive; brought to ED; found to be positive for COVID; admitted; cardiovascular condition worsened requiring 3 vasopressors; Acute kidney failure; family decided to make pt a comfort care only; pt expired in the hospital
1619943 2399188 2022-08-02 TN 69.00 COVID-related death, breakthrough case
1619873 2399118 2022-08-02 83.00 pt first had a positive COVID test 12/2021; was admitted to hospital on 3/12/22 for septic shock due to HCAP and CAUTI; IV fluids and ABX given; no COVID symptoms and no treatment needed; hypernatremia; poor prognosis; transitioned to comfort measures; pt passed away in the hospital
1619884 2399129 2022-08-02 TN 69.00 COVID-related death, breakthrough case
1619889 2399134 2022-08-02 83.00 pt admitted to hospital with a positive COVID test on 9/7/21; COVID pneumonia; AHRF; BiPAP dependent; pulls off BiPAP and O2 saturations dip to the 30s%; restraints used to keep from pulling O2 off; sedated; unable to take po; transitioned to comfort care with inpatient hospice; pt expired in the hospital
1619895 2399140 2022-08-02 73.00 2/14/22 pt had a positive COVID test; 2/17/22 pt found at home by wife deceased in recliner; EMS contacted; sudden cardiac death; acute COVID 19; brought to ED
1619904 2399149 2022-08-02 55.00 MODERNA COVID VACCINE #3 GIVEN 3/9/22, LOT #003J21-2A; 3/15/22 pt to ED in cardiac arrest, PEA; ROSC achieved after arrival to ED; intubated and sedated; septic shock, UTI, chronic sacral ulcer infection, positive for COVID; started on ABX and dexamethasone; concern for anoxic brain injury; poor neurological prognosis; family chose to withdraw care and pt expired in the hospital
1619917 2399162 2022-08-02 76.00 8/28/21 pt brought to ED with increasing SOB over past 4 days; pt states 4 dy ago she had a positive COVID test at a local pharmacy; sx have worsened since; O2 saturation 76% on RA; O2 supplementation - BiPAP; had a positive COVID test; CXR showed cardiomegaly, multifocal pneumonia, bilateral pleural effusion; given remdesivir, steroids, ABX, bronchodilators; dc'd ABX and given Baricitinib; pt had HTN and panic attacks; pt's condition worsened; desaturation into 70s% on BiPAP; continued to worsened; hospice called in and pt passed away in the hospital
1619918 2399163 2022-08-02 WI 75.00 Patient is a 75 y.o. year old male with complex medical history including bladder cancer receiving palliative chemo, and percutaneous nephrostomy tubes and urostomy, CKD, CAD with hx of CABG, GERD, admitted after cardiac arrest in the field, coded and ROSC, now in CCU, also found to be covid + on admission.
1619936 2399181 2022-08-02 85.00 pt brought to ED with severe SOB, AMS, severe respiratory failure; O2 supplementation; admitted; found to be positive for COVID; given remdesivir, steroid, ABX; DVT LLE; given heparin; renal failure - dc'd remdesivir; developed hypotension; pt continued to be unresponsive; family made pt DNR/DNI; the following day the family decided to dc all treatment; pt passed away in the hospital
1620106 2399354 2022-08-02 TX 73.00 Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Rec'd Moderna vaccine on 1/25/21, 2/25/21, and 9/08/21. Presented to ED 7/10/22, Covid+ 6/28/22 c/o progressively worsening covid-19 sxs. 6/29 developed multitude of sxs including n/v/d, pleuritic chest pain & back pain a/w cough, weakness, fatigue, poor appetite, SOB, DOE, fever. Labs 7/10: glucoe 241, Cr 2.05, Na 134, CO2 21, NT-ProBNP 1022, HSTNT 26, ferritin 1342, WBC wnl, H/H wnl. CXR 7/10/22: Ill-defined hazy opacities bilaterally, suggestive of Covid-19 PNA. Transferred to ICU on HFNC - worsening ARDS. Tx'd for bacterial PNA (H. Influenza) and ntermittent HD for electrolyte and volume issues. Worsened despite steroids and inhaled epoprostenol and max Airvo. Respiratory condition worsened in first few days after intubation despite maximum therapy including paralysis and proning. On 7/26/22, status changed to DNAR. Tx'd with cefepime, micafungin, doxycycline, vancomycin, remdesivir, and decadron. Expired 7/26/22.
1619968 2399213 2022-08-02 91.00 pt had a positive COVID test on 1/27/22 and was hospitalized at Hospital; pt is a DNR; admitted to Hospice of Care Center, 1/28/22; pt's condition worsened since admission for COVID and respiratory distress; tachypnea; accessory muscle use; comfort care only; pt passed away in hospice
1619986 2399232 2022-08-02 84.00 pt admitted to hospital 3/6/22 for evaluation and treatment of PVD with subsequent left TMA a nd right hallux amputation; given ABX; decline in renal function - started on HD; positive for COVID; DNR; pt's condition continued to decline; admitted to hospice.
1619998 2399244 2022-08-02 71.00 6/1/22 pt sent to ED from Cancer Center after a syncopal episode and hitting head; SOB; signs of bilateral pneumonia respiratory failure and positive for COVID; O2 supplement; ABX, remdesivir, steroids; developed recurrent bleeding during hospitalization related to esophageal CA; pt's respiratory status worsened; recurrent bleeding; pt transitioned to comfort care and expired in the hospital
1620054 2399300 2022-08-02 65.00 PFIZER COVID # 3 VACCINE GIVEN 8/19/21, LOT #EW0172; 1/23/22 pt brought to ED via EMS with increasing SOB; states took at home COVID test 2 days prior to coming to ED and it was positive; has been checking O2 saturations at home and they've been between 88-92%; productive cough, mild chest pain; poor oral intake; positive test for COVID; O2 supplementation; CXR showed multifocal pneumonia; given Decadron, Remdesivir, Baricitinib; respiratory status worsened requiring intubation; vasopressor requirements increased; progressively worsening shock; pt lost pulse; CPR x 3 rounds; pt pronounced dead in the hospital
1620084 2399331 2022-08-02 TX 68.00 Originally admitted for septic shock and liver failure, found to have COVID pna several days in. Fully vaccinated 4/2021. Required mechanical ventilation. Steroids, rocephin, vanc, vit-c, vit-d, cefepime, zinc. Not a candidate for remdesivir due to liver failure. Transitioned to comfort measures and expired.
1620120 2399368 2022-08-02 TX 79.00 Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna vaccine on 2/10/21 and 3/10/21. Presented to ED c/o AMS, disoriented and nonverbal. Anorexic and only responsive to pain. Pt found to be hypotensive and hypoxic in ER despite 1L NS via EMS en route. No vomiting or diarrhea. Admitted for sepsis 2/2 to COVID and UTI. Went to septic shock and acute respiratory failure. Continued to worsen and transition to comfort care. Tx'd w/decadron and cefepime. Pt expired on 7/28/22.
1620121 2399369 2022-08-02 TX 50.00 Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer BioNTECH vaccine on 1/28/21 and 2/26/21. Tested covid + at home 7/1 was initially admitted to OSF 7/14 for SOB and COVID PNA. Intubated, started on ATBs for superimposed PNA, and transferred 7/20. Severe ARDS and requiring fio2 100% and pressors. Req'd dialysis 7/25. Resp status cont to decline req max vent support. Unable to maintain sats > 92% became increasingly acidotic req'd add'l vasopressors and bicarb for pH correction. Cont'd to decompensate. On 7/28 O2 dropped to consistently < 80%. Transitioned to comfort care. Tx'd with vanc, micafungin, decadron, and cefepime. Expired on 7/29/22.
1620145 2399393 2022-08-02 WI 28.00 Presented to ED 7/7/2022 with acute hypoxic respiratory failure, septic shock, and acute renal failure. Respiratory failure due to COVID19 pneumonia and ARDS. Reported malaise for 1 week and shortness of breath x1 day. In ED she was hypoxemic and placed on BiPAP with improvement in SpO2 to 90's. Anemia: Hgb 5.9 AKI: Cr 3.7. Intubated overnight on 7/7. Septic shock was treated with vasopressors, stress-dose steroids and broad spectrum antibiotics. Transplant ID consult. Treated with tocilizumab for severe COVID. Transplant pulmonology and advanced heart failure also consulted. Respiratory failure progressively worsened with high ventilator requirements. She was proned and paralyzed. Treated with veletri to improve oxygenation. On 7/13, vasopressor requirements acutely increased with worsening septic shock. She was also noted to have dilated and non reactive pupils. Placed on comfort care. Pronounced dead at 14:45 on 7/13/2022.
1619325 2397946 2022-08-01 TN 67.00 Patient with PMH for Parkinson's disease presented to ED with chest pain and SOB. Patient was diagnosed with Covid-19 on 11/04/2021 with symptoms starting two days prior. Patient was treated with monoclonal AB and doxycycline and CTA at the time was negative for PE. He returned home that day and returned on 11/19/2021 from his PCP office with PNA and weight loss, he was found to have a small right apical pneumothorax and opted to return home with repeat CXR on 11/22/2021 as outpatient which showed no change in pneumo size. He returned to ED on 11/25/2021 with CP and worsened by exertion and deep breathing. Also had cough with productive sputum and dyspnea. CT showed lower lobe PE with mild flattening of intraventricular septum, multifocal PNA, small bilateral pneumothoraxes, and pneumomediastinum. Patient was admitted to ICU for acute hypoxemic respiratory failure requiring high levels of Oxygen, and noted to be in Afib with RVR. Patient family decided to patient patient comfort measures. Patient expired on 12/09/2021.
1619277 2397896 2022-08-01 MN 89.00 Admission 7/28/2022 for COVID-19 +, weakness, COVID-19 with associated abnormal LFTs and elevated troponin. 7/30 he had acute decompensation of his respiratory status with rhonchi, hypoxia, low-grade fever, and significant work of breathing 7/31/2022 Death
1619220 2397837 2022-08-01 TN 76.00 Admitted on 6/5 with nausea, diarrhea and abdominal pain for several days. CT showed left hemiocolonic colitis with ileus, acalcuous cholecystitis, cholangitis, papillitis, possible cystitis. Surgery consulted and started on antibiotics. Symptom improvement but persistnet abdominal pain. Covid + 6/6. Underwent HIDA on 6/7 with lap choly scheduled on 6/8 but cancelled due to wrsening clinical status. signs of septic shock and had celiac artery stent graft placement and superior mesenteric arter stent placement.Was on heparin drip and had NG tube for decompression. Pallative care consutled due to poor clinical status and comorbidities. Patient and family decided no further agressive treatmetn and proceeded with comfort care on 6/22. Supported for his pain, anxiety, feedings and control of diarrhea.
1619279 2397898 2022-08-01 TN 76.00 Patient was a resident of Siskin Hospital for Physical Rehabilitation, recovering from CVA with ataxia, and tested positive for Covid-19 on 7/29/2021 and transferred to the Covid unit. Patient received Decadron and Monoclonal antibodies, placed on 4.5 liters of O2 NC. Patient expired on 08/13/2022.
1619291 2397911 2022-08-01 KY 77.00 Pt. was diagnosed with COVID 19 post immunization and passed away.
1619317 2397938 2022-08-01 TN 63.00 Patient with hx of bronchogenic carcinoma presented to ED at Hospital with SOB and feeling feverish. During transport the patient was placed on oxygen. Patient was admitted to hospital for respiratory failure; found to have progressive small cell lung cancer as well as post obstructive versus Covid-19 PNA. He was oxygen replacement for illness, and completed 7 day course of ceftriazone and doxycycline. Patient was also in Afib with RVR and converted with IV Bblocker. On 02/18/2022 patient had sudden cardiopulmonary arrest and code blue was called, and patient expired on 02/18/2022.
1619424 2398049 2022-08-01 TN 83.00 Patient presented to Hospital, at the urgency of his oncologist. The patient reported dyspnea for several weeks. In ED oxygen saturation at 77% RA, and he then tested positive for Covid-19. He was anemic, thrombocytopenic, mildly elevated troponin, and signs of renal failure. CXR showed interstitial and mild groundglass opacities concerning for pulmonary edema. CT angiogram of chest showed no PE, did reveal patchy interstitial and groundglass airspace disease. Patient was placed on BiPAP, he was found to be occult blood positive, and was transfused. Patient was transitioned to comfort care and expired on 09/28/2021.
1619405 2398029 2022-08-01 KY 78.00 Pt. was dx.'d with COVID and passed away.
1619418 2398043 2022-08-01 47.00 Required hospitalization in COVID + vaccinated patient
1619453 2398079 2022-08-01 85.00 Hospitalization for COVID 19 pneumonia in a patient with 2 COVID vaccines and one booster
1619414 2398039 2022-08-01 TX 77.00 Patient presented to the emergency room at the hospital the day of admission with complaints of shortness of breath. The patient was discovered to have an oxygen sat of 82% air. Initially the patient had improvement with supplemental oxygen in the ER. The patient did test positive for COVID-19.He was admitted to the critical care unit and initiated on IV antibiotics, dexamethasone, Remdesivir, the convalescent plasma as well as supplemental vitamin therapy. The patient was noted to be bradycardic and Cardiology was consulted and followed along. The patient was initially stabilized on 100% non-rebreather and subsequently placed on Vapotherm at 85% Fi02. He was then placed on continuous BiPAP. He subsequently had to be intubated on the night of 08/06. Patient expired on 09/02/2021.
1619085 2397685 2022-07-31 TN 49.00 Patient transferred to the hospital on 01/24/2022. PMH AML diagnosed 11/2020, s/p allogeneic SCT 3/2021, complicated by chronic GVHD of the skin, currently on Xospata and Tanolimus) and DVT (d/t PICC line, previously on eliquis, stopped 11/2021) who was admitted to the CCU for acute hypoxic respiratory failure due to COVID pneumonia. Patient says he has had symptoms for about a week- intermittent fevers, fatigue, and SOB. He went to an urgent care on 1/19 and was diagnosed with COVID. He received a prescription for molnupiravir Patient stated SOB has gotten progressively worse, to the point that it was hard just walking around the room. He was measuring his pulse oximetry at home and his SPO2 was in the 70s on room air. He went to the hospital and his room air Sp02 was 55%. This improved on 15L high flow NC with a NRB. Troponin was elevated at .06, lactic acid was 2.5. CTA chest was negative for PE. He received 1 L NS, albuterol, dexamethasone 10, azithromycin, rocephin. PT was transferred to CCU and placed on max vapotherm. Patient eventually intubated. Fungus noted in sputum. Patient terminally extubated on 02/20/2022 and expired shortly after.
1619103 2397703 2022-07-31 TN 87.00 Patient tested positive for Covid-19 on 06/30/2022 at the Hospital. Patient was then accepted to hospice on 07/02/2022. Patient arrived to hospital via ambulance from hospital accompanied by EMT's. Patient presented nonverbal, decreased, negative purposeful movement, lungs with rales throughout, abdomen soft with hypoactive bowel sounds, skin hot to the touch and pale, left and right hands with 3+ edema, 4LNC of O2. Patient presented actively dying. Terminal diagnosis at facility was Covid-19.
1619097 2397697 2022-07-31 TN 55.00 Patient history of renal transplant presneted to hospital on 02/23/2022 as a transfer with SOB, hypoxia in the setting of a recent diagnosis of Covid-19. Patient was admitted to ICU with acute hypoxemic respiratory failure 2/2 Covid PNA. She required high flow nasal cannula, and progressed to needing BIPAP and then required intubation. Patient was treated with steroids. Blood cultures negative for any type of new bacterial infection. Patient was treated empirically with antibiotics for most of her hospital stay as well and amphotericin given persistent shock and leukocytosis. She required CRRT for worsening renal failure. Patient continued to decline and was transitioned to comfort measures. Patient expired on 03/12/2022.
1619093 2397693 2022-07-31 TN 87.00 Patient presented to hospital on 06/08/2022 as a transfer from another Hospital for the management of Covid-19. Patient developed progressive hypoxemic respiratory failure requiring hospitalization in the ICU. She initially showed small improvement with dexamethasone and IV antibiotics, she ultimately developed worsened respiratory failure and oliguric renal failure. Palliative care consulted. On 06/21/2022 patient continue to decline and became unresponsive with worsened hypoxic respiratory failure. MRI did not reveal acute change and encephalopathy was felt to be 2/2 respiratory failure. Patient expired on 06/22/2022.
1619086 2397686 2022-07-31 TN 84.00 Patient arrived to Medical Center on 09/07/2021 for generalized weakness, chronic back pain, feeling tired and fatigued. Additionally, patient reports having nonproductive cough, sore throat, mild shortness of breath for about 2-3 weeks. She reports being vaccinated for COVID-19 in March 202t with Pfizer. She was tested positive for COVID-19 on admission. Chest x-ray showed developing left lower lobe pneumonia. She received Zosyn in the ED however antibiotics were deferred after admission since her procalcitonin was negative, and no significant leukocytosis was noted. She was placed on nasal cannula at 2 L, and started on Decadron. Cardiology was consulted to recommend regarding her cardioprotective agents that she does not want to take. CT chest PE protocol was deferred since her D-dimer was mildly elevated and considered within normal limit for her age. Patient did not qualify for remdesivir secondary to low creatinine clearance. On 09/09/2021, her oxygen requirement went up, and she was requiring 8 L nasal cannula to maintain saturations low 90s at rest and was having dyspnea exertion with ambulation. Due to increased 02 requirement, she was changed from Decadron to IV Solu-Medrol frequently, and also started on Baricitinib. Chest x-ray from 09/09/2021 showed patchy infiltrates and/or edema slightly worsened therefore she was given a dose of Lasix x1. She was seen by Cardiology and setting was okay for her to not continue her Entresto if the patient wishes not to take the medication. Alternative, Cardiology recommended starting the patient on low-dose ACE-inhibitor therefore she was started on low-dose lisinopril. Family decided on palliative care; patient expired on 09/17/2021.
1618588 2397151 2022-07-30 LOST MORE TO THE VAX; This spontaneous report received from a consumer via a company representative via social media (J&J corporate social media account) concerned multiple patients. The patients weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, multiple people were lost due to vaccine and died from an unknown cause. It was unknown whether an autopsy was performed or not. The reporter reported that, "I've lost some to the flu and lost more to the vax..check your news sources". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220752266 and 20220749737.; Sender's Comments: V0: 20220749758 -covid-19 vaccine ad26.cov2.s -LOST MORE TO THE VAX. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
1618427 2396529 2022-07-29 MI 86.00 Admission Date: 7/20/2022 PRESENTING PROBLEM: Gross hematuria [R31.0] Bilateral pleural effusion [J90] Acute cystitis with hematuria [N30.01] Acute diastolic CHF (congestive heart failure) (HCC) [I50.31] Renal carcinoma, right (HCC) [C64.1] Adenocarcinoma of left lung (HCC) [C34.92] Atrial flutter, unspecified type (HCC) [I48.92] Acute congestive heart failure, unspecified heart failure type (HCC) [I50.9] Acute on chronic blood loss anemia [D62] HOSPITAL COURSE: Patient is an 86 year old male with PMHx of severe pulmonary hypertension, chronic right sided heart failure, CKD3, DM2, COPD on home 2L O2, renal carcinoma who presented to the hospital with acute on chronic right sided CHF exacerbation and acute on chronic hypoxic respiratory failure. The patient was diuresed as he had significant lower extremity edema. He had an ECHO that showed severe aortic stenosis. He was also found during eating and drinking to be coughing and choking. SLP was consulted and recommended a dysphagia diet. His renal function also continued to decline during his hospital stay. Given his multiple chronic medical conditions as well as the need for a chronic dysphagia diet to prevent aspiration pneumonia, the patient stated that he would rather live a shorter life with risk of aspiration than have to have his diet restricted. The patient had untreatable cancer, worsening renal dysfunction, severe aortic stenosis, as well as worsening right sided heart failure and pulmonary hypertension. After much discussion with the patient and family, the decision was made to consult hospice. Hospice consulted and there were plans for discharge from the hospital to a long term care facility with outpatient hospice services. Unfortunately when patient had a screening COVID-19 test prior to discharge, it was incidentally positive so this delayed the patient's discharge. The patient had no symptoms of COVID-19, so this was likely an asymptomatic or prior infection. Patient continued to aspirate with meals and liquids. He became progressively more hypoxic during his hospital stay and was becoming increasingly more uncomfortable. Patient was treated for his pain and shortness of breath with oral morphine with good improvement. On the morning of 7/28, the patient became very lethargic and his O2 dropped into the low 70's despite nasal cannula. The decision was made at that time to support the patient and withdrawal care in the hospital. Patient was provided medications for comfort, Oxygen was removed and the patient died peacefully on 7/28, family was present at the bedside.
1618292 2396390 2022-07-29 TN 67.00 COVID RELATED DEATH; BREAKTHROUGH CASE
1617792 2395774 2022-07-29 DIED; This spontaneous report received from a consumer via social media (J&J corporate) from a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death. It was reported as "Sister in law was told she had 4 months to live, died 3 days later. It accelerates whatever you've got". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220749758.; Sender's Comments: V0: 20220752266 -Covid-19 vaccine ad26.cov2.s -DIED. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
1617787 2395769 2022-07-29 HEART ATTACK; This spontaneous report received from a consumer via a company representative via social media concerned a 38 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose not reported, 1 total (dose 1) administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced heart attack and died. It was unspecified if an autopsy was performed. It was reported that, "a young 38 year old friends daughter died of a heart attack". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On an unspecified date, the patient died from heart attack. This report was serious (Death). This case, from the same reporter is linked to 20220750085, 20220750036, 20220750301, 20220752074 and 20220752219.; Sender's Comments: V0: 20220750167-covid-19 vaccine ad26.cov2.s- Heart attack. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable; Reported Cause(s) of Death: HEART ATTACK
1617784 2395766 2022-07-29 PA RARE UNKNOWN HEART CONDITION; OFF LABEL USE IN UNAPPROVED AGE GROUP; This spontaneous report received from a consumer concerned a 17 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. The patient was 17 year old and received vaccine which was (off label use in unapproved age group). The drug was associated with Off label use. No concomitant medications were reported. On an unspecified date, the patient experienced rare unknown heart condition. On an unspecified date, the patient died from rare unknown heart condition. It was unknown whether the autopsy was performed. The reporter stated that, "I have close friends that work for J and J and their 17 year old son passed away from an rare unknown heart condition." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use in unapproved age group was not reported. This report was serious (Death). This case, from the same reporter is linked to 20220745936 and 20220745839.; Sender's Comments: V0: 20220746027- covid-19 vaccine ad26.cov2.s- rare unknown heart condition. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: RARE UNKNOWN HEART CONDITION
1617541 2395001 2022-07-28 TX 73.00 Moderna COVID-19 Vaccine EUA Rec'd Moderna COVID Vaccines on 1/21/2021, 2/20/2021, and 11/6/2021. Arrived to ED. Admitted for acute resp failure w/hypoxia, acute metabolic encephalopathy and dementia. Req'd intubation. Underwent bronchoscopy, PNA panel positive for Pseudomonas, E.coli and Klebsiella. Cont'd to deteriorate despite abx therapy and suffered from multi-organ failure. Continuous EEG with no seizure activity noted and CT head with no acute abnormalities. Pt w/AKI req dialysis. Given no significant improvement transitioned to comfort measures. Expired 7/22/2022. Tx'd cefepime, Zosyn, vancomycin, and dexamethasone.
1617221 2394638 2022-07-28 DEATH; This spontaneous report received from a consumer via social media, a company representative concerned a 55-year old female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number, expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, after taking vaccine the patient died from an unknown cause of death and it was reported as " their vaccine killed mg 55 year old friend. Its listed her cause of death on death certificate...yeah they are a great company alright. Great at causing death look at their lawsuit history, and for what. And you took the jab lol". And it was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220749895-COVID-19 VACCINE AD26.COV2.S- Death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
1617421 2394879 2022-07-28 MI 73.00 patient was admitted on 7/22/2022 to the LTACH with covid pneumonia on 7/22/2022, tested positive for COVID 19 on 7/19/2022, 7/24/2022 pt was on 4L NC for o2 needs, during toileting patient began to show a decrease in oxygen levels and Heart rate, and became unresponsive. code blue initiated and patient expired.
1617430 2394888 2022-07-28 MI 70.00 patient tested positive for COVID 19 on 7/1/2022, hemodialysis patient admitted on 6/28/2022 on 4 l NC, over the course of the first few days oxygen needs increased from NC to non-rebreather to bipap to high flow nasal cannula. patient was a DNR and expired on 7/24/2022.
1617471 2394931 2022-07-28 MN 92.00 Resident was vaccinated on 7/14/22 approximately 1430. Resident spiked temp of 102 , generalized weakness, lethargy, and increased confusion. 24 hours later. Resident went into clinic and was told per PA that symptoms were result of adverse reaction to COVID-19 vaccine. Resident continued to become weaker and ended up falling and was sent to ER and admitted to Hospital in 7/17/22. Resident was then started on comfort cares and passed away on 7/20/22. Unknown if cause of death was directly related to vaccine or if death was due to underlying conditions.
1617584 2395045 2022-07-28 TN 75.00 Admitted on 6/21 due to progression of renal failure in the setting of borderline acute T-cell medicated rejection undergoing steroid treatment. Covid + and found to have pneumonia. Started on dexamethasone, remdesivir contraindicated due to renal failure. Started on dialysis. In ICU for several days due to respiratory failure then improved some. Remained on Vapotherm at 40% with flow rate of 40 L/Min. Completed a treament course of ceftiaxone for bacterial pnuemonia. Unfortunatley oxygen requirements and inflammatory marks increased with worsening Chest x-ray. Resumed ceftriaxone. Pallative care consulted and family decided on comfort care based on patient's wishes.
1617543 2395003 2022-07-28 TX 79.00 Moderna COVID-19 Vaccine EUA. Rec'd Moderna COVID Vaccines on 1/21/2021 and 2/26/2021. Arrived to ED for subdural hematoma and AMS, COVID + but relatively asymptomatic. ID consulted. Persistent AMS and confusion. Hospital course c/b hypernatremia 2/2 central DI. Nephrology consulted DDAVP started w/improvde NaCl. course c/b Covid PNA w/hypoxia req intubation, cont to decline. Transitioned to comfort care, expired 7/24/2022. Given cefepime, vancomycin, dexamethasone, and remdesivir.
1617544 2395004 2022-07-28 TX 70.00 Moderna COVID-19 Vaccine EUA Rec'd Moderna COVID Vaccines on 2/9/2021 and 3/9/2021. Presented to ED with malaise, SOB, COVID+ not hypoxic, thrombocytopenic, c/b AKI. Course c/b acute encephalopathy, metabolic acidosis, pancytopenia, worsening AKI, acute PE, and diverticultis. Hemodynamics worsened. Transitioned to comfort care. Expired on 7/24/22. Tx'd with Decadron, ceftriaxone, and zosyn.
1617545 2395005 2022-07-28 TX 82.00 Pfizer-BioNTech COVID-19 Vaccine EUA Rec'd Pfizer COVID Vaccines on 4/29/2021, 5/20/2021 and 11/22/2021. Presented to ED on 7/3 with SOB and malaise 2/2 COVID in a-fib with RVR in 150s tx'd w/amiodarone gtt w/improvement. O2 saturation down to 82% req'd NC. During stay pt also experienced KI. Pt cont'd to decline. Rapid response called 7/14 for a-fib and increasing O2 requirements. Transitioned to comfort care and moved to inpatient hospice. Expired on 7/18/22. Pt was tx'd with cefepime, ceftriaxone, remdesivir, and decadron.
1616854 2393219 2022-07-27 62.00 1/27/22 pt comes from ED; admitted to Medical Center with c/o feeling ill on 1/26/22 - fatigue, cough, congestion, SOB, dyspnea with exertion; O2 saturation 80% on RA; O2 supplementation; positive COVID test; BiPAP; given Decadron, ABX; transferred to ICU; DNR; status changed to DNR comfort care only; pt expired in the hospital
1616770 2393121 2022-07-27 76.00 Pt had a hospitalization on 11/1/21 after a positive COVID test; COVID Pneumonia; treated; had increasing O2 needs; 11/25/21 dx with bacterial pneumonia and interstitial fibrosis; 12/10/21 comfort care due to dyspnea, chest pressure, full body pain; pt terminal due to respiratory failure secondary to COVID 19; pt transferred to hospice where she passed away
1616776 2393127 2022-07-27 85.00 pt had been admitted to Hospital positive for COVID and respiratory failure; NRB and BiPAP; treated aggressively without improvement; became unresponsive, not eating or drinking; family requested comfort care; hospice; transferred to Hospice where he passed away
1616782 2393134 2022-07-27 75.00 1/5/22 pt initially taken to ED; found to be positive for COVID; increasing sx of cough, fever, SOB; treated with Remdesivir and ABX; 1/9/22 taken to different Hospital for further treatment and care; AHRF due to COVID pneumonia; BiPAP; transferred to ICU and required intubation; pt became DNR; pt's condition worsened and transitioned to comfort care; pt expired in the hospital
1616812 2393169 2022-07-27 61.00 11/29/21 pt had a positive COVID test at Hospital; she was admitted for increasing SOB and fatigue; treated with Augmentin; transferred to other hospital for further care; O2 saturation 83% on RA; given O2 supplementation; dexamethasone, ABX, remdesivir; CTA of chest revealed lymphovascular distribution of micronodules; pt's respiratory status worsened; critically ill; dependent on Vapotherm and NRB intermittently; eventually required intubation; AKI; condition worsened; pt was found without vital signs
1616833 2393195 2022-07-27 73.00 12/3/21 pt admitted to hospital after having a positive COVID test on 11/30/21 at SNF; sx of generalized weakness; acute septic encephalopathy; COVID test in the hospital was positive as well; AKI; steroids; no O2 needed; ATN due to COVID; MRI of the brain showed new lesion in right parietal region; recommended ABX and no steroids; pt status changed to DNR, comfort measures; pt passed away in the hospital
1616845 2393209 2022-07-27 88.00 pt brought to hospital ED after a fall at home; son reports generalized weakness and increased falling over last week; found to have a positive COVID test; COVID PNA; given dexamethasone; developed fever and worsening respiratory failure; O2 supplement; transitioned to comfort care and pt expired in the hospital
1616766 2393116 2022-07-27 65.00 pt brought to ED via EMS with increasing SOB; found to be positive for COVID and hypoxia; cough; worsening hypoxia; O2 supplementation; Dexamethasone; Remdesivir; pt's condition continued to decline despite measures taken to improve status; ICU; acute renal failure; suffered cardiopulmonary arrest and did not survive
1616917 2393282 2022-07-27 62.00 pt had a positive COVID test on 11/29/21 from clinic; 12/4/21 pt brought to ED in full cardiac arrest after EMS called for increasing SOB; EMS found pt down and started CPR; pt did not survive
1616911 2393276 2022-07-27 76.00 pt brought to ED in hospital via EMS with CPR in progress; pt never regained pulse, PEA on monitor; pt had a positive COVID test on 1/24/22 from family practice
1616950 2393316 2022-07-27 TN 89.00 Date of death: 7/26/2022 COVID + death Admitted on 7/22/2022 Tested positive: 7/22/2022 Admit diagnosis: Respiratory Distress
1616954 2393320 2022-07-27 86.00 8/28/21 pt was seen in the ED with a positive COVID test; monoclonal antibodies administered during the ED visit; pt was dc'd to home; 9/6/21 pt returned to ED via EMS with increasing SOB; sx have worsened over the last few days; O2 supplementation; pt having fever, nausea and vomiting; poor oral intake; COVID pneumonia; given remdesivir, dexamethasone, ABX; pt had a pulmonary embolism; sepsis; pt made herself DNR/DNI; comfort care measures; she passed away in the hospital
1616969 2393336 2022-07-27 75.00 PFIZER COVID VACCINE # 3 GIVEN 10/22/21, LOT #FE3590; pt states she had a positive home COVID test on 1/6/22; has had a cough and generalized weakness; 1/11/22 pt to ED with worsening sx; O2 saturation in 80s%; given dexamethasone, Vitamin C; pneumonia due to COVID; AHRF; pt's respiratory condition worsened requiring intubation; developed streptococcus bactremia; given IV ABX; on maximum ventilator support; pt's condition continued to worsened; transitioned to comfort care; pt expired in the hospital
1616977 2393344 2022-07-27 95.00 EMS called to pt's house due to confusion and generalized weakness; O2 saturation 62% on RA; placed on NRB; cold-like sx x8days; increase in O2 needs; placed on BiPAP; positive for COVID; AHRF; Pneumonia due to COVID; given Decadron, ABX, Remdesivir, Baricitinib; DNR/DNI; pt took BiPAP off several times; eventually was transitioned to comfort care; pt passed away in the hospital
1616987 2393354 2022-07-27 91.00 EMS called to pt's house due to fever, generalized weakness, cough, myalgias; O2 saturation 88% on RA; O2 supplement; found to be positive for COVID; admitted; AHRF secondary to COVID pneumonia; Decadron; US showed DVT left peroneal; started on Eliquis; placed on BiPAP; developed left pneumothorax, Chest tube placed; pt changed status to DNR/DNI, comfort measures only; pt expired in the hospital
1616929 2393295 2022-07-27 67.00 MODERNA COVID VACCINE #3 GIVEN 10/27/21, LOT # 076C21A; 1/6/22 pt to ED with malaise, fatigue, generalized weakness; found to be in SVT requiring cardioversion; septic shock with bilateral pneumonia requiring intubation; able to be extubated; 1/14/22 found to be positive for COVID; treated with steroids, ABX, Vitamin D and zinc; pt suffered cardiac arrest, ROSC achieved; enterococcal bacteremia; UTI; placed on BiPAP; respiratory status worsened requiring reintubation with mechanical ventilation; pt expired in the hospital
1616491 2391090 2022-07-26 99.00 11/2/21 pt had a positive COVID test; 11/7/21 pt to ED with AMS and in respiratory distress requiring intubation with mechanical ventilation upon arrival; positive COVID test; developed worsening shock; transferred to ICU; pt expired in the hospital
1616375 2390968 2022-07-26 59.00 pt brought to ED via EMS with dyspnea, diarrhea, hypoxia; O2 saturation 70% on RA; placed on NRB; found to be positive for COVID; pneumonia due to COVID; AHRF; treated with steroids, Remdesivir, Baricitinib; respiratory status worsened requiring BiPAP then intubation; transferred to ICU; AKI; was made DNR; pt's condition worsened and he expired in the hospital
1616391 2390984 2022-07-26 81.00 pt had a positive COVID test on 9/30/21 from Senior Living; 10/8/21 brought to ED with AMS and seizure like activity; pt had to gone to receive monoclonal antibody infusion, but had a change in mental status and was sent to ED before receiving infusion; pt tested positive for COVID in hospital; CT of head showed no acute findings, chronic left cerebral infarct; given O2 supplementation; pt suffered cardiac arrest twice, intubated, sent to ICU; was then made DNR and passed away in the hospital
1616398 2390991 2022-07-26 72.00 pt brought to ED with CPR in progress; CPR had been started 30-40 minutes prior to EMS call; code called to stop after 1 hr. 15-30 mins after initially started; reported to be positive for COVID; pt had a positive COVID test from hospital where pt was staying
1616406 2390999 2022-07-26 50.00 9/29/21 pt admitted to hospital with osteomyelitis; has been receiving out patient IV ABX; diarrhea and fever; dx with positive COVID test on 10/5/21; worsening respiratory status requiring intubation; AHRF; transferred to ICU; condition still worsened with acute renal failure in the setting of CKD; developed UTI - given ABX; developed fever; refractory shock and expired in the hospital
1616423 2391016 2022-07-26 52.00 pt admitted to hospital and had a positive COVID test on 10/20/21; given Remdesivir, dexamethasone; COVID pneumonia treated with ABX; pt spiked a fever; sepsis; hypoxic respiratory failure; ICU for worsening hypoxia and altered mental state; on BiPAP; pt began refusing nutrition and medical treatments; mental status deteriorating; became unresponsive; DNR/DNI; compassionate withdrawal of support after discussion with Ethics board; pt expired in the hospital
1616432 2391025 2022-07-26 79.00 pt's wife dx'd with COVID 2 wks prior to pt coming to ED; 11/1/21 pt admitted to hosp with worsened altered mental state; cough; 11/5/21 pt found to be positive for COVID; given remdesivir, Decadron, O2 supplementation; able to be weaned to RA; pt refused to eat or drink; family refused NG tube or PEG tube; given IV fluids to stay hydrated; transitioned to comfort measures and pt expired in the hospital
1616414 2391007 2022-07-26 87.00 pt brought to ED 11/23/21 after multiple falls at home; increasing SOB (on O2 2L via NC at home) with slightly productive cough; 11/23/21 pt test negative for COVID; has UTI; right middle lobe pneumonia; given ABX; 11/27/21 pt tested positive for COVID; using O2 supplement; pt became pulseless and expired in the hospital
1616524 2391125 2022-07-26 82.00 pt brought to ED with increasing SOB, cough, fever, headache; EMS states pt's O2 saturation between 68-80% in route; positive COVID test; admitted with AHRD secondary to COVID; O2 supplementation; DNI; given dexamethasone; worsening hypoxia; family transitioned pt to comfort care; pt expired in the hospital
1616543 2391144 2022-07-26 63.00 pt brought to ED from dialysis center after increasing SOB; dialysis had not been started yet; tachycardia; given O2 supplement; pt had a positive COVID test; pt developed CP and dyspnea; taken to cath lab and determined to have a distal embolus in distal LAD near apex of the heart; pt experienced cardiopulmonary arrest multiple times the day before and the day of her death; after multiple episodes, resuscitative measures were stopped and pt passed away in the hospital
1616577 2391178 2022-07-26 70.00 12/1/21 pt had a positive COVID test and was admitted to hospital for COVID PNA; dc'd to home due to not requiring O2; 12/8/21 pt to ED via EMS again for worsening sx - increasing SOB, cough, weakness, diarrhea; O2 saturation 78% on RA; give O2, steroids, ABX, Remdesivir; pt's condition declined and he was placed on comfort measures and passed away in the hospital
1616594 2391196 2022-07-26 74.00 Pt had a positive COVID test on 12/28/21; 1/2/21 another positive COVID test; EMS called to pt's house after wife (who was COVID positive) found the pt down; pt brought to ED cardiac arrest; CPR, ACLS protocol; intubated; defibrillated; pt expired in the hospital; found to have another positive COVID test
1616637 2391400 2022-07-26 IL 69.00 Acute Myocardial Infarction 48 hours after vaccine with cardiology and electrophysiology evaluations cleared patient within 2 months prior. Medically he was doing well - sudden death is unexplained other than a surprise coronary thrombosis induced by the COVID vaccine in a patient with known CAD.
1616532 2391133 2022-07-26 57.00 11/19/21 pt had a positive COVID test (outpatient) at facility; 11/23/21 pt to ED with AHRF; right leg hematoma after a fall; given Decadron, Remdesivir, Baricitinib; pt became hypotensive in spite of vasopressors; hemorrhagic shock; transferred to ICU; pt's condition continued to deteriorate; pt chose comfort care and passed away in the hospital
1616041 2388181 2022-07-25 64.00 pt to ED unconscious and unresponsive; required intubation; found to be positive for COVID; CXR with multifocal PNA; Head CT showed acute bleed; CT of abdomen and pelvis showed cirrhosis and portal HTN; pt had fever; transferred to ICU; given Decadron, ABX, Remdesivir; extubation a success; sudden change in mentation; code called; cardiac arrest; ACLS, chest compressions, rescue meds, shocked several times without success; pt passed away in the hospital
1615966 2388100 2022-07-25 KY 86.00 Hospitalized for COVID 19 on 6-22-22 and died on 7-18-22
1615988 2388124 2022-07-25 80.00 pt had a positive COVID test on 9/24/21; pt in GIP for dyspnea and agitation; COVID pna; pt found deceased in his room in Hospice.
1615991 2388127 2022-07-25 KY 86.00 Hospitalized on 5-23-22 for COVID 19 and died on 7-4-22
1616000 2388136 2022-07-25 79.00 pt had a positive COVID test 9/2/21; pt in hospice; pt expired in hospice on 10/3/21
1616012 2388151 2022-07-25 MI 60.00 Patient with 2 prior Moderna vaccinations who admitted to hospital with encephalopathy and positive COVID PCR. Provider and d/c summary below: "61-year-old female history primary lung cancer with metastasis including brain, chronic obstructive pulmonary disease, current nicotine use vaping, daily EtOH use, and steroid induced hyperglycemia presented to the ER on 07/23 for worsening swelling and pain in her right lower extremity. Prior ER visit 2 days prior, concern cellulitis, started doxycycline and discharge. RLE swelling did not improve. She presented to the ER by EMS which found the patient hypotensive in the field with blood pressure 73/50, heart rate 119, and hypoxic 73%.... Disposition: Patient's current clinical picture appears poor. Circulatory shock likely multifactorial, will continue volume resuscitation with vasopressor augmentation. S/p 2.6L normal saline from ER. There is concern for severe sepsis with blood cultures pending and broad-spectrum antibiotics started. Hypoxia is also multifactorial in the setting of metastatic lung disease, chronic obstructive pulmonary disease, and COVID-19 infection. Her AKI precludes remdesivir use. Monitor non oliguric AKI, likely circulatory shock/poor RBF vs carboplatin induced in nature. Patient remains DNR/DNI." "Upon arrival to the intensive care unit, she became more encephalopathic with increasing O2 needs. I discussed patient's case with her daughter who is the POA and very clear on her mother's wishes of DNR/DNI status. The patient initially started on Levophed via MRI port which was being used for chemotherapy. Most recent chemo 07/20/2022. She had already received 2.6 L normal saline from the ER and showing significant signs of volume overload though likely remained intravascularly depleted. This vasoressor was quickly escalated and required addition of vasopressin. I called the daughter again to inform her that patient was showing signs of multi-system organ failure and clinically declining very rapidly. Advised that she should come to the intensive care unit as soon as possible. She was present with her 2 sons. Patient became more hypotensive, apneic, then passed away"
1616088 2388228 2022-07-25 59.00 pt to ED with cough and increasing SOB; O2 saturation 60% on NRB; intubated in ED; found to be positive for COVID; pt developed ileus; fever; bilateral DVTs; pt's condition worsening; requiring multiple vasopressors; multisystem organ failure; transitioned to comfort care; extubated and pt expired in the hospital
1616046 2388186 2022-07-25 MI 68.00 Patient with 3 Moderna COVID vaccinations who admitted to hospital with complications from COVID and positive COVID PCR. Patient d/c'd to ALF and then returned 2 days later and subsequently died. Provider d/c notes from initial and second admission below: Initial: "69 YO male with h/o Alzheimer's dementia, hypothyrodism, GERD presenting to the ED for evaluation of AMS. Patient unable to provide any hx due to his baseline cognitive impairment. Entire hx obtained via chart review, calling co-POAs. Per one POA, patient is able to open eyes and could answer some questions in one word ""on a good day"". Able to tolerate regular diet with assistance though chronically bedbound. Patient currently appearing comfortable though with signs of respiratory distress. Opens eyes to noxious stimuli but unable to answer questions or follow commands. In the ED, pt is febrile to 102.2F, tachycardic. O2 sat 80% on RA, placed on 3L O2 with improvement though remain tachypneic. Lab work grossly unremearkable other than mildly elevated troponin, with negative delta. COVID positive. CT head, abd/pelvis, CXR nonacute. During his admission he required ventimask supplemental support but was quickly weaned to room air with dexamethasone and IV remdesevir. His mentation also improved and was at baseline per his caregiver and sister in law. He was discharged back to his AFC in stable condition with strict return precautions. " ED visit: "0001 69-year-old male presents after being found unresponsive in his AFC home, food and vomitus in the oropharynx, intubated by EMS due to poor oxygen saturation, in the 80% range, not improved after bag-valve-mask. Intubated without medications. Continued to remain unresponsive for EMS, arrived intubated, patient had bilateral breath sounds, significant emesis and food material in the oral airway. Patient febrile on arrival, slightly hypotensive, given a 500 mL fluid bolus. ET tube exchanged due to significant debris in the tube, chest x-ray confirmed new tube position. Oxygen saturations in the 90% range on 100% FiO2. On exam patient unresponsive, no spontaneous eye opening, no spontaneous movement of extremities, lower extremities withdraw to pain bilaterally. No response to pain to upper extremities. Broad array of laboratory studies sent, plan to obtain CT scan of head, neck, chest abdomen and pelvis 0035 Spoke with his sister and next of kin, who confirmed his wishes of DNR/DNI and that she would prefer to have him treated palliatively only with no aggressive measures, and comfort care only. 0053 Dr. has specifically discussed terminal extubation with patient's family, which is their wish. Will order palliative pain medication and extubate the patient, stop IV norepinephrine and propofol 0240 Prior to discussion about terminal extubation and comfort care, patient was given a dose of Zosyn, briefly was placed on Levophed to improve his blood pressure, given a dose of Tylenol IV for his fever. Started on minimal dose of propofol for the sedation. We were able to reach patient's medical decision maker prior to obtaining CT scan, after having the conversation about terminal extubation and comfort care, will not obtain the CT scan. 0242 All of patient's IV infusions have been stopped, he has been extubated, still with spontaneous respirations, placed on non-rebreather for comfort care, heart rate and oxygen saturation both in the 90s. Page placed to hospice team to discuss inpatient hospice admission for comfort care 0248 Patient beginning to desaturate, oxygen saturation in the 50% range 0257 Patient has died at 2:55 a.m., patient without a pulse, no heart tones auscultated. No pupillary response. Patient's Primary care team and medical examiner notified."
1616106 2388247 2022-07-25 72.00 9/6/21 pt brought to ED with cough, fever, increasing SOB; had a positive COVID test on 9/1/21; pt states his test was on 8/25/21; did receive Regeneron injection; steroids, vitamins C & D and zinc given; respiratory status worsened requiring ventilator; status did not improve; transitioned to comfort care; pt expired in the hospital
1616115 2388256 2022-07-25 38.00 pt in hospital from 9/10 - 9/28/21 - brought to ED for unresponsiveness; cardiac arrest in ED; intubated; ROSC achieved; pt had a stroke; transitioned to DNR; pt self-extubated and placed on BiPAP; no improvement; 9/14/21 pt had a positive COVID test in the hospital; transitioned to comfort care; GIP hospice; transferred to Hospice center 9/28/21 where she passed away
1616225 2388369 2022-07-25 KY 69.00 Patient received COVID19 vaccine on 03/16/2021; no booster doses given. Patient tested positive for covid19 on 07/07/2022, admitted to the hospital on 07/07/2022, died on 07/14/2022
1615605 2387593 2022-07-24 dropped dead on the soccer field; Another child has Myocarditis after getting it and dropped dead on the soccer field.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A child patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "dropped dead on the soccer field"; MYOCARDITIS (medically significant), outcome "unknown", described as "Another child has Myocarditis after getting it and dropped dead on the soccer field.". The patient date of death was unknown. Reported cause of death: "dropped dead on the soccer field". It was not reported if an autopsy was performed. Clinical Course: It was reported that, reporter had a caller on the line to complain about the Pfizer COVID 19 vaccine. She did not specify the complaint. Caller stated she had a product complaint. Pfizer was using social media and trying to get parents to get 5 year old vaccinated. She had several children in the (name-withheld) die after getting the doses. There was not news coverage and she goes to local town meetings. One child's father said his child dropped dead after getting 2nd dose. Another child had Myocarditis after getting it and dropped dead on the soccer field. These were young healthy children. She did not had any specific information to provide on any of these children to complete a report for. She was genuinely disgusted for people to gave their children something like sacrificial lambs. She does not know how call handler sleeps at night working for this company. She had a friend who works at (name-withheld) and said that people were sick in ICU after getting vaccine with complications from it. She did not had any specific information to provide on any of these patients to complete a report for. She did not wish to provide an address or email. If someone calls with an adverse event, she said do not censor it and make it count. She does not trust Pfizer. She just does not understand why Pfizer was pushing to vaccinate these young children when the virus does not even affect them. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: dropped dead on the soccer field
1615604 2387592 2022-07-24 One child's father said his child dropped dead after getting 2nd dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A child patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER: UNKNOWN), for Covid-19 immunization. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "One child's father said his child dropped dead after getting 2nd dose.". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical Course: It was reported that reporter had a product complaint. Pfizer was using social media and trying to get parents to get 5 year olds vaccinated. Reporter had several children in the (name-withheld) die after getting the doses. There was not news coverage, and she goes to local town meetings. One child's father said his child dropped dead after getting 2nd dose. These are young healthy children. Reporter did not have any specific information to provide on any of these children to complete a report for. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: One child's father said his child dropped dead after getting 2nd dose.
1614923 2386889 2022-07-23 My mother died after her 3rd Moderna; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (My mother died after her 3rd Moderna) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication was reported by reporter. No treatment medication was reported by reporter. Company comment: This spontaneous case concerns a unspecified age female gender, with no medical history, who experienced the unexpected fatal serious (medically significant) event of death, which occurred unspecified days after third dose of mRNA-1273 vaccine. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a unspecified age female gender, with no medical history, who experienced the unexpected fatal serious (medically significant) event of death, which occurred unspecified days after third dose of mRNA-1273 vaccine. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
1614912 2386878 2022-07-23 DIED; SICK; This spontaneous report received from a consumer concerned multiple patients of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose 1, 1 total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. The consumer stated that there was 60 sick and 9 died out of millions from the vaccination on an unspecified date. On an unspecified date, the patients died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patients died on an unspecified date, and the outcome of sick was not reported. This report was serious (Death).; Sender's Comments: V0- 20220743653 -covid-19 vaccine ad26.cov2.s- Died. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
1614932 2386898 2022-07-23 MN After the second dose of the Moderna Covid-19 vaccine the person's relative suffered a/After the first dose of the Moderna Covid-19 vaccine the relative experienced a heart attack; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jul-2022 and was forwarded to Moderna on 14-Jul-2022. This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDIAL INFARCTION (After the second dose of the Moderna Covid-19 vaccine the person's relative suffered a fatal heart attack /After the first dose of the Moderna Covid-19 vaccine the relative experienced a heart attack) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (After the second dose of the Moderna Covid-19 vaccine the person's relative suffered a/After the first dose of the Moderna Covid-19 vaccine the relative experienced a heart attack) (seriousness criteria death and medically significant). The reported cause of death was after the second dose of the moderna covid-19 vaccine the person's relative suffered a fatal heart attack.. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment medication details reported. Company Comment: This is a spontaneous case concerning a male patient of an unknown age with no medical history reported, who experienced the unexpected and serious AESI (seriousness criteria death and medically significant) event of myocardial infarction, unknown days after a second dose of mRNA-1273 vaccine. The patient was also reported to have a myocardial infarction after the first dose. It is unknown if an autopsy was performed. No concomitant or treatment medication was reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient of an unknown age with no medical history reported, who experienced the unexpected and serious AESI (seriousness criteria death and medically significant) event of myocardial infarction, unknown days after a second dose of mRNA-1273 vaccine. The patient was also reported to have a myocardial infarction after the first dose. It is unknown if an autopsy was performed. No concomitant or treatment medication was reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: After the second dose of the Moderna Covid-19 vaccine the person's relative suffered a fatal heart attack.
1614596 2433383 2022-07-22 74.00 Narrative: PATIENT PASSED AWAY DUE TO COVID-19. PT WAS HOSPTILIZED AND FULLY VACCINATED AT THE TIME OF HIS DEATH.
1614178 2379161 2022-07-22 71.00 pt admitted to hospital with SOB; found to be positive for COVID; acute respiratory failure secondary to COVID; given steroids, zinc, Vitamin C, Remdesivir, ABX; O2 supplementation - BiPAP; pt's condition continued to worsen despite aggressive measures; pt passed away in the hospital
1614186 2379169 2022-07-22 83.00 pt presents to ED with SOB worsening over past 2 days; O2 saturation 80% on RA; pt states she saw PCP and was dx with COVID; COVID test positive in ED; placed on O2; AHRF secondary to COVID; given dexamethasone, remdesivir, ABX; pt needed BiPAP but declined and chose comfort measures; she expired in the hospital
1614196 2379179 2022-07-22 80.00 pt stays in a local nursing home; tested positive for COVID on 9/16/21; placed in isolation; O2 supplementation; asymptomatic; DNR; patient expired in the nursing home.
1614204 2379188 2022-07-22 82.00 pt to ED from local facility; pt was less alert than normal; tested positive for COVID the morning she was brought to ED; AKI; hypernatremia; UTI; given IV fluids, IV ABX; developed hypoxic respiratory failure; pt's condition worsened; she transitioned to comfort measures and passed away in the hospital
1614491 2379475 2022-07-22 SD 35.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 02/24/2021, 03/24/2021, and 12/06/2021. They tested positive for COVID-19 on 05/29/2022 and 05/30/2022 upon admission to hospital. Primary complaint was respiratory distress. The individual experienced complications of COVID-19 pneumonia and dehydration. They also had an aspiration episode which worsened their health condition. They remained hospitalized until their death on 06/19/2022.
1614591 2430894 2022-07-22 82.00 Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
1614594 2433380 2022-07-22 89.00 Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
1614593 2433375 2022-07-22 72.00 Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
1614597 2433464 2022-07-22 75.00 Narrative: PATIENT PASSED AWAY DUE TO COVID-19. HE WAS HOSPITALIZED AND HAD RECEIVED SEVERAL COVID-19 VACCINE.
1614598 2433465 2022-07-22 70.00 Narrative: PATIENT PASSED AWAY DUE TO COVID-19. HE WAS HOSPITALIZED AND HAD RECEIVED THE COVID-19 VACCINE.
1614599 2433473 2022-07-22 83.00 Narrative: PATIENT PASSED AWAY DUE TO COVID-19. HE WAS HOSPITALIZED AND HAD RECEIVED THREE COVID-19 VACCINE.
1614600 2433475 2022-07-22 64.00 Narrative: Patient died in hospice care from Stage 4 colorectal cancer with mets to lung on 6/12/202 64yo male. He had received a covid vaccine (J&J EUA) on 8/26/2021. This death is not related to the covid vaccine. Reporting death post vaccine since EUA status vaccine.
1614601 2433476 2022-07-22 67.00 Narrative: PATIENT PASSED AWAY DUE TO COVID-19. PT WAS HOSPITALIZED HAD RECEIVED THREE COVID-19 VACCINE AT THE TIME OF DEATH.
1614602 2433480 2022-07-22 82.00 Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
1614603 2433483 2022-07-22 84.00 Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
1614604 2433524 2022-07-22 69.00 Narrative: Patient passed away due to COVID-19. He was hospitalized and had received a COVID-19 vaccine.
1614103 2432362 2022-07-21 84.00 Narrative: PT PASSED AWAY DUE COVID 19. HE HAD RECEIVED THE COVID 19 VACCINE.
1613845 2376668 2022-07-21 77.00 pt had a positive COVID test on 9/10/21 from Hospital; pt to ED at other Hospital on 9/13/21 with progressive SOB, cough, congestion, fever, chills; NRB; rapid COVID test positive; CXR shows viral pneumonia; given IV ABX and Dexamethasone; experienced PEA; ACLS; intubated; pt's condition worsened; on 100% ventilation; transitioned to comfort care; pt expired in the hospital
1613898 2376721 2022-07-21 GA 20.00 Patient had COVID in December 2020. He received his Pfizer vaccine in April and May of 2021. He contracted Covid on August 30,2021 and died on October 11, 2021. He was evaluated at local clinic on 9/2/2021 with joint pains and painful rash in mouth, hands and feet. He was hospitalized on 9/4/2021 and treated with REMDESIVIR, STEROIDS,ZPAK and LOVENOX and D/C to home on 9/7/2021. He went back to the ER and sent home with Doxycycline. He was again hospitalized on 9/15/202 and given REMDESIVIR, Vancomycin, Toradol, INVANZ, LOVENOX and DEXAMETHASONE. He was discharged on 9/23/2021. He was evaluated again at physicians office with purpuric rash over his body, angioedema of his lips, hypotension and anemic. He was sent back the hospital due to his septic appearance. He was hospitalized at another hospital and given multiple transfusions, antibiotics and steroids. He died after coding three times on October 11,2021.
1613951 2376775 2022-07-21 52.00 pt with abdominal pain and distention x 1 wk; saw PCP; was sent to ED for evaluation; renal insufficiency and sepsis; found to be positive for COVID; high concern for metastatic pancreaticobiliary malignancy with carcinomatosis and liver metastasis with ascites; pt went into cardiac arrest without ROSC and expired in the hospital
1613989 2376814 2022-07-21 SD 91.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 01/12/2022 and 02/11/2022. They tested positive for COVID-19 on 06/05/2022. They were admitted to hospital for this illness on 06/04/2022. They were diagnosed with COVID-19 pneumonia and acute hypoxic respiratory failure. They were discharged 06/07/2022. However, they then presented to Emergency Department again on 06/12/2022 with a primary complaints of shortness of breath and weakness. They were admitted to hospital again. Their condition declined rapidly and they died on 03/13/2022.
1614102 2432360 2022-07-21 71.00 Narrative: PATIENT PASSED AWAY DUE TO COVID-19 . HE HAD RECEIVED A COVID-19 VACCINE.
1614109 2433361 2022-07-21 64.00 Narrative: PATIENT PASSED AWAY DUE TO COVID-19. HE WAS HOSPITALIZED AND HAD RECEIVD A COVID-19 VACCINE.
1614104 2432363 2022-07-21 72.00 Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
1614105 2432366 2022-07-21 89.00 Narrative: PATIENT PASSED FROM COVID-19 ON 06/02/2022. PT WAS FULLY VACCINATED FOR COVID
1614106 2432513 2022-07-21 86.00 Narrative: PATIENT PASSED AWAY DUE TO COVID-19 PATIENT HAD RECEIVED COVID-19 VACCINE.
1614107 2432964 2022-07-21 76.00 Narrative: PATIENT PASSED AWAY DUE TO COVID-19. HE HAD RECIVED A COVID-19 VACCINE.
1614108 2433338 2022-07-21 85.00 Narrative: Patient passed away due to COVID-19. He had received an initial series of the Moderna COVID-19 vaccine.
1613420 2374747 2022-07-20 65.00 9/8/21 pt had a positive COVID test in Hospital; pt asymptomatic for COVID, no treatment required; was transferred to another Hospital for SDH; developed mechanical aortic valve requiring anticoagulation; developed worsening SDH on right side; had an emergent decompression craniotomy; developed seizure activity; intubated; sputum cultures grew Klebsiella pneumoniae; suffered refractory shock; acute renal failure; developed pulseless ventricular arrhythmia; CPR performed without good results; pt expired in the hospital
1613364 2374691 2022-07-20 25.00 pt had a positive COVID test on 9/15/21, pt died at home; no medical records; a post mortem COVID swab was obtained and found to be positive on 9/25/21
1613345 2374670 2022-07-20 TN 78.00 COVID Breakthrough death
1613377 2374704 2022-07-20 80.00 pt had a positive COVID test on 8/30/21; pt passed away in a nursing home - Healthcare.
1613391 2374718 2022-07-20 60.00 pt transferred from Medical Center; found to be positive for COVID; pt has a large intracranial hemorrhage and midline shift; uncal herniation; left sided paralysis, concern for a stroke; vomiting; intubated prior to transfer; neurology consulted and recommended comfort care to family; pt made comfort care, extubated, and he passed away in the hospital
1613398 2374725 2022-07-20 62.00 9/2/21 pt brought to ED with weakness and SOB; given O2 supplementation; during hospitalization, pt developed mucus plugging; DKA; NG tube placed; pt had a positive COVID test on 8/31/21; COVID pneumonia; DNR/DNI; worsened respiratory status; placed on comfort measures; pt expired in the hospital
1613405 2374732 2022-07-20 69.00 pt had a positive COVID test on 9/3/21 at Clinic; 9/5/21 EMS called to pt's house for unresponsiveness; found to not have a pulse; CPR started and cardioverted with ROSC achieved; intubated in the field; brought to ED; signs of anoxic brain injury with seizure-like activity; family stated pt did not want to be intubated; pt passed away in the hospital
1613408 2374735 2022-07-20 73.00 8/27/21 pt brought to ED with SOB; states he had a negative COVID test at an urgent care center; 8/28/21 pt had a positive COVID test in the hospital; given remdesivir, dexamethasone, ABX, O2 supplementation; required BiPAP; pt continued to worsen; respiratory status declined requiring intubation with mechanical ventilation; pt found without a pulse and in asystole; code called, ACLS protocol implemented with results; pt expired in the hospital
1613604 2374933 2022-07-20 WI 72.00 Patient admitted to Medical Center 1/6/2022. Per Death abstracted submitted by the state Patient Died 1/16/2022 at 14:04 of Covid pneumonia acute hypoxic respiratory failure. public health has no further information.
1613429 2374756 2022-07-20 88.00 pt had a positive COVID test on 9/2/21; lives in a nursing home; family declined ABX treatment for pt's COVID; requested comfort care; pt expired in the nursing home
1613442 2374769 2022-07-20 79.00 8/31/21 pt tested positive for COVID; lives in nursing home; 9/5/21 EMS called to nursing home due to pt being unresponsive; found to have agonal respirations, hypotension; was intubated and brought to hospital; given IV ABX; pt was to come out of quarantine today; family decided on comfort measures only; pt extubated and she expired in the hospital
1613529 2374856 2022-07-20 36.00 pt brought to ED with AMS, weakness, difficulty walking; pt found to be positive for COVID; CVA; CT of head/neck showed thrombus above right carotid artery bulb; placed on Aggrastat infusion; transferred to ICU; pt experienced asystole, ROSC achieved; grim prognosis; pt experienced cardiac arrest with ROSC; pt expired in the hospital
1613538 2374865 2022-07-20 46.00 pt brought to ED via EMS in cardiac arrest; EMS performed CPR; pt intubated and on mechanical ventilation; COVID test in ED positive; given IV ABX; pt suffered several episodes of cardiac arrest and expired in the hospital
1613545 2374872 2022-07-20 71.00 9/9/21 pt had a positive COVID test 9/14/21 pt to ED with c/o SOB, cough, fever, generalized weakness; COVID test showed positive result; COVID pneumonia; respiratory status worsened eventually requiring intubation; given Decadron, ABX, remdesivir; respiratory status continued to worsen; pt was changed to DNR; she passed away in the hospital
1613628 2374959 2022-07-20 SD 93.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 01/21/2021, 02/18/2021, and 11/03/2021. They tested positive for COVID-19 on 05/16/2022 at the nursing home at which they were a resident, after developing a cough. The individual was treated with Paxlovid. They experienced an acute myocardial infarction and died on 06/05/2022. I see no indication the individual was hospitalized related to this illness.
1613433 2374760 2022-07-20 MI 87.00 Patient with J+J on 07/17/2022 who admitted to hospital with failure to thrive who died on comfort care services. Provider d/c note below: "87-year-old female with a past medical history significant for Alzheimer's dementia, hypertension, recurring DVTs, left parietal meningioma, CKD stage 3, diverticulitis who presented with severe hypernatremia in failure to thrive secondary to refusal for any oral intake. It was noted on admission that the patient was nonverbal and responsive to noxious stimuli but refusing to eat or drink anything over the past week or longer. The son had visited the patient at Facility and the patient was not doing well and would likely be a hospice candidate in the coming week. When the patient got to the hospital sodium was notable for at 4:29 p.m., potassium 3.1, bicarb 21, WBC 20.1, lactate 4.0 CT head was negative excluding history of meningioma, CT abdomen pelvis had pancreatic lesions concerning for IPMN. Patient was evaluated in hospital by speech and patient is still refusing to eat anything. With the recent CT findings and patient refusal for oral intake with severe failure to thrive and severe dementia, with conversation with son patient was deemed to be comfort care by the son. Unfortunately, prior to discharge the patient was COVID(+). Patient remained at hospital as the patient was unable to discharge due to COVID status. The patient continued comfort directed care until expiration on 7/11/22 at 21:20. "
1613117 2373935 2022-07-19 86.00 pt brought to ED via EMS with fever, dyspnea, SOB, weakness; O2 saturation 78% when on 2 L via; positive for COVID; pneumonia; steroids; ABX; BiPAP; pt expired in the hospital
1612902 2373716 2022-07-19 64.00 pt had a positive COVID test on 9/1/21 from ; 9/3/21 EMS called to pt's house; unresponsive and not breathing; CPR; intubated; in ED ACLS medications provided; no response; DOA
1613084 2373901 2022-07-19 SD 92.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 12/28/2020, 01/25/2021, and 11/03/2021. They tested positive for COVID-19 on 05/20/2022 at the nursing home at which they were a resident. They experienced complications of a secondary bacterial infection and possible aspiration pneumonia. They were treated with Paxolvid. They continued to decline and died on 06/04/2022.
1613099 2373917 2022-07-19 MI 65.00 Discharge Provider: DO Primary Care Provider at Discharge: None Physician, DO None Admission Date: 6/28/2022 Discharge Date: 6/28/2022 PRESENTING PROBLEM: Hypoxia [R09.02] Atrial fibrillation with RVR (HCC) [I48.91] Acute congestive heart failure, unspecified heart failure type (HCC) [I50.9] COVID-19 [U07.1] HOSPITAL COURSE: Patient is a 65-year-old morbidly obese male who presented to the emergency department for concerns for rapid heart rate over the past 2-3 days that is not going away. Patient has a known history of atrial fibrillation and he is currently on Xarelto. He denies missing any of his anticoagulation doses. He also denies missing any doses of his PO cardizem which he states he is supposed to take 3 times a day despite being a 6 hour preparation. He reports difficulty breathing, fatigue and rapid heart rate. He also takes propanolol XL. He came in today because his symptoms were not improving. He denies any nausea vomiting chest pain or heaviness. He was recently admitted for similar atrial fibrillation with RVR earlier this month however he left AMA because he was unable sleep in the hospital. The ED staff spoke to his cardiologist who is familiar with this patient and he recommended continuing cardizem therapy and adjusting his dose to keep his rate under control. I was contacted by the ED staff and agreed to admit him on a cardizem gtt. I will increase his PO cardizem to 60 mg q 6 hours and monitor him on telemetry. Will endeavor to maintain K >= 4.0 and Mg >= 2.0. Will get echo when rate is better controlled. Patient became agitated with nursing staff after realizing he was on a fluid restriction with a 2 g sodium diet. Patient immediately asked for the doctor to come in and speak with him. He told nursing staff that he would time this on his phone to make sure the provider comes promptly. When the provider arrived the patient was angry that nurse told him he could not have his soda or Tacos. I explained to patient that he is on a heart healthy diet with fluid restriction based on his current medical needs. At this time patients heart rate was between 125 and 149. The patient then stated that" maybe I should just go home and never come back here". I told the patient that I do not recommend him leaving due to his hypoxia related to a new COVID-19 diagnosis as well as AFib with RVR. I explained to the patient that it takes time for the medication to work and that he should stay overnight to see things improve. And also told patient that he would still need to be on a fluid restriction and thus low-sodium diet. Once this was said patient made up his mind and stated "I wanna go home, where are the papers I need to sign". I brought AMA paperwork to the patient and told patient that with him leaving against medical advice there is an increased risk of mortality due to his hypoxia and rapid ventricular rate. Patient understood and paperwork was completed. Patient was discharged home AMA. Discharge Provider: MD Primary Care Physician at Discharge: NP Admission Date: 7/1/2022 PRESENTING PROBLEM: Hypoxia [R09.02] Longstanding persistent atrial fibrillation (HCC) [I48.11] Congestive heart failure, unspecified HF chronicity, unspecified heart failure type (HCC) [I50.9] COVID-19 [U07.1] Acute on chronic combined systolic and diastolic congestive heart failure (HCC) [I50.43] HOSPITAL COURSE: The patient is a 65 y.o. male with a PMH of coronary artery disease, atrial fibrillation (on Xarelto), hypertension, hyperlipidemia, Stage 3 COPD(FEV1 of 42%),HFmEF (lowest 45%, now 35%)-ischemic cardiomyopathy, who was admitted on 06/28 secondary to decompensated heart failure, renal failure and found to be COVID-19 positive on 06/28 (placed on Paxlovid- d/c 07/02) who is being transferred to intensive care unit for worsening acute on the chronic hypercarbic hypoxemia respiratory failure and acute renal failure. Presented on 06/28 secondary to dyspnea, and rapid heart rate consistent with atrial fibrillation with RVR. Subsequent left AMA and re-presented on 07/01 due to worsening shortness of breath and lower extremity swelling consistent with heart failure exacerbation. He was diuresed with 80 IV 2 times a day and thereafter transition Lasix drip on 07/03,Decadron 6 mg 0 7/0 1-present. Hyper response called on 07/03 secondary to hypotension, hypoxemia placed on 6 L nasal cannula and thereafter BiPAP, and stat lab work revealed a a combination of respiratory and metabolic acidosis pH 7.2/pCO2 57.8, bicarb 20, worsening renal failure with creatinine of 3.5 (baseline 1.5), BUN 81. Brief ICU Course: Upon presentation to the intensive care unit, was hemodynamically unstable, hypertensive, and bradycardic. Stat blood work showed mixed respiratory and metabolic acidosis pH 7.21/pCO2 50, bicarb 17 and potassium of 7.1. Telemetry concerning for high-grade AV block versus sinus bradycardia, atropine 0.5mg and calcium gluconate administered. Bedside echocardiogram with significant LV dilation and decreased LV function (although poor windows). He continued to remain hypoxic on 100% FiO2 on BiPAP, prompting need for intubation. On 07/17/22, patient had episodes of desat and hypotension in supination and was subsequently kept pronated. He continued to detoriate over the course of 07/17/22 and 07/18/22 requiring multiple pressor support and sedation at which point comfort care decisions regarding patient prognosis were initiated with the family and the patient was transferred to comfort care on 07/17/2022. Patient deceased on 07/18/22 at 1530.
1613115 2373933 2022-07-19 FL 76.00 Pt came into to hospital for dizzines and diagnosed with BPPV, pt went into PEA cardiac arrest pt intubated and ROSC achieved. Post code developed organ failure and need dialysis and tested positive for coivd. Pt continued to decline regardless of treatment for covid and organ failure. Family decided to withdrawl care. Pt expired on 7/17/2022
1613195 2374014 2022-07-19 TX 96.00 Pfizer-BioNTech COVID-19 Vaccine EUA Received Pfizer-BioNTech COVID Vaccines on 1/31/2021 and 3/18/2021. Arrived to ED acutely ill and was found to be very lethargic and barely able to open eyes. COVID+ x1 week. Placed on non-rebreather mask and O2 sat remained in low 80s. Pt was transitioned to DNR/DNI and comfort care. Pt expired 7/10/22. Given cefepime and vancomycin.
1613143 2373962 2022-07-19 FL 87.00 pt presented to hospital after mechanical fall with fracture, and tested positive for covid. Pt presented with dehydreation, and AKI. Pt went to OR for ORIF. Pt went into cardiac arrest after surgery, rosc was achieved and was mad a DNR. Despite medical treatment She then went into vtach and had a sudden drop in blood pressur and lost her pulse. Pt expired 07/16/2022
1613197 2374016 2022-07-19 TX 79.00 Pfizer-BioNTech COVID-19 Vaccine EUA Received Pfizer-BioNTech COVID Vaccines on 7/13/2021 and 8/10/2021. Arrived to ED 7/12/22 c/o progressively worsening SOB. Previously seen 7/7/22, dx'd w/COVID-19 PNA, and was COVID+ 10 days prior to ED visiti on 7/7/22. Placed on non-rebreather mask en route to hospital by EMS and hypoxia improved. Admitted to ED, O2 requirements progressed to Airvo. Pt removed Airvo and was found with O2 in 50s. Went into cardiac arrest and underwent compressions. Family decided to remove resuscitative measures. Pt expired 7/12/22. Pt given zosyn.
1613199 2374018 2022-07-19 TX 81.00 Pfizer-BioNTech COVID-19 Vaccine EUA Patient received Pfizer-BioNTech COVID Vaccines on 1/30/2021 and 2/20/2021.Pt presented from outside residential facility after sliding out of wheelchair and presented to ED with SOB. Pt was hypoxic en route with EMS, and was tachypneic, tachycardic, and hypoxic in ED. Was placed on 2L NC. Workup revealed Lactic 2.2, BNP 140, VBG O2 sat 43%, INR 1.3, Hgb 9.0, and COVID+ swab. Pt was admitted to floor and experienced significant deconditioning. He was unable to wean from oxygen. Pt was to be discharged to hospice as dyspnea worsened and pt was transitioned to comfort care. Pt expired 7/8/22. Pt given decadron.
1612519 2372450 2022-07-18 83.00 pt to ED via EMS after a fall at home; found supine; family guessing she has been there x 3 days; no evidence of fx; CT of brain showed no intracranial hemorrhage; pt had a sore throat and diarrhea earlier in the week; found to be positive for COVID; no O2 supplementation needed; echocardiogram shows 20% Ejection Fraction; cardiology consulted but cardiac catherization not done due to COVID positive; DNR/Comfort Care; pt passed away in the hospital
1612370 2372294 2022-07-18 73.00 pt was brought to ED (Medical Center) with AMS and dyspnea; found to be positive for COVID; COVID PNA; ICU: septic shock with multiorgan system failure; family decided on GIP hospice; admitted to Hospice on 9/17/21 where she passed away 9/19/21.
1612406 2372333 2022-07-18 88.00 8/14/21 pt was brought to ED for AMS and dyspnea; low O2 saturations; given O2 supplementation; had been at home with UTI and on IV ABX; positive for COVID; poor prognosis; on TPN; DNR; 8/27/21 dc'd to home with Home Care to follow patient since he does not quality for GIP hospice; patient died at home
1612494 2372424 2022-07-18 83.00 pt sent to ED by home health on 8/5/21 with hypotension, AMS, and SOB ;found to be positive for COVID; O2 supplementation; emaciated appearance; given ABX, Decadron, Vitamins C and D and zine; convalescent plasma; dc'd 8/23/21 to the nursing home where she passed away on 8/24/21
1612631 2372565 2022-07-18 SD 93.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 01/26/2021, 02/16/2021, and 10/28/2021. They presented to emergency department on 05/14/2022 with primary complaints of general weakness, difficulty standing up, and difficulty ambulating. They tested positive for COVID-19 on 05/15/2022 at the hospital. They were found to be experiencing complications of aspiration pneumonia and acute kidney failure. They remained hospitalized until their death on 05/28/2022.
1612568 2372502 2022-07-18 60.00 pt had a positive COVID test from Healthcare Drive Thru Testing Center on 8/30/21; pt died at home; no other medical records
1612632 2372730 2022-07-18 80.00 pt had a positive COVID test on 9/3/2021 pt died at home on 9/4/21; no other records on this patient
1612076 2371873 2022-07-16 Autopsy confirmed myocardial event and fluid around her heart and lungs; Autopsy confirmed myocardial event and fluid around her heart and lungs; Prior symptoms included fatigue; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the parent. A 19-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: CARDIOMYOPATHY (death), HYPERVOLAEMIA (death), outcome "fatal" and all described as "Autopsy confirmed myocardial event and fluid around her heart and lungs"; FATIGUE (non-serious), outcome "unknown", described as "Prior symptoms included fatigue". The patient date of death was 09Jul2022. Reported cause of death: "Autopsy confirmed myocardial event and fluid around her heart and lungs". The autopsy revealed "myocardial event" (cardiomyopathy); "fluid around her heart and lungs" (hypervolaemia). Clinical course: Patient died in her sleep 09Jul2022. Autopsy confirmed myocardial event and fluid around her heart and lungs. Prior symptoms included fatigue. Mother mentioned cause of death 13Jul2022 and that daughter was vaccinated, primary series and booster. Patient passed away in (withheld) and was taken to coroner on 09Jul2022. Event took place after use of product. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Autopsy confirmed myocardial event and fluid around her heart and lungs; Autopsy confirmed myocardial event and fluid around her heart and lungs; Autopsy-determined Cause(s) of Death: myocardial event; fluid around her heart and lungs
1612068 2371865 2022-07-16 WI MRI showed a large, fast-growing cancer in her abdomen; intense lower back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 71-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (death, medically significant), outcome "fatal", described as "MRI showed a large, fast-growing cancer in her abdomen"; BACK PAIN (non-serious), outcome "unknown", described as "intense lower back pain". The events "mri showed a large, fast-growing cancer in her abdomen" and "intense lower back pain" required emergency room visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: fast-growing cancer in her abdomen. The patient date of death was unknown. Reported cause of death: "MRI showed a large, fast-growing cancer in her abdomen". It was not reported if an autopsy was performed. Clinical course: Patient was in good health. No family history of cancer. Her husband had been diagnosed with Alzheimer. VAERS report indicates the baby my vaccinated daughter is carrying is a hundred fold more likely to have birth defects. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: MRI showed a large, fast-growing cancer in her abdomen
1611927 2371721 2022-07-16 OH had fever the week before; she had a wound; passed away from Covid; passed away from Covid; This is a spontaneous report received from a contactable reporter (Consumer or other non- HCP). A 98-year-old female patient received BNT162b2 (COMIRNATY), as single dose (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "the nursing home had positive cases" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death), COVID-19 (death) all with onset 06Jun2022, outcome "fatal" and all described as "passed away from Covid"; PYREXIA (non-serious), outcome "unknown", described as "had fever the week before"; WOUND (non-serious), outcome "unknown", described as "she had a wound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) positive. Therapeutic measures were taken as a result of wound included bleach solution. The patient date of death was 06Jun2022. Reported cause of death: "passed away from Covid". It was not reported if an autopsy was performed. Clinical course: patient was in nursing home, the nursing home had positive cases. Patient died that day, after she tested positive 06Jun2022. She had fever the week before, but they thought it was because she had a wound. They were cleaning her aunt's wound with bleach solution and it was painful. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: passed away from Covid; passed away from Covid
1611132 2370249 2022-07-15 80.00 Narrative: Patient passed away due to COVID-19. He had received a COVID-19 vaccine.
1611106 2370215 2022-07-15 83.00 Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
1611109 2370220 2022-07-15 79.00 Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
1611117 2370229 2022-07-15 77.00 Narrative: Patient passed away due to COVID-19. He was fully vaccinated at the time of death.
1611120 2370232 2022-07-15 71.00 Narrative: Patient passed away due to COVID-19. Pt was fully vaccinated at the time of death.
1611029 2370124 2022-07-15 MA 82.00 Somewhere between 20JUN2022 and 04JUL2022, the patient passed away; tinea corpus; osteoarthritis/Knee pain,hip/hip pain bilaterally/back pain; sciatica; rash; itch; Interchange of vaccine products; reported she had not been feeling well/had not been feeling well since she had received the Moderna vaccine; severe leg pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Somewhere between 20JUN2022 and 04JUL2022, the patient passed away) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A22B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Patient had never diagnosed with COVID positive test or diagnosis. and No other vaccines were given to the patient within 1 month prior to Moderna COVID-19 vaccine. The patient's past medical history included Thyroid cancer (Started on 2019 or 2020 (Unsure of exact date) and Cancer in remission) in February 2022. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1, Lot number: EM9809) on 13-Feb-2021, Pfizer (Dose 2, Lot number: EN6206) on 06-Mar-2021, Pfizer (Dose 1st booster, Lot number: FJ1620) on 18-Nov-2021, Simvastatin (elevated LFTs) and Cholestyramine (Cholestyramine (tight throat and abdomen)). Past adverse reactions to the above products included LFTs raised with Simvastatin; No adverse event with PFIZER BIONTECH COVID-19 VACCINE, Pfizer and Pfizer; and Throat tightness with Cholestyramine. Concurrent medical conditions included Drug allergy (Allergy to Cholestyramine, Simvastatin and Timolol), Penicillin allergy (Penicillin (vaginal infection)), Type 2 diabetes mellitus (Started 15 years ago), Blood pressure high (Started 20 years ago or so (Unsure of exact date) and currently in Stable condition), Obesity (Started 40 years ago (Unsure of exact date) and improved, with weight loss of about 17-18 lbs in 3 months from FEB2022 to MAY2022) and Glaucoma (Eye drops possibly for glaucoma). Concomitant products included DORZOLAMIDE for Glaucoma, AMLODIPINE, ACETYLSALICYLIC ACID (ASPIRINE), CLOTRIMAZOLE, COD LIVER OIL [COD-LIVER OIL], FLUOCINONIDE, MENTHOL, ZINC OXIDE (GOLD BOND), HYDROCHLOROTHIAZIDE, INSULIN LISPRO, INSULIN, KETOCONAZOLE, INSULIN GLARGINE (LANTUS), LATANOPROST, LEVOTHYROXINE, LEVOTHYROXINE SODIUM (SYNTHROID), LISINOPRIL, METFORMIN, CALCIUM, MAGNESIUM, ZINC, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and CYANOCOBALAMIN (VIT B12) for an unknown indication. On 25-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2022, the patient experienced MALAISE (reported she had not been feeling well/had not been feeling well since she had received the Moderna vaccine) and PAIN IN EXTREMITY (severe leg pain). On an unknown date, the patient experienced DEATH (Somewhere between 20JUN2022 and 04JUL2022, the patient passed away) (seriousness criteria death and medically significant), BODY TINEA (tinea corpus), OSTEOARTHRITIS (osteoarthritis/Knee pain,hip/hip pain bilaterally/back pain), SCIATICA (sciatica), RASH (rash), PRURITUS (itch) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash and Itch, at an unspecified dose and frequency; LIDOCAINE (LIDODERM) at an unspecified dose and frequency; DICLOFENAC (topical) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain, at a dose of UNK, prn. The patient died on an unknown date. The cause of death was not reported. An autopsy was performed, but no results were provided. At the time of death, BODY TINEA (tinea corpus), OSTEOARTHRITIS (osteoarthritis/Knee pain,hip/hip pain bilaterally/back pain), SCIATICA (sciatica), RASH (rash), PRURITUS (itch), MALAISE (reported she had not been feeling well/had not been feeling well since she had received the Moderna vaccine), PAIN IN EXTREMITY (severe leg pain) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PAIN IN EXTREMITY (severe leg pain) to be related. No further causality assessments were provided for DEATH (Somewhere between 20JUN2022 and 04JUL2022, the patient passed away), BODY TINEA (tinea corpus), OSTEOARTHRITIS (osteoarthritis/Knee pain,hip/hip pain bilaterally/back pain), SCIATICA (sciatica), RASH (rash), PRURITUS (itch), MALAISE (reported she had not been feeling well/had not been feeling well since she had received the Moderna vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). Patient height was reported as 5/4.5 Patient concomitant medications included Multivitamins with Iron and Neocin and Allergy tablet as needed. Patient had severe leg pain on the evening after receiving the vaccine. The pain had continued, and she had not been feeling well up until 13-Jun-2022. Patient then visited urgent care on 20-Jun-2022 to get a diagnosis and treatment for the leg pain she was experiencing. The urgent care report stated the patient's diagnoses as hip pain bilaterally, tinea corpus, hip, knee, back pain, osteoarthritis, and sciatica. Urgent care also prescribed medicine for rash and itch for the patient. However, caller was not aware of this complaint. Somewhere between 20-Jun-2022 and 04-Jul-2022, the patient passed away. Her deceased body was found on 04-Jul-2022 at her residence after a wellness check was performed. The exact date of death of patient is unknown. The medical examiner stated that the patient had passed away at least several days before being discovered. Toxicology was performed and however, the result will not be available for 90 days. The medical examiner has also stated that the patient's body had decayed enough, that if a clot was the suspect in the death, it would not be identified due to the decomposition of the body. Patient had not been feeling well since she had received the Moderna vaccine. The reporter thought that patient's leg pain could have been since she was running errands on 25-May-2022. She states that this could be a potential severe, rare side effect of the vaccine and finds it necessary to report it. Company Comment This spontaneous case concerns an 82-year-old female patient, with concurrent medical conditions of Type 2 diabetes mellitus, Blood pressure high, Obesity and past medical history of Thyroid cancer (Started on 2019 or 2020 and Cancer in remission in February 2022), who experienced the serious Fatal unexpected event of Death (Somewhere between 20JUN2022 and 04JUL2022, the patient passed away) and other non-serious events which occurred approximately after 25 days of fourth dose of mRNA-1273 vaccine in the covid-19 vaccination series. An autopsy was performed and the result and further details were not provided. Patient had severe leg pain on the evening after receiving the vaccine. The pain continued for 20 days later consulted and diagnosed as hip pain bilaterally, tinea corpus, hip, knee, back pain, osteoarthritis, and sciatica with medicine for rash and itch. Somewhere between 20-Jun-2022 and 04-Jul-2022, the patient passed away and identified by wellness check. The medical examiner has stated that the patient's body had decayed enough, that if a clot was the suspect in the death, it would not be identified due to the decomposition of the body. It was also noted that patient received 3 doses with PFIZER BIONTECH COVID-19 VACCINE prior to current vaccination (interchange of vaccine products). Patient's Concurrent medical conditions of Type 2 diabetes mellitus, Blood pressure high, Obesity and elderly age could be the risk factors and Thyroid cancer (Started on 2019 or 2020 and Cancer in remission in February 2022) could be contributing factors for the event death. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an 82-year-old female patient, with concurrent medical conditions of Type 2 diabetes mellitus, Blood pressure high, Obesity and past medical history of Thyroid cancer (Started on 2019 or 2020 and Cancer in remission in February 2022), who experienced the serious Fatal unexpected event of Death (Somewhere between 20JUN2022 and 04JUL2022, the patient passed away) and other non-serious events which occurred approximately after 25 days of fourth dose of mRNA-1273 vaccine in the covid-19 vaccination series. An autopsy was performed and the result and further details were not provided. Patient had severe leg pain on the evening after receiving the vaccine. The pain continued for 20 days later consulted and diagnosed as hip pain bilaterally, tinea corpus, hip, knee, back pain, osteoarthritis, and sciatica with medicine for rash and itch. Somewhere between 20-Jun-2022 and 04-Jul-2022, the patient passed away and identified by wellness check.The medical examiner has stated that the patient's body had decayed enough, that if a clot was the suspect in the death, it would not be identified due to the decomposition of the body. It was also noted that patient received 3 doses with PFIZER BIONTECH COVID-19 VACCINE prior to current vaccination (interchange of vaccine products). Patient's Concurrent medical conditions of Type 2 diabetes mellitus, Blood pressure high, Obesity and elderly age could be the risk factors and Thyroid cancer (Started on 2019 or 2020 and Cancer in remission in February 2022) could be contributing factors for the event death. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Somewhere between 20JUN2022 and 04JUL2022, the patient passed away
1611122 2370234 2022-07-15 75.00 Narrative: Patient passed away due to COVID-19. He was fully vaccinated at the time of death.
1611123 2370235 2022-07-15 69.00 Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
1611126 2370240 2022-07-15 72.00 Narrative: Patient found deceased at home on 6/28/22. Death was determined to be natural. Patient received Moderna COVID vaccine #4 on 6/14/22. No side effects were reported. Patient reported mild illness after 3rd dose, no mention of side effects with dose 1 or 2. No known history of covid. PMH significant for 1. Moderate aortic stenosis 2. HFpEF (EF 60% @ 14 Jun 2022) 3. T2 Diabetes mellitus 4. CKD (CrCl 44.8 ml/min; Cr 1.75 eGRF 38.5 K 4.3 @ 13 Jun 2022) 5. Hypertension 6. Obesity (276 lb BMI 44 @ Jun 2022) 7. Dyslipidemia 8. Varicose veins 9. Knee osteoarthritis (h/o infected knee replacement) 10. H/o melanoma R leg (chronic swelling)
1611131 2370247 2022-07-15 85.00 Narrative: Patient passed away due to COVID-19. He was on hospice and had received the COVID-19 vaccine,
1611238 2370571 2022-07-15 56.00 pt had a positive COVID test on 8/20/21 from Fast Pace Health in Kodak, TN; per death certificate information, pt died at home with the cause being COVID 19; there are no other records on this patient
1611133 2370250 2022-07-15 87.00 Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
1611203 2370534 2022-07-15 WI 79.00 HOSPITAL COURSE: Patient admitted for acute respiratory failure with hypoxia secondary to COVID pneumonia as well as presumed superimposed bacterial pneumonia. Her was given a 5 day course of remdesivir, prolonged daily course of dexamethasone, as well as azithromycin, ceftriaxone then later doxycycline. He had gradually increasing oxygen demand requiring high flow O2. Family did not wish to pursue any further options of oxygenation/ventilation. Patient has had limited to no oral intake over the last several days due to aspiration and lack of desire to intake food or fluid. Patient gradually declined in level of alertness. Patient expired naturally surrounded by family on July 14, 2022.
1611209 2370540 2022-07-15 70.00 pt had a positive COVID test on 8/18/21; 9/1/21 pt transferred from Medical Center to another Medical Center for respiratory failure, COVID, acute encephalopathy, Klebsiella UTI, sepsis, A Fib with RVR; had been given dexamethasone; on BiPAP when transferred; condition worsened requiring intubation; worsening shock and hypoxia; suffered bradycardic PEA; meds and CPR administered; family decided on no CPR and pt passed away in the hospital
1611300 2370639 2022-07-15 MN 74.00 Patient seen in the ED on 6/25 for shortness of breath with oxygen sats around 70's on room air. He was noted to have tested positive for COVID-19 a few days prior on 6/17. He was admitted to the hospital from 6/25-7/14 with severe sepsis, acute hypoxic respiratory failure, and recent COVID-19 infection. On 7/15, patient was found to be unresponsive and ultimately passed away in the hospital. Patient with medical history including dementia and metastatic cancer.
1611338 2370678 2022-07-15 WI 82.00 Patient was readmitted to the hospital after failed outpatient management of acute hypoxic respiratory failure secondary to Covid pneumonia. This was patient's second hospital admission. The patient was found to have hypoxia, Covid pneumonia with bilateral segmental and subsegmental pulmonary emboli found. There was initial concern for hospital-acquired pneumonia secondary to questionable infiltrate seen on imaging and the patient was initially started on antibiotic therapy. The following day antibiotics were discontinued due to a low pro-Cal and a low suspicion for a bacterial ideology. The patient received a heparin drip for the bilateral pulmonary emboli and then switched to oral Eliquis on day 3 of hospitalization. The patient continued to have worsening hypoxia and respiratory status requiring escalating amounts of oxygen. The patient did receive remdesivir during her first hospitalization and continue to receive all appropriate supportive cares including incentive spirometry, proning and a Combivent inhaler throughout her hospital stay. The patient's respiratory status became worse. Pulmonology was consulted Decadron was initiated, and a trial of diuresis failed to improve the patient's oxygen requirement and respiratory status. Repeat CT scan demonstrated worsening of pulmonary fibrosis and echocardiogram was unremarkable. Palliative care was consulted and family. The decision was made to pursue hospice. Patient met criteria for inpatient hospice. Patient died on 1/6/2022 at 11:34pm. Health Dept has no further information is known on this case.
1611381 2370721 2022-07-15 84.00 pt brought to ED with headache and nausea, vomited at home; thought to have come in contact with gas leak exposure at home; pt found to be positive for COVID; blood gases normal; in A Fib with RVR; O2 supplementation; COVID pneumonia; guarded prognosis; pt expired in the hospital
1611415 2370755 2022-07-15 83.00 pt to ED with fever, cough, chills, myalgias, diarrhea, nasal congestion x 1 wk; O2 saturation in 80s; O2 supplementation; bilateral pneumonia per CXR; positive for COVID; given ABX, dexamethasone, remdesivir; UTI; on BiPAP; DNR; guarded prognosis; pt expired while in the hospital
1611134 2370252 2022-07-15 75.00 Narrative: Patient passed away due to COVID-19. Pt had recieved three vaccines.
1610475 2369110 2022-07-14 85.00 9/28/21 pt to ED with cough and fever; tested positive for COVID; CXR showed bilateral pleural effusions and PE in RUL; admitted; O2 supplementation; dexamethasone, Tocilizumab; Eliquis for PE; worsening respiratory status; placed on BiPAP; DNR/DNI; pt passed away in the hospital
1610727 2370264 2022-07-14 100.00 Narrative: Patient passed away due to COVID-19. He had received a COVID-19 vaccine.
1610725 2370262 2022-07-14 96.00 Narrative: Patient passed away due to COVID-19. He had received a COVID-19 Vaccine.
1610723 2370260 2022-07-14 85.00 Narrative: 84 year old male admitted on May 29 2022 with with worsening hallucinations. He was found to be COVID positive on June 7 2022 during routine surveillance screening and had mild hypoxia, cough, and wheezing. He had received Moderna vaccine x 3 on February 11 2021, March 11 2021, and December 7 2021. He was treated with remdesivir 200 mg IV x 1 then 100 mg daily x 4 days and methylprednisolone 20 mg IV q8h x 3 days and then dexamethasone 6 mg orally daily x 5 days. On June 8 2022 patient was noted to have an elevated D-dimer and found to have PE. He was noted to have clinical deterioration and went to comfort care on June 13 2022 and expired on June 15 2022.
1610722 2370259 2022-07-14 88.00 Narrative: pt had first 2 doses of COVID Vaccine, then was COVID positive 1/19/22; pt died from cardiac arrest on 2/2/22 while in COVID ward at outside hospital
1610717 2370253 2022-07-14 69.00 Narrative: Patient passed away due to COVID-19. He was hospitalized and had received a COVID-19 Vaccine.
1610716 2370251 2022-07-14 90.00 Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
1610715 2370248 2022-07-14 72.00 Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
1610396 2369029 2022-07-14 41.00 pt had a positive COVID test 1/4/22; 3/29/22 pt to ED with c/o dry cough, SOB, chest pain; found to have pulmonary edema; elevated tropins; ejection fraction 15-20%; multiple intracardiac thrombi; suffered cardiac arrest multiple times with ROSC achieved; pt continued to decline; became a DNR; pt went into asystole, and passed away in the hospital
1610431 2369065 2022-07-14 SD 75.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 02/12/2021 and 03/12/2021. They tested positive for COVID-19 on 05/12/2022. They were admitted to hospital 05/09/2022 and transferred to a different hospital on 05/12/2022. They experienced complications of acute respiratory failure, septic shock, and cardiac arrest. They remained hospitalized until their death on 05/20/2022.
1610422 2369056 2022-07-14 63.00 pt to ED with weakness, nausea, fever, cough, diaphoresis, and falling at her house; when EMS arrived, pt was on 3 L O2 via NC with O2 saturation in the 70s%; NRB placed on pt; to ED and found to be positive for COVID; admitted; ICU due to progressive hypoxia; given remdesivir, dexamethasone, vitamins C and D, zinc; respiratory status worsened requiring intubation; type 2 NSTEMI secondary to hypoxia; AKI; worsening respiratory status; pt transitioned to palliative measures and made comfortable; she passed away in the hospital
1610411 2369045 2022-07-14 82.00 requested medical records from a residential facility; the ones received were very limited; the pt had a positive COVID test on 7/26/21; pt passed away in a residential facility - on 9/3/21; no other information
1610376 2369009 2022-07-14 MO 73.00 ADMITTED TO ICU WITH SEPTIC SHOCK, FOUND TO BE COVID POSITIVE. DEVELOPED HYPOXEMIA, LOWER ABDOMEN PAIN, WEAKNESS, VERTIGO, N/V, REQUIRED 3 LITERS O2 TO MAINTAIN O2 ABOVE 90%. FOUND TO HAVE DIVERTICULITIS, DUODENITIS. THEN DEVELOPED CARDIOVASCULAR SEPTIC SHOCK AND PATIENT EXPIRED
1610193 2368823 2022-07-14 TN 86.00 Death from COVID-19 S/p Vaccination
1610187 2368817 2022-07-14 TN 63.00 Death from COVID-19 s/p COVID-19 vaccination
1610729 2370266 2022-07-14 67.00 Narrative: PATIENT PASSED AWAY DUE TO COVID-19. PT WAS HOSPITALIZED HAD RECEIVED THREE COVID-19 VACCINE AT THE TIME OF DEATH.
1610728 2370265 2022-07-14 69.00 Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
1610753 2370300 2022-07-14 90.00 Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
1610731 2370268 2022-07-14 82.00 Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
1610746 2370288 2022-07-14 75.00 Narrative: Patient passed away due to COVID-19. He was hospitalized and had received several COVID-19 Vaccine.
1610754 2370301 2022-07-14 73.00 Narrative: 72yo male patient received a Covid healthcare professional vaccine (J&J) EUA on 4/8/2021. Pt died on 6/18/2022. Patient self-present to community emergency facility Emergency Notification Intake Date Presenting to the Facility: 06/18/2022 Chief Complaint: Cardiac Arrest Primary Diagnosis: Patient Admitted? No. ED/Death Note. Expired 6/18/2022 @ 2315 Appears death is not related to vaccine given long time between vaccine given and date of death from cardiac arrest.
1610732 2370269 2022-07-14 70.00 Narrative: Patient passed away due to COVID-19. He was hospitalized and had received the COVID-19 vaccine.
1610752 2370298 2022-07-14 84.00 Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
1610749 2370293 2022-07-14 82.00 Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
1610748 2370291 2022-07-14 81.00 Narrative: Patient passed away due to COVID-19. He was hospitalized and received a COVID-19 vaccine.
1610747 2370289 2022-07-14 83.00 Narrative: PATIENT PASSED AWAY DUE TO COVID-19. HE WAS HOSPITALIZED AND HAD RECEIVED THREE COVID-19 VACCINE.
1610751 2370296 2022-07-14 67.00 Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
1610745 2370287 2022-07-14 73.00 Narrative: PATIENT PASSED AWAY DUE TO COVID 19 .HE HAD RECEIVED COVID-19 VACCINE
1610738 2370277 2022-07-14 94.00 Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
1610737 2370275 2022-07-14 81.00 Narrative: PATIENT PASSED AWAY DUE TO COVID-19 . HE WAS IN THE HOSPITIZED AND HAD RECEIVED A COVID-19 VACCINE.
1610736 2370274 2022-07-14 74.00 Narrative: PATIENT PASSED AWAY DUE TO COVID-19. PT WAS HOSPTILIZED AND FULLY VACCINATED AT THE TIME OF HIS DEATH.
1610735 2370272 2022-07-14 79.00 Narrative: PATIENT PASSED AWAY DUE TO COVID-19. HE WAS HOSPITALIZED AND HAD RECEIVED THE COVID-19 VACCINE.
1610734 2370271 2022-07-14 89.00 Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
1610739 2370279 2022-07-14 91.00 Narrative: as described in events, do not believe death related to vaccine/booster. had received 3 doses of Moderna covid vaccine/booster previously with no reaction
1609567 2367617 2022-07-13 TN 49.00 Patient presented to hospital on 01/14/2022 with rectal and GI bleeding, with abdominal pain, nausea and dizziness. In the ED tested positive for Covid-19. CT abdomen/Pelvis impression: abnormal wall thickening, hepatic cirrhosis associated with splenomegaly and small volume ascites, moderate hiatal hernia. Patient eventually needed intubation and requiring vasopressor support for sepsis. Patient expired on 01/22/2022 from sepsis d/t Covid-19 as well as colitis with septic shock and multiorgan failure.
1609745 2367796 2022-07-13 75.00 pt had a positive COVID test on 8/3/21; 8/31/22 pt to ED after a MVA with AMS; pt had a PE; suffered cardiac arrest; ROSC achieved; transferred to ICU; intubated; anemic; given 2 units PRBCs; suffered bradycardia and cardiac arrest; ROSC achieved; pneumothroax requiring chest tube; pt suffered cardiac arrest again; family made pt a DNR and he passed away in the hospital; records state PE likely secondary to previous COVID infection
1609704 2367755 2022-07-13 88.00 Pt had a positive COVID test on 7/14/21 at Hospital; 8/31/21 pt to hospital and admitted with SOB and cough; diagnosed with pneumonia post COVID and respiratory failure; O2 supplementation; DNR/DNI; desires hospice care and comfort measures; pt expired in the hospital.
1609597 2367648 2022-07-13 88.00 pt had a positive COVID test on 8/20/21 from local Regional Health System; no medical records on this patient; he passed away at home with cause being COVID 19
1609586 2367636 2022-07-13 TN 68.00 Patient transferred to local hospital on 01/22/2022 with multiple complaints including abdominal pain and diarrhea. Work up was consistent with sepsis, acute cystitis, acute diverticulitis and Covid infection. Patient was not eating and was not participating in therapy or treatment. Was transferred to ICU for worsening clinical status and hypotension. Patient was given IV fluid boluses, bicarb infusion, vasopressin drip. Eventually palliative care was consulted. Patient was made DNR and expired on 02/15/2022.
1609387 2367437 2022-07-13 MI 84.00 Admission Date: 7/1/2022 Discharge Date: Jul 5, 2022 PRESENTING PROBLEM: Acute on chronic diastolic heart failure (HCC) [I50.33] Hypokalemia [E87.6] Respiratory insufficiency [R06.89] Increased oxygen demand [R68.89] Acute on chronic congestive heart failure, unspecified heart failure type (HCC) [I50.9] COVID-19 virus infection [U07.1] HOSPITAL COURSE: Acute on chronic hypoxic hypercapnic respiratory failure on admission not resolved prior to discharge patient is still on BiPAP however patient's family had decided on comfort measures, there was an attempt to take patient home on comfort measures yesterday but this was postponed to today. I discussed with the patient's son by the bedside this morning and he confirmed the patient is do not resuscitate and family wants comfort measures, he understands the patient is dying actively, but he wants us to be able to arrange patient to go home on BiPAP with ambulance today so that patient can pass it with quietly at home amongst his family. On discharge I prescribed a comfort measure medications like morphine, Ativan and scopolamine. Medical social worker will arrange for hospice at home to continue adjusting his meds however I would doubt if patient with being home long enough for hospice to visit, patient seems to be actively passing away. Blood pressures have dropped, patient's son is aware of these and he understands the patient might pass away today, but he would prefer patient passed away at home Patient passed on 7/5/22 at his residence.
1609543 2367593 2022-07-13 TN 74.00 Patient was being treated at local Medical Center for Covid-19 PNA with hypoxic respiratory failure but showed no improvement despite all interventions. Patient was on max Airvo 100% flow rate of 60L, patient was also encephalopathic, head CT was negative for any acute process. Patient transferred to hospice care service and was placed on comfort care. Patient expired on 08/17/2021.
1609419 2367469 2022-07-13 70.00 MODERNA COVID VACCINE BOOSTER GIVEN 11/12/21, LOT # 077C21B; pt brought to ED on 4/19/22 with dyspnea and cough x 2 days; O2 saturation 80% on RA; admitted; O2 supplementation; positive for COVID; fever; bone marrow and lymph bx done; worsening condition; prognosis guarded; DNR; rectal bleeding the morning of her death; all aggressive treatments were stopped; pt passed away in the hospital
1609378 2367428 2022-07-13 TN 100.00 Patient was a resident of a health care facility who tested positive for Covid-19 on 08/01/2021. Patient expired on 09/02/2021 with Acute Stroke listed as cause of death. Other significant contributing factors listed include dysphagia, failure to thrive, coronary artery disease, and recent Covid-19 infection.
1609826 2367877 2022-07-13 TN 69.00 Patient was admitted to Medical Center on 08/18/2021 with Covid-19 resulting in acute hypoxic respiratory failure. The patient initially did well with nasal cannula, but gradually required an increasing oxygen requirement to Vapotherm, Bipap, and was eventually intubated on 08/22/2021. She was treated with dexamethasone, remdesivir was not give d/t renal insufficiency. She developed secondary bacterial infection, and treated with Vancomycin, Zosyn, and micafungin. The patient improved and shock resolved briefly, but returned abruptly, with worsening vasopressor requirement with levophed, vasopressin, epinephrine, phenlephrine without adequate blood pressure. Family decided on comfort measures and patient was extubated. Patient expired on 09/02/2021.
1609808 2367859 2022-07-13 88.00 pt also received 2 additional Moderna COVID vaccines - Moderna 11/9/21, lot #033F21A and on 5/3/22, lot #001M21A. pt was living in a nursing home, tested positive for COVID in nursing home; CT of the head showed left parietal intraparenchymal hemorrhage; DNR; High Point Hospice, saw pt for palliative care until he passed away in the nursing home.
1609649 2367700 2022-07-13 MN 75.00 Dose 1 2/11/2021 Moderna Lot # 031L20A Pt was hospitalized with Covid 19 at Medical Center hospitalized 6/24/22-7/12/22. patient died 7/12/22
1609837 2367888 2022-07-13 TN 73.00 Patient presented to Medical Center on 01/11/2022 with c/o low oxygen. Patient recently had tested positive for Covid-19. In the ED the patient was 67% on RA and placed on 15L NRB. Patient also c/o sore throat, malaise. Chest xray consistent with Covid-PNA. Patient was admitted and started on steroids. Patient was administered remdesivir, and lovenox for DVT prophylaxis. During the hospitalization he was noted to have ST elevation, and was taken to the Cath lab. Patient received a stent to LAD, and was also found to have chronically occluded RCA. He was placed on aspirin and prasugrel in addition to beta-blocker and ACE inhibitors. Patient had worsening hypoxemia and was placed on CPAP, did not tolerate and was transferred to CCU. Patient required intubation. Patient required worsening shock refractory to high-dose vasopressor and expired on 01/29/2022.
1609909 2367961 2022-07-13 TN 92.00 Patient admitted to Medical Center on 02/01/2022 for a recently diagnosed Covid infection and hypoxia. Chest Xray impression: ill defined basilar infiltrates, PNA, and/or edema. Patient was given Remdesivir and Dexamethasone. He had progressive respiratory failure requiring high flow 100% vapotherm. Patient and family decided DNR was best. Patient expired on 02/14/2022.
1609850 2367901 2022-07-13 TN 85.00 Patient presented to Hospital on 08/26/2021 with increased SOB, confusion and hypoxia, with O2 saturation in the 70's. In the ED patient was tested positive for Covid-19, the patient was placed on nasal cannula and admitted to hospital services. Patient required both optiflow and NRB over with sill borderline oxygen saturations. CT imaging revealed extensive pneumonia r/t Covid-19. Patient continued to decline despite maximum therapy and CAP. Palliative care was consulted and decision and was made for comfort care. Patient expired on 09/03/2021.
1609946 2367998 2022-07-13 NV 58.00 Patient was sick after testing for covid. Within a month he was hospitalized for 5 days. They pumped him full of crap at the hospital that in turn caused him to be released worse off. He got 2 vaccines and had not been the same since this. He was constantly sick, short of breath, exhausted, and flu like continuously. Pt died June 10th, 2022 almost exactly 6 months from the 2nd vaccine. He died of myocardial infarction. he Never had health issues. granted he was 58 but he had a physical before testing that he passed with flying colors. I believe the hospital GAVE him covid with their test. Then talked him into getting the vaccine. I NEVER got covid. I never tested for it and I believe he was given COVID from the test to push this worthless killer vaccine!
1609924 2367976 2022-07-13 70.00 pt had a positive COVID test on 8/10/21; 8/17/21 pt admitted to hosp with increasing SOB; COVID pneumonia; given Decadron and ABX; required intubation; cardiac arrest - CPR and ACLS protocol; went into Ventricular Fibrillation; 6 shocks with meds and never achieved ROSC; pt passed away in the hospital
1609919 2367971 2022-07-13 TN 74.00 Patient presented to Hospital on 01/02/2022 via EMS in supraventricular tachycardia that was symptomatic. Vagal maneuvers were unsuccessful. Patient received 2 boluses of adenosine, and started on amiodarone bolus plus drip. Chest Xray alveolar airspace disease in the left lower lobe, small effusion has developed in the right lung base and right minor fissure. Covid returned positive. Patient was started on dexamethasone, bronchodilators. Patient was admitted to ICU and required intubation. She develop PEA arrest. She was pronounced dead on 01/04/2022.
1610037 2368089 2022-07-13 SD 95.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual received a mixed regimen of COVID-19 vaccine, having received 1 dose of the Jansen product on 03/10/2021 and 1 dose of Pfizer on 04/19/2022. The individual tested positive for COVID-19 on 05/11/2022 at the facility at which they were a resident. I see no indication they were hospitalized for this illness. They experienced complications of respiratory arrest, and pneumonia aspiration. They died on 05/15/2022.
1609890 2367941 2022-07-13 TN 61.00 Patient presented to Hospital on 04/07/2022 with SOB. Per EMS, patient was 78% on RA and placed on 3LNC. Patient has a hx of asthma, lung cancer, liver cancer, and brain cancer, with home O2 use. She was found to be Covid-19 positive. D/t her underlying medical conditions, the only therapy available was oxygen and dexamethasone. Patient had a sustained run of V tach and required ACLS despite her automatic implantable cardioverter-defibrillator. Patient was transferred to ICU. She became more hypoxic and required intubation. Her family chose to pursue hospice care and comfort care. Patient was palliatively extubated. Patient expired on 04/11/2022.
1609863 2367914 2022-07-13 TN 51.00 Patient admitted to Medical Center on 01/30/2022 with c/o seizure and worsening progressive debility, and placed on IV Keppra. She continued to decline and a new CT scan and CTA was done showing a new acute CVA with distribution of both the left MCA and PCA. Decision was made by family to make hospice for comfort care. Discharge diagnosis to GIP/Hospice included new acute stroke, Covid-19PNA, seizure disorder, PRES syndrome, hypertension. Patient expired on 02/26/2022.
1609860 2367911 2022-07-13 57.00 pt had a positive COVID test on 1/29/22 in rehab center; pt transported to medical center's ED with hypoxic respiratory failure related to COVID PNA; pt was intubated and on a ventilator; Emergency helicopter ride to a different medical center; decompensated and went into cardiac arrest after landing; ROSC achieved; pt was pulseless in ED; coded off and on for 1.5 hrs and never achieved ROSC
1608589 2365849 2022-07-12 died 2 weeks later; was diagnosed w COVID; was diagnosed w COVID; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). An 80-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "died 2 weeks later"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "was diagnosed w COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: diagnosed w COVID, notes: was diagnosed w COVID. The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The clinical course was reported as follows: elderly woman 80 years-old who was fully vaccinated with Pfizer's vaccine otherwise healthy traveled this summer to visit family. Upon return home was diagnosed with COVID and died 2 weeks later. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: died 2 weeks later
1608825 2366099 2022-07-12 84.00 Tested positive for COVID on 10/29/21, received monoclonal antibody infusion; 11/1/21 c/o increasing SOB and chest discomfort; taken to ED where he was hypertensive; hypertension treated; COVID pneumonia and acute CHF exacerbation; placed on BiPAP; transferred to ICU; given Decadron and Remdesivir; Ejection Fraction 25-30%; DNR/DNI; pt was transferred to a Rehab center in stable condition on 11/6/21; pt then dc'd to home from rehab center where he passed away naturally with cause of death being COVID 19 pneumonia
1608705 2365976 2022-07-12 FL 93.00 Pt unable to get dialysis related to testing positive for covid. Altered mental status related to metabolic encepholopathy. Pt also presented with anemia requiring blood transfusion, diarrhea, wounds and aspiration pnuemonia. Family decided to transfer patinet to hospice, Patient expired on 07/04/2022 Hopitalization dates 06/14/2022-07/03/2022
1608717 2365988 2022-07-12 91.00 pt had a recent heart transplant rejection 26 years post transplant twice, both of which were responsive to alterations in immunosuppression therapy and steroids; pt started having diarrhea, fever, cough 1 day before coming to ED from a nursing home; pt had a positive COVID test; admitted; DNR; COVID PNA; all meds except comfort meds dc'd; on O2 supplementation with O2 saturations still in low 80s; pt passed away in the hospital
1608723 2365995 2022-07-12 TN 83.00 Chronically ill patient with a PMH of systolic HF, afib, COPD was admitted to Medical Center on 12/17/2021 with Covid-19 PNA and acute CHF exacerbation and renal failure. Patient was encephalopathic on admission. Patient received Remdesivir x 5 days, Baricitinib, and Decadron. Patient was discharged to Home Hospice on 12/30/2021- Hospice name unknown. Patient expired on 01/21/2022 at home.
1608729 2366001 2022-07-12 88.00 8/25/21 pt admitted to hospital after a fall at home where he hit the right side of his face; CT showed acute IPH and SAH; found to be positive for COVID on admission; O2 supplementation; dexamethasone; pt's condition worsened; he refused PEG tube or any advanced measures; condition declined; inpatient hospice care; pt expired in the hospital
1608740 2366012 2022-07-12 TN 85.00 Patient presented to Hospital on 08/17/2021 via EMS for low O2 saturation. Family members noted patient to be more confused than normal and lethargic with worsening SOB. Lab results in ED indicated significantly elevated WBC of 21.6, hypoxemia on ABG results with a PO2 of 74 on 6 L NC, hyperglycemic with a blood glucose of 214, elevated CRP >190, elevated proBNP 2364, elevated lactic acid of 4.4. Patients rapid Covid test was positive. Patient underwent CTA of the chest which indicated bilateral pneumonia. Patient was admitted and treated with antibiotic therapy, steroids, remdesivir, convalescent plasma, Ivermectin. Patient needed increased oxygen requirements. Patients family made him a DNR and placed on comfort care. Patient expired on 08/24/2021.
1608741 2366013 2022-07-12 86.00 pt states he had a positive COVID test on 8/18/21 and was told by his dr (name not in medical record) to self-isolate; since then he has progressive fatigue and SOB; EMS brought him to ED on 8/23/21; positive for COVID; O2 saturations in the 80s; placed on O2 supplementation; AHRF, hypertensive urgency, AKI, hyperlipemia; hypertension treated also given decadron, vitamins, zinc; transferred to ICU; respiratory status worsened; given Tocilizumab; renal function worsened; pt made a DNR; poor prognosis; comfort care and placed into inpatient hospice where he passed away
1608791 2366065 2022-07-12 67.00 pt had a recent hospitalization from 12/15 - 12/20/21 with COVID 19; was on O2, Remdesivir, and dexamethasone; back to hospital on 12/27/21 with fever, AHRF; bacterial pneumonia superimposed on COVID 19; given dexamethasone, ABX; worsened respiratory status; transferred to ICU; intubated; dismal prognosis; family decided on comfort care and the pt passed away in the hospital
1608801 2366075 2022-07-12 TN 64.00 Patient presented to Medical Center on 01/31/2022 with severe fatigue, worsening of his nonproductive cough and SOB. CXR showed multifocal PNA. He was given a dose of vancomycin, cefepime, IV steroids and fluids, and supplemental oxygen. Patient was admitted to hospital for treatment of acute hypoxic respiratory failure and sepsis secondary to Covid-19 PNA. He was placed on dexamethasone, but remdesivir was not administered d/t kidney function. Empiric treatment for bacterial coinfection with ceftriaxone an azithromycin was started. Started on bicarbonate drip for metabolic acidosis. On 02/04/2022 he began requiring high glow nasal cannula. He was then transferred to CCU. He required intubation and intermittent HD. On 02/23/2022 comfort care measures initiated and patient expired.
1608967 2366243 2022-07-12 90.00 pt to ED 8/22/21 testing positive for COVID; AHRF; given steroids; Remdesivir not given due to elevated Liver Function Tests; O2 supplementation; DNR/DNI; worsening respiratory status; comfort measures; in patient hospice where pt passed away
1608850 2366124 2022-07-12 64.00 pt admitted to Medical Center on 12/30/21 and dx with COVID and AHRF; dc'd to home on 1/12/22; 1/17/22 became increasingly SOB, EMS called; O2 saturation in 70s; brought to ED and placed on BiPAP; no evidence of PE; placed on steroids and ABX; transferred to ICU; sepsis; worsening respiratory status requiring intubation and mechanical ventilation; continued to decompensate; given vasopressors; went into cardiac arrest; CPR performed; didn't achieve ROSC; pt expired in the hospital
1608874 2366149 2022-07-12 NY 93.00 3/21/2022- Sent from a UC for SOB and Covid + test.Was taken., was weak and lethargic over last couple weeks, regularly on 2L NC at HS. 84% o2 sat on RA, placed on 4L NC, o2 rose to 94%. T: 101.1, HR: 130 RR:27. WBC: 23.4 D-Dimer:1505 CXR: bilateral pulmonary infiltrates and small bibasilar pleural effusions. ABG:7.37/45.4/74/26.3 on RA. Ordered decadron, baricitinib, remedesivir and Cefepime. 1 dose of lopressor, HR down to 110-120. Start vancomycin ,Zosyn, pipercillin tazobactam and metronidazole for possible aspiration pneumonia. Admit acute hypoxemic respiratory failure s/t Covid 19 pneumonia in the setting of parietoalveolar pnuemopathy. Bipap placed fio2 60
1608934 2366210 2022-07-12 IL 85.00 Pfizer Dose 1 1/20/21 (EL0140) Pfizer Dose 2 2/10/21 (EL9261) Pfizer Dose 3 12/3/21 (FG3527) COVID Positive 1/20/22 1/22/22: 85-year-old female patient with a history of hypertension, CAD, hypothyroidism, Parkinson's disease, dementia, COPD, chronic constipation, adult failure to thrive lives at a local nursing home. Patient was sent to the emergency room via paramedics as the patient was found to be not very responsive to the staff at the nursing home. The patient normally is able to perform a few of her activities of daily living and be herself in the wheelchair around the nursing home. The patient also verbalizes her needs at the nursing home. The patient was diagnosed with SARS-CoV-2 infection on 1/20/2022. Since then, patient has been weak, fatigued with no oral intake and reaching state of not being very responsive. When the paramedics reach the nursing home, the patient's pulse ox was at 78%. Patient was placed on non-rebreather mask with 15 L of oxygen and brought to the hospital. Upon evaluation, patient is noted to have a urinary tract infection and was given IV antibiotics. She is also noted to have elevated CK levels with acute renal failure, hypernatremia and hyperchloremia. Patient's son does not wish for any aggressive treatment but reported treatment with IV fluids, antibiotics. Patient is a DNR/DNI. If the patient is not responsive in the next 48-72 hours, the son would like to proceed with hospice care for the emergency room provider. 1/24/22: 85-year-old female patient with a history of CAD, hypothyroidism, hypertension, COPD, dementia, Parkinson's disease, chronic constipation and failure to thrive was admitted on 1/22/2022 for altered mental status. The patient was recent diagnosed with SARS-CoV-2 infection as of 1/20/2022. The patient was noted to have fever on admission. She was also diagnosed with E coli tract infection and requiring significant amount of oxygen at 15 L via OxyMask. I discussed patient's case with the son on admission who wanted to wait for for clinical to 48 hours to see how the patient responded to treatment. The but there was no significant improvement in the patient's clinical condition and he decided to proceed with comfort care. The patient was made comfort care as of 1/23 and transferred to the nursing home this care. The son did not want to proceed with any further aggressive treatment and with the patient to be comfortable. The case manager also has spoken with the son prior to discharge.
1609019 2366295 2022-07-12 86.00 PFIZER COVID VACCINE BOOSTER GIVEN 11/21/21, LOT # FJ160; 5/19/2022 pt to ED with c/o SOB, weakness, fatigue, productive cough this morning with blood noted; poor oral intake; taking Levaquin x 1 wk per PCP for pneumonia with improvement; O2 saturation in ED 72% on RA; AHRF; admitted; O2 supplementation; ABX; A Fib with RVR and drop in EF to <15%; cardiology consulted; 5/30/22 pt tested positive for COVID; given steroids; worsening renal and respiratory status; before pt could go to hospice, pt passed away in the hospital
1609035 2366311 2022-07-12 75.00 pt had a previous hospitalization and positive COVID test on 8/25/21; pt left the hospital earlier than advised to go home; 8/29/21 pt to ED with O2 saturation on NRB in low 90s; admitted to ICU; DNR/DNI; given ABX; placed on Vapotherm; poor prognosis; pt passed away in the hospital
1609063 2366339 2022-07-12 90.00 8/13/21 pt brought to ED due to low responsiveness; no distress; found to be positive for COVID; plan was to transfer her to a nursing home with a COVID unit, but unable to get her in one; pt taken home where she passed away
1609134 2366412 2022-07-12 WI 90.00 Patient was hospitalized at Facility on 5/27/2022 for COVID-19. D/C from hospital 6/8/2022. Death abstract indicates patient died on June 17, 2022 at hospice facility: HOSPICE/FAMILY HOSPICE. Death abstract indicates immediate cause of death: COMPLICATIONS OF INFECTION WITH NOVEL CORONAVIRUS (COVID-19) OTHER SIGNIFICANT CONDITIONS contributing to death but not resulting in the underlying cause: CONGESTIVE HEART FAILURE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, STROKE Submitter does not have access to further medical records. If more information is needed, please contact above hospice location, or Hospital as previously listed.
1609139 2366417 2022-07-12 SD 82.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 01/11/2021 and 02/01/2021. They had both a positive and a negative antigen test on 10/29/2021 and a positive PCR test on 10/29/2021. All three of these tests were administered at the facility at which the individual was a resident. They .had a hospital encounter 10/27/2021 and were discharged 11/04/2021. The chief complaints/problems for this hospital encounter included: unspecified pain, COVID-19, palliative care, Type I Diabetes, unspecified anxiety disorder, and dementia. The individual died on 11/06/2021.
1609165 2366455 2022-07-12 SD 90.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual also died 6 days after receipt of third dose of the Moderna product. The positive test occurred after receipt of second dose but before the third. The individual was vaccinated with the Moderna product on 01/07/2021, 02/04/2021, and 11/01/2021. They tested positive for COVID-19 on 10/15/2021 at the assisted living facility at which they were a resident. They were hospitalized related to this illness 10/17/2021-10/20/2021 in an out-of-state hospital. They experienced complications of COVID-19 pneumonia. They died on 11/06/2021.
1608249 2364476 2022-07-11 TN 59.00 Patient was admitted to Medical Center on 08/13/2021 with Covid-19, she was transferred and required intubation and mechanical ventilation. Patient status continue to decline. She required 4 codes during the day of 9/2/21 after experiencing worsening bradycardia. Patient expired on 09/3/21.
1608059 2364283 2022-07-11 MI 70.00 Patient was admitted because of cough congestion and sore throat for 5 days. He went to urgent care on November 26. After discharge he had a COVID-19 test resulted positive. In emergency department he was having a generalized body ache and very mild symptoms of a cough and shortness of breath. Emergency room physician expressed that he could of possibly go home but his creatinine is slightly elevated he is dehydrated need some IV hydration so patient is admitted for close monitoring. He required high levels of oxygen but did not require mechanical ventilation and was progressing well on medical floor. 12/28 rapid response called for sudden mental status change. Code stroke activated, CT/CTA head negative for intracranial pathology. Pt was intubated for airway protection and transferred to the ICU. 12/29/2021. Remains intubated VC/AC 14/450/8/60%. EEG performed, results pending. SAT performed and patient following commands. Ammonia check 107. 12/30/2021. EEG yesterday read severe diffuse nonspecific slowing of the background rhythm, indicative generalized subcortical and cortical neuronal dysfunction likely seen in significant encephalopathic state including cerebral hypoxia. Agitation off sedation, Precedex added. Trial lasix. Creat 1.2. Ammonia 82. Trail SAT/SBT today 12/31/2021. Remains intubated VC/AC 14/450/8/45%, breathing above vent. Trial on CPAP. Fluctuating mentation, reported response early this morning but unresponsive even to noxious stimuli during rounds. Oliguric renal failure. Creat 1.6. Nephrology consulted. Ammonia 101, lactulose increased. 1/1/2022. Pt successfully extubated. Requiring HFNC 60L/60%. Ammonia 110. Small bowel movement overnight, rifaximin added. AST/ALT 518/370, total bili 6.0 and Alk Phos 369. U/S Abdomen ordered. Creat 2.0. U/O remains inadequate 1/2/2022. Remains extubated but more encephalopathic. No bowel movements with soap sud enemas. Pt was started on heparin infusion for portal vein thrombosis and GI consulted. This morning INR 5.8 and heparin infusion discontinued. Ammonia 146. Hepatic panel worsening. Creat 2.6. Pt removed NG overnight. Pt was made a DNR and they would like to proceed with CMO-AND tomorrow when all significant family members can be present. 1/3/2022: Family arrived at bedside and again expressed wishes to transition to comfort care measures in the setting of his critical illness with multi-organ failure. Comfort care measures initiated and he passed @1450.
1608157 2364383 2022-07-11 63.00 pt had a positive COVID test on 7/20/21; pt to ED on 7/22/21 with SOB, lethargy; in DKA, was treated accordingly; given Tocilizumab; O2 supplementation; 7/24/21 had another positive COVID test in hospital; respiratory status worsened requiring intubation, mechanical ventilator support; multiorgan failure; acute renal failure; family made pt DNR and he was admitted to GIP hospice with comfort care; pt extubated and he expired in the hospital
1608185 2364412 2022-07-11 66.00 pt had a positive COVID test on 8/11/21 from a local Medical Center; pt died at home ; natural death; causes of death: Acute CVA, coagulopathy with thromobocytopenia, COVID 19
1608248 2364475 2022-07-11 70.00 PFIZER COVID BOOSTER GIVEN 01/11/2022, LOT #999; pt to ED on 2/11/22, states he did an at home COVID test on 2/3/22 and it was positive; found to be positive in ED for COVID; increasing SOB; hypotensive with hypoxia; given fluids; placed on NRB mask; given Dexamethasone; Tocilizumab; Pneumonia secondary to COVID; pt requested DNI, but is ok to receive cardiac meds and CPR if needed; respiratory status worsened requiring BiPAP; pt kept removing BiPAP; placed on Vapotherm and 100% NRB; grave prognosis; wife made pt a DNR/comfort care; pt expired in the hospital
1608336 2364564 2022-07-11 76.00 pt to ED on 12/28/21 with AMS and dyspnea; on 2L O2 via NC at a residential facility, now requiring 6L via NC; found to positive for COVID and influenza B in ED; pneumonia due to COVID; AKI; given IV fluids, ABX, steroids, baricitinib; respiratory status worsened requiring BiPAP; DNR/DNI; condition continued to worsen and pt expired in the hospital
1608276 2364504 2022-07-11 76.00 pt reports having a positive COVID test on 8/16/21 from Clinic; he was given medication but his condition worsened; pt to ED on 8/21/22 with increasing SOB; found to have a positive COVID test in ED; O2 supplementation; Remdesivir; Zinc; Vitamin E; ABX; pt is a DNR; pt's condition continued to decline and he passed away in the hospital
1608294 2364522 2022-07-11 76.00 Patient fully vaccinated (J&J), but not boosted, admitted to the hospital on 6/30/22 with COVID-19 and associated hypoxia. Patient expired on 7/1/22. Patient was admitted after dose #1 of J&J vaccine.
1608368 2364596 2022-07-11 69.00 8/13/21 pt had a positive COVID test; 8/18/21 pt brought to ED via EMS with increasing SOB, positive for COVID, labored breathing; c/o pain in chest; given O2 supplementation; ABX and Decadron; COVID pneumonia; pt's condition worsened and she expired in the hospital
1608391 2364619 2022-07-11 WI 74.00 "Admitted to hospital on 6/18/2022 for treatment of acute hypoxemic respiratory failure likely in the setting of right lower lobe PE and possible contributory effects of COVID-19 pneumonia (during hospital stay was treated with dexamethasone from 6/18-6/28 and remdemsivir from 6/19-6/23) Hospital course was complicated with aspiration pneumonia that led to septic shock eventually required transition to ICU and use of pressors. Pneumonia was treated with IV vancomycin and Zosyn. Patient already on admission with severe protein calorie malnutrition and cachexia in setting of chronic hematologic malignancy and frequent hospitalizations. This condition got worse during hospital stay and it was in part contributing to his worsening clinical status and failed video swallow study. After family meeting and palliative care team assessment patient was transitioned to comfort plan of care on 7/1/2022. During 7/3/2022 alternative plan made for hospice in hospital but while waiting for transfer patient passed away around 1:50 PM on 7/3/2022." If further medical records are needed, please contact Hospital
1607327 2362628 2022-07-08 IL 66.00 Pfizer Dose 1 1/25/22 (33025BD) COVID Positive 2/10/2022 2/10/22: Patient is a 66-year-old male with past medical history significant for hypertension, COPD, hyperlipidemia, rheumatoid arthritis, history of pneumococcal pneumonia status post lung surgery at outside hospitals has come to the emergency room with complaints of worsening shortness of breath for 10 days. He apparently was not vaccinated for COVID-19 till 10 days ago. He thinks that soon after vaccination he started having symptoms which gradually progressed. He had associated cough with occasional yellow sputum. He denied any sore throat or loss of sense of smell or taste. He denies any nasal congestion. He denies any vomiting but had nausea. He denies any diarrhea. He had mild headache. He denies any fever or chills. He finally presented to the emergency room where he was needing BiPAP support to maintain the oxygenation. He was weaned to 5 L OxyMask at my exam. Patient's COVID test was pending initially, but came back positive at the time of my exam. He had the highly elevated D-dimer for which he underwent a CT chest which was negative for PE but did show fibrotic chronic interstitial lung disease. There was also possible pneumonitis with chronic changes. Patient is being admitted for further management. Patient denies any chest pain, he denies any abdominal pain or any other concerns except for shortness of breath and cough during my exam in the emergency. He has no other acute health concerns. 3/22/22: Course during Hospitalization: 2/10: 66-year-old male patient with history of hypertension, dyslipidemia, rheumatoid arthritis, COPD was admitted to the hospital on 02/10. Patient was vaccinated on 02/01 for the SARS-CoV-2 virus. Patient was started on remdesivir and dexamethasone and given dose of Actemra. 2/13: Pulmonology consultation was obtained for acute hypoxic respiratory failure. Patient was maintained on BiPAP. 2/17: Patient was transition to OptiFlow to maintain pulse ox above 90%. Possibility of rheumatoid arthritis affecting the lungs was considered. Antitussives and Xanax were given for relief due to cough and anxiety respectively. 2/21: Patient was started on Solu-Medrol per pulmonology as patient also has history of COPD to see if he could get some relief. Patient also had a brief run of SVTs. Minimal movement even in bed was causing significant hypoxia. 2/28: Patient expresses his significant fatigue with OptiFlow and wants to be intubated. Intubation performed per anesthesia. 3/1: Patient started on low-dose of Levophed for hypotension. Solu-Medrol. Started on a Zosyn. 3/3: Patient's urine, sputum, blood cultures from 3/1 are NGTD 3/4: Sedation vacation was tried. Pt able to follow commands and coughing. 3/7: Tube feeld held due to significant amount of copious secretions. Dietitian consulted. 3/8: Checked Abdominal series for constipation-normal X-ray 3/9: Slow introduction of Tube feeds. 3/11: s/p trach and PEG placement. Pt had significant arrhythmias from SVT, atrial fibrillation and V-tach overnight 3/12: 1 DES to the RCA placed, Levophed and dopamine started. Significant oral and G-tube secretions present. 3/13: Patient off of dopamine. Tube feeding held. 3/17: Pt not tolerating the tube feeds, unable to get the tip of the tube into the jejunum. Currently tip present between 2nd and 3rd part of duodenum. 3/18 : LUE Cephalic vein thrombosis+, on BID dosing of Lovenox. 3/20: Patient tolerating tube feeds better. Tracheal secretions present. 3/21: Patient's FiO2 increased from 80-100% today. Tracheostomy area erythematous. Patient made DNR/DNI. 3/22: Patient on 100% FiO2. Started on Levophed at 30 mcg/minute Patient went into PEA at around 18:10 and asystole at 18:13 and passed away on 3/22/2022.
1606984 2362196 2022-07-08 DE 94.00 Hospice put in the death certificated that she dies from complication with the Moderna shot; got Alzheimer dementia; complained about her arm; started having trouble walking/ a couple of weeks after that she was not able to walk; was concern because the shot was not administer right; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (Hospice put in the death certificated that she dies from complication with the Moderna shot), DEMENTIA ALZHEIMER'S TYPE (got Alzheimer dementia), LIMB DISCOMFORT (complained about her arm) and GAIT DISTURBANCE (started having trouble walking/ a couple of weeks after that she was not able to walk) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in March 2022. Previously administered products included for Product used for unknown indication: Flu shot (given within 1 month prior to Moderna COVID-19 vaccine). Past adverse reactions to the above products included No adverse event with Flu shot. In 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced VACCINATION COMPLICATION (Hospice put in the death certificated that she dies from complication with the Moderna shot) (seriousness criterion death), DEMENTIA ALZHEIMER'S TYPE (got Alzheimer dementia) (seriousness criteria death and medically significant), LIMB DISCOMFORT (complained about her arm) (seriousness criterion death), GAIT DISTURBANCE (started having trouble walking/ a couple of weeks after that she was not able to walk) (seriousness criterion death) and PRODUCT ADMINISTRATION ERROR (was concern because the shot was not administer right). The patient died on 15-Jun-2022. The reported cause of death was hospice put in the death certificated that she dies from complication with the moderna shot, got alzheimer dementia, complained about her arm and started having trouble walking/ a couple of weeks after that she was not able to walk. An autopsy was not performed. At the time of death, PRODUCT ADMINISTRATION ERROR (was concern because the shot was not administer right) outcome was unknown. Relevant concomitant medications were not reported. It was reported that 3 months ago the patient got the booster and the end of Feb-2022 begging of Mar-2022, and that got a little sick with first and second shot, but after the booster got a rapid declined. She complained about her arm and then she started having trouble walking. A couple of weeks after that she was not able to walk, and after that got Alzheimer dementia, and she did not know her family. On 15-Jun-2022 she died, something happened with that shot at that pharmacy, was a rapid declined, she was gardening and driving the day of the booster. The doctor was surprised because she got a psychical. Patient's son was concern because the shot was not administered right, or she was to old and fragile to get the shot. The amalgamation of what happened was incredible three months. All this people were okay at the time of report, except for his mother. The Hospice put in the death certificated that she dies from complication with the Moderna shot. The adverse event cause patient to seek medical care (office visit, Urgent care, ER, hospitalized) to ER. They could not get the Autopsy done because of her age. Treatment information was not provided. The patient experienced no a similar event in the past. This case was linked to US-MODERNATX, INC.-MOD-2022-599998 (E2B Linked Report). Company Comment: This spontaneous case concerns a 94-years-old, female patient with no relevant medical history, who experienced the unexpected fatal serious events of vaccination complication, dementia Alzheimer's type (medically significant), limb discomfort, gait disturbance, product admiration error, which occurred unspecified days after third dose of mRNA-1273 vaccine. It is reported that after booster vaccination patient complained about her arm and started having trouble walking and after couple of weeks patient wasn't able to walk and then patient diagnosed with Alzheimer dementia and family didn't about this and patient died on 15 AUG 2022, autopsy results were unknown. Cause of death is mentioned as vaccination complication, dementia Alzheimer's type (medically significant), limb discomfort, gait disturbance, product admiration error. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 94-years-old, female patient with no relevant medical history, who experienced the unexpected fatal serious events of vaccination complication, dementia Alzheimer's type (medically significant), limb discomfort, gait disturbance, product admiration error, which occurred unspecified days after third dose of mRNA-1273 vaccine. It is reported that after booster vaccination patient complained about her arm and started having trouble walking and after couple of weeks patient wasn't able to walk and then patient diagnosed with Alzheimer dementia and family didn't about this and patient died on 15 AUG 2022, autopsy results were unknown. Cause of death is mentioned as vaccination complication, dementia Alzheimer's type (medically significant), limb discomfort, gait disturbance, product admiration error. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-599998:Master case; Reported Cause(s) of Death: Hospice put in the death certificated that she dies from complication with the Moderna shot; got Alzheimer dementia; complained about her arm; started having trouble walking/ a couple of weeks after that she was not able to walk
1607227 2362524 2022-07-08 IA 67.00 Pfizer Dose 1 2/17/21 (en6201) Pfizer Dose 2 3/11/21 (EN6204) Pfizer Dose 3 10/13/21 (FF2587) COVID Positive 1/12/22 1/6/22: A 67-year-old male with a past medical history of hypertension, hyperlipidemia, hypothyroidism, anxiety and depression and acute myelogenous leukemia on Gleevec follows with Dr., is transferred from Medical Center for GI bleed and acute kidney injury. Patient presented to the Medical Center on 01/02/2022 after he fell and syncopized in service, was evaluated in the ED, noted to have acute fracture medial tibial plateau of right knee and the acute anti 10th rib fracture, nondisplaced. Patient was evaluated by Dr., orthopedic surgery, and recommended non operative management with the TTWB RLE and pain management. Patient was also noted to have low hemoglobin, 6.7, was given 2 unit PRBC transfusion. Patient was noted to have black stools, FOBT is positive. No hematemesis or abdominal pain or chest pain or dizziness. Today his BUN and creatinine went up to 47 and 2.7, and patient is transferred for further GI and Nephrology evaluation. Patient denies any history of prostate enlargement, no urgency or hesitancy. Patient states that he had recent colonoscopy and small bowel capsule endoscopy with Dr. about a year ago, and no bleeding was noted. He also follows with Dr. for acute myelogenous leukemia, and has been on Gleevec for the past 15 years. Patient had COVID-19 infection in October 2020. He is vaccinated against COVID-19. 2/9/22: A 67-year-old gentleman presented to medical center as a transfer from ED with a history of GI bleed and acute kidney injury. The patient had a fall 4 days prior to admission. He is sustained a tibial plateau fracture as well as 10 rib fractures that were nondisplaced. He was transfused him with 2 units of PRBC for acute blood loss anemia. The patient eventually underwent EGD that shows that the patient has peptic ulcer strictures and GERD with some esophagitis and duodenitis. The patient was started on Diflucan as well as proton pump inhibitors. While in the hospital patient developed acute kidney injuries and was noted to be constipated and not to be able to tolerate any meals. His abdomen was distended. He was eventually diagnosed with ileus. The patient did not have any objective mechanical obstruction. Surgery was consulted and recommended conservative management with NG tube for decompression, IV fluid and eventually TPN. Patient's kidney function did not improve and was started on hemodialysis. The patient had a long, long stay in the hospital with no improvement of his condition. He could not tolerate any food. He remained on the hemodialysis with no insight to improvement of his renal function. After further discussion with the family and the patient being lucid, has opted for comfort measures and will be discharge under hospice care on February 10, 2022. At this point, all aggressive management has been discontinued and comfort measures have been initiated. Family member, a daughter, is in arguments with the patient, who has been stating that he is ready to meet the Lord and he wanted to go to the Lord. The patient will be discharged with hospice care management. 2/11/22: Patient deceased
1607261 2362558 2022-07-08 TN 61.00 Presented to hospital on 6/17 with increasing shortness of breath. Intubated and chest tube inserted due to peural effusion. Admitted to critical care. Test for COVID +. Started on zosyn and zyvox. and vasopressor support for septic chock. Weaned off prssors and extubated on 6/19. WBC count started to increase and escalated to cefepime and vancomycin. Chest tube not functioning well so surgical site tube inserted and patient reintubated. Continued to decompensate. CT of abd showed abscess and drains placed. Little improvement and had radiology drain placement of chest. WBC continued to be high. Palliative care consulted. Famy changed code status to intubate only and wanted to transition to comfort care only.
1607264 2362561 2022-07-08 TN 56.00 Patient Date of death: 7/4/2022 County: local COVID (+) Death Admitted to local MEDICAL CENTER on 6/27/2022 Tested positive for COVID on 6/29/2022 Admit reason: Acute respiratory failure with hypoxia. 3 DOSES COVID VACCINE PRIOR TO DEATH.
1607266 2362563 2022-07-08 TN 90.00 COVID-related death / breakthrough case
1607318 2362617 2022-07-08 IL 59.00 Pfizer Dose 1 3/13/21 (EN6207) Pfizer Dose 2 4/3/21 (ER8729) COVID Positive 1/6/22 COVID Positive 1/9/22 1/9/22: Patient is a 60-year-old morbidly obese male with past medical history significant coronary artery disease status post bypass grafting x3, essential hypertension, hyperlipidemia, pre- diabetes has come to the emergency room with complaints of worsening shortness of breath for 2 days. He reports that his stepson has symptoms and is currently being tested. He apparently started having symptoms about a week ago but in the last 2 days had worsening of symptoms. He reports having sore throat for a few days but not anymore. He had intermittent fevers, shortness of breath, cough, decreased appetite, and fatigue. He denies having any diarrhea. He denies any nausea or vomiting or headache. He apparently received his vaccination for COVID-19 with Pfizer vaccine. He reports not receiving the booster yet. Patient denies any swelling in the lower extremities. He denies any chest pain or palpitation. He reports no other acute health concerns. During the emergency room evaluation, patient was noted to 80's severely hypoxemic needing to be put on 15 L and then BiPAP with FiO2 of 70%. He did have a fever of 101�F. He is noted to be in acute kidney injury with creatinine of 2.33, mild elevation of AST at 61 and mild troponin elevation. Patient did not have any leukocytosis. Chest x-ray showed diffuse bilateral pneumonia. Patient's COVID test is pending. Influenza testing is negative. Patient is being admitted for acute hypoxemic respiratory failure likely from COVID 19 infection based on current pandemic and patient's symptoms. Since patient is needing BiPAP support patient will need to be admitted to ICU. 2/6/22: 60-year-old morbidly obese male patient with history of CAD, hypertension, type 2 diabetes, can be age, dyslipidemia new was admitted to the hospital on 1/9/2022 with complaints of shortness of breath. Patient received 2 doses of the COVID-19 vaccine but was yet to receive his booster does prior to admission. He was noted to have a pulse ox of 80% on admission and was placed on 15 L and subsequently transitioned to BiPAP. He was also noted to have a fever of 101� F on admission. He was also noted to be in acute renal failure with metabolic acidosis, hyponatremia and volume overload and hence Nephrology consultation was obtained. Patient was admitted to the ICU for close monitoring and Dr. was consulted from pulmonology. Patient had a central line placed. Patient required hemodialysis for his renal failure caused due to acute tubular necrosis from COVID-19 infection. Patient underwent intubation within the 1st 48 hours of admission. He had elevated D-dimer level and CRP. Patient was placed on heparin drip and given a dose of Actemra also. Since he was hypotensive, pressor support was given with Levophed. Patient was initiated on tube feedings. He completed his course of antibiotics since admission. He was also noted to be in paroxysmal atrial fibrillation for which anticoagulation therapy with Eliquis was initiated. Patient was taken off of propofol after 14 days of being on ventilator. Patient was awake, responsive in an un-purposeful manner and was agitated. A long discussion with the wife with regards to the prognosis and his long-term treatment plan, tracheostomy and PEG tube placement was discussed along with the tunnel catheter placement for dialysis. The wife reluctantly agreed to the placement of the tracheostomy as she wanted the patient to be enrolled in comfort care but however the patient's kids wanted the procedure to be performed. Post tracheostomy placement, the patient remained agitated and required pressor support on and off. Dr. from pulmonology did discuss with the patient's son, and all questions were answered on 02/05. They were to make a decision about not proceeding with any further surgical interventions such as tunnel catheter placement and PEG tube placement. The patient's wife, POA decided for the patient to be DNR. In the early hours of 2/6, the patient had wide complex tachycardia. The wife was called who did not want any further prolongation of his treatment. The patient passed away at 07:36 on 02/06/22. The family was informed.
1607321 2362621 2022-07-08 IL 68.00 Moderna Dose 1 3/16/21 (013A21A) Moderna Dose 2 4/29/21 (025B21A) COVID Positive 1/2/22 1/2/22: 69-year-old female with past medical history of rheumatoid arthritis, diabetes mellitus, hyperlipidemia, obesity, pacemaker placement, previously treated pulmonary embolism presents with worsening shortness of breath. As per patient she has been sick with pneumonia for the last 5-6 weeks. She has been trialed on multiple antibiotics however has had persistent symptoms. She presented to the ED in mid December and was discharged for treatment of pneumonia. Over the last couple of days the patient has developed a nonproductive cough and worsening shortness of breath. Patient has been tested multiple times for COVID and has been negative. In the ED the patient want to be hypoxic with pulse ox at 86%; the patient is persistent requiring 4 L nasal cannula. Chest x-ray is showing bilateral pneumonia. 1/15/22: At 10:37 on 1/15/22, ACLS protocol initiated d/t PEA. Pt received 4 rounds of epinephrine, 3 rounds of bicarb and 1 round of calcium. Pt's son and POA was contacted and agree that continuation of ACLS would be futile and decided to stop resuscitation. Pt expired at 10:54.
1607402 2362704 2022-07-08 76.00 pt to ED with c/o nausea, vomiting, diarrhea, SOB; states was recently diagnosed with COVID; has been at home and is worsening; weakness and poor appetite; CXR showed pneumonia; tested positive for COVID; placed on BiPAP; decadron; DNR; pt's condition worsened; she refused ventilator; pt expired in the hospital
1607407 2362709 2022-07-08 MO 79.00 Patient diagnosed + Covid 1/17/2022, Patient lived in a long term care nursing facility.
1607432 2362735 2022-07-08 85.00 pt to ED with increasing hypoxia; states had a positive COVID test day before coming to ED; PCP encouraged him to come to ED; O2 sat 89% on RA in ED; pt had a positive COVID test in ED: given IV steroids, remdesivir, baricitinib; cardiac consult for aortic stenosis; pt didn't want to be intubated; NRB, high flow NC with blended O2; pt's condition worsened and he passed away in the hospital
1607448 2362751 2022-07-08 37.00 pt brought to ED with c/o SOB; coded in ambulance after respiratory failure; intubated; found to have a positive COVID test; ROSC; treated for fulminant heart failure; went into ventricular tachycardia; defibrillated; CPR; very poor prognosis; poor ejection fraction; husband decided to make pt DNR; pt expired in the ED
1607494 2362797 2022-07-08 72.00 pt had a positive COVID test on 8/30/21 from Pharmacy; to ED on 9/5/21 with SOB; placed on O2 supplementation; O2 sats continued to worsen; pt did not want CPR but was willing to be intubated if needed; COVID pneumonia; worsening respiratory status; intubated; became pulseless; ACLS protocol followed with no response
1607519 2362990 2022-07-08 SD 98.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 01/03/2021 and 01/31/2021. They tested positive for COVID-19 twice via antigen test on 10/14/2021 at the nursing home at which they were a resident. The individual died on 10/30/2021. I do not see any indication the individual was hospitalized related to this illness.
1607543 2363123 2022-07-08 MN 94.00 Severe heart pain occurred same day, about 3:45pm with patient expressing 10/10 pain level (I witness a pill given to patient and soon after the pain subsided They kept the patient in hospital to monitor 3 more days because of low grade fever. The patient was released on Jan 8, 2022 (he had diarrhea that day) and was readmitted on Jan 12, 2022 because developed shallow and rapid breathing. Tested +for Covid on the 12th. After readmission to hospital he lost his ability to speak clearly and swallow. He died Feb. 9, 2022. I believe he suffered a stroke after Jan 12th. Patient was active before getting the 3rd Covid vaccine. he then declined rapidly after receiving it.
1606787 2361250 2022-07-07 SD 81.00 This is an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated with the Moderna product on 01/03/2021 and 01/31/2021. They first tested positive for COVID-19 on 10/16/2021; a second test on 10/16/2021 was negative. They had a symptom onset date of 10/18/2021 and also tested positive of this day. They experienced complications of pneumonia and died on 10/28/2021. I see no indication they were hospitalized related to this illness. They were a resident of a nursing home.
1606763 2361225 2022-07-07 WI 81.00 Client tested antigen positive for Covid-19 on 6/16/2022 at his long term care facility residence: He was admitted to the hospital on 6/19/2022 and died at the hospital on 6/19/2022 - reportedly he died of Covid-19 disease. Client received two doses of Moderna Covid vaccine: 2/5/2021 lot number 043L20A, and 12/29/2021 lot number 045J21A Submitter does not have any other information on this client. For further medical record information, please contact nursing home and hospital as noted above.
1606523 2360979 2022-07-07 MT 62.00 Patient hospitalized with COVID while vaccinated.
1606451 2360907 2022-07-07 IL 60.00 Pfizer Dose 1 3/20/21 (ER2613) Pfizer Dose 2 4/17/21 (EW0164) Pfizer Dose 3 9/21/21 (FF2588) COVID Positive 1/7/2022 1/7/22: The patient presents with worsening shortness of breath. Onset: gradual . Location: generalized. Context: The patient is a 60 year old male presents to the ED with worsening shortness of breath. He has associated fever, chills and body aches. The patient denies chest pain. He does not endorse any other pains and symptoms such as abdominal pain, nausea, and vomiting. The patient has a Hx hypertension, hyperlipidemia, diabetes, stage III renal disease and hepatic cancer with liver transplant. His transplant was done at hospital in 2009. The patient tested positive for COVID 19 recently. He was evaluated. Patient was hospitalized, while he was admitted he did require supplemental O2. He was recently discharged earlier in the week without any oxygen requirements. Today, he is requiring 3L via nasal canula which is new requirement for him. . Timing: gradual. Character: moderate. Associated Symptoms: moderate and fever, chills and body aches. 1/21/22: Severe septic shock with multi organ failure on Levophed, phenylephrine, Ang II, vasopressin, Adrenaline ;Family decided on comfort measures and patient expired Acute hypoxemic respiratory failure due to COVID-19 pneumonia Possible superimposed hospital associated pneumonia Alcoholic cirrhosis status post liver transplant in 2009, markedly elevated LFTs and lactic acid, possibly shock liver Chronic immunosuppression for liver transplant Acute kidney injury on CKD stage IIIA Diabetes mellitus with hyperglycemia Hypertension, now hypotensive on pressors Hyperlipidemia Obesity Chronic low back pain Insomnia Leucocytosis The patient expired from progressive multiorgan failure due to Acute covid-19 infection while immunosuppressed and in the background of extensive comorbiditeis
1606179 2359706 2022-07-06 66.00 PFIZER COVID VACCINE #3 GIVEN 11/15/21, LOT #30155BA; pt had a positive COVID test (out patient) on 1/10/22; he saw his PCP and was given Augmentin and Prednisone; did not improve, worsened; 1/12/2022 pt to ED via EMS for SOB, hypoxia, generalized weakness, cough, diarrhea; started on BiPAP in ED; in renal failure; sent to ICU; experienced respiratory arrest and was intubated; extremely poor prognosis; family made pt a DNR C; pt expired in the hospital
1605993 2359520 2022-07-06 TX 11.00 Subsequent Covid-19 infection resulting in Hemorrhagic Myocarditis and death.
1605739 2359230 2022-07-06 53.00 passed away via embolism shortly; This spontaneous case was reported by an other health care professional and describes the occurrence of EMBOLISM (passed away via embolism shortly) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 026B21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EMBOLISM (passed away via embolism shortly) (seriousness criteria death and medically significant). The patient died in May 2021. The reported cause of death was passed away via embolism shortly. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication details was provided. No treatment medication details was provided. It was reported that patient's brother was looking to understand that his sister passed at a fairly young age as patient was extremely strong and healthy at the time it was reported and She was unexpectedly passed away within 2 weeks of the last dose. Company Comment: This spontaneous case concerns a 53-year-old female patient with no reported medical history, who experienced the unexpected, serious (fatal and medically significant) adverse event of special interest Embolism on an unknown date after receiving the second dose of mRNA-1273 vaccine. The event occurred within two weeks of vaccination and led to a fatal outcome shortly thereafter. Cause of death was reported as embolism. Autopsy report was not provided. Patient received the first dose of mRNA-1273 vaccine 33 days prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 53-year-old female patient with no reported medical history, who experienced the unexpected, serious (fatal and medically significant) adverse event of special interest Embolism on an unknown date after receiving the second dose of mRNA-1273 vaccine. The event occurred within two weeks of vaccination and led to a fatal outcome shortly thereafter. Cause of death was reported as embolism. Autopsy report was not provided. Patient received the first dose of mRNA-1273 vaccine 33 days prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: passed away via embolism shortly
1606178 2359705 2022-07-06 MD 63.00 infection control nurse notified this pharmacy ops manager that a resident received a COVID vaccine at Hospital on 6/23/2022. Nurse notified us that the patient passed away on 7/3/22.
1606057 2359584 2022-07-06 IA 73.00 Pfizer Dose 1 3/5/21 (EN6206) Pfizer Dose 2 3/25/21 (ER8732) COVID Positive 1/21/22 1/21/22: Patient is a 73 year old female resident of local long-term care facility. Patient is a poor historian. History was obtained per chart review, ED staff and daughter who is at bedside. Nursing staff noticed that the patient was lethargic in her wheelchair today, unable to support her neck which was deviated to the right side. Has not been eating or drinking for the past several days. Patient's daughter stated that she has had a progressive decline in her health since her last hospital admission on 12/1. She was seen by her PCP on 01/04 with concerns of worsening confusion and disorientation. Infectious and metabolic workup was unremarkable. The patient does have a chronic meningioma, PCP ordered CT scan determine if there has been any changes, meningioma remains stable. Patient was seen and examined in ED. She responds to her name, which per family is her baseline. She is unable to follow commands or answer questions appropriately. She has a past medical history of schizophrenia, dementia, asthma/COPD, tobacco use and hyperlipidemia. On arrival to ED the patient was hypertensive 156/82. Laboratory findings were significant for hypernatremia 151. Hypokalemia 3.4. Urinalysis WBC 11-30. IV Rocephin 1 g given in ED. IV hydration given with NS 0.9% 1 L bolus. 2/9/22: Comfort measures per family's request. Will discharge to hospice facility. Discussed with care coordination
1606201 2359728 2022-07-06 IL 90.00 Patient received moderna vaccine on 1/22/21, 2/19/21 and 10/22/21. Presented to ER on 6/19/22 and found to be COVID19 positive. Initial admission patient acute kidney injury abnormal LFT. Bilirubin was normal alk phos was 61. Patient was found to have problem the COVID positive but due to his abnormal labs, see rounding MD note, not a candidate for remdesivir at that time. Was treated with Decadron. Patient condition fluctuated. He also was hypotensive and little bit of shock. Treated with appropriate measures at that time. He had improved for couple days then again started getting worse. 48 hours prior to this patient again started having experiences significant increased amount of shortness of breath. Chest x-ray still shows infiltrate. Patient remains afebrile Patient does not want BiPAP and wanted more comfort measures and was placed on comfort measures. Due to severity of shortness of breath and distress, patient was placed on IV morphine drip. He expired today as expected. This morning when I saw him, at that time patient was comfortable. Mild tachypnea but no distress. Not much respond to any verbal stimuli suggesting that he was comfortable overall. Yesterday was very restless and very uncomfortable. He expired 7/1/22 as expected under proper comfort measures.
1606285 2359825 2022-07-06 SD 76.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 02/06/2021 and 02/27/2021. There is a third dose in the state immunization system, but it has an administered date of 04/06/2022 which is after this person's death so it is likely this is an error. The individual tested positive for COVID-19 on 10/06/2021 at an out-of-state hospital. They had been hospitalized from 10/04/2021 to 10/19/2021. They were then re-admitted on 10/22/2021. They experienced complications of COVID-19 pneumonia, acute kidney injury, multiple organ failure, sepsis, and cellulitis. They were placed on comfort cares and died on 10/28/2021. Specific state issued the death certificate.
1606214 2359743 2022-07-06 83.00 12/8/21 pt admitted to hospital from Medical Center with dx of LLE BKA; infection following a procedure; tested positive for COVID on 1/11/22; pneumonia due to COVID; pt's condition worsened and he was admitted to another hospital (no records received from them); pt was dc'd on 1/25/22 to facility with hospice care where he expired on 1/27/22.
1605531 2357959 2022-07-05 SD 66.00 This is an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated with the Pfizer product on 02/17/2021, 03/10/2021, and 08/31/2021. They tested positive for COVID-19 twice on 10/14/2021. They were also admitted to hospital on 10/14/2021 after presenting to emergency department with a primary complaint of shortness of breath. The individual experienced complications of acute kidney injury, cardiac arrest, acute hypoxic respiratory failure, COVID-19 pneumonia, and acute respiratory distress syndrome. After aggressive treatments did not improve their condition, they were transitioned to comfort care and died on 10/25/2021.
1605518 2357946 2022-07-05 TX 76.00 Admitted for COVID pna. Fully vaccinated. Treated with O2/Bipap, cefepime, azithro, steroids, lovenox, zinc, vit-c and d, singulair, toci. Progress to intubation/vent support. Added remdesivir. Condition continued to decline. Pt coded 11/20 and expired.
1605515 2357943 2022-07-05 TX 73.00 Admitted for resp failure and afib RVR, multiple comorbidities. COVID swab positive after admit and dx w COVID pna. Given zinc, vit-c and d, steroids, pepcid. Progress to intubated/vent support. Care eventually withdrawn and pt expired in hospital.
1605502 2357930 2022-07-05 NJ 76.00 Within 1 hour of injection began to have flu like symptoms. Symptoms persisted over several weeks time. Was tested for flu and covid multiple times with negative results. Flu like symptoms persist and worsen. Begins to have shortness of breath and loss of apatite. January 30th began having bouts of vomiting. Unable to go to work on January 31. Feb 6 visit Urgent Care again test negative for Flu and Covid. Was prescribed Pantoprazole SOD DR 40 mg and Ondansetron HCL 4 mg for nausea and vomiting. February 7 had difficulty breathing-taken to Emergency Room at Medical Center. Tested negative for covid. Had internal bleeding and bleeding into lungs. Ventilated and admitted to ICU from February 7- February 11.
1605460 2357888 2022-07-05 TN 81.00 PATIENT COVID POSITIVE 6/13/2022 AT REHAB. ADMITTED TO MEDICAL CENTER ON 6/14/2022 WITH ACUTE RESPIRATORY FAILURE SECONDARY TO COVID-19. PATIENT EXPIRED ON 6/29/2022.
1605426 2357854 2022-07-05 TN 76.00 COVID-related death, breakthrough case
1605418 2357846 2022-07-05 TX 87.00 Pfizer BioNTech and Janssen (J&J) COVID Vaccines: COVID-19 case resulting in Hospitalization / Death. Rec'd Pfizer BioNTech on 1/14/21 and 2/3/21 and Janssen (J&J) on 1/13/22. Presented to the ED for hypoxia. Admitted for acute hypoxemic resp failure 2/2 Covid19. Rec'd dexamethasone, azithromycin, and ceftriaxone. Patient progressively worsened and was transitioned to comfort care. Patient expired 6/28/22.
1605417 2357845 2022-07-05 TX 77.00 Moderna COVID Vaccine: COVID-19 case resulting in Hospitalization/Death. Rec'd Moderna Vaccines on 2/26/2021 and 3/26/2021 and Pfizer on 11/26/2021. Presented to ED URI sxs. Admitted for PNA 2/2 Covid c/b resp failure w/hypoxia and lactic acidosis. Tx'd w/remdesivir x5 days, steroids x10 days. Extubated 6/26/22. Continued to struggle with respiratory distress. Developed worsening respiratory status 7/2/22 and started on BiPAP 7/2. Improvement in pH and pCO2 but developed hypotension and concern for sepsis into 7/3. Broad spectrum antibiotics and pressors initiated. Transitioned to comfort care and expired on 7/4/22 at 1645.
1605410 2357838 2022-07-05 TX 68.00 Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Rec'd Moderna Vaccines on 1/30/2021, 2/28/2021 and 9/16/2021. Presented to OSH tacypneic w/acute hypoxic resp failure w/known diagnosis of COVID-19 and recent onset of sxs 48 hrs. prior. Req'd 100% O2 via NRB. Tachycardic to 150 transferred to Med Ctr for further management. Admitted to ICU profoundly hypoxic requiring NIPPV immediately followed by intubation. Developed PEA arrest at 7am while CPR was in progress he was transitioned to DNR/COT per family's wishes. Tx'd with solumedrol, ceftriaxone, and azithromycin. Expired on 6/23/22.
1604223 2356172 2022-07-03 MA He did have positive PCR test result; He did have positive PCR test result; His symptoms were gastrointestinal issues including excessive diarrhea; His symptoms were gastrointestinal issues including excessive diarrhea; vomiting; passed away on Saturday, 09Jan; The initial case was missing the following minimum criteria: ICH-Reporter with No First-hand knowledge. Upon an updated that Pfizer colleague reported for a patients AE even the information did not come from the individual who experienced effects and has First-hand knowledge , this case now contains all required information to be considered valid. This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 20-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death) with onset 09Jan2022, outcome "fatal", described as "passed away on Saturday, 09Jan"; DRUG INEFFECTIVE (death, medically significant), SARS-COV-2 TEST POSITIVE (death, medically significant), outcome "fatal" and all described as "He did have positive PCR test result"; GASTROINTESTINAL DISORDER (death), DIARRHOEA (death), outcome "fatal" and all described as "His symptoms were gastrointestinal issues including excessive diarrhea"; VOMITING (death), outcome "fatal". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The patient date of death was 09Jan2022. Reported cause of death: "passed away on Saturday, 09Jan", "He did have positive PCR test result", "His symptoms were gastrointestinal issues including excessive diarrhea", "vomiting". It was not reported if an autopsy was performed. Additional information: I am not aware which vaccine he received and have not reached out to ask. I completed my reporting training and will enter the information into the system. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: passed away on Saturday, 09Jan; He did have positive PCR test result; His symptoms were gastrointestinal issues including excessive diarrhea; vomiting; His symptoms were gastrointestinal issues including excessive diarrhea; He did have positive PCR t
1603906 2355837 2022-07-03 NJ COVID-19 PNEUMONIA; ACUTE RESPIRATORY FAILURE; ACUTE MYELOID LEUKEMIA (AML); SCLERODERMA; SJOGREN'S SYNDROME; SUSPECTED CLINICAL VACCINATION FAILURE; CHRONIC MYELOMONOCYTIC LEUKEMIA (CMML); This spontaneous report was received from company representative via social media (traditional media report) and from other health professional via literature: This report concerned a 74 year old female of unspecified race and ethnicity. The objective of this study was to present a rare case of CMML (chronic myelomonocytic leukemia) after receiving the J and J COVID-19 vaccines, in association with limited scleroderma. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, hypertension, dyslipidemia. On an unspecified date in OCT-2020, Laboratory data included: Absolute neutrophil count (NR: 1.7 - 7) 3.7 10x3/uL, Eosinophils (NR: 0 - 0.5) 0.2 10x3/uL, Hematocrit (NR: 34.9 - 44.5) 35.8 percent, Hemoglobin (NR: 12 - 15.5) 11.8 g/dL, Lymphocytes (NR: 0.9 - 2.9) 1.8 10x3/uL, Monocytes (NR: 0.3 - 0.9) 0.6 10x3/uL, Platelet count (NR: 150 - 450) 199 v10x3/uL, Red blood cell count (NR: 3.9 - 5.03) 3.77 10x6/uL, Reticulocyte count (NR: 0.5 - 1.5) not reported, and White blood cells (NR: 4.4 - 11) 6.3 103x/uL. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 08-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient presented to the emergency department with complaints of shortness of breath and generalized weakness for two days. The patient reported that symptoms began after receiving the first dose of the Johnson and Johnson vaccine for COVID-19. Patient was hemodynamically stable with a heart rate of 94, a respiratory rate of 21, and a saturation rate of 99 percent on room air. Physical examination was widely unremarkable except for decreased air entry with mild diffuse wheezes bilaterally on lung auscultation. No cyanosis or edema of the extremities. On 12-MAY-2021, Laboratory data included: Absolute neutrophil count 3.9 10x3/uL, Eosinophils 0.1 10x3/uL, Hematocrit 29.5 percent, Hemoglobin 9.9 g/dL, Lymphocytes 3.8 10x3/uL, Monocytes 11.5 10x3/uL, Platelet count 37 10x3/uL, Red blood cell count 3.01 10x6/uL, Reticulocyte count not reported, and White blood cells 19.4 10x3/uL. On 18-JUN-2021, Laboratory data included: Absolute neutrophil count 9.6 10x3/uL, Eosinophils 0.0 10x3/uL, Hematocrit 20 percent, Hemoglobin 6.8 g/dL, Lymphocytes 5.5 10x3/uL, Monocytes 19.1 10x3/uL, Platelet count 10 10x3/uL, Red blood cell count 1.99 10x6/uL, Reticulocyte count 1.9 percent, and White blood cells 34.5 10x3/uL. On 12-MAY-2021, patient presented with anemia, thrombocytopenia, and leukocytosis after the COVID-19 vaccine. The hepatitis panel and human immunodeficiency virus were negative. The thrombocytopenia was concerning for vaccine-related immune thrombocytopenic purpura (ITP). The patient received a tapering dose of steroids and two doses of intravenous immunoglobulin (1 g/kg) as a treatment for ITP, with only a transient rise in platelets. On further follow-up, platelets continued to trend down, even refractory to steroids. Eventually, the patient developed transfusion-dependent thrombocytopenia. Patient also started complaining of dry mouth, difficulty swallowing, and new-onset episodes of whitish discoloration of the fingers in cold temperatures. Patient had concomitant CMML and scleroderma, which were unmasked after the patient received the COVID-19 vaccine and patient had scleroderma with elevated centromere 2b antibodies and the symptoms of difficulty swallowing and Raynaud's phenomenon. On an unspecified date, the patient had Sjogren's syndrome with elevated anti-SSA and dryness of the mouth. Rheumatologic workup was positive for anti-centromere antibodies and Sojgren's anti-SSA (anti Sjogren's-syndrome-related antigen A autoantibodies). C-ANCA, P-ANCA (Antineutrophil Cytoplasmic Antibodies), RF (Rheumatoid factor), anti-SSB, and anti-scleroderma 70 were negative. Cryoglobulin, cold agglutinin, and direct coombs were also negative. On follow-up, it was observed that the patient was progressing to severe anemia and leukocytosis with persistently high and up-trending monocytes. Flow cytometry on peripheral blood and bone marrow biopsies was done to rule out leukemia. Bone marrow biopsy results were significant for chronic myelomonocytic leukemia stage 0 (CMML 0) in a hypercellular marrow. The blasts and promonocytes were not increased; in the setting of severe anemia and thrombocytopenia with monocytosis (AMC 12.6 K/�L - 53.8 percent of total leucocytes) was consistent with CMML 0. Next-generation sequencing detected KRAS (Kirsten rat sarcoma viral oncogene homolog), NPM1 (nucleophosmin gene), and TET2 (Tet methylcytosine dioxygenase 2) gene variations, and karyotyping showed 46, XX female karyotypes. Flow cytometry showed monocytosis (60 percent) and dysgranulopoiesis with no increased blasts or lymphoproliferative disorder. There is no increase in CD34-positive myeloblasts, and they comprise 0.4 percent of the total cells. The monocytes (60 percent) are increased with decreased CD13 and CD14 and increased HLA-DR (Human leukocyte antigen), suggesting left-shifted maturation. The granulocytes (19 percent) show decreased side scatter, suggesting hypogranularity with left-shifted CD13/CD16 maturation pattern and aberrant CD56 coexpression, suggesting dysgranulopoiesis. The B-cells (1.7 percent) are polytypic and the T-cells (8.2 percent) show a normal CD4:CD8 ratio with no pan T-cell antigen deletion. Viability is 91.13 percent. The AML panel in the cytogenetics FISH (fluorescence in situ hybridization) study was negative for RUNX1T1/RUNX1 (ETO/AML1), KMT2A (MLL), PML/RARA, CBFB rearrangement, negative for monosomy 5, and deletion of CSF1R/RPS14 on the long arm of chromosome 5 at q33, negative for monosomy 7, and deletion of MDFIC on the long arm of chromosome 7 at q31. The MPN/CML (Chronic myeloid leukemia) panel was also negative for BCR/ABL1 rearrangement, trisomy 8, 9, and deletion of DLEU1, DLEU2 on the long arm of chromosome 13 at q14, and deletion of PTPRT on the long arm of chromosome 20 at q12. Risk stratification based on the Molecular Model classified her as high risk with a score of 3 points and intermediate-risk. Based on the functional status and physical fitness, the patient was deemed to be an intermediate risk but infusion dependent as patient has received multiple platelets and pRBC (Packed red blood cells) transfusions. As a result, the patient was started on Azacitidine therapy, which significantly improved her cell count after two cycles. However, on further follow-up, it was found that patient had progressed to AML (acute myeloid leukemia) and died due to acute respiratory failure secondary to COVID-19 pneumonia. Thus, patient had suspected clinical vaccination failure. It was unknown whether autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the acute myeloid leukemia (aml), scleroderma, chronic myelomonocytic leukemia (cmml), suspected clinical vaccination failure and sjogren's syndrome was not reported. The authors emphasized the fact that, based on the previous studies reported, the association of scleroderma with CMML is very rare. Also they suspect that the COVID-19 vaccine has triggered and unmasked both the CMML and the associated scleroderma in patient, considering the acute onset and absence of other known triggering factors. The importance of the COVID-19 vaccine is undeniable during this time. This case suggested the possibility of developing CMML associated with limited scleroderma after receiving the J and J COVID vaccine. However, further research needs to be done to confirm the hypothesis and to know the pathogenesis behind the association. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint: 90000236774.; Sender's Comments: V0:20220645431- covid-19 vaccine ad26.cov2.s-acute respiratory failure,COVID-19 pneumonia, scleroderma, sjogren's syndrome - The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220645431- covid-19 vaccine ad26.cov2.s-chronic myelomonocytic leukemia, acute myeloid leukemia - The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.( Temporality considered as not suggestive as patient started experiencing events within 4 days; diagnosed as chronic myelomonocytic leukemia which progressed to acute myeloid leukemia ) 20220645431-COVID-19 VACCINE Ad26.COV2.S--suspected clinical vaccination failure . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.; Reported Cause(s) of Death: COVID-19 PNEUMONIA; ACUTE RESPIRATORY FAILURE
1604018 2355953 2022-07-03 Mom passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Mom passed away) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on September 2021 The patient died in September 2021. The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use information was not provided by the reporter. Treatment information was not provided. Company comment: This is a spontaneous case reported by the patient's son, concerning a female patient of unknown age with no reported medical history, who experienced the unexpected serious (death and medically significant) event of death. The event occurred after the unknown dose number of mRNA-1273 vaccine administration. The cause of death was not reported. It is unknown if autopsy was performed. No other information surrounding the event was reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-594693 (Patient Link).; Sender's Comments: This is a spontaneous case reported by the patient's son, concerning a female patient of unknown age with no reported medical history, who experienced the unexpected serious (death and medically significant) event of death. The event occurred after the unknown dose number of mRNA-1273 vaccine administration. The cause of death was not reported. It is unknown if autopsy was performed. No other information surrounding the event was reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
1604753 2356724 2022-07-03 she died of cardiac arrest; SYSTEMIC CAPILLARY LEAK SYNDROME; COVID-19 test was positive by RT-PCR; COVID-19 test was positive by RT-PCR; Compartment syndrome of all four extremities; AKI requiring CRRT; hemoconcentration; DIC; Liver failure; This is a literature report. A 56-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "lower extremity weakness" (unspecified if ongoing); "fever" (unspecified if ongoing); "shortness of breath" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CARDIAC ARREST (death, medically significant), outcome "fatal", described as "she died of cardiac arrest"; CAPILLARY LEAK SYNDROME (medically significant, life threatening), outcome "unknown", described as "SYSTEMIC CAPILLARY LEAK SYNDROME"; DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), 3 weeks after the suspect product(s) administration, outcome "unknown" and all described as "COVID-19 test was positive by RT-PCR"; COMPARTMENT SYNDROME (medically significant), outcome "unknown", described as "Compartment syndrome of all four extremities"; ACUTE KIDNEY INJURY (medically significant), outcome "unknown", described as "AKI requiring CRRT"; HAEMOCONCENTRATION (medically significant), outcome "unknown", described as "hemoconcentration"; DISSEMINATED INTRAVASCULAR COAGULATION (medically significant), outcome "unknown", described as "DIC"; HEPATIC FAILURE (medically significant), outcome "unknown", described as "Liver failure". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 80/60, notes: hypotensive; Laboratory examination: Normal; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of capillary leak syndrome, covid-19, compartment syndrome, acute kidney injury, haemoconcentration, disseminated intravascular coagulation, hepatic failure. The patient date of death was unknown. Reported cause of death: "died of cardiac arrest within 72 hours". It was not reported if an autopsy was performed. Clinical information: After her 2nd-dose of Pfizer BioNTech SARS-COV-2 vaccine 3-weeksago presented with lower extremity weakness, fever, and shortness of breath. She was hypotensive (80/60) but the rest of the examination was normal. COVID-19 test was positive by RT-PCR. She remained hypotensive despite aggressive resuscitation with IV fluids, albumin, vasopressors, and steroids. She deteriorated quickly, developed ARDS requiring intubation, compartment syndrome of all four extremities, AKI requiring CRRT, hemoconcentration, DIC, and liver failure. She also received IV Ig but despite maximal support, she died of cardiac arrest within 72 hours. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate; Reported Cause(s) of Death: died of cardiac arrest within 72 hours
1603667 2355124 2022-07-02 MN 82.00 My mother passed away recently, following her 2nd Covid booster shot. She got the shot on May 17th, 2022, at her annual well-visit, from which I have a copy of her normal lab results. She became increasingly ill, short of breath, and exhausted each day afterwards. She contacted her primary care physician a few days later, complaining of pain in her upper back, thinking it was stress-related (in hindsight, most likely caused by inflammation in her lungs). She was taken to the emergency room and admitted to the hospital on May 25th. She was tested for COVID-19 twice in the hospital; both times the result was negative. She was transferred to the ICU on May 26th, due to her increasing need for oxygen. She was tested for various types of atypical viral pneumonias via Clinic; all results were negative. She was tested for bacterial and fungal pneumonia; she had neither. Neither antibiotics nor steroids helped her lungs clear up. She suffered a severe heart attack the morning of June 2nd, while on a ventilator, and died.
1603529 2347626 2022-07-01 WI 87.00 Brought to ED on 5/10/2022 with SOB, covid-19 and hypoxia, SpO2 82%. Report indicated she had been diagnosed Covid-19 about 6 days prior, though the only lab report found was from 5/10/2022. Had prior script for Paxlovid - unclear if she initiated the medication. Report indicated client and family not interested in pursuing Remdesivir treatment and dexamethasone continued. Admitted to hospital 5/10/2022. Discharge date not indicated. Client died 6/4/2022 of Covid-19 pneumonia at nursing home. Client vaccinated for Covid 19- Moderna: 3/31/2021 008B21A; 5/8/2021 017C21A: 12/9/2021 031H21A Submitter does not have access to further medical records for this client. If more information is needed regarding hospital course, please contact hospital.
1603503 2347599 2022-07-01 IA 79.00 Pfizer Dose 1 2/8/21 (EL1283) Pfizer Dose 2 3/2/21 (EN6203) Pfizer Dose 3 10/4/21 (lot NA) COVID Positive 1/27/22 1/27/22: Patient is a 79-year-old male with past medical history of advanced Parkinson's disease with intermittent hallucinations, history of frequent falls, hypertension presented to the emergency department for multiple falls. Patient is a poor historian history primarily obtained from ED provider sign-out on chart review. Reportedly wife is caretaker patient at home has had Parkinson's for 19 years and over the last 3 years has had increased confusion/hallucinations. Reportedly had close contact/exposure with possible COVID-19 positive case earlier this week and was noted over last 3 days patient was more restless had not slept as well, had multiple falls this week. Has had history of reported "brain bleed" reportedly was seen restless and writing in chair so was brought into the emergency department today for further evaluation. Blood work demonstrated no significant abnormality in Chem panel, mild CK elevation blood gases without acute derangement, no significant leukocytosis or anemia, UA with elevated spec graft. D-dimer was elevated and rapid COVID was positive. CT head and CT PA were done in ED and initial results reportedly were negative. Patient was reoriented in ED and did not require any medication for agitation or confusion. However with recurrent falls request was made to admit to medical service for further evaluation therapy evaluation and possible placement. At bedside patient is lying comfortably in bed he is awake however cannot provide history, social history or medication history. He denies any lightheadedness, dizziness, chills, fever, nausea, vomiting, diarrhea, chest pain, palpitations, abdominal pain. Family history could not be obtained. 2/9/22: Pt w severe Parkinson's disease presented with delirium, acute hypoxic respiratory failure secondary to COVID-19 pneumonitis and aspiration pneumonia. Pt condition continued to decline and family elected hospice, patient remained in the hospital due to poor condition he remains in the hospital until he passed away in February 9th at 00:20.
1603486 2347582 2022-07-01 TN 82.00 Patient was a resident of Health and Rehab Center who tested positive for Covid-19 on 01/13/2022 at facility. Patient was not hospitalized for illness and expired at facility on 01/15/2022.
1603480 2347576 2022-07-01 TN 73.00 /Patient was admitted to a Medical Center on 09/25/2021 for acute hypoxemic respiratory failure d/t Covid-19. She was started on Decadorn but did not quality for remdesivir d/t her liver and kidney disease. Patient was attempted to be diuresed but developed an acute kidney injury and Nephrology felt she may have hepatic renal syndrome. She was noted to have a significant decline and functional status and increased weakness during hospitalization. On 10/05/2021 patient was placed on V60 machine, and expired on 10/06/2021.
1603473 2347569 2022-07-01 TN 85.00 Patient tested positive for Covid-19 on 01/16/2022 and was treated for Covid-19 at Medical Center. He was admitted for weakness, respiratory failure d/t Covid PNA. He was treated with remdesivir and steroids and improved and then was placed Health Center for Rehab and Healing for PT and OT. Patient expired on 02/09/2022.
1603465 2347561 2022-07-01 TN 87.00 Patient was a resident who tested positive for Covid-19 on 01/24/2022. Patient went on hospice with a primary hospice diagnosis of chronic obstructive pulmonary disease, respiratory failure with hypoxia, Covid-19, muscle weakness, anxiety, anorexia, repeated falls, oxygen dependence. Patient expired on 02/12/2022.
1603425 2347520 2022-07-01 TN 80.00 Patient brought into Hospital via EMS d/t seizures on 06/05/2022. CT angiography Chest w/ w/o contrast showed anomalous course of right subclavian artery tracks posterior to esophagus. Mild atherosclerotic changes of thoracic aorta. Images of upper abdomen: 11 mm nodule from the posterior aspect of right kidney, 7mm gallstone. Atelectasis of left lower lobe, bronchial occlusion leading into small left chest pneumothorax, irregular calcified opacity lateral right upper lobe, infiltrate's in right middle lobe. Patient tested positive for Covid-19 on 06/05/2022. Patient was admitted to hospital, NGT was placed, was give IV heparin qtt, remdesivir, and steroids. Patient went into respiratory distress and expired on 06/12/2022.
1603417 2347511 2022-07-01 TN 73.00 Patient tested positive for Covid-19 at Facility on 01/20/2022. On 02/05/2022 the patient was found lying in bed with no response, no breathing or heart rate.
1603395 2347489 2022-07-01 57.00 Patient presents to Medical Center on 01/03/2022, a week after being diagnosed with Covid-19. He presented with c/o worsening SOB, cough and chest congestion. He was noted to be hypoxic with SPO2 of 85% on 15% non rebreather. CXR showed diffuse bilateral infiltrates. Patient was admitted to hospital. He was transferred on day of admission to ICU and placed on BiPAP at 70% FiO2, and continued on BiPAP for several days with minimal improvement. He was treated with Remdesivir, steroids, vitamin C, D and Zinc. On 01/16/2022 patient deteriorated and required intubation. After 14 days of intubation, a Trac was placed, he continued to require extensive vent support. On 02/03/2022 patient was made comfort measures with palliative care. Patient expired on 02/03/2022.
1603291 2347382 2022-07-01 TN 65.00 Patient diagnosed with Covid 19 on 11/02/2021 and received monoclonal antibody treatment. Patient presented to Medical Center on 11/07/2021 worsening SOB and hypoxemia. Patient was placed on Vapotherm and admitted to hospital. Patient received Remdesivir, Dexamethasone, prone positioning as able, Vapotherm, Lovenox. He also presented with acute pulmonary embolus. 11/19/2021 Patient started to require BiPAP at night. 11/20/2021: Patient was moved to ICU and BiPAP was started. 11/25/2021 Patient developed increased SOB and tachycardia, he was unable to maintain his oxygen saturation and was emergently intubated. Patient developed asystole and expired on 11/27/2021.
1603106 2344873 2022-06-30 TN 76.00 Patient resident of nursing home. Patient had tested positive for Covid-19 on 12/16/2021. On 01/05/2022 patient reported to nurse she was not feeling well. Patients blood pressure was low, and blood glucose high. No SOB noted on exam. Edema noted on CXR. Midodrine 5mg x 1 given. Patient was then found unresponsive and expired at 1102.
1603059 2344826 2022-06-30 TN 64.00 Patient with extensive PMH, with recent hospital admission for COVID PNA, reports back to Medical Center on 05/22/2022 with c/o SOB. In the ED she was placed on BiPAP and given Lasix. Portable chest xray demonstrated prior median sternotomy and left rib fixation. Cardiac silhouette remained moderately enlarged, diffuse pulmonary vascular engorgement with bilateral mixed interstitial and alveolar infiltrates, favoring pulmonary edema as an etiology. ECG revealed prior inferior infarct, RBBB. She was admitted to the hospital and transferred to ICU where she required intubation. On 5/28/2022 patient had cardiac arrest, started on amiodarone. 06/01/2022 family in agreement with DNR status, and patient expired on 06/03/2022.
1603088 2344855 2022-06-30 TN 63.00 Patient was a resident of a Healthcare, with a hx of insulin-dependent diabetes, stable hypertension, hypothyroidism, dyslipidemia. Patient tested positive for Covid-19 at NHC on 11/12/2021. Patient was not hospitalized for this, and expired at the facility on 12/29/2021.
1603097 2344864 2022-06-30 TN 84.00 Patient presented to Hospital on 06/03/2022 with worsening chest and back pain. CT scan showed a significant enlargement of her descending aorta and several ulcers with concerning hematomas around the aorta. Patient recently tested positive for Covid-19 on 05/27/2022. Patient was admitted to hospital services and refused any intervention, knowing that the aneurysm may rupture and lead to death. Patient requested palliative care and passed on 06/06/2022.
1603072 2344839 2022-06-30 TN 81.00 Assisted living patient at Health center who tested positive for Covid-19 on 12/20/2021. At the time patient was asymptomatic. Patient expired at same facility on 01/22/2022.
1603109 2344876 2022-06-30 IA 77.00 Pfizer Dose 1 3/8/21 (EN6203) Pfizer Dose 2 4/2/21 (ER8734) COVID Positive 3/2/22 3/2/22: Patient is a 78-year-old female with past medical history of anemia, anxiety, arthritis, hypertension, insomnia with BMI 16 and recent unintentional weight loss that is presenting with recent onset shortness of breath. Presents today with her granddaughter and POA. Patient is somewhat difficult to understand, therefore granddaughter is assisting with history. Of note, patient's granddaughter believes her speech is worse than normal. Additionally, she has had a productive cough, upper respiratory symptoms, diarrhea, and chest pain over the past week. Denies fevers, chills, nausea, vomiting. Appetite has been decreased. She has taken some Tylenol for arthritic pain, has otherwise not taken any over-the-counter medications. Symptoms have all been progressive and they presented today to the emergency department for evaluation. ED course: Patient presented tachycardic at 1:14 a.m., 89% on room air. Lab significant for: AST 72, ALP 164, lactic acid 2.1, lipase 6, BNP 2 675; VBG showed pH 7.43, bicarb 34; CBC normal with MCV 106.8. UA unremarkable, COVID rapid antigen and PCR positive, influenza negative. Chest x-ray showed bibasilar infiltrates, more severe on the left. CT of the chest negative for PE, showed completely collapsed left lower lobe with patchy airspace disease in the middle and lower right lobe, concerning for pneumonia however an obstructing mass cannot be ruled out. CT of the head showed no acute findings, chronic atrophic changes and micro angiopathy disease. Patient was given 500 mg of azithromycin and 2 g of Rocephin in addition to 10 mg of Decadron. 1 L normal saline administered. Patient's granddaughter expresses concerns with patient's overall health deteriorating over the past several weeks. Patient lives at home, however is unclear if she is able to take care of herself sufficiently or not. She has refused nursing home care, granddaughter believes because she used to work in a nursing home. Patient is still driving, however there were some concerns about this. Granddaughter believes that patient has been seeing an oncologist however she is not sure why this is the case. Currently, the patient denies any acute pain and believes she is feeling better since arrival. Breathing has improved. Patient is admitted to the for for further management. 3/7/22: Pt. is a 78 year old female with pmh anemia, aniety, arthritis, HTN, insomnia and BMI of 16 with recent weight loss that presented on 3/2 with recent onset SOB. She is not on home oxygen. She has been vaccinated to COVID. Per patient's granddaughter, POA, patient had lost over 15 pounds unintentionally. Her appetite has been decreased over the past several weeks and she has not been eating. Overall she believes her health has been declining and she had not left her apartment in some time. Granddaughter states she has been seeing a hematologist/oncologist for anemia, but is unaware of any recent malignancies. She believes her speech has been more difficult to understand and she has also had a cough, URI, diarrhea, and chest pain that all started within the last week. When her shortness of breath progressed, her granddaughter urged her to go to the ED. ED course per EMR: "Patient presented tachycardic at 1:14 a.m., 89% on room air. Lab significant for: AST 72, ALP 164, lactic acid 2.1, lipase 6, BNP 2 675; VBG showed pH 7.43, bicarb 34; CBC normal with MCV 106.8. UA unremarkable, COVID rapid antigen and PCR positive, influenza negative. Chest x-ray showed bibasilar infiltrates, more severe on the left. CT of the chest negative for PE, showed completely collapsed left lower lobe with patchy airspace disease in the middle and lower right lobe, concerning for pneumonia however an obstructing mass cannot be ruled out. CT of the head showed no acute findings, chronic atrophic changes and micro angiopathy disease. Patient was given 500 mg of azithromycin and 2 g of Rocephin in addition to 10 mg of Decadron. 1 L normal saline administered." Patient was admitted for hypoxic respiratory failure secondary to COVID-19. Pulmonology was consulted and she received rocephin, azithromycin, decadron, remdesivir, actemra, RT, and duonebs. CRP and D-dimer was trended. Patient's oxygen was weaned down to room air and pulmonology signed off. In regards to her cachexia and weight loss, nutrition was consulted and assisted in supplementing diet. MR brain was obtained due to concern for malignancy given weight loss and lesion on CT chest that could not rule out mass. This showed no acute processes. Patient became intermittently confused, agitated, and combated as her mental status fluctuated, oftentimes refusing medications and meals. All medications that could be exacerbating her AMS were discontinued. Her chronic conditions were initially managed with her home medications. Due to an elevated proBNP, an echo was performed which showed an EF of 40%. Palliative medicine was consulted due to patient's deteriorating health status. They had a family meeting with patient's grad daughter, and she stated that her grandmother would want to transition to comfort measures and not suffer any longer than necessary. Hospice was consulted as a result. These comfort measures were initiated on 3/5 and all medications that were not contributing to her comfort were discontinued. Patient continued to receive prn medications to aid in comfort, however patient passed away on 3/7 around 1630. Family was present and was able to see her before transfer to funeral home.
1603142 2344910 2022-06-30 IL 86.00 Pfizer Dose 1 2/8/21 (EN6201) Pfizer Dose 2 3/1/21 (EN6203) Pfizer Dose 3 10/1/21 (NA) COVID Positive 3/2/22 COVID Positive 3/4/22 3/4/22: The patient known to have advanced Alzheimer's dementia living at the nursing home referred to the hospital due to noticed cough with mild shortness of breath and became more confused in compared and weak. The patient does have poor coherence and cannot answer my questions, history gathered from the ED provider and the medical report. Does not look in pain or distress, at the Emergency the patient oxygenation was normal on room air but occasional dropped to 87% required 2 L of oxygen through nasal cannula. Her labs are not completed at the ED, on her CBC show stable chronic anemia. Her chest x-ray show bilateral infiltrate. Her COVID-19 test is positive on March 2nd 3/14/22: The patient respiratory distress with hypercoagulability state and hyperviscosity Continue comfort measures The patient is laying comfortably in her bed and is not agitated or aggressive, DC sitter Plan to discharge her to hospice tomorrow, discussed with the family DNR/DNI Patient deceased 3/14/22
1603125 2344892 2022-06-30 57.00 pt had a positive COVID test on 1/14/22 at Clinic; 1/22/22 pt brought to hospital by EMS in respiratory extremis, unknown blood pressure or O2 saturation; placed on mechanical ventilation; vasopressors; family decided on DNR for pt and comfort measures; pt died in the hospital
1603151 2344920 2022-06-30 IA 80.00 Pfizer Dose 1 2/26/21 (EN6200) Pfizer Dose 2 3/24/21 (ER2613) COVID Positive 1/5/22 1/19/22: Pt. is a 81 year old female, who presented to ED with complaints of shortness of breath. She has been vaccinated and boosted against Covid-19. However, she did test positive on Jan 5th at her Nursing Facility. She was quarantined until Jan 10 and placed on Levaquin prophylactically. Patient does not wear oxygen at baseline. She was admitted back in December for a recurrent UTI. Patient stated she started becoming short of breath yesterday. Experiencing generalized weakness and decreased appetite. Some nausea without vomiting. No diarrhea. Denies chest pain. She has a past medical history of hypertension, hyperlipidemia, type 2 diabetes mellitus (diet managed) CKD, pulmonary fibrosis, chronic lower back pain and aortic valve stenosis On arrival to ED the patient was febrile 99.5, hypertensive 171/97 and hypoxic on room air at 86%, 15 L non-rebreather was applied with improvement in oxygen saturation, patient was eventually weaned down to 10 L non-rebreather. Laboratory findings were significant for CKD stage G 3B creatinine 1.21. ProBNP 3800. Leukocytosis 24.64. D-dimer 3.52. Chest x-ray moderate bilateral airspace disease, likely viral pneumonia. Chest x-ray no PE. Scattered bilateral areas of airspace disease likely representing viral pneumonitis or multilobular pneumonia. Levaquin was initiated in ED. 1/25/22: 81 year old female with a history of diet-controlled T2 dm, CKD 3, resident in LTC and pulmonary fibrosis. Patient admitted for acute hypoxic respiratory failure secondary to COVID-19 pneumonia. She was initially diagnosed on 01/05/2022. She was placed on usual treatment for COVID-19 infection but oxygen requirement continues to deteriorate. She was initially placed on high-flow oxygen via nasal cannula then oxygen via OptiFlow and BiPAP yet response was quite poor. She was a DNR. Three days ago she was made comfort care only and expired this early morning.
1602708 2341918 2022-06-29 TN 80.00 Patient presented to Hospital on 09/26/2021 reporting GI bleed at SNF. The patient was Covid positive at SNF. In ED patient had large blood stool. CT scan of chest showed bilateral PE's. CXR showed multifocal PNA. Patient was admitted and transfused in ED. Patient expired on 09/26/2021 at 2335.
1602696 2341906 2022-06-29 TN 85.00 Patient tested positive for Covid-19 on 09/22/2021. Patient was not hospitalized for this illness. It is noted that the patient expired on 11/19/2021, with Covid listed as a reason.
1602528 2341733 2022-06-29 59.00 pt had a positive COVID test on 5/23/22 at SNF; was transported to Hospital for hypotension and leukocytosis; admitted and treated for hypotension and leukocytosis with ABX and vasopressors; peritoneal catheter placed with improvement; later, pt c/o dyspnea and was transferred to another Hospital for further evaluation and treatment; given O2 via NC; required multiple transfusions due to blood loss from colon CA; CT revealed metastatic colon CA with carcinomatosis; C. difficile, treated with ABX; dexamethasone and Baricitinib given for COVID; pt's condition declined; family decided on inpatient hospice, but pt expired prior to hospice
1602720 2341930 2022-06-29 TN 73.00 Patient with a h/o multivessel disease and endstage CHF presented to ED c/o worsening SOB. Patient reported getting SOB on exertion. In the ED the patient was hypotensive and tachycardia, troponin elevated, heparin qtt started, and levophed drip started per cardiology. Patient also tested positive for Covid-19. For concerns of sepsis, Vanc and Zosyn started. Echocardiogram revealed EF <25%, left atrium severely dilated, and severe mitral regurgitation. On 05/26/2022 patient becoming more hypotensive, MAP was not maintained with levophed and dobutamin qtts. Patient made comfort care on 05/27/2022 and expired on 5/29/2022.
1602790 2342002 2022-06-29 KY 96.00 pt vaccinated on 2/19/2021 admitted to hospital on with covid 19 complication on 6/19/2022 passed away on 06/26/2022
1602226 2338863 2022-06-28 IA 90.00 Patient was found deceased in his home the next morning after receiving the covid vaccine.
1602100 2338737 2022-06-28 KY 55.00 Patient died from Covid 19 complications after being fully vaccinated. Also tested for Influenza A.
1602126 2338763 2022-06-28 TN 30.00 Patient had recent hospitalization (05/12/22-05/25/22) with fever, hypotension concerning for sepsis. Imaging at that time showed progression of lymphoma nd ureteral compression. On the morning of 5/31/22 patients husband noted worsening lethargy, and brought the patient to ED. In the ED patient's HR 118, BP 78/42. Patient was given 3 L of IV fluid and admitted for encephalopathy and shock requiring pressors. Patient was found to be Covid positive and maintained saturations on home 2-3L O2. After arriving patient developed worsening encephalopathy and was no longer able to follow commands. Per discussion with husband, decision was made to transition to comfort care. Pressors stopped on the evening of 05/31/2022. Patient passed away on 06/02/2022.
1602142 2338779 2022-06-28 78.00 Pt had a positive COVID test on 2/18/22 at the hospital (Medical Center) and was dc'd on 2/19/22 without qualifying for any COVID treatments; 3/4/22 pt brought to ED and admitted to hospital with AMS; initial CT of head showed no abnormal findings; pt did have a UTI; A Fib with RVR - started on heparin drip; later CT of head showed subdural hematoma - surgery not recommended; family decided on comfort care measures and pt expired in the hospital
1602149 2338786 2022-06-28 TN 66.00 Patient presented to Medical Center on 01/10/2022 for 1 week of diarrhea. Patient stated family members in house have tested positive for Covid-19. Admitted for AKI, given multiple fluid boluses in ED, started on a sodium bicarb qtt. On 01/15/2022 patient was intubated and ventilated with severe covid PNA. Placed on pressors, sedation and bicarb. Patient received CRRT. 01/21/2022, patient refractory shock, unable to maintain perfusion pressure despite maximum vasopressors, unable to oxygenate or ventilate. Patient expired on 1/21/22.
1602163 2338800 2022-06-28 74.00 10/1/21 pt had a positive COVID test, ordered by Clinic; 10/4/21 pt came to ED and was admitted with AHRF secondary to COVID pneumonia, likely community acquired pneumonia; decreasing respiratory status requiring intubation with mechanical ventilation; cardiogenic shock - treated; acute renal failure with progress multi-system failure; critical; DNR with full treatment otherwise; 10/11/21 pt had a second positive COVID test in the hospital; family request pt be sent to facility with higher level of care; while making arrangements for Air EVAC, pt went into bradycardia which progressed to asystole and loss of BP; pt expired at the hospital prior to leaving
1602176 2338813 2022-06-28 TN 57.00 Patient tested positive for Covid-19 on 05/25/2022 at Clinic. Ordering provider. No other information available. Patient expired at home on 05/27/2022.
1602178 2338815 2022-06-28 56.00 pt had a positive COVID test on 12/30/21 at the local County Health Department; 12/31/21 pt was found unresponsive by her husband at home in bed; EMS called; asystolic; ACLS started with CPR; ETT was placed and 3 rounds of epinephrine given during transport to hospital; pt remained in asystole and was pronounced dead at the hospital ED
1602180 2338817 2022-06-28 TN 93.00 Patient tested positive for Covid-19 on 05/24/2022 and expired at home on 05/31/2022.
1602268 2338905 2022-06-28 IA 83.00 Moderna Dose 1 3/5/21 (NA) Moderna Dose 2 4/9/21 (NA) COVID Positive 2/18/22 2/17/22: Patient is 84-year-old female coming from home with past medical history of chronic hypoxia on 3 L oxygen at home, atrial fibrillation anticoagulated with Eliquis, moderate aortic stenosis awaiting for TAVR, HFpEF, essential hypertension, pulmonary hypertension and gout. She was brought to the emergency room by family members for complaint of generalized weakness, decreased appetite, nausea and altered mental status. Earlier this evening, patient was noted by her children not feeling herself. Per family members, she was noted to be confused. She was noted to be sliding down on her chair neck. Patient reported she has been having poor appetite with belly pain for the past 2 days. No report of nausea or vomiting. Patient reported dry cough. No report of chest pain fever chills or rigors. Patient is fully vaccinated for COVID-19. No recent sick contacts. Patient reported she has been having progressively worsening exertional dyspnea for the past 7-8 months. She has moderate/severe aortic stenosis. She is scheduled to have TAVR. Patient denied use of tobacco products or alcohol products. Upon evaluation at the emergency room, she was afebrile and hemodynamically stable. She was maintaining 3 L of oxygen to maintain saturation which is her baseline. Labs were significant for mild transaminitis, creatinine of 1.07 which is close to her baseline, proBNP of 2993, and macrocytic anemia with hemoglobin of 11.6 gram/deciliter. Nasopharyngeal swab was positive for COVID-19. Chest x-ray revealed bilateral infiltrates. Urinalysis revealed small leukocyte esterase. Patient was recently treated for UTI. At the emergency room, patient received Lasix 40 mg IV and ceftriaxone 1 g IV. 3/6/22: -Continue with the current management. -appreciate pulmonology recommendations. -steroid taper per pulmonology -Continue Precedex, will continue to wean the Precedex. Patient previously did poorly with Ativan and Haldol. Xanax through the NG tube p.r.n.. - monitor and replace electrolytes as indicated. -appreciate pulmonology initiating thrombocytopenia workup. -possible intubation later on 03/06/2022. -Code status: Full code DVT ppx: Patient was started on heparin drip on 03/05/2022 due to elevated D-dimer. Disposition: Patient was made DNR by the family. Patient expired on 03/06/2022 evening.
1602270 2338907 2022-06-28 TX 80.00 Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 6/11/21, 7/12/21 and 1/04/22. Presented to the ED via EMS after being found unresponsive in her home, O2 sat of 80% and placed on O2 by EMS. Intubated in ED, fever 105.8 rectally, cooling was initiated. Leukocytosis, acute kidney injury, lactic acidosis. Admitted for UT, AKI, resp failure, AMS, hyperthermia and severe sepsis. Administered IV fluids and abx, transferred to ICU. Previously elected DNR status. Tx'd with decadron, ampicillin, and cefepime. Expired on 6/24/22.
1602271 2338908 2022-06-28 IA 73.00 Pfizer Dose 1 3/11/21 (EN6204) Pfizer Dose 2 4/2/21 (EN6198) Pfizer Dose 3 10/26/21 (FF2593) COVID Positive 1/26/22 1/26/22: A 74-year-old female with past medical history of chronic atrial fibrillation on anticoagulation with Coumadin, hypertension, stage III CKD, CAD, PAD, chronic HFrEF, COPD not on home oxygen, hx ppm implantation is sent to ED by ambulance from nursing home for generalized edema. Patient states that she does not remember why she is sent here but she states she was kept on oxygen at the facility. At this time she feels much better, denies chest pain or shortness of breath, feels tired and weak. As per the EMR she was blood culture generalized edema, she was saturating 93% on 2 L oxygen. Patient is vaccinated for COVID-19. She was recently discharged from the hospital on 01/21/2022 after she was treated for dehydration, diuretics were held at that time. In the ED, she was afebrile, pulse ox 96 on room air, blood pressure stable. Blood work is significant for mild elevation in BUN and creatinine, leukocytosis, elevated proBNP, with mild lactic acidosis. Urinalysis positive for nitrate. 1/31/22: Patient was admitted and started on IV diuretics as well as empiric IV antibiotics. She was diuresed and given increased doses of Coumadin for subtherapeutic INR and developed supratherapeutic INR. Did not diurese well on intermittent IV Lasix and was switched to a Lasix infusion on hospital day 3. Urine culture was negative and antibiotics were stopped. She was continued on the Lasix infusion. Lasix infusion was stopped on hospital day 5. She was noted to have increasing confusion and CT head was obtained given her supratherapeutic INR and returned negative. At approximately 6:55 a.m. in the morning on hospital day 6 she was found to be unresponsive and apneic and a code was called. ACLS was started and patient received multiple doses of epinephrine and was intubated by the ED physician. ROSC was obtained and she was transferred to the ICU, she soon went into PEA arrest despite being on 2 pressors and ACLS was resumed. A pulse was not obtained after the 2nd arrest and time of death was called at 8:02 a.m. on 01/31/2022. Pupils were fixed and dilated and no heart or breath sounds were present.
1602280 2338917 2022-06-28 IA 66.00 Pfizer Dose 1 3/2/21 (EN6200) Pfizer Dose 2 4/2/21 (ER8734) Pfizer Dose 3 9/16/21 (EW0177) COVID Positive 12/2/21 (pt reported) COVID Positive 1/31/22 1/31/22: Patient is a 67-year-old male with a past medical history significant for follicular lymphoma, depression, hypertension, hyperlipidemia, former smoker. The patient presents to the ED today with complaints of generalized weakness. He complains of generalized weakness that has been ongoing since the end of November that has worsened over the last few days. He was apparetly seen by his visiting nurse today who found that he was tachycardic and had a low pulse ox level. The patient states he had COVID-19 in December 2021 and since testing positive he has never fully recovered. He originally tested positive on 12/2/2021. He states since testing positive in early December his symptoms have not been improving. He complains that over the last couple of das he has became significantly more weak and states he was unable to ambulate without the assistance of a walker which is not normal for the patients. He states that even with assistance from the walker he was having balance difficulty and difficulty walking distances due to becoming easily fatigued. His accompanying symptoms include productive cough with green sputum, shortness of breath, weakness, body aches, ore throat, and dizziness. He denies any palpitations, chest pain, nausea, vomiting or diarrhea. The patient is vaccinated for COVID-19 x3. He denies any alcohol abuse, illicit drug abuse or tobacco use. He recently quit smoking in December 2021 when his illness began, prior to that he did smoke 1/2 pack of cigarettes per day. Upon arrival to ED patient's temperature is 101.8�, heart rate 176, respirations 16, pulse ox 88% on room air, blood pressure 85/54. The patient was subsequently placed on 15 L oxygen via OxyMask to maintain O2 saturations greater than 90%. The patient was found to be in atrial fibrillation with RVR, the patient has a known history of this. The patient received 3 doses of IV Cardizem with some resolution of tachycardia, however patient's blood pressure was low. The patient was subsequently started on amiodarone per recommendations from Dr., cardiologist. Patient is currently on an amiodarone drip and Levophed drip due to patient's blood pressure being low. Patient also received 2 g IV magnesium sulfate, 125 mg IV Solu-Medrol, 500 mg IV azithromycin, 500 mg IV calcium gluconate, 1 g IV Rocephin, 3 L IV normal saline, 40 mEq IV potassium chloride in the ED. chest x-ray reveals multifocal airspace disease concerning for viral pneumonia/pneumonitis. Patient's laboratory findings are significant for potassium 3.1, glucose 116, ALT 58, AST 52, ALP 365, total protein 4.1, albumin 2.3, calcium 7.4, magnesium 1.2, phosphorus 2.2, hemoglobin 10.3, hematocrit 31.1, INR 1.4, CRP 8.50, rapid COVID-19 antigen is positive. The patient was seen and examined at the bedside in the ED. The patient states he feels better than prior to arrival. He admits he has been ill since initially testing positive for COVID-19 in December 2021, however, at that time he did not require inpatient treatment. His biggest complaint is significant and worsening weakness and fatigue that has been ongoing and worsening since December. 2/21/22: Patient was managemend aggressively with broad spectrum IV antimicrobials, vasopressors, cardioversion for atrial fibrillation He was intubated, extubated however unable to sustain without mechanical ventilation Despite maximal effort including CRRT and continued mechanical ventilation, multiple vasopressor medications, the patient did not progress in a recovery direction. His clinical status continued to deteriorate. Family transitioned him to comfort measures and patient eventually passed away in the afternoon of February 21, 2022
1602285 2338922 2022-06-28 IA 69.00 Pfizer Dose 1 3/6/21 (EN6199) Pfizer Dose 2 3/27/21 (EN6207) COVID Positive 1/10/22 1/14/22: A 70-year-old male with a past medical history of type 2 DM, hypertension, hyperlipidemia and gout brought to ED by ambulance for worsening shortness of breath and hypoxia. Patient states that he has been feeling sick for 1 week, with generalized weakness, cough, SOB and body aches. Patient states he got tested for COVID 19 about 4 days ago, and was reported positive. Patient was seen by family physician, was asked to monitor pulse ox. Patient states his pulse ox has been mostly in 70s, but he did not come to the emergency room. He received monoclonal antibody infusion yesterday. Patient says he is vaccinated against COVID-19 x2 doses, but no booster. His friend who lives with him also has mild symptoms. Denies nausea or vomiting, but had some loose stools. Per EMS his oxygen saturation was 74% on room air. In the ED, he was afebrile, blood pressure stable, pulse ox 92% on 15 L oxygen by mask. Blood work shows leukocytosis with neutrophilia and lymphopenia. Mild hyponatremia and elevated BUN and creatinine noted. Chest x-ray showed extensive bilateral infiltrates, with left hemidiaphragm elevation with mass effect. Patient was given IV dexamethasone 6 mg in the ED. 1/30/22: 70 year old male with hypertension presented for dyspnea and hospitalized for acute hypoxic respiratory failure secondary to COVID 19. Patient's oxygen requirement progressively increased and ended up getting intubated and requiring progressively increasing support on the ventilator. Patient received Actemra, Remdesivir, Dexamethasone and later Solu-Medrol. Patient was treated for superimposed bacterial pneumonia with course of antibiotics including ceftazidime and vancomycin. Patient developed afib w RVR which was appropriately treated medically and converted after synchronized cardioversion for hypotension. Patient's oxygen requirement worsened requiring maximal oxygenation support on the ventilator and developed septic shock with multiorgan failure which was refractory to vasopressors. Gaols of care was discussed with the family by the critical care attending and they decided on DNR/DNI and patient died on 1/30/2022 at 1836. Cause of death COVID 19.
1602294 2338931 2022-06-28 IA 56.00 Moderna Dose 1 4/26/21 (002C21A) Moderna Dose 2 5/24/21 (035C21A) COVID Positive 2/18/22 2/18/22: Pt. is a 57-year-old male with PMH history of renal transplant x 2 due to APOL-1 related FSGS, current CKD 4, immunocompromised status, atrial fibrillation on chronic anticoagulation, CHF, and HTN who presented to ED today for swelling of bilateral legs and increased dyspnea on exertion. He states his feet are killing him and have made it difficult to stand. His wife notes his legs are the most swollen may have ever been. He also notes significant shortness of breath with activity as minimal as sitting or drinking water. Associated symptoms include a dry cough, lightheadedness, chills, and decreased appetite. He believes symptoms have been coming on for 3-4 days, however his wife believes symptoms have been present for 1-2 months. He notes that he has not been urinating much recently. His torsemide dose is 200 mg however he is able to titrate himself down as he feels necessary, and he has been taking 200 mg for the past couple days. He does note missing 2 days of all medications in a row prior to this. He takes albuterol which very slightly improved his symptoms. Per chart review, patient had end-stage renal disease presumed secondary to APOL-1 related FSGS s/p deceased donor kidney transplant in 1999, which lasted to 2004, then subsequently on chronic hemodialysis followed by 2nd kidney transplant on 11/1/15. Noted baseline at most recent nephrology visit on 2/3/22 indicated baseline creatinine 2.5-3.0, with Cr 3.91 1/31/22. At that time there were no clear signs of rejection of kidney. Last seen in clinic 2/10/22 with Cr 5.94. He is taking torsemide 100 mg for diuresis, to titrate up to 200 mg as patient deems fit. Current medications for history of transplant include mycophenolate, prednisone, and tacrolimus. In the ED patient presented with pulse 115, BP 99/67, saturating 98% on room air. Labs notable for Na 131, anion gap 23, glucose 58, creatinine 8.14, total bili 8.0, lactate 3.9, proBNP >70000, troponin 0.18, platelets 43, INR 2.4. EKG indicated atrial fibrillation with RVR, RAD, incomplete right bundle branch block. CXR indicated cardiomegaly and pulmonary vascular congestion, patchy airspace disease in bilateral lungs could represent pulmonary infiltrate versus pulmonary edema. Due to clinical status, central line was placed in right IJ, CXR indicated termination within the SVC. In the ED he was given 2 mg of Bumex and 250 mL NS. Surgical Hx: Kidney transplant 1999, 2015. Family Hx: Noncontributory SH: Denies current tobacco, alcohol, or recreational drug use 2/27/22: patient is a 57-year-old male with PMH history of renal transplant x 2 due to APOL-1 related FSGS, current CKD 4, immunocompromised status, atrial fibrillation on chronic anticoagulation, CHF, and HTN who initially presented to ED 2/18/22 for swelling of bilateral legs and increased dyspnea on exertion. In the ED labs were notable for creatinine over 8 with baseline 2.5-3, in addition to pro BNP greater than 70,000, lactate 3.9, platelet 43, and troponin 0.18 which trended to 0.17 with repeat. He was found to be in AFib with RVR in the ED and started on diltiazem drip which was transitioned to PO on day 3 of hospitalization. Nephrology was consulted and patient was initially on bicarb and Bumex drip however ultimately required dialysis starting 2/21/22. He had a supratherapeutic INR at admission and this continued to rise despite holding warfarin. Patient was also noted to have thrombocytopenia for which he did receive platelet transfusions. Hematology was consulted. Patient was treated for possible concurrent CAP. Patient was difficult to manage from a dialysis standpoint as he had both fluid overload and hypotension. Due to this, on 2/27 patient was transferred to the ICU with plan to initiate CRRT. Pulmonology was also consulted as patient had had several episodes of respiratory distress requiring placement of BiPAP. Patient arrived to the ICU initially in stable condition, on 5L NC. Had rapid decompensation with PEA. Patient was coded 5 times and ROSC was achieved with each attempt. Patient was intubated after first code Patient was noted to have large amount bloody fluid in output from OG tube, GI bleed was believed to be the reason for his decompensation. Patient received 2 units pRBCs, 2 units platelets, 2 doses Kcentra. Discussion was had with family (see Dr.'s note) and decision was made not to code patient again. Family came to the bedside and patient passed away.
1602307 2338945 2022-06-28 IA 70.00 Moderna Dose 1 5/5/21 (lot NA) Moderna Does 2 6/1/21 (lot NA) COVID Positive 2/19/22 2/19/22: Pt, is 71-year-old female past medical history significant for coronary artery disease, hypertension, hypothyroidism, Parkinson's disease, tremor, GERD, anxiety/depression, schizoaffective disorder, and bipolar disorder. Patient was admitted after she was admitted for COVID pneumonia and stayed for 4-5 day after she presented with fatigue and was found to have low pulse ox of 80%. Patient was admitted for 5 days and completed antiviral medication with remdesivir and Decadron. Patient had CT of the chest with no pulmonary emboli at that time Currently she still feels short of breath but denies any chest pain fever chills or rigors 3/7/22: I have been reviewing the chart and the long complicated clinical course. The specialists and family had agreed with comfort measures, the patient expected to not survive after extubation, but has been hanging on with poor responsiveness and no signs of improvement. Will approach the family about hospice therapy and possible discharge to a hospice facility. UDPATE I have just been informed that the patient passed away at 08.46 pm.
1602314 2338953 2022-06-28 IA 82.00 Pfizer Dose 1 2/12/21 (EN6201) Pfizer Dose 2 3/7/21 (EN6199) COVID Positive 1/7/22 1/7/22: 83-year-old lady presented hospital with history of increasing shortness of breath overnight. Staff at nursing home noted that the patient was struggling with breathing, oxygen saturation dropped to 78. She was put on 2 L and that improved and placed on CPAP. The patient was transferred to the emergency department for further management. Apparently, patient tested positive for COVID last week and has not had any symptom until last evening. In the emergency room, patient was noted to be desaturating. Currently has been put on BiPAP, saturating 92% on BiPAP. Patient is a poor historian. Her daughter reports that she is DNR, DNI, but has agreed that the patient is set up for BiPAP use. The patient has a history of multiple myeloma, chronic anemia, and CKD. 1/13/22: An 83-year-old lady presented to the emergency room with history of increasing shortness of breath. She had a history of multiple myeloma with severe __________ and severe malnutrition. The patient's exam was suggestive of pneumonia, malnutrition, COVID-19 infection. Further lab workup revealed that the patient had bacteremia due to Enterococcus faecalis. The patient's antibiotic therapy was adjusted. She was on and off BiPAP. Her oxygen saturation improved with BiPAP up to 2 L; however, she remained very deconditioned. She required nutrition via TPN and p.r.n. by mouth. The patient, unfortunately, overnight, suddenly aspirated, and respiratory status worsened. She remained obtunded and unconscious following that episode. After discussion with the family about the prognosis, family opted for comfort measures, that were initiated. The patient eventually passed away on January 13, 2022, at 1:10 p.m. the family members were at the bedside at time of passing.
1601775 2335857 2022-06-27 OK 84.00 hospitilization of covid positive pt fully vaccinated
1601710 2335791 2022-06-27 CT 51.00 Patient received COVID booster and Pneumovax during PCP appointment on 6/13/22. Later that day, awoke from a nap with a bad headache. Took Tylenol, and the next day complained of bilateral jaw pain and told to continue tylenol. Increased headache by Saturday 6/18 and patient presented to ED. While in the ED, she had a deterioration of neurologic status and a head CT was performed with results as below. Started on clevidipine infusion, received tranexamic acid, mannitol, hypertonic saline. Unable to received transfusions per religion. Repeat head CT showed increased size of hematoma and vasogenic edema, with worsening mass effect and midline shift, as well as herniation. Unable to perform surgical intervention due to thrombocytopenia. Herniation on 6/19 and transitioned to comfort measures, with brain death on 6/20/22.
1601712 2335793 2022-06-27 AR 75.00 Pt was hospitalized with covid on 6/10/22 and died on 6/25/22
1601729 2335810 2022-06-27 61.00 pt to ED on 4/24/22 with AMS, syncope, unresponsive; when pt regained consciousness he requested to allow natural death; DNR; pt passed away in the ED; post-mortum testing done at Institute showed a positive COVID test
1601733 2335814 2022-06-27 TN 77.00 Patient presented to Healthcare on 8/4/2021 with unknown past medical history found to be hypoxic on EMS arrival, presents critically ill on mechanical ventilation in the Covid ICU. Left lower extremity with severe mottling, cold to touch. The patient continued on mechanical ventilation, developed worsening renal failure requiring dialysis, unable to be weaned from vent. He had persistent metabolic encephalopathy d/t sepsis and Covid-19. The patient did not improve after 2 weeks on the ventilator and the family decided to make him comfort care. The patient was palliatively extubated and expired immediately thereafter.
1601734 2335815 2022-06-27 TN 73.00 Patient diagnosed with COVID-19 6/20/2022. Admitted through ER locally, on 6/26/2022. Patient died 6/26/2022 at 1800 per hospital report.
1601739 2335820 2022-06-27 TN 68.00 Patient transferred to Hospital on 02/02/2022 from Health System for encephalopathy and failure to wan off the vent. Patient received a positive Covid-19 test on 01/12/2022. He had worsening confusion requiring frequent reorientation. On 01/22/2022 wife brought him to ED, he was initially on room air but decompensated and was intubated on 01/24/2022. He received Decadron and finished treatment on 01/31/2022. Patient failed to wean off the vent d/t issues with severe agitation and tachycardia and tachypnea. He was placed on broad spectrum antibiotics. MRI obtained on 01/25/2022 without acute abnormality. He continued to have fevers and worsening respiratory distress. Doppler revealed a DVT, and placed on Eliquis. On 02/7/2022 patient developed Afib with RVR. Patient developed worsening kidney failure. Continued to deteriorate and required nor epi and vasopressin. Palliative consulted and extubated on 02/15/2022.
1601750 2335831 2022-06-27 TN 86.00 Patient tested positive for Covid-19 01/25/2022. Patient was admitted to Medical Center on 02/24/2022 after a fall with multiple intracranial hemorrhage and HTN urgency. Patient had bilateral frontal and right temporal subdural hematoma, right frontal parenchymal hemorrhage, trace parafalcine subdural hemorrhage. Patient started on comfort measures on 02/28/2022 and expired on 03/04/2022.
1601755 2335837 2022-06-27 TN 69.00 The patient presents to a local HCF on 12/30/2021 with altered mental status. Upon admission to the ER patient was noted to be in severe sepsis with significant lactic acidosis metabolic acidosis leukocytosis and borderline low blood pressure and rapid Covid positive. PNA on CT of chest. MRI of brain shows punctate recent infarction. The patient was intubated after a few hours in the ER, and had a central line was started on pressor and empiric antibiotics. The patient had multiorgan failure including acute renal failure and severe metabolic acidosis. Patient was given bicarb boluses and initiated on bicarb drip. On 01/02/2022 patient underwent cardiac arrest without successful resuscitation and was pronounced dead.
1601782 2335864 2022-06-27 TN 89.00 Patient presented to ED on 02/04/2022 with ongoing and progressive SOB and cough. Patient endorsed weakness and intermittent chill. In ED patient tested Covid Positive. CXR consistent with ill-defined opacities in the right lung base and peripheral left lung, atelectasis versus airspace disease. Patient admitted to hospital with acute hypoxic resp failure. Palliative care consulted and patient agreed to DNR code. Patient expired on 03/06/2022.
1601776 2335858 2022-06-27 TN 63.00 Patient brought to ED at a local HCF on 01/01/2022 for increased SOB after of diagnosis of Covid. She noted fever, increased swelling, increased shortness of breath and cough with mucus/blood. In the ED oxygen was in low 80;s on room air. She was placed on nonrebreather where she was at 86% oxygen. Due to continued hypoxia the patient was placed on BiPap. Patient admitted with acute hypoxic respiratory failure 2/2 Covid PNA. Patient started on bronchodilators, IV steroids, O2. Patient was intubated on 1/12/22, then developed refractory hypoxemia. Patient was made DNR and passed on 1/22/2022.
1601795 2335879 2022-06-27 FL 82.00 Diagnosed with COVID-19 on 06/07/2022
1601819 2335903 2022-06-27 NM 73.00 Rashes and unexplained bruises because apparent Nov 30, 2021. COVID booster was given on 12/20/2021. Started having abdominal pain January 2022. March 2, 2022 diagnosed with rare Anaplastic T Cell Non Hodgkins Lymphoma ALK type negative
1601859 2335944 2022-06-27 TN 63.00 Patient was admitted on 02/18/2022 with ventilator dependent acute resp failure d/t stroke. On 02/02/2022 patient noted to be Covid Positive. Since then patient had lingering neck shoulder and arm pain. Patient was intubated and admitted to ICU. Admitted with acute CVA due to left MCA occlusion complicated by malignant cerebral edema and acute hypoxic respiratory failure. Patient was transitioned to comfort care and expired on 02/27/2022.
1601871 2335956 2022-06-27 TN 42.00 Patient presents to ED due to SOB and cough. Patient presented drowsy and disoriented. He was found to be covid positive in ED, and was also covid positive in March. In ED H/H was 6/19- 1 unit PRBC ordered. CT chest showed subcutaneous emphysema and pneumomediastinum and bilateral airspace consolidation, patient was bradycardic in the 30's, atropine 0.5mg x 1 given. Patient was admitted to hospital. On 5/25/2022 patient was ESRD, permcath placed to be dialyzed. 06/06/2022 patient declined in condition, increased WOB on HFNC d/t hypoxia, more hypotensive and hypoglycemic. Patient expired on 6/8/2022.
1601886 2335971 2022-06-27 TN 65.00 Patient admitted for Covid-19 PNA and acute resp failure with hypoxia. Patient was started on Decadron and remdesivir. Patient acutely decompensated on 01/22/2022 and was transitioned to AVAPS on 01/23/2022. Patient required intubation and course complicated by worsening renal failure. 02/06/2022 Patient condition continue to decline and multiorgan failure worsened. Patient required pressors and renal failure/hyperkalemia worsening despite dialysis. Patient expired on 2/6/2022.
1601898 2335983 2022-06-27 TN 62.00 Reports to ED c/o 2-3 months history of dyspnea on exertion. Hx of being exposed to Covid by family member, patient began to fill ill at that time. Since then he has had progressive weakness with no improvement in SOB. Patient admitted with acute respiratory disease d/t severe acute respiratory syndrome coronavirus on 03/27/2022. Patient was intubated on 04/02/2022. Patient was terminally extubated and expired on 04/14/2022.
1601941 2336026 2022-06-27 KY 77.00 Pt contracted Covid 19 and passed away
1601325 2335253 2022-06-25 NJ He died on the 11May; I would say may be a week or two later his dementia got a lot worse; Acute renal failure; He started developing twitches, big twitches; He started acting strange; This is a spontaneous report received from a contactable reporter(s) (Physician). A 62-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FJ6369), in arm for covid-19 immunisation. The patient's relevant medical history included: "He had an underlying neurologic disease that's called Cadasil" (unspecified if ongoing), notes: he had an underlying neurologic disease that's called Cadasil. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 Immunization; Bnt162b2 (Dose 2, single), for COVID-19 Immunization; Bnt162b2 (Dose 3 (Booster), single), for COVID-19 Immunization. The following information was reported: ACUTE KIDNEY INJURY (medically significant) with onset 05Feb2021, outcome "unknown", described as "Acute renal failure"; ABNORMAL BEHAVIOUR (non-serious) with onset 05Feb2021, outcome "unknown", described as "He started acting strange"; MUSCLE TWITCHING (non-serious) with onset 05Feb2021, outcome "unknown", described as "He started developing twitches, big twitches"; DEMENTIA (medically significant) with onset 05Feb2021, outcome "unknown", described as "I would say may be a week or two later his dementia got a lot worse"; DEATH (death) with onset 11May2022, outcome "fatal", described as "He died on the 11May". The events "i would say may be a week or two later his dementia got a lot worse", "acute renal failure", "he started developing twitches, big twitches" and "he started acting strange" required emergency room visit. The patient underwent the following laboratory tests and procedures: Lab Work: Unknown results, notes: Doctor stated, He had a lot of it at the hospital. Therapeutic measures were not taken as a result of dementia, acute kidney injury, muscle twitching, abnormal behaviour. The patient date of death was 11May2022. The reported cause of death was unknown. No autopsy was performed. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events death, dementia, acute kidney injury and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: He died on the 11May
1600729 2331872 2022-06-24 MN 90.00 Patient vaccinated against and then tested positive for COVID19
1600519 2331657 2022-06-24 OK 63.00 Patient COVID positive prior to admission into the hospital. Vaccinated plus one booster
1600771 2331916 2022-06-24 86.00 1/18/22 pt had a positive COVID test ordered by a local HCF; per death certificate, the manner of death was natural, the cause of death was COVID 19; the pt died at his residence
1600765 2331910 2022-06-24 87.00 12/29/21 pt had a positive COVID test ordered by Agency; per death certificate pt died at his home with the manner of death being natural and the causes being: cardiopulmonary arrest, respiratory failure, COVID
1600243 2329080 2022-06-23 MN 80.00 Patient presented to the emergency department via EMS on 5/27/2022 with altered mental status, tested Covid-19 positive via PCR that day, and subsequently diagnosed with pneumonia due to Covid-19 and was admitted. Patient continued to overall decline during admission and ultimately passed away on 6/4/2022. In medical chart, Covid-19 is not listed as a cause of death.
1600046 2328882 2022-06-23 KY 77.00 Discharge Provider: MD Primary Care Physician at Discharge: DO Admission Date: 6/10/2022 PRESENTING PROBLEM: Thrombocytopenia [D69.6] Febrile neutropenia [D70.9, R50.81] Electrolyte abnormality [E87.8] Pulmonary embolism, unspecified chronicity, unspecified pulmonary embolism type, unspecified whether acute cor pulmonale present [I26.99] Pneumonia due to COVID-19 virus [U07.1, J12.82] Acute respiratory failure with hypoxia [J96.01] HOSPITAL COURSE: Patient is a 78 y.o. female with history of active small cell lung carcinoma s/p radiation therapy and was on active chemotherapy (last session completed two weeks ago), COPD, HTN who presented initially due to sepsis in the setting of febrile neutropenia who was also found to be positive for COVID-19. She was admitted on 6/10 from the infusion clinic after having 1-week of worsening shortness of breath, cough, and chills. She had sepsis due to Pseudomonas bacteremia and pneumonia. During hospitalization she declined and developed AHHRF was placed on BiPap with worsening VBG and was transferred to ICU and subsequently intubated on 6/12. During her stay she was also found to have a new acute thrombus right lower extremity and small pulmonary emolism. She had severe pancytopenia with platelets <10 so an IVC filter placed on 6/12 and unable to anticoagulate. She then suffered from worsening renal failure and required renal replacement therapy. Found to have worsening respiratory status, as well as a candida bacteremia. Shock persisted. A family meeting on 6/21/2022 with first degree relatives agreed upon comfort care measures given that her wishes were not to be kept alive on life support. Family presented at bedside and comfort care measures in place. Patient was pronounced at 6:54pm on 06/21/2022 secondary to respiratory failure in the setting of pseudomonas pneumonia, covid pneumonia, and candida bacteremia. Called and updated family over the phone
1600058 2328894 2022-06-23 57.00 PFIZER COVID VACCINE #3 GIVEN 9/9/21, LOT # FC3184; pt had a positive COVID test at Medical Center; per death certificate, pt passed away at home with cause of death being COVID 19; no other records.
1600106 2328943 2022-06-23 78.00 1/12/22 pt brought to Ed via EMS reporting poor oral intake; O2 sats 85% on RA; placed on NRB; decreased responsiveness, diarrhea x 2 days, vomiting 1 x; admitted started on ABX and fluids; found to be positive for COVID; given Remdesivir, Heparin; pt's condition worsened became hypothermic requiring Bair Hugger blanket; severe sepsis; poor prognosis; DNR; in patient hospice where he expired
1600189 2329026 2022-06-23 64.00 1/5/22 pt brought to ED with c/o vomiting, diarrhea and not eating; found to be anemic and positive for COVID; CT of abdomen showed bilateral mass-like lesion; admitted; received 3 units PRBCs; AKI on CKD; hemodialysis; pt's condition worsened; became unresponsive; PEA; ACLS initiated; ROSC achieved; pt intubated and on mechanical ventilation; transferred to ICU; pt's condition continued to decline; made DNR and comfort care; pt expired in the hospital
1600191 2329028 2022-06-23 MI 79.00 Pt to ED 1/22 for hypotension, respiratory distress and AFib, upon arrival pt is not alert to any stimuli. COVID+ 1/22, on Vancomycin. Pt coded twice, first time for 5 minutes second for 1 minute, pt received antibiotics and multiple boluses. Family changed code status to comfort care, pt expired 1/22.
1600211 2329048 2022-06-23 FL 53.00 The decedent received his first COVID shot 2 weeks prior to death (8/23/2021). A week before death, the decedent had severe cough and vomitting.
1600381 2329219 2022-06-23 85.00 per our records, pt had a positive COVID test on 1/18/22 with the ordering facility being Hospital; requested records, but they did not find records of pt between 1/12/22 - 2/1/22; per death certificate, pt passed away of acute diastolic congestive heart failure and COVID 19 viral infection; attempted to get a fax number to request records but the phone line continued to be busy, I tried for 2 days.
1600274 2329111 2022-06-23 73.00 1/7/22 to ED with c/o chest pain and increasing SOB over past month; 2 days prior to ED visit, pt seen in outpatient clinic and placed on antibiotic for possible pneumonia; admitted; found to be positive for COVID; placed on BiPAP; increasing weakness, decreasing appetite; steroids; AHRF secondary to COVID pneumonia; dc'd to inpatient hospice where she passed away
1600302 2329139 2022-06-23 82.00 pt brought to the ED on 5/26/22 after a fall; left hip fractured; CT of head and C-spine without acute abnormalities; A fib with RVR; pt found to be positive for COVID; c/o cough and scratchy throat x 2 wks; O2 supplementation; dexamethasone; ORIF; suffered cardiac arrest the following day and never regained ROSC after 2nd arrest
1600316 2329153 2022-06-23 75.00 MODERNA COVID VACCINE #3 GIVEN 10/26/21, LOT # 012F21A; 5/9/10 pt brought to ED via EMS with generalized weakness, SOB; found to be hypoxic and had a positive COVID test (although throughout hospital course, pt's COVID tests were all negative after the initial; possible false positive test); given O2, dexamethasone, admitted; worsening right pleural effusion and ascites; right chest tube placed with some improvement; decline later in status; family decided on comfort measures only and pt was put into hospice where he expired.
1600367 2329205 2022-06-23 94.00 PT lives at at nursing home; pt had a positive COVID test on 11/23/21 in the nursing home; placed in isolation; DNR; comfort measures; pt passed away in the nursing home.
1600388 2329226 2022-06-23 87.00 12/31/2022 pt had a positive COVID test in Healthcare Center; DNR; 01/05/2022 pt went to ED at Hospital for SOB; per death certificate, pt expired at her house with causes of death being acute on chronic hypoxia and hypercapneic respiratory failure, exacerbation of COPD at end stage, and COVID 19 infection;
1600445 2329669 2022-06-23 TX 74.00 This all started on January 27th, Patient had not been feeling well and had fallen and I had to call EMS to help get him back to bed. He had been getting weak during the previous week. On January 28th he fell again, this time EMS came and I insisted he go to the hospital. At the hospital they did blood work and an Xray, put him on IV fluids to help with the weakness. They came in and advised that he had COVID and gave him some medication through the IV we were told. He was feeling a little better and they did a test on his oxygen level and because of the level he was at they sent us home. He was home getting weak again and on February 16the we went to see Dr in his office because Patient was not feeling much better. had an exray of his esophagus on that day and Dr gave him his booster shot for COVID. On March 6 Patient again got very weak,, and fell gettting up from his chair. Again EMS came out and I was beginning to think he may have had a stroke. He was slurring his words a little, and was still not eating due to the COVID. The EMS took him to Hospital and they admitted him. They did an electrocardiogram, an Ultrasond of both sides of his head and neck to check the blood flow, An MRI to check for a stroke and that was negative. He at this point was not able to get up easily because of weakness. They admitted him and continued care with Physical therapy and conntinued blood work until he was released on March 17th. He came home walking with a walker and was still weak. He still was not eating. He said everything he put in his mouth just would roll up in a ball and he would spit it out. He was scheduled for Rehab outpatient the week of March 28th on Monday, Wednesday and Friday. The following Monday which was April 4th (I think)he said he just could not get up and go and stayed in bed all day. He still was not eating. That evening when he would not eat I took him back to the Emergency room and they admistted him. The following day Dr came by and said there was nothing he could do about the eating problem and that he could put in a feeding tube if Patient wanted to go that route and Patient agreed. Surgery was done to put in a Jtube for feeding. They could not put in a normal feeding tube into the stomach because of previous stomach stapeling surgery. The Jtube went directly into the intestine, he was at the hospital for I think 2-3 days and then he was transferred to Rehab. He was admitted there on April 11th. On April 15th I received a call and ws told that his Jtube had come out and they were going to transfer him to hospital because that is who they worked with. He was transferred by Ambulance to hospital. There they did blood work, CT scan, EKG, and Xrays. He arrived there about 6 pm on April 14th and after all the tests they did around 10PM tht day they told us they were transferring him back to Hospital because none of the Physicians wanted to touch him because the surgery was done elsewhere. They again transported him to hospital around midnight April 15th. He was admitted and Dr and Dr the original surgeon came and Dr took him back into surgery on April 16th, to place a different Jtube in and clean out everything that had leaked out of the previous tube in the cavity. Dr said he wanted him to have a Wound Vac and so he had an open wound at the top of his incision this time. His original wound where the surgery was, was about 8 inches long. The top 4 inches were left open with the wound vac attached. This was attached and changed every 3 days until he passed away. Once the second surgery was completed and he had a couple of days to recover, he was transferred to Rehab. He still could not eat. When this all started, he weighed in at Dr's office on February 16th and his weight that day was 328lbs. He was in rehab from April 18th until May 29th when he passed away. During his stay they would pick him up out of bed with a lift because he did not have the strength to get out of bed himself. They would put him in a wheel chair and take him to do physical therapy in their therapy area. He continued to get weaker. We tried to get him to eat but nothing would work I even made his favorite soup and he would not even drink the broth because he said there was no taste at all. During this time he lost down to 248 lbs at the time he passed away. He just got weaker and even when he talked his words would get mixed up and not make any sense many times. At the end he was having trouble seeing anything. I would try to read to him and he just would not want to hear anything and just wanted to sleep. They were still trying to get him to eat and do some kind of therapy in bed but he was too weak. This DARN COVID is not something to mess with. Again, he passsed away on May 29th 2022.
1599265 2326930 2022-06-22 FL 95.00 Pt presented with CHF and covid. Treated with iv diuretics. pt didn't repond to treatment and was admitted to hopice and deceased.
1599169 2326751 2022-06-22 TN 59.00 ACUTE MYOCARDIAL INFARCTION; ACUTE RESPIRATORY FAILURE; COVID-19 PNEUMONIA; DIABETIC KETOACIDOSIS; CARDIAC ARREST; VENTRICULAR FIBRILLATION; ATRIAL FIBRILLATION; HYPERVOLAEMIA; POLYURIA; ENDOTRACHEAL INTUBATION; EXTUBATION; PERCUTANEOUS CORONARY INTERVENTION; SARS-COV-2 TEST POSITIVE; STENT PLACEMENT; INTENSIVE CARE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS), concerned a 59 year old male of an unspecified race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total administered on 24-MAR-2021 for an unspecified indication. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 59 years old. No concomitant medications were reported. On 28-JAN-2022, the patient presented to hospital with inferior STEMI (ST-elevation myocardial infarction), acute myocardial infarction, percutaneous coronary intervention (PCI), diabetic ketoacidosis (DKA) and covid-19 pneumonia (Covid-PNA). Hospital course was complicated by acute hypoxic respiratory failure 2/2 PNA, volume overload (hypervolaemia) and experienced new onset of atrial fibrillation. On admission to critical care (intensive care), the patient was intubated (endotracheal intubation) and sedated and patient tested positive for COVID and patient was not on remdesivir because of being intubated. Laboratory data included: SARS-CoV-2 test which resulted positive. Patient was treated with steroids. For PNA (covid-19 pneumonia) he was started on antibiotics and diuresis (polyuria) for volume overload and was extubated. Patient was transferred to step down and started on remdesivir. The patient with inferior STEMI who underwent emergent percutaneous coronary intervention and drug-eluting stent (DES) to the RCA (Right coronary artery) then developed VF (Ventricular fibrillation) arrest with inability to achieve ROSC (Return of spontaneous circulation). The patient died on 01-FEB-2022. It was unspecified if an autopsy was performed. The number of days of hospitalization was not reported and it was unspecified if the patient was discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from an unknown cause of death on 01-FEB-2022, and the outcome of the events acute myocardial infarction, acute respiratory failure, atrial fibrillation, covid-19 pneumonia, cardiac arrest, diabetic ketoacidosis, ventricular fibrillation, endotracheal intubation, extubation, hypervolaemia, percutaneous coronary intervention, polyuria, sars-cov-2 test positive, stent placement and intensive care was reported as fatal. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000235951. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. Additional information was received from central complaint vigilance department on 16-JUN-2022. The following information was updated and incorporated into case narrative: product quality complaint result.; Sender's Comments: V2: The follow up adds: product quality complaint result. This new information does not change prior causality assessment. 20220620773-covid-19 vaccine ad26.cov2.s-Acute myocardial infarction, Acute respiratory failure, Covid-19 pneumonia, Diabetic ketoacidosis, Atrial fibrillation, Cardiac arrest, Ventricular fibrillation, Endotracheal intubation, Extubation, Hypervolaemia, Percutaneous coronary intervention, Polyuria, Sars-cov-2 test positive, Stent placement ,Intensive care. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
1599095 2326653 2022-06-22 died within five months of the second dose.; cjd; her left hand and side began to tremble; stress; disease progressed; not being able to sit and walk independently; significant changes in the right side of her brain; This is a literature report for the following literature source(s): "Studies suggest that there is a link between Covid-19 - "vaccines" and a rapidly evolving, incurable and deadly disease, which is known as Creutzfeldt-Jakob disease.". A female patient received BNT162b2 (BNT162B2), on 21Sep2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (first dose of Pfizer on 29Aug2021), administration date: 29Aug2021, for COVID-19 immunization. The following information was reported: DEATH (death), outcome "fatal", described as "died within five months of the second dose."; CREUTZFELDT-JAKOB DISEASE (medically significant), outcome "unknown", described as "cjd"; TREMOR (non-serious), outcome "unknown", described as "her left hand and side began to tremble"; STRESS (non-serious), outcome "unknown"; DISEASE PROGRESSION (non-serious), outcome "unknown", described as "disease progressed"; GAIT INABILITY (non-serious), outcome "unknown", described as "not being able to sit and walk independently"; BRAIN SCAN NORMAL (non-serious), outcome "unknown", described as "significant changes in the right side of her brain". The event "stress" required physician office visit. The patient underwent the following laboratory tests and procedures: Scan brain: significant changes in the right side of her brain, notes: The scans confirmed that (Name withheld) had significant changes in the right side of her brain. Therapeutic measures were taken as a result of stress. The date and cause of death for the patient were unknown. Clinical information: Please see attached a spontaneous case sent to us by a Pfizer colleague who reviewed local websites (withheld). This is a spontaneous report published on a (website withheld) and reported by a Pfizer colleague. I am attaching the translation of the article in English. At your disposal, COVID 'vaccines' linked to new type of incurable, lethal degenerative brain disorder Studies suggest that there is a link between Covid-19 - "vaccines" and a rapidly evolving, incurable and deadly disease, which is known as Creutzfeldt-Jakob disease.(Name withheld) Lawyer at (Organization withheld) and journalist of The Defender. (Organization withheld) 07Jun2022 (Web link withheld) Studies suggest that there is a link between an incurable and fatal disease known as Creutzfeldt-Jakob disease (CJD) and COVID-19 vaccines. Researchers believe that the area of the original spike protein of (Place withheld) variant of COVID-19 virus was incorporated into mRNA "vaccines"- and carrier adenovirus "vaccines" administered to billions of people can cause a new type of rapidly evolving sporadic CJD. According to the (Clinic withheld), Creutzfeldt-Jakob disease (CJD) is a degenerative disorder of the brain [which turns the brain into a mizithra] and leads to dementia and, ultimately, to death. Although the Omicron variant has no region in its spike protein, the current COVID-19 vaccines continue to use the genetic material including the region of the (place withheld) parent strain. A study published in May2022 on the relationship of the COVID-19 'vaccine' and CJD, identified a new form of sporadic CJD that appeared within days of taking a first or second dose of COVID-19 vaccines of Pfizer and Moderna. The researchers analysed 26 cases of Creutzfeldt-Jakob disease (CJD) and found that the first symptoms appeared on average 11.38 days after the injection of the COVID-19 'vaccine'. By the time the study was published, of the 26 cases, 20 had died and 6 were still alive. As the researchers wrote: "The 20 deaths occurred 4.76 months after injection. Among them, 8 of them led to sudden death (2.5 months); This confirms the radically different nature of this new form of CJD, while the classical form takes several decades to manifest itself." Dr. (Name withheld), lead author of the study, on 06Jun said in The (publication withheld) that all 26 cases led to death. According to the Centres for Disease Control and Prevention (CDC), diseases are a family of rare progressive neurodegenerative disorders affecting humans, and livestock. Diseases are usually rapidly evolving and always fatal. Although appear naturally in the brain and are usually harmless, they can be disturbed or not folded normally, affecting nearby and causing a change in their structure and behavior; The abnormal folding of proteins ' leads to brain damage and characteristic signs and symptoms of Creutzfeldt-Jakob disease (CJD)", says the website of the CDC. Sporadic Creutzfeldt-Jakob (CJD) occurs when a person becomes infected without obvious Reason. Once a single is contaminated, it will develop into another and there is no cure that can it can stop it.The region of the original spike protein of the (withheld) virus strain that exists in all COVID "vaccines", can interact with human Cells. Although the Omicron variant has no area in its spike protein, researchers said other variants of COVID-19, including the maternal (withheld) strain used in vaccines currently administered, have. As the researchers wrote: "We are now studying the first cases of patients with Omicron, in particular. In all these cases, the area has disappeared." However, the spike protein gene information of the (Withheld) virus variant including the region were incorporated into the 'vaccines' mRNA of Pfizer and the Moderna and "vaccines" with carrier genetically modified monkey adenovirus virus of AstraZeneca and Johnson & Johnson. "We have also proven whereas the Pfizer and Moderna mRNA injections also contain the same area. The same applies to all other "vaccines" -SARS-CoV2, because all are made from the Spike sequence of the (Withheld) SARS-CoV2 virus, which we showed that contains the area." With the mRNA "vaccines"-, once the mRNA is incorporated into the cells, the cell converts mRNA guidelines into a COVID-19 spike protein that tricks cells into to believe that it is infected, so that the body creates an immune memory against a piece of the virus. With the "vaccines" with carrier a genetically modified monkey adenovirus, its DNA spike protein is transferred to the cell and then to the nucleus where it is stored all human DNA. After the DNA is transcribed into mRNA and converted to spike protein; An (Withheld) study of 2022, published in Microorganisms showed that the area of the SARS-CoV-2 spike protein incorporated in the COVID-19 "vaccines" is capable of interaction with human cells; Although the CDC repeats unsubstantiated that COVID-19 "vaccines" "cannot to change our DNA", studies show that mRNA can be converted into DNA and incorporated into the human genome. An (Withheld) study of 2021, titled: "Worse than the disease? Review of some possible unintended consequences of mRNA vaccines against COVID-19," he hypothesized that a incorrect folding of the spike protein could create an incorrect folded saw area, which can interact with a healthy to cause damage, leading to CJD disease; (published in the Journal of Vaccine, Practice, and Research (Withheld) An case report published in 2021, suddenly identified cases of CJD that appeared after vaccination with vaccines Pfizer, Moderna and AstraZeneca, suggesting a link between vaccination and disease.Creutzfeldt-Jakob Disease After the COVID-19 Vaccination, Turk J Intensive Care, Dec2021.(Link Withheld) A study published in 2021 in Microbiology & Infectious Diseases found a possible relationship between the Pfizer "vaccine" and disease in humans. ((Name withheld) COVID-19 RNA Based Vaccines and the Risk of Disease. Microbial Infect Dis. 2021; 5(1): 1-3. (Link Withheld) Despite the existence of new variants of SARS-COV-2, people still receive the COVID-19 "vaccines" developed with the spike protein of the parent variant of the virus of (Withheld). Many cases of CJD disease were reported in the U.S. Among the case reports of Creutzfeldt-Jakob disease (CJD) in the US in Mar2022, one was about 64-year-old (Name withheld) battle with CJD disease, which developed a few days after the second dose of Pfizer's "vaccine" for COVID-19. The report stated: "We cite the case of a 64-year-old woman, who has a rapidly declining loss of memory, behavioural changes, headaches and gait disorders about a week after the administration of the second dose of the new mRNA of Pfizer-BioNTech-Covid-19 "vaccine". After extensive research, definitive evidence identified the fatal diagnosis of sporadic Creutzfeldt-Jakob disease'. In an interview with The Defender in Aug2021, (Name withheld) daughter, (Name withheld), said that her mother's regression was heart breaking: From being able to work and do normal daily activities ended up not being able to walk, talk or control the movement of her body; She felt that her head was about to "explode" and died within three months of taking the second dose of Pfizer. In a written statement to The Defender, the doctor of (Name withheld) said: "In her case, possible side effects that could occur after the administration of the new Covid 19 "vaccine" are identified. Clinicians should take into account their differential diagnoses when a patient has rapidly progressing dementia, particularly after a recent vaccination, neurodegenerative diseases such as disease (e.g. sporadic Creutzfeldt-Jakob disease), autoimmune encephalitis, infections, non-epileptic seizures, toxic-metabolic disorders, etc.; Although there is currently no cure for the sporadic Creutzfeldt-Jakob disease (sCJD), early diagnosis is vital to avoid unnecessary administration of drugs for suspected psychological or neurological disorders; In addition, monitoring of side effects could potentially lead to further understanding of both the new mRNA "vaccine"- for COVID-19 and the etiologic of sCJD. Most importantly, recognizing the adverse effects provides individuals with vital important information to make a more informed decision about their health." (Name withheld), in an interview with The Defender, said that his mother, (Name withheld), knew that the Creutzfeldt-Jakob's disease was associated with Moderna's "vaccine". (Name withheld) made her first dose of Moderna on 16Feb2021 and did not report any complaints. But soon after the second dose on 17Mar, "felt different." Her symptoms began with numbness that spread from the hand where the injection was made to the entire left side of her body; She complained that something was wrong with her. Her brain could not combine her thoughts, understand things, developed diplopia and blindness and began to have hallucinations. The doctors initially thought that (Name withheld) had suffered a stroke due to... Anxiety. The MRIs later showed that there were abnormalities in her cerebellum. Her condition progressed quickly and she was eventually diagnosed with Creutzfeldt-Jakob disease (CJD) and they gave her days of life. She died within months of taking the second dose of Moderna. Her doctors submitted a report to the Vaccine Adverse Event Reporting System of CDC (VAERSID#). But, to date, the CDC have not communicated with the family despite an autopsy that confirmed that her death was caused by CJD-disease that manifested itself after the COVID-19"vaccine". (Name withheld), in an interview with The Defender, said that his wife, (Name withheld), showed the CJD disease after Pfizer's COVID-19 "vaccine" and died within five months of the second dose. She did her first dose of Pfizer on 29Aug2021 and her second dose on 21Sep2021. Her husband remained unvaccinated, but (Name withheld) had to be vaccinated compulsorily because of her professional employment. Four days after the second dose, (Name withheld) experienced the first episode of a "sudden" strange event that he could not explain." She started to have more episodes and her left hand and side began to tremble. On 13Oct2021, (Name withheld) returned to the doctor, who prescribed Xanax for the... stress. (!!!) The disease progressed rapidly to the point of not being able to sit and walk independently. The scans confirmed that (Name withheld) had significant changes in the right side of her brain. A new medical team did a systematic check on the spine and confirmed that the (Name withheld) had cjd. Until that moment, (Name withheld) could not get out of bed. "Your brain just disappears. It's crazy. You have a completely healthy body and your brain dies within a few months," said (Name withheld) who was informed that his wife will not recover. (Name withheld) died on 21Feb five months after her second dose of Pfizer. According to the latest data of the reference system of the side effects of vaccines (VAERS), as of 14Dec2021, 56 cases of rapid onset of the disease have been reported CJD after COVID-19 "vaccines". As has been shown, in federal reporting system of side effects of vaccines (VAERS) only 1% of all side effects of 'vaccines' are reported. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of death,Creutzfeldt-Jakob disease. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate; Reported Cause(s) of Death: died within five months of the second dose
1599211 2326795 2022-06-22 died within three months of taking the second dose of Pfizer; CJD disease; loss of memory; behavioral changes; headache; gait disorder; This is a literature report. A 64-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE: 1), for COVID-19 immunization. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "died within three months of taking the second dose of Pfizer"; CREUTZFELDT-JAKOB DISEASE (medically significant), outcome "unknown", described as "CJD disease"; AMNESIA (non-serious), outcome "unknown", described as "loss of memory"; BEHAVIOUR DISORDER (non-serious), outcome "unknown", described as "behavioral changes"; HEADACHE (non-serious), outcome "unknown"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "gait disorder". The date and cause of death for the patient were unknown. Please see attached a spontaneous case sent to RA by a Pfizer colleague who reviewed local websites (withheld). This is a spontaneous report published on a (website withheld) and reported by a Pfizer colleague. I am attaching the translation of the article. At your disposal, COVID 'vaccines' linked to new type of incurable, lethal degenerative brain disorder. Studies suggest that there is a link between Covid-19 - "vaccines" and a rapidly evolving, incurable and deadly prion disease, which is known as Creutzfeldt-Jakob disease.(Name withheld) Lawyer at (Organization withheld) and journalist. (Organization withheld) 07Jun2022 (withheld) Studies suggest that there is a link between an incurable and fatal prion disease known as Creutzfeldt-Jakob disease (CJD) and COVID-19 vaccines. Researchers believe that the prion area of the original spike protein of (Place withheld) variant of COVID-19 virus was incorporated into mRNA "vaccines"- and carrier adenovirus "vaccines" administered to billions of people can cause a new type of rapidly evolving sporadic CJD. According to the (Clinic withheld), Creutzfeldt-Jakob disease (CJD) is a degenerative disorder of the brain [which turns the brain into a mizithra] and leads to dementia and, ultimately, to death. Although the Omicron variant has no prion region in its spike protein, the current COVID-19 vaccines continue to use the genetic material including the prion region of the (Place withheld) parent strain. A study published on the relationship of the COVID-19 'vaccine' and CJD, identified a new form of sporadic CJD that appeared within days of taking a first or second dose of COVID-19 vaccines of Pfizer and Moderna. The researchers analyzed 26 cases of Creutzfeldt-Jakob disease (CJD) and found that the first symptoms appeared on average 11.38 days after the injection of the COVID-19 'vaccine'. By the time the study was published, of the 26 cases, 20 had died and 6 were still alive. As the researchers wrote: The 20 deaths occurred 4.76 months after injection. Among them, 8 of them led to sudden death (2.5 months); This confirms the radically different nature of this new form of CJD, while the classical form takes several decades to manifest itself." Dr. (Name withheld), lead author of the study, on 06Jun said in The (publication withheld) that all 26 cases led to death. According to the Centers for Disease Control and Prevention (CDC), prion diseases are a family of rare progressive neurodegenerative disorders affecting humans, and livestock. Prion diseases are usually rapidly evolving and always fatal. Although prions appear naturally in the brain and are usually harmless, they can be disturbed or not folded normally, affecting nearby prions and causing a change in their structure and behavior; The abnormal folding of prion proteins ' leads to brain damage and characteristic signs and symptoms of Creutzfeldt-Jakob disease (CJD)", says the website of the CDC. Sporadic Creutzfeldt-Jakob (CJD) occurs when a person becomes infected without obvious Reason. Once a single prion is contaminated, it will develop into another prion and there is no cure that can it can stop it. The Prion region of the original spike protein of the (withheld) virus strain that exists in all COVID "vaccines", can interact with human Cells. Although the Omicron variant has no prion area in its spike protein, researchers said other variants of COVID-19, including the maternal (withheld) strain used in vaccines currently administered, have. As the researchers wrote: "We are now studying the first cases of patients with Omicron, in particular. In all these cases, the Prion area has disappeared." However, the spike protein gene information of the (Withheld) virus variant including the prion region were incorporated into the 'vaccines' mRNA of Pfizer and the Moderna and "vaccines" with carrier genetically modified monkey adenovirus virus of AstraZeneca and Johnson & Johnson. "We have also proven whereas the Pfizer and Moderna mRNA injections also contain the same prion area. The same applies to all other "vaccines" -SARS-CoV2, because all are made from the Spike sequence of the (Withheld) SARS-CoV2 virus, which we showed that contains the Prion area." With the mRNA "vaccines"-, once the mRNA is incorporated into the cells, the cell converts mRNA guidelines into a COVID-19 spike protein that tricks cells into to believe that it is infected, so that the body creates an immune memory against a piece of the virus. With the "vaccines" with carrier a genetically modified monkey adenovirus, its DNA spike protein is transferred to the cell and then to the nucleus where it is stored all human DNA. After the DNA is transcribed into mRNA and converted to spike protein; An (Withheld) study of 2022, published in Microorganisms showed that the prion area of the SARS-CoV-2 spike protein incorporated in the COVID-19 "vaccines" is capable of interaction with human cells; Although the CDC repeats unsubstantiatedly that COVID-19 "vaccines""cannot to change our DNA", studies show that mRNA can be converted into DNA and incorporated into the human genome. An (Withheld) study of 2021, he hypothesized that a incorrect folding of the spike protein could create an incorrect folded saw area, which can interact with a healthy prion to cause damage, leading to CJD disease. An case report published in 2021, suddenly identified cases of CJD that appeared after vaccination with vaccines Pfizer, Moderna and AstraZeneca, suggesting a link between vaccination and disease. (Link Withheld) A study published in 2021 found a possible relationship between the Pfizer "vaccine" and prion disease in humans. Microbiol Infect Disk, Despite the existence of new variants of SARS-COV-2, people still receive the COVID-19 "vaccines" developed with the spike protein of the parent variant of the virus of (Withheld). Many cases of CJD disease were reported Among the case reports of Creutzfeldt-Jakob disease (CJD) in Mar2022, one was about 64-year-old (Name withheld) battle with CJD disease, which developed a few days after the second dose of Pfizer's "vaccine" for COVID-19. The report stated: "We cite the case of a 64-year-old woman, who has a rapidly declining loss of memory, behavioral changes, headaches and gait disorders about a week after the administration of the second dose of the new mRNA of Pfizer-BioNTech-Covid-19 "vaccine". After extensive research, definitive evidence identified the fatal diagnosis of sporadic Creutzfeldt-Jakob disease'. In an interview in Aug2021, (Name withheld) daughter, (Name withheld), said that her mother's regression was heartbreaking: From being able to work and do normal daily activities ended up not being able to walk, talk or control the movement of her body; She felt that her head was about to "explode" and died within three months of taking the second dose of Pfizer. In a written statement, the doctor of (Name withheld) said: "In her case, possible side effects that could occur after the administration of the new Covid 19 "vaccine" are identified. Clinicians should take into account their differential diagnoses when a patient has rapidly progressing dementia, particularly after a recent vaccination, neurodegenerative diseases such as prion disease (e.g. sporadic creutzfeldt-jakob disease), autoimmune encephalitis, infections, non-epileptic seizures, toxic-metabolic disorders, etc.; Although there is currently no cure for the sporadic creutzfeldt-jakob disease (sCJD), early diagnosis is vital to avoid unnecessary administration of drugs for suspected psychological or neurological disorders; In addition, monitoring of side effects could potentially lead to further understanding of both the new mRNA "vaccine"- for COVID-19 and the etiology of sCJD. Most importantly, recognizing the adverse effects provides individuals with vital important information to make a more informed decision about their health." (Name withheld), in an interview, said that his mother, (Name withheld), knew that the Creutzfeldt-Jakob's disease was associated with Moderna's "vaccine". (Name withheld) made her first dose of Moderna on 16Feb2021 and did not report any complaints. But soon after the second dose on 17Mar, "felt different." Her symptoms began with numbness that spread from the hand where the injection was made to the entire left side of her body; She complained that something was wrong with her. Her brain could not combine her thoughts, understand things, developed diplopia and blindness and began to have hallucinations. The doctors initially thought that (Name withheld) had suffered a stroke due to... Anxiety. The MRIs later showed that there were abnormalities in her cerebellum. Her condition progressed quickly and she was eventually diagnosed with Creutzfeldt-Jakob disease (CJD) and they gave her days of life. She died within months of taking the second dose of Moderna. Her doctors submitted a report to the Vaccine Adverse Event Reporting System of CDC (VAERSID#). But, to date, the CDC have not communicated with the family despite an autopsy that confirmed that her death was caused by CJD-disease that manifested itself after the COVID-19"vaccine". (Name withheld), in an interview, said that his wife, (Name withheld), showed the CJD disease after Pfizer's COVID-19 "vaccine" and died within five months of the second dose. She did her first dose of Pfizer on 29Aug2021 and her second dose on 21Sep2021. Her husband remained unvaccinated, but (Name withheld) had to be vaccinated compulsorily because of her professional employment. Four days after the second dose, (Name withheld) experienced the first episode of a "sudden" strange event that he could not explain." She started to have more episodes and her left hand and side began to tremble. On 13Oct2021, (Name withheld) returned to the doctor, who prescribed Xanax for the... stress. (!!!) The disease progressed rapidly to the point of not being able to sit and walk independently. The scans confirmed that (Name withheld) had significant changes in the right side of her brain. A new medical team did a systematic check on the spine and confirmed that the (Name withheld) had cjd. Until that moment, (Name withheld) could not get out of bed. "Your brain just disappears. It's crazy. You have a completely healthy body and your brain dies within a few months," said (Name withheld) who was informed that his wife will not recover. (Name withheld) died on 21Feb five months after her second dose of Pfizer. According to the latest data of the reference system of the side effects of vaccines (VAERS), as of 14Dec2021, 56 cases of rapid onset of the disease have been reported CJD after COVID-19 "vaccines". As has been shown, in federal reporting system of side effects of vaccines (VAERS) only 1% of all side effects of 'vaccines' are reported. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of death and Creutzfeldt-Jakob disease . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate; Reported Cause(s) of Death: died within three months of taking the second dose of Pfizer.
1599246 2326911 2022-06-22 FL 72.00 Pt presented to hospital with covid hypoxic failure, pnuemonia, cdiff, VRE in urine, and acute renal failure. Pt continued to delcine with treatment and famliy signed withdrawal of care, pt deceased.
1599637 2327303 2022-06-22 71.00 Pt had a positive COVID test on 12/27/21 from; 1/11/22 positive COVID test from Hospital 2/2/22 and 2/22/22 had positive COVID tests from Medical Center; 4/8/22 admitted to Hospital with fever, fatigue, SOB; dx with pneumonia secondary to pneumocystis; given ABX; hypoxic; noninvasive ventilation; DNR; inpatient hospice where pt passed away..
1599283 2326948 2022-06-22 FL 52.00 pt presented with covid and altered mental status, pt had poor prognosis and brother made him comfort measures, pt deceased.
1599603 2327268 2022-06-22 WI 89.00 Came to ER on 5/31/2022 with generalized weakness and shortness of breath. Placed on supplemental oxygen and admitted to medical floor. Tested positive for Covid with home test. Admitted to inpatient hospice on 6/12/2022 and died on 6/14/2022. Primary cause of death: Community-acquired pneumonia. Secondary cause of death cardiac arrest. Tertiary cause of death heart failure with reduced ejection fraction.
1599646 2327312 2022-06-22 81.00 PFIZER COVID #3 VACCINE GIVEN 8/23/21, LOT # FC3184; pt admitted to hospital on 2/7/22 and dx with AHRF secondary to multilobe pneumonia from COVID virus, bacterial infection, PE; Airvos at 90% support; ABX, remdesivir, steroids, heparin drip, Vitamins C, D and zince; multiorgan failure; suffered cardiopulmonary arrest with ACLS protocol followed; passed away in the hospital
1599552 2327217 2022-06-22 MI 58.00 Provider Summary: ""Patient is a 59 year old female with history of COPD, HTN, HLD, CAD, MI, chronic pancreatitis, tobacco use and alcohol abuse presenting with two days of worsening lower extremity swelling and pain as well as head and lumbar back pain after sustaining a fall in her bathtub. Patient admitted to taking 8-500 mg extra-strength tylenol daily with 3-4 ""generic over-the-counter tylenol"" of unknown strength daily with norco daily. She was tachycardic on presentation, otherwise her vitals were stable. She was a cachectic, elderly appearing female with bilateral pitting edema to the knees and some generalized weakness on physical exam. Labs demonstrated a bicytopenia with a hemoglobin of 10.4 and a thrombocytopenia of 69,000. Additionally she had a BNP of 2,447, an elevated venous lactate of 8 (fluid bolus and vancopmycin ordered as patient was meeting sepsis criteria) and a procalcitonin of 16.69. Her D-dimer was elevated to 1,730 (CT chest ordered). She was hypokalemic to 2.2 (K replaced), with elevated AST of 1,927 and ALT of 328 with a total bilirubin of 6.0. Acetaminophen level was 38.8. A hepatitis panel was negative. INR was 6.4. GI was consulted and she was administered NAC for acetaminophen-induced acute hepatitis. She was placed on CIWA protocol and thiamine and folate were ordered. Pancreatic enzyme replacement ordered for pancreatic insufficiency. Fluids for lactic acidosis. Ultrasound of the bilateral lower extremities was negative for DVTs. CT of the chest demonstrated subsegmental pulmonary embolism with right heart strain and bronchitis. She was started on a heparin gtt. Chest x-ray demonstrated no acute cardiopulmonary process. ECG showed sinus tachycardia with low voltage QRS and non-specific T-wave changes in the inferior and anterior leads. Right upper quadrant ultrasound demonstrated possible medical liver disease with abnormal gallbladder findings. Abdominal X-ray showed evidence of chronic pancreatitis without evidence of mechanical obstruction. ECHO demonstrated an EF of ~50%, some mild LVH, mild left ventricular dysfunction, basilar hypokinesis, mild MR, and no evidence of intracardiac thrombus or pericardial effusion. HIDA scan demonstrated a patent cystic duct without cholecystitis. CTA abdomen pelvis demonstrated diffuse wall thickening of the colon and stomach with moderate ascites, small bilateral pleural effusions and anasarca. On 6/3 the patient was admitted to the ICU. She had some frank blood per rectum. Imaging as discussed above. Platelet count decreased and INR worsened. Heparin drip was discontinued and she was administered cryoprecipitate. She was started on Zosyn for potential colitis. Fluids were switched to bicarb gtt. Consideration for transfer to tertiary liver center. Patient was accepted to Facility for transfer pending bed availability. Patient experienced acute respiratory failure and was placed on BiPAP. She was started on Rifaximin and Lactulose. Her INR began to improve. She was having difficulty with urination, urology was consulted and a foley catheter was placed. Patient became increasingly encephalopathic. She was started on diuretics as her pitting edema extended to the thighs. Attempt to transfer patient to Facility was declined as patient was improving and bed was not yet available at Facility. She was taken off of BiPAP. Lactic acidosis improved. She had no additional episodes of blood per rectum. Repeat CT demonstrated stable PE. On 6/5 she was transferred out of the CCU and Zosyn was discontinued. 6/6 Patient admitted to some visual hallucinations but was A&Ox3 (stage II Hepatic Encephalopathy per GI). Lactulose was titrated to meet goal bowel movements. Her INR and LFTs gradually improved. As there was continued improvement in patient's encephalopathy and coagulopathy attempt at transfer was put on hold. Patient continued to be mildly encephalopathic. Patient had poor oral intake and diet was supplemented with Ensure. On 6/10 her hgb was 7.0 but she was asymptomatic without signs of overt bleed. She was started on diuretics. As patient was less encephalopathic voiding trial was attempted per urology recommendations. Patient was able to urinate on her own with some continued retention. Accuracy of bladder scans was compromised by ascites. On the morning of 6/13 patient experienced three episodes of brownish-red emesis, shortness of breath and abdominal pain. Her hemoglobin dropped to 6.8. GI planned for upper GI scope so patient was transfused 1 unit RBCS and 2 units platelets and placed on protonix. Scope revealed esophageal erosion vs shallow ulceration in distal esophagus, a widely patent, non-obstructing and mild Schatzki ring, a medium-sized hiatal hernia, gastric erosions, and duodenitis. H. Pylori stool antigen was negative. Patient also started on albumin challenge as lower extremity edema showed little improvement. On 6/15 bedside ultrasound-guided paracentesis was performed yielding 10 cc of clear straw-colored fluid. Analysis revealed transudate with no growth of organisms on cx. On 6/17 that patient's hgb dropped to 6.8. She was administered a unit of RBCs. During the transfusion she anxious and ox sat dropped to 84 on 2L. NC was titrated up to 3L. On 6/17 the patient tested positive for COVID. Given liver and kidney function patient was not a candidate for Remdesivir or Decadron. Oxygen requires continued to increase. IRN began to worsen. She went into Afib with RVR. She was hypoglycemic and tachycardic to 200. D50 was administered. IV metoprolol administered. Vitals stabilized. Patient had continued complaint of chest pain. CT pulm redemonstrated PE, with moderate worsening pleural effusions, worsening atelectasis/infilitrate lower lobs, complete atelectasis of right middle lobe, with worsening edema within the mediastinum and neck base. Bilateral lower extremity venous ultrasound showed no dvts. Patient was transferred to PCU. On 6/18 patient had additional episode of Afib with RVR. Rate was controlled. On the morning of 6/19 patient was hypoglycemic to 27 and tachycadic. Amp of D50 was administered as well as IV metoprolol and small IV bolus. Vitals stabilized. Patient was more lethargic. By the evening patient had produced almost no urine. Renal ultrasound did not demonstrate hydronephrosis or other acute renal pathology. Patient also had swelling of the right upper extremity. US of the extremity did not show DVT. CT of the head did not demonstrate acute intracranial abnormalities. Her kidney function worsened. Family requested that we attempt to transfer patient to tertiary center again. Patient was accepted to Facility but a bed was not available. Patient decompensated overnight. Her blood pressure dropped. She was not following commands. Her heart rate dropped into the 30's. Patient's family requested comfort care measures, code status updated to DNR/DNI. Patient given fentanyl, ativan and scopolamine patch and placed on BiPAP. Family was at bedside as patient passed away at 3:50AM on 6/21/22."
1598893 2325666 2022-06-21 WI 56.00 Client admitted to Hospital on 5/11/2022 with altered mental status. Client had known metastatic disease to the brain and had just started radiation. Covid positive status could be a creatinine attributing factor to the change in mental status. Lungs reported as clear to auscultation and client in no respiratory distress. Reported died on 5/21/2022 at Hospice - primary cause: metastatic lung cancer; contributing cause: Covid-19 Submitter does not have access to full medical record. For further medical record information, please contact.
1598798 2325568 2022-06-21 MN 45.00 Pt seen in the ED on 6/17 with progressive dyspnea, acute on chronic hypoxic respiratory failure, and was intubated . Tested positive for COVID-19 on 6/17 via PCR. Due to worsening respiratory failure in the new setting of positive COVID test, family decided to extubate and patient passed on 6/17. History of breast cancer diagnosed 2/2021, has had marked decline in her condition since April/Early May 2022.
1598691 2325459 2022-06-21 67.00 12/20/21 pt had a positive COVID test. 12/24/21 pt to Medical Center via EMS with increasing SOB x 3 days; EMS found O2 sats to be between 60 - 70s on RA; 80% on NRB; admitted; also had a positive COVID test; placed on BiPAP; acute renal failure; IV fluids given; AHRF secondary to COVID pneumonia; steroids, ABX; worsening respiratory status; intubated; Baricitinib and Remdesivir given; pt's condition continued to decline; family decided to transition to comfort care; extubated and pt passed away in the hospital
1598682 2325450 2022-06-21 80.00 1/8/22 admitted to hospital for AMS and generalized weakness x 3 days; known exposure to COVID; found to also be positive for COVID; acute on chronic kidney injury; did not meet criteria for remdesivir or steroids; on RA; CT of abdomen showed abscess; given ABX; dehydrated; IV Fluids given; NG tube placed; family decided on comfort care and hospice; 1/25/22 pt dc'd to a home care; this is where the pt expired
1598651 2325419 2022-06-21 NY 88.00 12/10 - transferred from local Hospital with unstable spine fracture for surgery. Tested covid positive at hospital before transfer. SOB at rest. Plan to remain intubated post emergent spine surgery. INR 1.7. Plan to give Kcentra over 20 minutes prior to surgery. 12/11 - extubated but with worsening hypotension and resp distress. Placed on BiPAP. Vasopressors started. Septic shock 12/12 - worsening shock. Temp 103.3, HR 114, RR 25, SpO2 92%. Central line inserted. Started on Levophed. Vancomycin, Cefepime, Flagyl, Vasopressin, Vitamins continued. Started hydrocortisone IV, vitamins, Heparin. Oliguric serum Cr 3.1 12/14 - Dialysis started for Kidney failure. BUN 65/Cr 4.8. - worsening mental status, was stopped and patient intubated. Septic encephalopathy 12/15 - Septic shock causing low platelet-23, D-dimer 6916. Suspecting DIC. CRRT continued. SBO suspected. Prognosis poor due to multi-organ failure. No response to pain/verbal stimuli. Requires 3 pressors to maintain BP-vso, phenylephrine and precedex. 12/16 - Made Palliative by family, extubated. Patient expired @11:36.
1598646 2325414 2022-06-21 NY 89.00 12/5/2021 - In ED via EMS for weakness/fall. Vitals WNL except RR 24, Temp 94.3. Admit for pneumoperitoneum/sepsis.Covid negative on admit and until 12/24. 12/24 - Patient pending discharge to extended care facility in am following neg covid swab. Found now to be Covid positive and asymptomatic. Started Decadron, Lovenox. Not a candidate for Remdesivir due to AKI. Discharge held for 10 days. Vitals WNL 12/28 - Sodium level that has been an issue that resolved has resurfaced - now 148, serum osmality 345. Increased free water plus hydrochlorathiazide. Increased BUN-93- d/c decadron and IV Flagyl. 12/30 - d/c Losinipril per Nephrology consult 1/2/ -covid test negative. Preparing to discharge in am 1/3 - HgB 7.6 and BUN elevated again. GI consulted. 1/5 - received 1U PRBC. Lovenox d/c. started A-fib with controlled rate. Had previous episodes short term. 1/9 - Potassium elevated 6.1 - question etiology- started Kayexalate, D 50 and insulin, calcium gluconate. Later on patient went into cardiac arrest and expired @1616.
1598190 2324181 2022-06-20 MI 95.00 Admission Date: 6/9/2022 PRESENTING PROBLEM: Atrial fibrillation with RVR [I48.91] Acute on chronic respiratory failure with hypoxia [J96.21] Acute on chronic congestive heart failure, unspecified heart failure type [I50.9] COVID-19 virus infection [U07.1] HOSPITAL COURSE: The patient is a 96 yo female with PMH which includes HTN, HLD, DM II, hypothyroidism, osteoporosis, arthritis and chronic back pain, b/l cataracts, recent bouts of community-acquired pneumonia and recently diagnosed (5/4/22) Atrial fibrillation with RVR, started on diltiazem and Eliquis the day prior to presentation. She came in with a chief complaint of worsening back pain and shortness of breath/respiratory distress. Patient was found to have severe sepsis and acute on chronic hypoxic hypercapneic respiratory failure likely secondary to acute COVID 19 infection, A fib with RVR, and concern for acute heart failure (no prior history, but elevated BNP). Patient tachycardic, tachypneic (initially, now some intermittent apnea/bradypnea), worsening confusion/AMS with periods of lethargy/minimal responsiveness, consistent with severe sepsis at the time of admission. Mental status improved, although still some mild intermitt confusion. Continued to require increased respiratory support with HFNC/Non-breather at times with CXR showing worsening effusions and colidations.Patient had some intermittent improvement with IV steroids and lasix. However, CTA thorax was obtained on 6/11 due to concern PE with worsening chest pain, tachycardia, and elevated D-dimer (b/l doppler US negative). CTA showed no evidence of PE, but worsening bilateral pleural effusions, including her chronic complex R pleural effusion with thickening and concern for possible exudative process. Bilateral lower lobe consolidations were significantly worse as well, especially on the left. On 6/12/22, patient asked to stop aggressive cares and transition to hospice. Team spoke with patient's activated DPOA (son) and he was in agreement with patient's desire to become comfort care/hospice. Palliative care was consulted, active treatment was discontinued and comfort meds initiated. Paged by nursing that patient had passed on evening of 6/14. On my evaluation, patient not responsive to verbal stimuli or sternal rub. Pupils fixed and nonreactive. No heart or lung sounds heard after a full minute of auscultation. Peripheral pulses not present. Death pronounced at 7:25pm. Personally notified patient's son and DPOA, of death. All questions answered.
1598179 2324170 2022-06-20 74.00 1/14/22 pt found to be positive for COVID after 1 wk of increasing SOB and cough; Chest x-ray showed bilateral pneumonia; A Fib with RVR; on Vapotherm and steroids; dc'd to rehab facility (Health and Rehab for myopathy/polyneuropathy related to COVID respiratory failure; will need to improve overall functioning to return to home; OT and PT in facility; pt to continue O2 supplementation, albuterol inhaler, Breo Ellipta, Mucinex; found pt unresponsive and with a thready pulse in facility; code blue called; ROSC never achieved; pt expired in the facility
1598184 2324175 2022-06-20 NJ 61.00 I am the epidemiologist reporting on behalf of 61 year-old male patient. This patient experienced a fatal heart attack the same day as receiving the fourth dose of a Pfizer vaccine on 4/22/22, according to state immunization records. He previously received the first dose of the Pfizer vaccine on 4/23/2021, the second dose of the Pfizer vaccine on 5/14/2021, and the third dose of the Pfizer vaccine on 12/3/2021. The patient has previously tested positive for COVID-19 on 1/9/22 and 1/10/22 via PCR. He subsequently had two negative PCR tests on 3/4/2022, 3/29/22 and 4/21/22, according to records. There is no previous infection history documented prior to 2022. According to provider notes, The patient was found down unresponsive and pulseless. On EMS arrival, ACLS was begun and he was found to be in pulseless electrical activity (PEA). He received 40 minutes of advanced cardiovascular life support (ACLS) with 5 rounds of epi, achieved return of spontaneous circulation (ROSC) twice, and was intubated for airway protection, but he lost pulses again prior to arrival. On arrival, CPR in progress with Lucas device, rhythm PEA. Calcium and epi were given. After 2 rounds of CPR ROSC was achieved. Levophed was started as he was hypotensive. Propofol and fentanyl initiated. Femoral central line and left radial arterial line were placed. Patient was last seen eating dinner at 7 PM by facility staff and was noted to be more tired than usual. The HPI, ROS, past medical history, social history and family history documentation element(s) were limited due to the patient being unconscious. Etiology of cardiac arrest is unclear at this time, consider pulmonary embolism (PE) given his malignancy although he was not hypoxic on resuscitation will consider hypoxic in the setting of large pleural effusion and malignant. Patient has a past medical history of Anemia, Cerebral amyloid angiopathy (CODE), CKD (chronic kidney disease), Diabetes mellitus, Diabetes type 2, controlled, Esophageal reflux, History of peptic ulcer disease, Hyperlipidemia, Hypertension, and Metastatic breast cancer (03/07/2019). The cause of death is listed as ?multiorgan failure as a consequence of acute myocardial infarction and metastatic breast cancer? on the death certificate. This patient is also currently being enumerated as a COVID-19 related fatality, based on previous infection history.
1598185 2324176 2022-06-20 TN 81.00 Pfizer vaccine x 2. Tested positive for Covid 01/15/2022. Admitted to Medical Center on 06/17/2022. Expired on 06/18/2022.
1598186 2324177 2022-06-20 MI 81.00 Pt was complaining of chest congestion 2-3 days before admission and wife noted that he was breathing louder and harder. Pt had a PMH of COPD, but was brought to the ER due to a fall at home and it appeared that the patient had suffered an anoxic brain injury. He also had COVID-19 pneumonia.
1598242 2324234 2022-06-20 82.00 1/19/22 pt admitted from a residential facility to a local Medical Center for periumbilical hernia with vomiting and nausea; no surgery needed per consult; pt tolerating oral intake and ready to be dc'd to a residential facility; 1/20/22 pt had a positive COVID test; asymptomatic; dc'd to another Health Care Center where she passed away of cardiac arrhythmia and COVID 19.
1598200 2324191 2022-06-20 TN 70.00 breakthrough COVID-related death
1598263 2324255 2022-06-20 MN 79.00 Dose 1 Moderna received on 2/17/2021 Lot # 02M20A Pt hospitalized and died at on 6/19/2022 from renal carcinoma, failure to thrive and Covid 19 infection
1598286 2324279 2022-06-20 TX 69.00 Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Received Moderna Vaccines on 4/02/2021, 5/1/2021 and 12/22/2021. Presented to ED on 6/7 with SOB. Recently had hip sx and was admitted to outside nursing facility for rehab following hip hardware replacement in Jan. c/b sepsis. EMS arrived on site and found pt tachypnic in 30s - 40s w/O2 sat 70%, placed on BiPAP w/improvement in O2 sat. Previously tested COVID+ in facility and w/UR sxs. During current stay, she was tachypneic, HR 124, temp 95.8�. Creatinine of 1.18, w/anion gap acidosis cont. Lactic acid was 3.4. Troponins 0.13. ProBNP elevated, leukocytosis 12.6. ABG showed a pH of 7.34, pCO2 was 29, bicarb 16. CXR - multifocal PNA. Tx'd w/decadron, vancomycin, zosyn, and remdesivir. Transitioned to comfort care and DNR with no intubation/CPR on 6/11/22. Pt expired on 6/12/22.
1598287 2324280 2022-06-20 TX 60.00 Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Rec'd Pfizer Vaccines 1/23/2021 and 2/13/2021. Presented to ED 6/10 w/SOB x 1 wk. Recently vacationed. On 6/4, he developed URI sx and went to outside ER where he tested negative for COVID, but + for flu. Prescribed tamiflu and doxycycline x 5days. SOB worsened; readmitted to outside ED where he was intubated for resp dist and transferred to facility. In the ED, afebrile w/HR ranging 90s-100s, and hypotensive requiring levo. Req'd Vent settings of 100/20. Labs significant for BSG 325, Cr 4.0 (baseline around 2.5),cont K 5.9, CO2 20, procal 0.09, trop 0.75, BNP 1000, Lactate 2.5, ABG with pH 7.28, pCO2 46. Hgb normal WBC 12.4. COVID+, flu negative. CTA without PE but w/multifocal PNA. Admitted to ICU. During stay, pt experience uncontrolled hyperglycemia which was tx'd multiple times with lokelma,insulin, ca glu, and bicarbonate. Volume overloaded but unable to diurese given his shock and pressor requirements. Cont'd to decompensate with hypotension and hypoxia. Transitioned to DNR/COT status. Tx'd with remdesivir, cefepime, and decadron. Pt expired on 6/14/22.
1597985 2323904 2022-06-18 NJ died of a heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A male patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID 19", start date: 02Dec2020 (unspecified if ongoing), notes: He had been previously diagnosed with COVID 19 on or about 02Dec2020. The patient's concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant) with onset 09Apr2021, outcome "fatal", described as "died of a heart attack". The patient date of death was 09Apr2021. Reported cause of death: "died of a heart attack". Clinical course: The patient received his first COVID 19 vaccine on 06Apr021. He died of a heart attack on 09Apr2021. He had been previously diagnosed with COVID 19 on or about 02Dec2020. He had no symptoms of indicating a heart issue prior to his heart attack. It has been thought by the reporter that it was important to report, in regards to efficacy and side effects of the vaccine. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: died of a heart attack
1597947 2323866 2022-06-18 Caller stated that she knows 2 patients who have died and 2 patients who had stroke.; Caller stated that she knows 2 patients who have died and 2 patients who had stroke.; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown" and all described as "Caller stated that she knows 2 patients who have died and 2 patients who had stroke.". The patient date of death was unknown. Reported cause of death: "Caller stated that she knows 2 patients who have died and 2 patients who had stroke". It was not reported if an autopsy was performed. Reporter who was a nurse for 30 years wanted to know if and when the COMIRNATY-labeled vaccine will be available and stated that she did not want to get the EUA-approved Pfizer COVID-19 vaccines due to liability and that she is not an "experimental rat". Reporter stated that she knows 2 patients who have died and 2 patients who had stroke. Unable to gather more information on patients. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the serious events and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Caller stated that she knows 2 patients who have died and 2 patients who had stroke
1597942 2323861 2022-06-18 MS Cardiac arrest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, This man was boosted, he had all three doses), for Covid-19 immunization; Bnt162b2 (Dose 2, This man was boosted, he had all three doses), for COVID-19 immunization. The following information was reported: CARDIAC ARREST (death, medically significant), outcome "fatal". The patient date of death was unknown. Reported cause of death: "Cardiac arrest". It was not reported if an autopsy was performed. Clinical Course: It was reported that caller just read a case report about an older man who died of cardiac arrest after his Pfizer COVID-19 Vaccines. This man was boosted, he had all three doses. Caller does not have any further information about this man to provide. For his COVID-19 Vaccines are unknown. States this was from a article and the first case reported. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Cardiac arrest
1597856 2323769 2022-06-18 Seizures; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizures) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Seizures) (seriousness criteria death and medically significant). The reported cause of death was Seizures. It is unknown if an autopsy was performed. Concomitant medication was not provided. Reporters dad and cousin died from vaccine. Reporters dad ended with strokes after Pfizer shot, and cousin died from seizures from moderna. Don't even. Reporters dad died days before fathers day last year. Treatment medication information was not provided by the reporter. Company comment: This is a spontaneous case concerning unspecified age and gender, with no medical history reported, who experienced the fatal unexpected serious (medically significant) AESI event of seizure, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. The reported cause of death was Seizures. It is unknown if an autopsy was performed. Date of death is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning unspecified age and gender, with no medical history reported, who experienced the fatal unexpected serious (medically significant) AESI event of seizure, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. The reported cause of death was Seizures. It is unknown if an autopsy was performed. Date of death is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Seizures
1597517 2323110 2022-06-17 78.00 12/7/21 pt to ED with c/o poor oral intake, weakness, dyspnea x 3 days; fell yesterday at home; no LOC; x-rays show no acute injury; admitted; positive test for COVID; COVID pneumonia; AKI; hyperglycemia; super therapeutic INR, borderline hypotension; given O2, Decadron, Baricitinib; not a candidate for Remdesivir; worsening respiratory status; family decided to transition pt to comfort care; pt expired in the hospital
1597437 2323028 2022-06-17 FL 83.00 Hospitalization for shortness of breath and cardiac arrest, positive for COVID on dates 5/15/2022- 5/27/2022. Treated with dexamethasone, methylprednisolone, zinc, and other IV drips in the ICU for organ support.
1597159 2322706 2022-06-17 This spontaneous report received from a consumer via social media (Johnson and Johnson Corporate) from a company representative concerned 4 adult male patients of an unspecified age, race and ethnic origin. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that, on an unspecified date, "4 adult males who died supposedly of Covid/ died of the gain of function flu, but 3 were fully jabbed " and had suspected clinical vaccination failure. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of suspected Covid 19 infection / died of the gain of function flu on an unspecified date, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20220126450, 20220126708, 20220126582 and 20220130063. This report was associated with product quality complaint: 90000211848. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. Upon review, the following information was corrected: case corrected from invalid to valid and narrative updated accordingly, batch no statement updated as per recent update. Sender's Comments: V1- Upon review, the following information was corrected: case corrected from invalid to valid and narrative updated accordingly, batch no statement updated as per recent update. This updated information does not alter the causality of previously reported events. 20220126174-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Suspected Covid 19 infection/ died of the gain of function flu. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20220126174-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Suspected clinical vaccination failure- This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: DIED SUPPOSEDLY OF COVID/DIED OF THE GAIN OF FUNCTION FLU.
1597466 2323058 2022-06-17 MI 75.00 Pt to ED 6/6 by EMS for respiratory distress, arrived to ED on bipap. COVID+ 6/6, maintained on vancomycin and zosyn. 6/8 pt in respiratory failure due to COVID-19 and large pleural effusion, paroxysmal atrial fibrillation, pt is on vent. 6/9 pt remains on the vent; no respiratory difficulties noted. 6/11 pt remains on the vent; no respiratory difficulties noted, labs show worsening renal function. 6/12 pt remains sedated & on vent, tachypneic, Prop & fent gtts infusing per order. Pt with decreased urine output, worsening kidney function, and worsening oxygenation. 6/13 pt unresponsive, kidney started to deteriorate. 6/14 no pulse on doppler, no heart sounds noted, no response to stimuli. Pt deceased 6/14.
1597463 2323055 2022-06-17 71.00 2/7/22 pt to ED via EMS with increasing SOB and cough x 1 wk; O2 sat 70% on RA; placed on 15 L NRB with O2 sat 75%; placed on BiPAP with improvement in O2 sats; CXR showed bilateral pneumonia; positive test for COVID; admitted; given Remdesivir, Decadron, Baricitinib; transferred to ICU; A Fib with RVR - treated; AKI; pt's condition worsened requiring intubation and mechanical ventilation; while being intubated, pt suffered cardiac arrest; ROSC achieved; sputum grew staph haemolyticus, given ABX; pt's condition worsened; pt extubated and placed on BiPAP; family decided to transition pt to DNR with comfort care measures; pt expired in the hospital
1597564 2323159 2022-06-17 88.00 PFIZER COVID VACCINE #3 GIVEN 1/17/22, LOT # 330258D; pt to hosp on 2/5/22 via EMS with SOB, non-productive cough x 2 wks; found to be positive for COVID; O2 supplementation; 2/7/22 dc'd to home; 4/24/22 pt passed away at home with COVID being one of the causes of death
1597641 2323236 2022-06-17 68.00 2/1/22 pt had a positive COVID test; was hospitalized (name of hospital not in record) for COVID; dc'd to Rehab for generalized weakness to receive OT and PT; pt was found without respirations and pulseless in the center
1597647 2323242 2022-06-17 TN 82.00 Arrived to ED on 6/8 with stroke symptoms, aphasia, slurred speech, left hemiparesis. Had had a colonoscopy earlier in the day where anticaogulation was held. CTH/CTA revealed right MCA occulsion. Given tNK and taken for thrombectomy. No improvement post procedure. MRI and CT head showed large evolving infarct with developing cerebral edema. Hyperosmolar therapy inititiated. Fever and hypoxia developed on 6/12. Patient's family COVID + and patient tested and + also. Discussion with family members and desired to proceed with comfort care.
1597577 2323172 2022-06-17 85.00 8/31/21 pt had a positive COVID test from a Family Clinic; 9/10/22 pt admitted to a local Medical Center for complications due to COVID; treated with Remdesivir, Decadron; dc'd on RA; 9/20/22 pt back to hosp with increase in dyspnea and cough x 2-3 days; hypoxic with O2 sats 70% on RA; placed on O2 supplementation; pneumonia; negative COVID test; pt's condition continued to deteriorate; family transitioned pt to comfort care and he passed away in the hospital
1596879 2321949 2022-06-16 TN 87.00 Came to ED on 5/19 with hypoxia, O2 sat 72%. Diagnosed with pneumonia on 5/9 and had taken levaquin. Admitted and placed on broad spectrum anitbiotics. Cardiology consulted due to drop in EF to 15%. Given amiodarone and metoprolol. Had espisodes of confusion. On 5/29 HR, respirations and WBC increased. Restarted antibiotics. 5/30 tested + for COVID 19. Placed on steroids with confusion increasing. Signs of worsening renal failure. Extended family met on 6/7 and decided on comfort care.
1596612 2321481 2022-06-16 MI 74.00 This spontaneous report received from a health care professional by a Regulatory Authority, Vaccine Adverse Event Reporting System (VAERS Inbound Unit) concerned a 74 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: compression fracture of T12 (twelfth thoracic) vertebra, and deep vein thrombosis (DVT) of lower extremity, and concurrent conditions included: X-Ray showed lytic lesion of bone, malignancy breast, anxiety, depression, B12 deficiency, iron deficiency anemia due to chronic blood loss, anemia in stage 4 chronic kidney disease, lambda light chain myeloma, stage 3b chronic kidney disease, chemotherapy induced thrombocytopenia, leukopenia due to antineoplastic chemotherapy, severe protein calorie malnutrition, vitamin D deficiency, antineoplastic chemotherapy induced pancytopenia, refractory anemia with excess of blasts 1, failure to thrive in adult (FTT) and drug allergy (Flomax). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: unknown) dose was not reported, single dose, 1 total administered on 14-JUN-2021 for an unspecified indication. Age at time of vaccination 74 years old. The latency was 303 days. Concomitant medications included colecalciferol, dexamethasone, fludrocortisone acetate, folic acid, lenalidomide, omeprazole, and venlafaxine hydrochloride. On 10-APR-2022, the patient had a COVID-19 PCR (polymerase chain reaction) test which detected Covid-19. On 13-APR-2022, the patient was admitted with Covid-19 pneumonia which quickly progressed to the need for HFNC (high flow nasal cannula) despite treatment with steroid. The patient experienced severe thrombocytopenia and was not safe to add anticoagulation despite platelet transfusion. The patient experienced advanced multiple myeloma (coded as plasma cell myeloma) and was on chemotherapy, condition aggravated and was sars-cov-2 (severe acute respiratory syndrome coronavirus 2) test positive. On 13-APR-2022, the patient had a sudden death and died from hypoxia. It was unknown if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of sudden death, hypoxia, plasma cell myeloma, Covid-19 pneumonia, thrombocytopenia, Covid-19, condition aggravated, sars-cov-2 test positive, chemotherapy and platelet transfusion on 13-APR-2022. This report was serious (Death). This report was associated with a product quality complaint. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related, batch and lot tested and found within specifications based on the product quality complaint evaluation/investigation performed. Additional information received from Complaint Department on 10-JUN-2022. The following information was updated and incorporated into the case narrative: Product quality complaint number and investigation result. Upon review, the following information was corrected: event level medically confirmed corrected to blank from yes. Sender's Comments: V2 Additional information in this version updates of Product quality complaint number and investigation result. Upon review, the following information was corrected: event level medically confirmed corrected to blank from yes. This updated information does not change the prior causality assessment of reported events. Covid-19 vaccine ad26.cov2.s- Sudden death, Covid-19 pneumonia, Covid-19, condition aggravated, sars-cov-2 test positive, Hypoxia, The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. Covid-19 vaccine ad26.cov2.s-Plasma cell myeloma, chemotherapy. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related. (Additionally patient has medical history of light chain Myeloma). Covid-19 vaccine ad26.cov2.s-Thrombocytopenia, platelet transfusion. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.(Also patient has medical history of chemotherapy induced thrombocytopenia); Reported Cause(s) of Death: HYPOXIA.
1596623 2321494 2022-06-16 TX 30.00 passed away; he fell down 3 times but like in slow motion, he fell on the floor with his face down; face was more swollen; face started changing colors, it became burgundy, blue, and kind of red; his legs and arms were going numb; tested twice for COVID and the results came back as positive; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (passed away) and COVID-19 (tested twice for COVID and the results came back as positive) in a 30-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy to antibiotic and Diabetes (Ongoing up until death) since 2021. Concomitant products included INSULIN GLARGINE (LANTUS) for Diabetes. On 21-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In February 2022, the patient experienced COVID-19 (tested twice for COVID and the results came back as positive) (seriousness criterion death) and HYPOAESTHESIA (his legs and arms were going numb). On 21-Feb-2022, the patient experienced SWELLING FACE (face was more swollen) and ERYTHEMA (face started changing colors, it became burgundy, blue, and kind of red). On 25-Feb-2022, the patient experienced FALL (he fell down 3 times but like in slow motion, he fell on the floor with his face down). The patient died on 26-Feb-2022. The cause of death was not reported. An autopsy was not performed. At the time of death, SWELLING FACE (face was more swollen), FALL (he fell down 3 times but like in slow motion, he fell on the floor with his face down), HYPOAESTHESIA (his legs and arms were going numb) and ERYTHEMA (face started changing colors, it became burgundy, blue, and kind of red) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 35-36 35F-36F. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. No treatment drug was provided by reporter. It was reported that for an unknown concomitant medication description was given as Antidepressant. Company Comment: This spontaneous case concerns a 30-year-old male patient, with relevant medical history of Allergy to antibiotic and Diabetes, who experienced the unexpected serious event of Death, the unexpected AESI of COVID-19. The events Swelling Face, Hypoesthesia, and Erythema, occurred approximately 1 day after receiving the first dose of mRNA-1273 Vaccine. The patient suddenly experienced Fall 4 days later that led to an emergency call to paramedics. However, upon evaluation of vital signs, the patient was reported to have suffered a fatal event. The cause of death was not reported. An autopsy was not performed due to the positive SARS-CoV-2 test. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 30-year-old male patient, with relevant medical history of Allergy to antibiotic and Diabetes, who experienced the unexpected serious event of Death, the unexpected AESI of COVID-19. The events Swelling Face, Hypoesthesia, and Erythema, occurred approximately 1 day after receiving the first dose of mRNA-1273 Vaccine. The patient suddenly experienced Fall 4 days later that led to an emergency call to paramedics. However, upon evaluation of vital signs, the patient was reported to have suffered a fatal event. The cause of death was not reported. An autopsy was not performed due to the positive SARS-CoV-2 test. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
1596789 2321693 2022-06-16 three friends die; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. A 39-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "three friends die". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. For the query of the caller, �Can you tell me where I can get Comirnaty vaccine, not the biotech labeled product', it was answered that �my daughter is being forced to take a vaccine they say is Comirnaty but I don't get that because the labeled product is not available'. According to the CDC website that she last looked at this past Friday they specifically state that the Comirnaty would not be available until all EUA products not available. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200835906 same reporter/drug/event for different patients.;US-PFIZER INC-202200835907 same reporter/drug/event for different patients.;; Reported Cause(s) of Death: three friends die
1596795 2321700 2022-06-16 Three friends die; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-healthcare professional) from medical information team. A 39-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: Unknown) for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Three friends die". The patient date of death was unknown. Reported cause of death: "Three friends die". It was not reported if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200835754 same reporter/drug/event for different patients.;US-PFIZER INC-202200835906 same reporter/drug/event for different patients.;; Reported Cause(s) of Death: Three friends die
1596849 2321919 2022-06-16 81.00 MODERNA COVID VACCINE # 3 GIVEN 11/18/21, LOT #027H21B; pt lives at an assisted living facility, 2/14/22 pt had a positive COVID test in the facility; was followed by Home Health and Hospice care; pt is O2 dependent prior to COVID; SOB is worse with exertion, but pt is not compliant with wearing her O2 in the facility; pt was found deceased on 2/28/22 in the facility
1596856 2321926 2022-06-16 70.00 7/31/21 pt had a positive COVID test that resulted in a hospitalization with COVID pneumonia; pt dc'd; 9/14/21 pt presents to ED with AMS; found to be hypoglycemic; interventions performed without improvement in mental status; transferred to ICU; intubated; persistent encephalopathy; palliatively extubated; placed in hospice where pt passed away from respiratory failure
1596794 2321699 2022-06-16 three friends die; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. A 39-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "three friends die". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. It was reported that after assisting caller with her questions, prior to disconnection, the caller states we had "three friends die, 39-year-old, die. Yea." No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200835907 same reporter/drug/event for different patients.;US-PFIZER INC-202200835754 same reporter/drug/event for different patients.;; Reported Cause(s) of Death: three friends die
1596910 2321983 2022-06-16 84.00 4/15/22 pt presented to ED with fever, nausea, generalized weakness, and shaking spells x past 24 hrs; found to have a UTI and positive for COVID; treated with dexamethasone, Vitamins C & D; not a candidate for remdesivir; suffered cardiac arrest twice, 2 minutes each before ROSC was achieved; intubated; family decided to transition to comfort measure; pt expired in the hospital
1596932 2322005 2022-06-16 45.00 pt had a positive COVID test on 10/11/21 at local clinic; 10/20/21 pt to ED with fevers, aches, coughing, fatigue, increasing SOB; COVID pneumonia; Hypoxic Respiratory Failure; given ABX, dexamethasone, O2 supplementation; transferred to CCU; worsening respiratory status; intubated; condition worsened; poor prognosis; DNR; pt passed away in the hospital
1596945 2322018 2022-06-16 71.00 1/27/22 pt entered the hosp for scheduled esophagectomy; metastasis to lymph nodes; 2/2/22 pt found to be positive for COVID; 2/15/22 pt intubated for hypoxic respiratory failure; sputum culture grew Klebsiella pneumoniae; 2/18/22 self extubated; developed COVID ARDS, increase in O2 requirements; intubated and sedated; family decided to transition pt to Comfort Measures with DNR; pt expired in the hospital
1596953 2322026 2022-06-16 66.00 1/11/22 pt saw PCP and was positive for COVID; 1/13/22 worked up in ED, given Decadron, albuterol, ABX and dc'd to home; 1/15/22 pt back to ED for increasing SOB, cough, flu-like sx (x 8 days); CT in ED showed multifocal pneumonia; admitted; O2 supplementation; 1/31/22 pt went into respiratory arrest and was intubated; PEA arrest requiring CPR, ACLS protocol followed; poor prognosis; required a 2nd round of CPR; family transitioned pt to Comfort Care; palliatively extubated and pt expired in the hosp
1596965 2322039 2022-06-16 77.00 2/24/22 pt admitted to hosp from transitional care center (after having a stroke and experiencing deficit) positive for COVID; increasing SOB; suspected aspiration pneumonia; transferred to ICU; required ventilator (x 21 days); given ABX; despite treatments, pt was brain dead; family made pt a DNR, comfort care and pt expired in the hospital
1597079 2322400 2022-06-16 CA 78.00 Patient is a 78 yo male w hx of a fib, cva, htn, and covid-19 mRNA injections. He was weak and could not get up. Per daughter the weakness was generalized and not focal. Pt was admitted for bilateral pna and metabolic encephalopathHe was on high oxygen amount. Pt was treated w iv anbx and breathing rx and iv steroid. He was fully injected with covid-19 mRNA shots. His lungs showed diffuse interstitial pneumonitis. It was also likely due to autoimmune pneumonitis induced by covid-19 mRNA shots. He suddently went into cardiac arrest and expired despite resuscitation.
1596920 2321993 2022-06-16 85.00 PFIZER COVID VACCINATION #3 GIVEN 10/30/21, LOT #F63527; pt presents to ED on 2/7/22 with increasing weakness; found to be positive for COVID; encephalopathy; UTI; pneumonia; pt expired in the hospital; limited medical records sent from the hospital
1596133 2320248 2022-06-15 77.00 Narrative: Patient COVID positive on 8/9/21 (fully vaccinated) admitted for hypoglycemia and tachycardia. Patient began requiring HFNC with suboptimal saturations and ultimately required intubation on 8/13/21. Patient then developed septic shock and passed away on 8/18/21.
1596187 2320343 2022-06-15 74.00 12/28/21 pt to ED with generalized malaise and poor po intake; FTT x 3-4 months; found to be positive for COVID; no respiratory sx; elevated tropins; NSTEMI; no intervention recommended; pt does not want a feeding tube; supplemental shakes; pt had an episode of A Fib; 2 L O2 via NC; small pleural effusion and enlarged heart; pt went into V Fib arrest and passed away in the hospital
1595886 2319924 2022-06-15 This spontaneous pregnancy report received from a consumer via a company representative concerned a neonate of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient's parent received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose and start therapy date were not reported, 1 in total was administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient was exposed to vaccine in utero via transplacental (fetal exposure during pregnancy). It was reported that the pregnancy was discovered one month after vaccination. On an unspecified date, the patient was born with a heart defect (heart disease congenital) and passed away from unknown cause of death at 4 weeks of birth. It was unknown if an autopsy was performed. The reporter suspected it to be an adverse event related to the vaccine. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died from an unknown cause of death, and the outcome of congenital heart defect and fetal exposure during pregnancy was not reported. This report was serious (Death, Congenital Anomaly/Birth Defect, and Other Medically Important Condition). This parent/child case is linked to 20220617426. Sender's Comments: V0: 20220617386 -COVID-19 VACCINE AD26.COV2.S- Death, Congenital heart defect. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220617386 -COVID-19 VACCINE AD26.COV2.S-Fetal exposure during pregnancy. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered not related. Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH.
1596153 2320272 2022-06-15 77.00 Narrative: Admission: fully vaccinated, COVID positive admitted with CAP/COVID pneumonia, passed away during admission. Patient passed away 1/13/22 due to hypoxic respiratory failure reported as secondary to COVID pneumonia.
1596146 2320265 2022-06-15 80.00 Narrative: Vaccine failure as pt died 2/2 COVID-19 pna
1596135 2320250 2022-06-15 75.00 Narrative: Patient COVID positive on 7/12/21 (fully vaccinated) and admitted with hypoxic respiratory failure secondary to COVID pneumonia. Patient was transferred to ICU on 7/15 and intubated on 7/21. Patient passed away on 7/26/21 following PEA arrest d/t COVID ARDs.
1596094 2320179 2022-06-15 77.00 Narrative: 77 yo male died on 6/2/2022 of unknown cause found at home by lawn care company at his residence. Pt had received a covid EUA vaccine (J&J) on 5/25/21. No info in chart regarding circumstances of pt's death. Past Medical History: Perforation of intestine (SCT 56905009) Colostomy bag changed (SCT 183209007) Renal failure (SCT 42399005) Recurrent urinary tract infection (SCT 197927001) Malnutrition (SCT 2492009) Gastroesophageal reflux disease (SCT 235595009) Cluster headache (SCT 193031009) Tobacco use (SCT 110483000) Anemia (SCT 271737000) Seen by palliative care medicine service (SCT 305824005) Postoperative peritonitis (SCT 427883005Pyelonephritis (SCT 45816000) Neck pain (SCT 81680005) Degeneration of cervical intervertebral disc (SCT 69195002) Mild cognitive disorder (SCT 386805003) Colonoscopy in 2003- normal. (ICD-9-CM 799.9) Osteopenia (ICD-9-CM 733.90) ACQUIRED (ICD-9-CM 727.03) Basal Cell Cancer (ICD-9-CM 173.9) Unspecified disorder of adrenal glands (ICD-9-CM 255.9) Headache (ICD-9-CM 784.0) Basal cell carcinoma - primary (ICD-9-CM 173.9) Benign essential hypertension (SCT 12010Hyperlipidemia (SCT 55822004) GERD (ICD-9-CM 530.81) Degeneration of lumbar intervertebral disc (SCT 26538006) Abdominal aortic aneurysm (SCT 233985008Anxiety reaction (SCT 48694002) Panic disorder without agoraphobia with Vitamin B12 deficiency (non anemic) (SCT 64117007) Chronic cluster headache (SCT 230473009)Kidney stone (SCT 95570007) Active problem list reviewed
1596126 2320236 2022-06-15 78.00 Narrative: Patient admitted 10/19/21 to ICU (fully COVID vaccinated, doses on 1/28 and 2/1/21 Pfizer) with positive COVID test on 10/18/21. Patient admitted with sepsis, passed away on 10/19/21 due to sepsis per notes.
1596125 2320235 2022-06-15 93.00 Narrative: Fully COVID vaccinated, positive on admission and passed away due to hypoxic respiratory failure due to COVID
1596116 2320220 2022-06-15 75.00 Narrative: 75yo male died on 5-22-22 at skilled nursing facility. Pt had received a covid J&J vaccine on 6/9/2021. It appears death is not related to this vaccine. Pt with declined dementia.
1595902 2319941 2022-06-15 This spontaneous case was reported by a consumer and describes the occurrence of DEATH NEONATAL (Three babies died in her hospital last week/one was sent to the ICU) in a neonate of an unknown age and gender exposed to mRNA-1273 (Spikevax), while the mother received the product for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. MEDICAL HISTORY (Parent): The mother's past medical history included Maternal exposure during pregnancy. No Medical History information was reported. On an unknown date, the mother received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the neonate was diagnosed with DEATH NEONATAL (Three babies died in her hospital last week/one was sent to the ICU) (seriousness criteria death, hospitalization and medically significant) and FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy). The neonate was diagnosed with DEATH NEONATAL (Three babies died in her hospital last week/one was sent to the ICU) and FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. The neonate died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy) had resolved. No concomitant and treatment information were reported. Company comment: This spontaneous case concerns a neonate with no reported medical history, who experienced unexpected, fatal (hospitalization, medically significant) event of Death neonatal which occurred at an unknown time with regards to the mRNA-1273 vaccination. Fetal exposure during pregnancy was also noted. The caller inquired if mRNA-1273 has trials with pregnant women. The caller also claims that people are dying, and three babies died in the hospital, with two still born and one was brought to the intensive care unit. The cause of death is unknown, and no autopsy report was given. No further information was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-586147 (Patient Link). Reporter did not allow further contact. Sender's Comments: This spontaneous case concerns a neonate with no reported medical history, who experienced unexpected, fatal (hospitalization, medically significant) event of Death neonatal which occurred at an unknown time with regards to the mRNA-1273 vaccination. Fetal exposure during pregnancy was also noted. The caller inquired if mRNA-1273 has trials with pregnant women. The caller also claims that people are dying, and three babies died in the hospital, with two still born and one was brought to the intensive care unit. The cause of death is unknown, and no autopsy report was given. No further information was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reported Cause(s) of Death: Unknown cause of death.
1595892 2319931 2022-06-15 32.00 KILLED; This spontaneous report received from a parent via a social media, via a company representative concerned a 32 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Age at time of vaccination 32 years old. No concomitant medications were reported. On an unspecified date, the patient was killed. The patient died from unknown cause of death. It was unknown if an autopsy was performed. It was reported that, "killed my 32 year old stepson in 5 hours". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220624757 -Covid-19 vaccine ad26.cov2.s-Killed. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
1596203 2320359 2022-06-15 82.00 1/3/22 pt in Medical Center for AMS; tested positive for COVID; hx of falls at home; NRB in hospital; dobhoff tube placed, but pt ripped it out; family decided on comfort feeding with comfort measures and hospice; 1/11/22 admitted to Hospice with dx COVID PNA; on O2 6 L via NC for SOB; pt found by nurse without a pulse or heart beat; expired in Hospice
1596195 2320351 2022-06-15 59.00 PFIZER COVID VACCINE #3 GIVEN 9/8/21, LOT #FF2589; 1/13/22 pt to ED with increasing SOB and cough; states had a positive COVID test 2 days prior to coming to ED; sx have worsened; positive COVID test in ED; pt diaphoretic and c/o epigastric pain without radiation; found to have moderate to large pericardial effusion; during hospitalization, pt experienced cardiac arrest - repeat episodes; intubated; transferred to MICU; given IV ABX and IV pressors; family then made pt a DNR, comfort care; pt extubated and he passed away in the hospital
1596157 2320313 2022-06-15 81.00 Narrative: Vaccinated, not boosted patient admitted for COVID and bacterial PNA. Required ICU care and transitioned to palliative care. Ultimately Deceased
1596207 2320363 2022-06-15 TN 81.00 1/6/22 COVID test positive; ordered by Medical Center; no medical records on this patient; pt per Death Certificate died at Hospice on 1/11/22
1596359 2320517 2022-06-15 91.00 PFIZER COVID VACCINE #3 GIVEN 11/18/22, LOT #32030BD; 1/12/22 pt had a positive COVID test ordered. 1/16/22 pt had a second positive COVID test at Medical Center, dc'd from hospital to another Hospital on 1/19/22; COVID PNA for dyspnea; pt passed away in the hospice facility on 1/23/22
1596240 2320397 2022-06-15 81.00 PFIZER VACCINE #3 GIVEN 8/19/21, LOT #FC3183; 1/10/22 pt to ED with increasing SOB, generalized fatigue, nasal congestion, productive cough, diarrhea; states was diagnosed with COVID 1 wk prior to ED; COVID test positive in ED as well; O2 sats on 2 L via NC were 69% in ED; placed on NRB with improvement; transferred to ICU; AHRF secondary to COVID pneumonia; given IV Solu-Medrol, baricitinib, ASA, Lovenox, remdesivir; respiratory status continued to worsen requiring intubation with mechanical ventilation; pt continued to decline; pt became unresponsive, asystole; expired at the hospital
1596488 2320652 2022-06-15 TN 64.00 Patient death from COVID S/p COVID vaccine
1596479 2320643 2022-06-15 83.00 pt lives in a living facility; 12/23/21 pt tested positive in facility for COVID; occasional cough, diarrhea; pt continued to decline and passed away in the facility
1596452 2320616 2022-06-15 68.00 9/6/21 pt to hosp; found to be positive for COVID; COVID pneumonia; dexamethasone; remdesivir; O2 demand increased; pt transferred to ICU; required intubation and mechanical ventilation; 9/20/21 able to be extubated, but the next day worsened and required intubation; experienced a brief cardiac arrest and then multiorgan failure; family chose to withdraw care; extubated and pt passed away in the hospital
1596393 2320554 2022-06-15 70.00 12/12/21 pt had a positive COVID test in Health and Rehab Center; cough; not SOB initially; breathing became labored with O2 sat of 88% on RA; placed on 2L O2 via NC; sent to ED then returned back to facility on the same day; family desired to transition pt to palliative care; over time, pt began to not eat, drink, or take meds; zinc and dexamethasone ordered for pt, but unable to swallow meds; pt continued to decline and passed away in the facility.
1596404 2320565 2022-06-15 75.00 1/17/22 pt to ED for worsening SOB; found to be positive for COVID; supplemental O2 given; admitted; eventually required BiPAP; family decided on hospice care for pt; pt had inhospital hospice; he passed away in the hospital
1596354 2320511 2022-06-15 WI 93.00 Patient presented to the medical center on 6/8/2022 complaining of change in mental status, hematuria and SOB. Patient was a memory care resident who was initially brought to the ED on 06/07 due to hematuria. Patient had indwelling Foley catheter due to urinary retention. Foley catheter was exchanged and he was sent back to the memory care facility. Patient was brought back to ER again with recurrent hematuria and change in mental status. His vitals were stable. He was slightly tachypneic. Chest x-ray was suggestive of worsening congestive heart failure with increasing edema as well as increasing bilateral infiltrates suggestive of bilateral pneumonia. He was COVID positive. ED physician discussed patient with cardiologist, considering hematuria no anticoagulation/antiplatelets, continue beta-blockers. Hospitalist team was called to admit patient for further management. Patient with Bilateral COVID-19 pneumonia. This likely triggered his change in mental status and pulmonary congestion. Remdesivir not started as noted CKD with creatinine clearance less than 30. Supportive care was provided. Suspected UTI due to indwelling Foley catheter with gross hematuria. Foley catheter was exchanged on 06/07 on the initial ED visit. Persistent hematuria. Patient had CBI started in the ED with some improvement. When CBI was stopped in the ED hematuria recurred. Patient was started on vancomycin cefepime. NSTEMI. Known CAD. Likely triggered by acute infectious process as discussed above. Metoprolol was started in the ED. No anticoagulation or antiplatelets agents due to gross hematuria. Patient was admitted to floor. Physician was called to patient room due to patient being found unresponsive. Patient died 6/9/2022 at 19:55
1596340 2320497 2022-06-15 KY 95.00 Tested positive and was hospitalized with COVID pneumonia
1596287 2320444 2022-06-15 81.00 PFIZER COVID VACCINE #3 GIVEN 11/10/22, LOT # FF2593; 1/29/22 pt brought to ED via EMS after a fall at home; x-rays with no acute findings; positive for COVID; congested, hoarse, febrile; DNR/DNI; retroperitoneal hematoma; 1/31/22 pt had increased O2 demand and placed on O2 supplementation; weaned to RA on 2/2/22; given dexamethasone, remdesivir, ABX; 2/7/22 pt had low BP and elevated BG; minimally responsive; O2 sats dropped requiring 9 L O2 via NC; soon able to wean to 2 L O2; transferred to ICU; transient improvement with BP; family wanted to transition pt to comfort care; pt expired in the hospital
1596257 2320414 2022-06-15 78.00 12/13/22 pt brought to ED with c/o not feeling well last few days, decrease in appetite; bilateral LE edema; found to be in worsening renal failure; 12/21/22 pt had a positive COVID test; acute on chronic hypoxic respiratory failure secondary to COVID 19; diastolic heart failure; pulmonary edema; pleural effusion; on Vapotherm; thoracentesis bilaterally; poor prognosis; DNR; pt's condition worsened; increase in hypoxia; transitioned to comfort care and pt expired in the hospital
1596246 2320403 2022-06-15 76.00 12/28/2022 pt brought to ED with hematuria after home health nurse changed suprapubic catheter; came from assisted living facility; in ED, pt was febrile, hypertensive, tachycardia and tachypnea; had a positive COVID test; admitted with sepsis and COVID; blood cultures positive for Klebsiella; antibiotic given; volume resuscitation; DNR; pt continued to decline with increasing tachycardia and tachypnea; transitioned to comfort care and he expired in the hospital
1595664 2319086 2022-06-14 NC 51.00 Patient commited suicide 05/18/22 (self inflicted gunshot wound). Family all had COVID19 Oct 2021, and patient never recovered from fatigue and lack of motivation. Wife thinks his symptoms (fatigue) got worse after Pfizer-BioNTech COVID-19 Vaccine 03/30/2022 & 04/22/2022. Wife says his underlying restless leg syndrome got worse with more sleep disturbance. Seen in PCP office 4/25/22 with overwhelming sense of fatigue. Little motivation to do anything. Said everything in his life "feels like a chore". Actively treated long-term for depression, followed by psychiatrist. Actively treated long-term for restless leg syndrome, requiring low dose Methadone with better success than any other RLS medicine, Rx by neuro.
1594892 2318138 2022-06-14 DIED; This spontaneous report received from a consumer via social media via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose not reported, 01 total administered on an unspecified date for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patients died. The patients died from unknown cause of death. It was unknown if an autopsy was performed. It was reported that, "I know too many people that died after those covid shots". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0- 20220612688-covid-19 vaccine ad26.cov2.s- Died. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
1594907 2318158 2022-06-14 VA 78.00 Got a brain bleed; started falling multiple times a day,Started falling, patient fell; In the brain, he was having little/mini ischemic strokes (Dysarthria, Balance disorder, Gait disturbance and Cognitive disorder); This spontaneous case was reported by a consumer and describes the occurrence of ISCHAEMIC STROKE (In the brain, he was having little/mini ischemic strokes (Dysarthria, Balance disorder, Gait disturbance and Cognitive disorder)), CEREBRAL HAEMORRHAGE (Got a brain bleed) and FALL (started falling multiple times a day,Started falling, patient fell) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 011A21A) for COVID-19 prophylaxis. The patient's past medical history included Short-term memory loss (Short term memory problems even before the 1st dose for about 2 years.). Concurrent medical conditions included Seasonal allergy. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ISCHAEMIC STROKE (In the brain, he was having little/mini ischemic strokes (Dysarthria, Balance disorder, Gait disturbance and Cognitive disorder)) (seriousness criteria death and medically significant), CEREBRAL HAEMORRHAGE (Got a brain bleed) (seriousness criteria death, hospitalization and medically significant) and FALL (started falling multiple times a day,Started falling, patient fell) (seriousness criterion death). The patient was hospitalized for 3 days due to CEREBRAL HAEMORRHAGE. The patient died on 24-Sep-2021. The reported cause of death was Ischemic stroke, Hemorrhage brain, Slurred speech, Balance difficulty, Gait disturbance, Falling and Cognitive disturbance. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Aug-2021, Magnetic resonance imaging: little/mini ischemic strokes in the brain Little/Mini ischemic strokes in the brain (Lungs were clear, carotid arteries were clear, but, in the brain, he was having "little/mini ischemic strokes). No Concomitant Medication provided. The patients slurred speech worsened within 4 to 5 hours, started having balance and gait issues and was leaning to the right and his balance was off and from that day forward, he started falling multiple times a day. The doctors did MRI to see if he was clotting, lungs were clear, carotid arteries were clear but, in the brain, he was having "little/mini ischemic strokes". Patient started having balance issues, he started falling and there was decline in cognitive function, decline in slurred speech, decline in balance. Eventually the patient fell and got a brain bleed and was hospitalized for the brain bleed as he was in ICU for 3 days and then was discharged to skilled nursing facility. Patient had treated with memory medication. Company Comment: This is a Spontaneous case concerning a 79-year-old male patient, with relevant medical history of short-term memory loss, who experienced the unexpected, fatal AESIs of Cerebral haemorrhage (also seriousness criteria of hospitalization) and Ischaemic stroke, and the unexpected and fatal event of Fall. Within 4 to 5 hours after the second dose of mRNA-1273 vaccine, the patient's slurred speech worsened, he started having balance and gait issues and was leaning to the right. His balance was off and from that day forward, he started falling multiple times a day. MRI was performed and showed that lungs were clear, carotid arteries were clear but, in the brain, he was having "little/mini ischemic strokes". Once started having balance issues, he started falling and there was decline in cognitive function, decline in slurred speech, decline in balance. Eventually the patient fell and got a brain bleed and was hospitalized as he was in ICU for 3 days and then was discharged to skilled nursing facility. Patient�s death occurred approximately 5 months and 2 weeks after the second dose of mRNA-1273 vaccine. The reported cause of death was ischemic stroke, hemorrhage brain and falling. It is unknown if an autopsy was performed. Patient�s elderly age, as well as relevant medical history of short-term memory loss, could be confounders for Ischaemic stroke, which could be a contributory factor for patient�s fall and consequent cerebral haemorrhage. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-585136 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 79-year-old male patient, with relevant medical history of short-term memory loss, who experienced the unexpected, fatal AESIs of Cerebral haemorrhage (also seriousness criteria of hospitalization) and Ischaemic stroke, and the unexpected and fatal event of Fall. Within 4 to 5 hours after the second dose of mRNA-1273 vaccine, the patient's slurred speech worsened, he started having balance and gait issues and was leaning to the right. His balance was off and from that day forward, he started falling multiple times a day. MRI was performed and showed that lungs were clear, carotid arteries were clear but, in the brain, he was having "little/mini ischemic strokes". Once started having balance issues, he started falling and there was decline in cognitive function, decline in slurred speech, decline in balance. Eventually the patient fell and got a brain bleed and was hospitalized as he was in ICU for 3 days and then was discharged to skilled nursing facility. Patient�s death occurred approximately 5 months and 2 weeks after the second dose of mRNA-1273 vaccine. The reported cause of death was ischemic stroke, hemorrhage brain and falling. It is unknown if an autopsy was performed. Patient�s elderly age, as well as relevant medical history of short-term memory loss, could be confounders for Ischaemic stroke, which could be a contributory factor for patient�s fall and consequent cerebral haemorrhage. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Ischemic stroke; Hemorrhage brain; Slurred speech; Balance difficulty; Gait disturbance; Falling; Cognitive disturbance
1595624 2319044 2022-06-14 NC 74.00 This patient reportedly received his COVID vaccination at the hospital on 6/2/2021. The following morning, he was found lying on the bathroom floor. His brother checked on him throughout the day, and the following day (6/4/2021) he was found in the same place but unresponsive. An autopsy examination was performed, and the cause of death was determined to be hypertensive and atherosclerotic cardiovascular disease. No definitive direct link could be made between the vaccine and death during the autopsy examination, but it was decided to report the death. I have no further details of the vaccination.
1595628 2319049 2022-06-14 FL 91.00 Presented to hospital with altered mental status. pt was asymptomatic for Covid. Pt treated for pulmonary edema from CHF. Diuretics given. Pt failed to repsond to diuretics and was put on hospice. Pt deceased on 6/11.
1595684 2319106 2022-06-14 FL 67.00 Pt presented with respiratory failure and sepsis reltated to covid pneumonia, he developed a saddle PE and DVTs. Pt was moved to hospice and expired. CT showed hepatic lesions suggesting metastatic disease.
1595677 2319099 2022-06-14 63.00 01/30/2022 pt diagnosed positive for COVID as outpatient; 2/8/22 pt brought to ED via EMS with worsening dyspnea; fever and increasing cough; intubated and on mechanical ventilation in ED for worsening dyspnea; positive COVID test; in A Fib; given ABX, dexamethasone; OG tube in place; coded in ED where pt passed away
1595687 2319109 2022-06-14 81.00 Pfizer COVID vaccine #3 given 9/29/21, lot # FC3182; 1/29/22 pt brought to ED via EMS with cough, wheezing, increasing SOB; sx started 2 days prior; O2 supplementation; dexamethasone, baricitinib; ICU; eventually required ventilator support; pneumonia; Pseudomonas pneumonia enterococcal infection; hypertensive; family requested palliative extubation; extubated on 2/21/22 and she passed away on 2/24/22 in the hospital
1595709 2319132 2022-06-14 82.00 1/15/22 Pt tested positive for COVID at SNF; pt brought to ED via EMS with c/o increasing dyspnea over past 12-24 hrs; in A Fib with RVR, treated with improvement in HR; on BiPAP; given decadron, remdesivir, Baricitinib; DNR; hematochezia with worsening anemia; PRBCs transfused; pt found to be minimally responsive on 1/18/22; RRT initiated; respirations slowed, heart bradycardic which led to asystole; pt expired in the hospital
1595722 2319314 2022-06-14 87.00 10/27/21 pt had a positive COVID test in HCF; 11/4/21 to ED with worsening SOB; dx with AHRF secondary to acute COVID pneumonia; given Decadron, ABX, O2 supplementation; DNR/DNI; pt passed away on 11/23/21
1594733 2317423 2022-06-13 VT 45.00 Decedent was reportedly feeling unwell with respiratory complaints for several days to week prior to death, progressively became more ?wiped out? and tired, staying in bed most of the time. She was found unresponsive in the bathroom where she was pronounced dead by EMS. Autopsy confirmed bilateral pulmonary thromboemboli as cause of death, with multiple risk factors including obesity (BMI 46.9), recently sedentary, COVID-19 and Influenza vaccinations, and Desogestrel/ethinyl estradiol
1594717 2317407 2022-06-13 MN 85.00 He presented to the ED on 06/08/22 after a syncopal episode at home, likely due to dehydration and diarrhea. He was found to be COVID-19 positive.
1594714 2317404 2022-06-13 NY 70.00 The following behaviors started in early April 2021, about two weeks after patient's second Covid-19 shot and increased in severity until her death they are not all in order. Understand that patient was extremely modest and meticulous prior to this condition. Used her cell phone less, did not return calls, still carries on a conversation. Throw items away or putting them in odd places. Could not remember how to turn on the car's windshield wipers, called me at home, could not fasten seatbelt, can no longer figure out how to drive, keys taken away. Becomes offended quickly, dressing a nightmare. Walks with rollers in her hair, no make-up, dresses inappropriately for occasions. Displayed odd behavior in restaurants (ordering too much food, starting to eat napkin or drink salad dressing, going to other people's tables, talking loudly, swirling bread in butter dish). Unable to open door locks. Let dog out of daughter's house while holding granddaughter and yelling, I've got him. Often had faraway look, could not use her credit card or calculate tips, wore chipped fingernail/toe polish, hair in disarray, said, I think I have a condition. Asks same question repeatedly. Takes 45 minutes to get a pair of mismatched shoes on, often on the wrong feet. Unable to tie shoes. Becomes manic with clothing, often manipulating the same item in her hands for up to 30 minutes. Puts several pairs of panties on, over her pants sometimes. Could not get her bra on, tried to put bra on her feet arguing that it was socks. Could not get blouses/pants on; pulls blouses on like a skirt. Unable to put pierced earrings on. Would not wear pajamas or change, wears same clothes to bed. Tears bed clothes off bed. Not accountable for wallet, keys, credit cards, handbag, and phone. Unable to remember alarm code and panicked Obsessed with the color purple, purchased odd merchandise, especially at holiday time. Unable to cook or operate oven/microwave. Put a frozen piece of pizza on a paper plate, then on a wicker plate holder, and put entire assembly in heated oven. Went to make fruit drink, stopped to clean floor with Clorox wipe, then squeezed it into the drink. Cleans shoes with sponge, then uses it to wash dishes. Lacks ability to reason, becoming extremely sensitive to sound, touch, and quick movement. Cannot find light switches, panics in dark rooms, starts grabbing/knocking over things. Hangs on to towels and tears pictures from the wall. At nail salon, put feet in soaking tub with shoes on, became upset when told not to do so. At hair salon, forgot wallet and could not pay, became very upset. Started seeing people in the house that weren't there or playing peekaboo with her granddaughter who was not present. Asked characters on TV if they wanted me to make breakfast for them. Difficulty speaking in sentences, cannot finish thoughts. When verbally profane, could often speak in full sentences. Showered with clothes on, refuses to bathe anymore; Hospice got her to bathe twice, then never again, just sponge baths. Incontinence started small and grew worse, she would urinate on the floors/rugs, sit on the toilet seat with the lid down and urinate, Depends helped. She would throw used toilet paper on the floor, in the sink, tub, and hamper, wiped herself with a towel and put it in the bowl. Put a full roll of toilet paper in the toilet. Started stuffing odd things down the bathroom sink drain. Often walked out of the bathroom with toilet paper still between her legs and trailing the entire roll behind her. She stopped brushing her teeth. Can no longer write. Once a prodigious reader she no longer reads. December 2021 (+/-): Thinner, stringy hair unkempt. Will not leave house. Walks around naked, argues she has beige pants on. Talked about past often, laughed often when speaking to visitors. Slept for extended periods of time, not eating or drinking for the entire day. Sat on couch for extended periods of time, crossing and uncrossing legs, manipulating a blanket for hours. Will attempt to twist off a non-existent bottle cap for long periods of time. Would say something, and when responding in an attempt to clarify what she wanted, she would deny saying it. Would answer 'yes' to most questions, would not ask for anything, did not talk about grandchildren, asked constantly about her dog and its location (she did not have a dog). Watched TV shows she never would have watched, and baby/puppy videos for hours on end. Smiled when grandchildren visited but did not address them by name. Sang all TV commercials and started reacting to people on TV. Became extremely empathetic, but moods changed rapidly, became verbally aggressive and profane. Resistant to taking medications. Started arguing with TV show characters, then mood would suddenly change and she would be pleasant. Polite with strangers/visitors, very oppositional, uncooperative and profane with caregivers (husband and sister). Eventually, family members witnessed mood swings and they became targets of profanity. Would repeat same thought for hours sometimes. Hearing remained excellent throughout. February 2022 on: Most of the above, plus, no longer walked around, very profane when in a mood, pleasant when not. Hands starting to shake and balance becoming unstable. Feed her and hydrate her as much as she allowed us, weight loss extreme. No longer walking. Last month of her life would not eat, last three weeks would not drink. Breathing started to change, responded less, slept more.
1594574 2317257 2022-06-13 WI 58.00 Patient is a 58 y.o. male with PMH follicular lymphoma s/p bendamustine/obinutuzumab, hypogammaglobulinemia s/p IVIG, hx of COVID-19 PNA (2/1/22) with subsequent cryptogenic organizing pneumonia (per 4/2022 surgical lung biopsy) who presents on 6/1/22 from Pulmonary Clinic with hypoxia, tachycardia, and chills. Patient initially diagnosed with follicular lymphoma on 1/19/2021 and has been following with outpatient Hematology. He was hospitalized 3/4/2022-3/12/2022 for COVID-19 pneumonia and has had a difficult course since then. He was again hospitalized from 3/19/2022-3/27/2022 for persistent fevers felt to be related to COVID-19 and given his immunosuppressed status there is a possibly he is unable to clear the infection. He was hospitalized again from 4/4/22-4/18/22 for acute hypoxic respiratory failure and is s/p bronch+BAL with extensive infectious workup which was unrevealing except for persistently positive COVID antigen. Open lung biopsy on 4/12/2022 showed organizing for which the patient was started on steroids. He was hospitalized again from 4/30/22-5/3/22 for recurrent fevers with negative infectious workup was discharged on prednisone and Bactrim prophylaxis. He was hospitalized again from 5/13/22-5/15/22 when a single blood culture was positive for GPC (felt to be contaminant) and repeat blood cultures were negative. Bactrim prophylaxis was changed to atovaquone for PJP prophylaxis. The patient presents to pulmonary clinic follow-up today and was noted to be hypoxic, tachycardic, and experiencing chills. Upon my evaluation the patient tells me he had a fever 102� F 2 days ago. He continues to have intermittent chills throughout the day in addition to cold sweats. Other symptoms include shortness of breath with activity and bilateral knee pain that started several days ago. Early this morning he did have some chest pain which felt like dull ache under his left rib cage that lasted about 30 minutes. Denies palpitations, dyspnea at rest, nausea, vomiting, hematemesis, cough, hemoptysis, abdominal pain, dysuria, hematuria, constipation, diarrhea, melena hematochezia.
1594474 2317155 2022-06-13 TN 82.00 Fully vaccinated with Moderna x 3. Tested positive for Covid 19 on 05/11/2022. Admitted to Medical Center 05/14/2022-05/24/2022. Expired on 06/11/2022.
1594240 2316748 2022-06-12 MI 61.00 Pt was admitted on 12/12 after presenting to the ECC after a witnessed cardiac arrest. The patient lived in an group home and was noted to stand up from the dinner table and suddenly collapsed. CPR was started by staff. Arrival of EMS noted a PEA arrest. Two rounds of CPR and 2 mg of epi were administered prior to ROSC. Upon arrival to the ECC, he was noted to have minimal neurologic response with no gag reflex, no corneal reflex, and pupils fixed and dilated. He also had a witnessed seizure of 15-30 seconds in the ECC and received Ativan with termination of the seizure activity. CT of the head was performed which resulted as negative. Lab work showed no leukocytosis, hemoglobin 12.5, platelets normal, potassium 3.3, creatinine 1.4, troponin negative, lactic acid 6.3, negative procalcitonin, UA negative, urine tox screen negative, COVID-19 positive. Cardiology was consulted. Patient was admitted to the ICU. 12/13-12/14 patient remained intubated and sedated on propofol. Receiving Jevity 30. Noted to have myoclonic jerks and intermittent episodes of severe hacking and coughing. Neurology consulted. EEG reported to be severely abnormal consistent with post-anoxic mild clonus status epilepticus after cardiac arrest/severe diffuse anoxic ischemic brain injury and with an extremely poor prognosis for survival. 12/16: Remained intubated, off infusions, unresponsive, myoclonic jerks and seizure-like activity was noted. Episodes of emesis. 12/17: Patient was extubated to BiPAP. Remained unresponsive. GCS 3. Continued myoclonic jerks. Neurology resumed home medications of Klonopin. Depakote added. 12/18: Early a.m., patient was noted to have episodes of desaturation of 83-87% on 6 L O2. He was transitioned back to BiPAP. Patient remained in significant distress in spite of multiple doses of morphine. Patient was continued on BiPAP/Ativan/morphine for comfort. The evening of 12/18, patient was found to have marginal blood pressures. He continued on BiPAP with high settings. Guardian was contacted again-requested no escalation of care. 12/19: Patient remained on supportive care . He developed significant bradycardia with decreasing SpO2. Clergy was called in for bedside prayer. The patient developed asystole with no breath sounds or respirations noted at 0220 hr with a five-minute confirmation. Discharge Diagnoses: PEA cardiac arrest, acute hypoxic respiratory failure, anoxic brain injury, COVID-19 pneumonia, AKI, death.
1594111 2316608 2022-06-11 FL 100.00 within 24 hours of this vaccine, the patient had a stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). An 101-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 2, single (Lot number: EL9267) at the age of 100 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. There were no known allergies. No covid prior vaccination. Vaccination history included: BNT162b2 (Prev dose lot number: EL9269, Prev dose administration date: 25Feb2021, Prev dose dose number 1, Prev dose vaccine location: Left arm), administration date: 25Feb2021, when the patient was 100-year-old, for Covid-19 Immunization. No other vaccine was taken in four weeks. The following information was reported: CEREBROVASCULAR ACCIDENT (death, disability, medically significant) with onset 19Mar2021, outcome "fatal", described as "within 24 hours of this vaccine, the patient had a stroke". Therapeutic measures were not taken as a result of cerebrovascular accident. No covid tested post vaccination. The patient date of death was 22Mar2021. Reported cause of death: "within 24 hours of this vaccine, the patient had a stroke". It was not reported if an autopsy was performed. The patient was not tested covid post vaccination.; Reported Cause(s) of Death: within 24 hours of this vaccine, the patient had a stroke
1593530 2315510 2022-06-10 71.00 Pt had a positive COVID test on 1/31/22 and was treated with ABX; did not receive monoclonal antibodies; 2/7/22 EMS brought pt to ED with increasing SOB over past 3 hrs; NRB placed with improvement in O2 sats; pt coded in the ED; intubated and placed on ventilator; family requested removing support and pt passed away in the ED
1593053 2314898 2022-06-10 DEATH; This spontaneous report received from a consumer via a company representative via media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry date: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death. It was unknown whether the autopsy was performed. Reporter stated that "I know a lot of people suffering after having your jab, one is dead". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220562523.; Sender's Comments: V0:20220601898-covid-19 vaccine ad26.cov2.s-Death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
1593308 2315184 2022-06-10 FL 63.00 mild side effects ( after both doses); died of a pulmonary embolism/shower of tiny blood clots" in her lungs; she hurt her knee exercising.; She had torn her minescous.; shortness of breath/trouble catching my breath/looked like she stopped breathing; she felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (died of a pulmonary embolism/shower of tiny blood clots" in her lungs) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient never a smoker and did not had any unhealthy habits.Since Covid started in March 2020, she never got sick once. Never a cold or sniffles. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced FATIGUE (she felt tired). In September 2021, the patient experienced DYSPNOEA (shortness of breath/trouble catching my breath/looked like she stopped breathing). In October 2021, the patient experienced JOINT INJURY (she hurt her knee exercising.) and MENISCUS INJURY (She had torn her minescous.). On 26-Apr-2022, the patient experienced PULMONARY EMBOLISM (died of a pulmonary embolism/shower of tiny blood clots" in her lungs) (seriousness criteria death and medically significant). On an unknown date, the patient experienced IMMUNISATION REACTION (mild side effects ( after both doses)). The patient died on 26-Apr-2022. The reported cause of death was Pulmonary embolism. An autopsy was performed. At the time of death, IMMUNISATION REACTION (mild side effects ( after both doses)), DYSPNOEA (shortness of breath/trouble catching my breath/looked like she stopped breathing), JOINT INJURY (she hurt her knee exercising.), MENISCUS INJURY (She had torn her minescous.) and FATIGUE (she felt tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2021, Pulmonary function test: normal (normal) Normal. On 26-Apr-2021, Heart rate: never got a pulse (abnormal) never got a pulse. On 26-Apr-2021, Oxygen saturation: no reading showed (abnormal) no reading showed. On an unknown date, Blood iron: low (Low) Low iron. On an unknown date, Blood test: normal (normal) Normal. On an unknown date, Chest X-ray: normal (normal) Normal. On an unknown date, Electrocardiogram: normal (normal) normal. No concomitant product was provided. The patient was in medical field as a certified registered nurse anesthetist. She experienced mild side effects post shot. In Sep 2021she and her husband went to state. She complained of shortness of breath the first day out there, but that was it. She felt fine the rest of the trip. In Oct 2021, she hurt her knee exercising. She had torn her meniscus. The tear was so small, the orthopedic doctor said surgery was not required. He suggested her to take 12 weeks off. She rested her knee for 12 weeks to let it heal. On 05 Apr 2021 she told her daughter that she was experiencing shortness of breath when going up the stairs. She went to a pulmonologist. The blood work she had gotten done was to test to see if she was genetically predisposed to any clotting disorders. All of those came back negative. On Monday 25 April 2021 pulmonary functions test done. That night she told she felt tired, but that was normal for her after a work day. On April 26, at 7:58 am ambulance called as she had trouble breathing. She reached hospital around 8:30 am. In emergency room it was told that she passed. She had trouble catching breath. Her heart and lungs sounded fine. The pulse oximeter and no reading, she was still talking and suddenly stopped talking and then shortly thereafter, looked like she stopped breathing. Her husband started doing CPR. At one point while he was doing CPR on her, her eyes popped back open and she started to lift her head up, but then it fell back to the floor and her eyes closed again. The medics in the ambulance never got a pulse on her and the ER doctor never got a pulse on her in the hospital. The autopsy was done. The medical examiner found a shower of tiny blood clots in her lungs and told her she died of a pulmonary embolism. Medical examiner thought that a big clot formed in her sleep Monday night. The reporter believed that the vaccine made her and sedentary. Patient died on 26 Apr 2022 around 8:30 am. Company Comment This spontaneous case concerns a 63-year-old female patient with relevant medical history of knee injury and prolonged rest, who experienced the unexpected serious(death) AESI of Pulmonary embolism, 1-year 3months after receiving the 2nd dose of mRNA-1273 vaccine. Immediately after the shot, the patient had experienced mild symptoms (unspecified). Seven months later she had brief episode of shortness of breath. A month later she suffered knee injury with a small meniscal tear. An orthopaedician saw her, ruled out the need for surgery and advised rest for 12 weeks. The patient rested her knee for the said period and by the end, developed shortness of breath while climbing stairs. She consulted a pulmonologist and was screened for any genetic predisposition for clotting disorders � they all were negative. Pulmonary function test was done which turned out to be normal. The same night she complained of tiredness, but later resolved. The next day she was found unconscious, CPR was attempted at home but by the time the ambulance and medics arrived, she did not have any pulse or O2 saturation. An autopsy was done which revealed pulmonary embolism. Details of concurrent conditions, concomitant medications, detailed clinical course, further investigation reports and treatment were not provided. The patient has received the two primary doses of mRNA-1273 vaccine. Age of the patient could be a risk factor. Medical history of knee injury and prolonged rest remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-584085.; Sender's Comments: This spontaneous case concerns a 63-year-old female patient with relevant medical history of knee injury and prolonged rest, who experienced the unexpected serious(death) AESI of Pulmonary embolism, 1-year 3months after receiving the 2nd dose of mRNA-1273 vaccine. Immediately after the shot, the patient had experienced mild symptoms (unspecified). Seven months later she had brief episode of shortness of breath. A month later she suffered knee injury with a small meniscal tear. An orthopaedician saw her, ruled out the need for surgery and advised rest for 12 weeks. The patient rested her knee for the said period and by the end, developed shortness of breath while climbing stairs. She consulted a pulmonologist and was screened for any genetic predisposition for clotting disorders � they all were negative. Pulmonary function test was done which turned out to be normal. The same night she complained of tiredness, but later resolved. The next day she was found unconscious, CPR was attempted at home but by the time the ambulance and medics arrived, she did not have any pulse or O2 saturation. An autopsy was done which revealed pulmonary embolism. Details of concurrent conditions, concomitant medications, detailed clinical course, further investigation reports and treatment were not provided. The patient has received the two primary doses of mRNA-1273 vaccine. Age of the patient could be a risk factor. Medical history of knee injury and prolonged rest remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Pulmonary embolism
1593401 2315376 2022-06-10 FL 9.00 Exposed to COVID at school. Symptoms May 25th, to emergency care, given Tessalon pearles, fluticasone, and Tylenol. Progressed, back to ED next day. Given IV acetaminophen and IV saline bolus, decadron and reglan. Discharged with acetaminophen, ibuprophen, phenergan and zofran. Still progressed, found unresponsive on May 28th, to ED. Unresponsive, brain dead. May 28: redesivir, dexamethasone, vancomycin ceftriaxone, and metronidazole.
1593396 2315273 2022-06-10 MI 66.00 Patient is fully vaccinated. COVID positive on 5/9/2022. 67-year-old female, history of end-stage renal disease on peritoneal dialysis daily, CAD hypertension hyperlipidemia, COPD and CHF, oxygen dependent on 5 L presented to the ED with substernal chest pain and shortness of breath that was occurring all day yesterday that acutely worsened overnight while she was doing dialysis.no abdominal pain, no cough, no fatigue, no fever, no headache, no nausea, no numbness, no palpitations, no vomiting and no weakness.Adenocarcinoma of left lung. CXR revealed Infiltrative changes in the region of left upper lobe. ESRD. Cr 11.03.Chronic respiratory failure with hypoxia. NSTEMI. Troponin level 3.18. SpO2 95%. Treatment: Solu=Medrol, oxygen, breathing treatments, Spiriva, metoprolol, dialysis, lasix, asprin. Admitted to hospice. Expired on 6/2.
1593543 2315524 2022-06-10 74.00 Pfizer COVID vaccine # 3 given 12/3/21, lot # 33130BA; pt presented to ED on 12/27/21 with fever, confusion and weakness; hx of cough, myalgias, weakness x 3 days; positive for COVID in ED; on O2 supplementation; given ABX, dexamethasone, remdesivir; pt did not improve; transferred to ICU where he passed away on 1/2/22
1593553 2315536 2022-06-10 83.00 12/19/21 Pt had a positive COVID test; given Vitamin C, D and zinc; 12/27/21 brought to ED with persistent more SOB, altered mental status; BP dropped, apneic; code initiated; intubated; oropharynx full or purulence; purulence continued through ET tube; pt didn't respond, no pulse; pt passed away in the ED
1593709 2315916 2022-06-10 SD 89.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 01/03/2021 and 01/31/2021. They were vaccinated in the thigh, which is not a preferred site for an adult. I do not have any further information about why the thigh was used instead of the deltoid. They became symptomatic for COVID-19 on 10/14/2021 and tested positive for COVID-19 same day, at the nursing home at which they were a resident. I see no indication this person was hospitalized related to this illness. They died on 10/24/2021. COVID-19 is in part one of the death certificate.
1592655 2314090 2022-06-09 73.00 Pt had a positive COVID test on 8/31/21 and was hospitalized, treated and dc'd; 9/26/21 Pt was brought back to ED from for low BP and increased pulse; presumptive dx of sepsis; given ABX; found to have a low Hgb and HCT; transfused with packed RBCs; pleural effusion; thoracentesis; acute renal failure; did not want dialysis; on 10/3/21 his respiratory status deteriorated; transferred to ICU and was intubated; MRSA infection; status changed to comfort measures and he passed away in the hospital on 10/5/21.
1592587 2313972 2022-06-09 TN 93.00 Presented to ED, Hospital, with c/o cough and hypoxia. Patient was diagnosed with Covid-19 on 04/10/2022. Since then he has had SOB and nonproductive cough. Chest Xray revealed some bilateral pulmnary infiltrates. Patient was also found to have a UTI and started on Macrobid for 7 days. Patient was discharged home with home health. Patient expired on 05/13/2022.
1592588 2313973 2022-06-09 TN 90.00 Patient admitted 03/08/2022 after he stopped eating and drinking after having contracted Covid-19 at home. He was admitted to the hospitalist service and he was in renal failure as well as having an AMS and PNA. His renal function worsened and he was not responding to therapy, family decided to make him DNR/Comfort care. Patient expired on 03/11/2022.
1592590 2314020 2022-06-09 TN 83.00 Patient arrived to ED on 03/08/2022 in cardiac arrest. By the time the patient arrived to ED patient without a pulse for approximately 1 hour or more. ET tube was beginning to fill with blood. Patient had no reactivity to her pupils and was making no spontaneous movements. Rapid covid-19 antigen returned positive. Patient expired on 03/08/2022.
1592599 2314030 2022-06-09 89.00 Patient reported to hospital on 01/18/2022 with inability to walk and right extremity weakness. Acute stroke was not seen on CT of brain. Patient underwent CT MRI EEG and echo, no evidence of acute stroke. Patient did test positive for Covid-19. Patient was placed on oxygen for comfort. Patient was discharged back to long term care facility. Patient expired on 04/05/2022.
1592607 2314038 2022-06-09 TN 91.00 Patient resident of healthcare facility. Patient with dementia was trying to use walker at home and stumbled an fell at home breaking his left femur. He is s/p total hip arthroplasty. Admitted to hospital on 02/08/2022. Patient tested positive for Covid-19 on 02/15/2022. Patient expired on 02/19/2022.
1592614 2314046 2022-06-09 TN 76.00 Patient presented to ED on 02/07/2022 with increased SOB. Patient had chronic hypoxic respiratory failure on 3 L O2 at home. Patient experienced several syncope episodes. Recently had a carotid surgery back in December 2021. Patient stated he developed increase cough over past several days and coughed to point of passing out. Patient tested Covid-19 positive on 02/07/2022. Patient presented to ED in hypoxic respiratory failure. Chest Xray shows edema and infiltrates. Patient admitted to hospital. Patient was started on Remdesivir, dexamethasone, and baricitinib due to bilateral covid-19 PNA. Patient was started on Vapotherm. Patient was discharged home with home health and oxygen on 02/20/2022. Patient expired on 04/06/2022.
1592611 2314042 2022-06-09 TN 86.00 Patient reported to PCP on 03/04/2022 with loss of appeitite, fatigue/weakness, nausea, and headache for 5 days. Patient tested positive for Covid-19. Patient received antibodies on 03/04/2022, since then patient has been in bed. Patient was admitted to home hospice services. Patient expired on 05/03/2022.
1592661 2314096 2022-06-09 76.00 1/17/21 pt presents to ED with diarrhea, nausea, hx of a fall within last few days where he hit his head; unsure if lost consciousness; found to be positive for COVID; on 2L O2 via NC; AKI; AHRF secondary to COVID pneumonia; CT of head is negative for acute pathology; COVID treatment protocol followed; pt's overall condition worsened; worsened respiratory status; status changed to comfort measures only and pt expired in the hospital
1592773 2314209 2022-06-09 WV 83.00 Patient came to ED with worsening shortness of breath, fever, and chills. Patient admitted to hospital with Covid pneumonia treated with baricitinib. Patient placed on ventilator 6/4 due to declining respiratory status. Patient became hypotensive and hypoxic on 6/8 and passed away.
1592805 2314241 2022-06-09 MI 84.00 Pt presents to ED via EMS for mental status changes and hypoxia 2/10. COVID positive 2/10, on 6 liters nasal oxygen with a saturation of 100%. On 2/11 pt firing up sepsis; wbc 28.3; lactic 6.1, 4.8, and 7.5; patient received 1L bolus in ER; on IV Zosyn, Vanco, and NS at 125cc. 2/12 RRT called for hypotension and hypoxia. Pt placed on 15L HF with non rebreather, but he remains hypotensive and hypoxic. Pt asystole on the telemetry monitor. Writer checked on patient. Pt bradycardic, not breathing. Pt became deceased 2/12.
1592924 2314365 2022-06-09 MN 79.00 Hospitalized with a fall, intracranial bleed, COVID + on admit. Remdesivir x 3 days. Required intubation and vent for resp failure 6/2/2022, subdural hematoma increased in size, 6/7/2022 progressed to comfort care due to no hope of meaningful recovery from intracranial bleed.
1592971 2314516 2022-06-09 WI 86.00 Admitted to Hospital with COVID Symptoms. with cough, sob, fever, loss of taste and smell. COVID -19 positive. no other details provided in submitted Web report. patient was vaccinated Pfizer x2.
1593005 2314566 2022-06-09 MT 91.00 Case completed primary Covid vaccine in April 2021, then died of Covid in May 2022. Hospitalized at Medical Center. Was admitted to hospital with Change in mental status, fevers and exacerbation of COPD. She progressively grew more ill, and died in hospital after 3 days of care.
1592135 2313205 2022-06-08 TN 55.00 Patient presented to ED on 08/08/2021 with difficulty breathing with h/o DM, renal transplant. She was covid positive on presentation. Patient had severe SOB with exertion, placed on oxygen with NC. Patient also c/o productive cough. Chest xray in ED was consistent with cardiomegaly and bilateral infiltrates with small pleural effusion. The patient was admitted on supplemental oxygen which was escalated to high-flow nasal cannula, continued to worsen and required mechanical ventilation and intubation on 08/17/2021. She was on mechanical ventilation, the patient continued to decline. ICU course was complicated by streptococcus bacteremia and lower GI bleed which resolved with supportive transfusions and surveillance. On 09/07/2021, patient had multiple cardiac arrests and subsequently died.
1591860 2312725 2022-06-08 TX 81.00 death; shortness of breath; Nausea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 81-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jun2022 at 11:15 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "Heart failure" (unspecified if ongoing); "acute kidneyfailure" (unspecified if ongoing); "covid " (unspecified if ongoing), notes: prior vaccination. No other vaccine in four weeks. The patient took prescribed concomitant medications in two weeks. Past drug history included: Tramadol, reaction(s): "Allergy"; Levaquin, reaction(s): "Allergy". The following information was reported: NAUSEA (non-serious) with onset 04Jun2022 at 17:30, outcome "not recovered"; DEATH (death, medically significant) with onset 04Jun2022 at 17:30, outcome "fatal"; DYSPNOEA (non-serious) with onset 04Jun2022 at 17:30, outcome "not recovered", described as "shortness of breath"; VOMITING (non-serious) with onset 04Jun2022 at 17:30, outcome "not recovered". The events "death", "shortness of breath", "nausea" and "vomiting" required emergency room visit. Therapeutic measures were not taken as a result of death, dyspnoea, nausea, vomiting. The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Covid was not tested post vaccination. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: death
1591990 2313060 2022-06-08 IN 67.00 Patient vaccinated 5/28/21, tested positive for COVID-19 3/7/22 and expired 6/4/22.
1592029 2313099 2022-06-08 TN 62.00 Patient with hx of multiple medical problems lung cancer on chemo, colon and renal cancer, obesity , COPD, former smoker and Oxygen dependent was recently discharged from hospital d/t Covid-19 infection, presented back to ED on 10/07/2021 with confusion, tremors, and found to be in acute renal failure, severely dehydrated and was uremic. Patient was admitted to ICU. CT scan revealed cavitary lung lesion on right lower lobe, known to be squamous cell CA. On 10/18/2021, patient remained minimally responsive, comfort measures in place. Patient expired on 10/18/2021.
1592072 2313142 2022-06-08 72.00 MODERNA COVID VACCINE #3 GIVEN 8/19/21, LOT # 053E21A; pt was admitted to hospital and found to be positive for COVID; treated with decadron, remdesivir, O2 supplementation; increased hypoxemia requiring BiPAP at 100%; progressive hypotension renal azotemia; decreasing condition; family decided to transition pt to comfort care and she passed away in the hospital
1592102 2313172 2022-06-08 83.00 Pt had a positive COVID test on 8/27/21 at a pharmacy; was admitted to hospital from 8/27/21 - 9/17/21; he was treated with remdesivir, baricitinib, dexamethasone; dc'd; back to hosp on 10/17/21 with worsening SOB; on 4 L O2 via NC; CXR showed worsening pulmonary opacities; treated with ABX; admitted with pneumonia; COVID test was now negative; respiratory status did not improve; treated with steroids; developed acute respiratory needs, transitioned to Vapotherm and transferred to PCU; weaned from Vapotherm to O2 via NC; worsening thrombocytopenia; PT worked with patient and he passed out from being to weak to do PT; planned to send pt home with hospice, but pt expired in the hosp before able to go home
1592108 2313178 2022-06-08 TN 74.00 Patient presented to ED on 01/10/2022 with AMS, the onset was abrupt. The patient was transferred from small clinic for evaluation and management of a head bleed after a fall, and Covid positive. CT showed occipital fracture, subdural bleed, bilateral subarachnoid frontal bleed. Prior to presentation, history of flu like symptoms for the past week. Patient was admitted to NCCU. On 01/13/2022 patient presented with worsening neurological exam, extensor posturing, not protecting airway, patient was intubated, repeat CT head with worsening edema and evolving left pica stroke with mass effect. Patient code status was changed to DNR. Patient expired on 01/15/2022.
1592129 2313199 2022-06-08 TN 61.00 Patient recently diagnosed with lung cancer with metastatic disease to liver, presented to ED with altered mentation secondary to seizure with status epilepticus and subsequently intubated. Etiology of seizures appeared to be related to metastatic brain disease from lung cancer. Family wished to make the patient DNR.. Patient also tested positive for Covid-19. Patient expired on 1/11/2022.
1592226 2313470 2022-06-08 TN 96.00 Patient tested positive for Covid-19 on 01/19/2022 at PCP office. Patient expired on 01/30/2022. Patients PCP office located.
1592139 2313209 2022-06-08 TN 92.00 Patient recently diagnosed with Covid-19 prior hospitalization, presented with increasing SOB and weakness. She was hospitalized, she was placed on IV antibiotics. She developed worsening oliguric renal failure, metabolic acidosis. She was placed on a bicarbonate drip. Abdominal US did not show hydronephrosis or other abdominal catastrophe. Chest xray showed worsening bilateral infiltrates. She expired unexpectedly on 02/08/2022.
1592144 2313214 2022-06-08 TN 79.00 Patient tested positive for covid-19 on 01/05/2022. Patient then presented to ED on 03/19/2022 with presyncope/syncope complicated by past medical history of AMS, recent VRE/MRSA in urine and blood, GERD, CAD s/p CABG, HTN. Patient was discharged to SNF on 03/23/22. Discharge diagnosis included Hypotension, Near syncope, AKI. Patient expired on 03/29/2022
1592210 2313454 2022-06-08 TN 75.00 Patient presented to ED on 03/05/2022 with generalized weakness. Patient was previously hospitalized at facility on 01/11/2022 to 02/09/2022 with failure to thrive and Covid-19, Right segmental PE. Since discharge from the facility, the patient has became progressively worse, and unable to care for himself. In ED chest xray revealed bibasilar airspace opacities, and UTI, started on antibiotics. Patient was discharged on 03/14/2022 to hospice. Patient expired on 04/02/2022.
1592214 2313458 2022-06-08 TN 70.00 70 year old patient recently hospitalized for aspiration PNA directly admitted from TCC after testing positive for Covid-19 at their facility. Patient reports intermittent diarrhea. Patient was discharged from facility and expired on 03/07/2022.
1592223 2313467 2022-06-08 TN 78.00 Patient had recent endarterectomy presented to ED with c/o of stating her oxygen has been dropping. Patient has mild pain on left side, in ED CT showed severe bilateral multifocal mixed interstitial alvelolar PNA. Patient was placed on NC oxygen. Patient was admitted to hospital services. On 12/28/2021, rapid response called, family requested hospice services. Covid-19 PCR came back positive on 12/29/2021. Patient expired on 12/30/2021.
1592227 2313471 2022-06-08 TN 72.00 Patient arrived to ER via EMS d/t being found unresponsive. Patient admitted to hospital for comfort measures. Diagnosed with cardiopulmonary arrest, Covid-19 PNA, acute hypoxic respiratory failure. Patient expired on 01/13/2022.
1591315 2311647 2022-06-07 81.00 pt had a positive COVID test on 2/17/22, and was left with chronic hypoxic respiratory failure; 4/20/22 pt presents to Medical Center with acute on chronic dyspnea; increasing SOB, wheezing, non-productive cough x 1 wk; saw PCP (name not included in med records) and was treated with steroid and Bactrim; no improvement; increase in fatigue and malaise; severe COPD exacerbation with acute renal failure and hyperkalemia; treated with IV steroids, O2 supplementation, duoneb, pulmincort; dc'd to home on 4/22/22; pt passed away in her home on 5/8/22 with acute respiratory failure
1590991 2311233 2022-06-07 Hemorrhaging; Multiple heart attacks; Heavy clotting; patient received JANSSEN COVID-19 VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Hemorrhaging), MYOCARDIAL INFARCTION (Multiple heart attacks) and THROMBOSIS (Heavy clotting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (Hemorrhaging) (seriousness criteria death and medically significant), MYOCARDIAL INFARCTION (Multiple heart attacks) (seriousness criteria death and medically significant), THROMBOSIS (Heavy clotting) (seriousness criteria death and medically significant) and INTERCHANGE OF VACCINE PRODUCTS (patient received JANSSEN COVID-19 VACCINE). The patient died on an unknown date. The reported cause of death was Hemorrhage, Heart attack and Clot blood. It is unknown if an autopsy was performed. At the time of death, INTERCHANGE OF VACCINE PRODUCTS (patient received JANSSEN COVID-19 VACCINE) outcome was unknown. No concomitant product was provided. No treatment information were reported. Causality for JANSSEN as per reporter and mfr. was possible. Company comment. This fatal spontaneous case concerns a female patient (unknown age) with no medical history reported, who experienced the unexpected, serious (medically significant and fatal) AESI of myocardial infarction and thrombosis, and the unexpected serious event of haemorrhage. Temporal association cannot be assessed due to lack of information on onset date of the events and vaccination date. The patient received mRNA-1273 vaccine reported as booster vaccination in her COVID � 19 vaccination schedule, previously she received a dose of Janssen COVID � 19 vaccines (interchange of vaccine products could be considered). The report stated that the patient died of hemorrhaging with heavy clotting and multiple heart attacks. It was unspecified if an autopsy was performed. No further details were provided for medical review. Co � suspect product Janssen COVID � 19 vaccine remains as confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This fatal spontaneous case concerns a female patient (unknown age) with no medical history reported, who experienced the unexpected, serious (medically significant and fatal) AESI of myocardial infarction and thrombosis, and the unexpected serious event of haemorrhage. Temporal association cannot be assessed due to lack of information on onset date of the events and vaccination date. The patient received mRNA-1273 vaccine reported as booster vaccination in her COVID � 19 vaccination schedule, previously she received a dose of Janssen COVID � 19 vaccines (interchange of vaccine products could be considered). The report stated that the patient died of hemorrhaging with heavy clotting and multiple heart attacks. It was unspecified if an autopsy was performed. No further details were provided for medical review. Co � suspect product Janssen COVID � 19 vaccine remains as confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Hemorrhage; Heart attack; clot blood
1591270 2311602 2022-06-07 FL 74.00 congestion like head cold started on 1-4-22 . Low grade fever and abdominall discomfort on 1-5-22. Told to isolate at home since vaccinated x2 and boosted. O2 stats ok. On morning of 1-6-22 found unconscious at home by my son. Was able to be aroused and coherent. Taken to Hospital ER. In acute distress with STAT echocardiogram showing massively dilated left heart and ejection fraction 10% Admitted with acute covid myocarditis and cardiogenic shock. To cardiac ICU intubated and placement left ventricular assist device. Transferred to another Hospital for advanced heart failure team in that ICU. Multisystem organ failure. 9 weeks of ICU care no renal function, could not speak or swallow, covid coagulopathy,, lower GI bleed and other complication. Finally taken off life support. Expired 3-3-22.
1591286 2311618 2022-06-07 97.00 9/12/21 Pt had a hospital admission for a positive COVID test; was treated with ABX; dc'd to SNF for continued care; pt admitted to hosp on 9/28/21 via ambulance with weakness, FTT, coughing, difficulty eating; PEG tube placed; dc'd back to SNF for continued care where she passed away on 11/16/21
1591292 2311624 2022-06-07 35.00 pt had a positive COVID test on 1/9/22; was hospitalized for 2 months for COVID pneumonia at a local Medical Center; had a 2nd hospital admission on 3/24/22 at a second Hospital for increase in SOB with fever, on 2L O2 via NC; had a positive COVID test again on 3/27/22; respiratory status worsened requiring intubation; developed pneumothorax and pneumomediastinum; transitioned to comfort measures and was extubated; she passed away in the hosptial
1591302 2311634 2022-06-07 84.00 PFIZER COVID VACCINE #3 GIVEN 11/18/21, LOT #FF2593; pt came to hosp and was admitted on 4/24/22 with weakness, SOB, fever, cough, congestion, decrease in appetite; 4/25/22 positive COVID test; 80% O2 sat on RA; placed on O2 supplementation with improvement; CXR showed left lower lobe pneumonia; given ABX; pt passed away in the hospital the following day
1591556 2320221 2022-06-07 73.00 Narrative: 73yr old male died on 5/12/2022. No other info in chart. Pt had only received a covid vaccine EUA (J&J) from the agency on 6/16/2021.
1591327 2311659 2022-06-07 85.00 pt in HCF after a stroke; had a positive COVID test on 1/24/22; on 2/1/22 pt was lethargic and hard to awaken; low BP; poor po intake x 4 days; refusing medications; pt passed away in the HCF on 2/8/22
1591551 2320198 2022-06-07 56.00 Narrative: 55yo male died on 03/16/2022 at home. Pt died of stage 4 brain cancer. Pt had received a covid vaccine eua, (J&J) on 3/16/2021. This death is not related to the covid vaccine.
1591555 2320217 2022-06-07 65.00 Narrative: Male 64 yo patient died on 3/25/2022 of cardiac arrest at outside community hospital on 3/25/2022. Pt had received a covid EUA vaccine on 7/30/2021 (J&J). See pt's problem list below per medical chart: 12 Problems ST PROBLEM LAST MOD PROVIDER A Alcohol dependence (SCT 66590003) (ICD-10-CM 06/17/2021 F10.29) A Severe alcohol dependence (SCT 713862009) 12/23/2020 (ICD-10-CM F10.20) A Pulmonary emphysema (SCT 87433001) (ICD-10-CM 03/31/2020 J43.9) A House rented from housing association (SCT 04/06/2018 160939001) (ICD-10-CM Z59.9) A Unemployed (SCT 73438004) (ICD-10-CM Z56.0) 04/06/2018 A Full thickness rotator cuff tear (SCT 202843000) 12/01/2017 (ICD-10-CM M75.122) A Tear of left rotator cuff (SCT 08/20/2017 11892411000119102) (ICD-10-CM S46.092S) A Glaucoma (SCT 23986001) (ICD-10-CM H40.9) 08/20/2017 A Hyperlipidemia (SCT 55822004) (ICD-10-CM E78.5) 02/23/2017 A History of mechanical aortic valve replacement 10/26/2015 (SCT 125411000119107) (ICD-10-CM I35.0) A Hyperlipidemia (SCT 55822004) (ICD-10-CM E78.0) 10/26/2015 A Persistent alcohol abuse (SCT 284591009) 10/13/2015 (ICD-10-CM F10.10) Likely vaccine not related to pt's death given history of heart condition. Info in chart regarding ER admission to community hospital below: Patient self-presented to community emergency facility Emergency Notification Intake Date Presenting to the Facility: 3/16/2022 Hospital Chief complaint: CARDIAC ARREST Primary Diagnosis:CARDIAC ARREST Patient Admitted? Yes Route of Admission: ER Date/Time of Admission:3/16/2022 Admitting Diagnosis:CARDIAC ARREST Community Care Provider: Confirm Level of Care: Acute Inpatient Care
1591340 2311672 2022-06-07 85.00 pt had a positive COVID test on 2/14/22 ordered by facility; pt admitted to facility for rehab due to a fall on Left hip; underwent a hemiarthroplasty; pt passed away in the facility of hypoxia
1591443 2311777 2022-06-07 WI 84.00 Patient presented to ER with difficulty talking and increase confusion and had putrid smelling urine. Patient was found to be septic with tachycardia, leukocytosis, altered mental status, and acute kidney injury. Patient was severely dehydrated. CT was negative for acute findings. Patient was discharged from hospital 4/11/2022 for complicated UTI. Rehab facility has noted that patient had been fatigued, weak, and confused over the past week and symptoms have progressively worsened. Goals of care discussed were discussed with patient's daughter/POA. Patient was COVID positive 5/25/22, and Pfizer vaccinated 5/16/21 and 6/6/21. Patient was not expected to survive hospitalization. Patient was transitioned to hospice.
1590716 2310326 2022-06-06 WV 73.00 Patient was in the hospital for pneumonia and developed Covid pneumonia and was transferred to the ICU where she went into cardiac arrest and passed.
1590644 2310253 2022-06-06 84.00 MODERNA COVID VACCINE #3 GIVEN 11/18/21, LOT #077C21B; pt was in Transitional Care and Rehab, when she tested positive for COVID; asymptomatic; placed in isolation room; pt also has a UTI and is taking ABX; dc'd to home on 1/31/22 where she later passed away
1590629 2310236 2022-06-06 85.00 MODERNA COVID VACCINE #3 GIVEN 8/15/21, LOT #017E21A; 1/27/22 pt was recently treated for COVID infection; 2/8/21 pt to hosp via EMS for worsening productive cough, hypoxia, pleuritic chest pain, generalized weakness; AKI; hypokalemia; community-acquired pneumonia given IV ABX; acute MI; refused cardiac catherization; made comfort care; pt passed away in the hospital
1590627 2310234 2022-06-06 WI 93.00 Acute systolic CHF (congestive heart failure) 5/19/22 COVID-19 virus detected 5/19/22
1590622 2310229 2022-06-06 73.00 Moderna COVID vaccine given 11/8/21, lot # 077C21B; 11/29/21 pt admitted to Hospital for altered mental state, weight loss, poor po intake, trouble swallowing and weakness x 1 wk; found to be positive for COVID; severe tremors and jerks - given carbidopa-levodopa; PEG tube placed; pt went into Hospice where he passed away
1590485 2310090 2022-06-06 OK 53.00 death of a fully vaccinated COVID positive pt.
1590220 2309579 2022-06-04 Impacts negatively, should haven't died from this Pfizer crap/ whenever one is dead already; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Impacts negatively, should haven't died from this Pfizer crap/ whenever one is dead already". The date and cause of death for the patient were un-known. It was not reported if an autopsy was performed. It was reported that, as reporter was not willing to provide further details and abruptly hung up the call. Hence product details (LOT#, expiration date, NDC# and UPC#), purchased details and further probing could not be done. Limited information was available over the call and appropriate response could not be provided. QR comment:- AE Filed conservatively. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Impacts negatively, should haven't died from this Pfizer crap/ whenever one is dead already
1590211 2309570 2022-06-04 died a few months after getting the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 16-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "died a few months after getting the vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: Consumer called to find out the status of the safety effects she reported 13 months ago after getting the Pfizer BioNTech Covid-19 Vaccine and asked why no one was able to follow up on her. Consumer stated that she had called pfizer's (option 1) and was referred to Pfizer to inquire about the adverse event status she had reported 13 months ago. consumer stated that she experienced 30 hours after she got the second dose of the Pfizer BioNtech Covid-19 vaccine on 13Apr2021. Consumer also stated that she had to be put on a walker/wheelchair because of the side effect and stated that she was previously active and doing "ms 150 backride" prior to getting the vaccine. Consumer also stated that she was connected with 2 other people who got the same lot number of the vaccine, one was a 16 year old who died a few months after getting the vaccine (still connected with the father) and the other one was a mother who had "intravenous globular syndrome. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: died a few months after getting the vaccine
1589557 2308361 2022-06-03 MI 89.00 Pt presents to ED from assisted living facility with reported abdominal pain for 2 days and a brown emesis on 4/13. COVID positive 4/13. Placed on nasal o2 at 6l due to vomiting. Pt placed on cardiac monitor, with audible crackles noted. Pt very tachypneic increasingly tachycardic, SPO2 66% RA with good pleth on monitor. Pt placed on O2 via NRB at 15lpm 4/13. Patient admitted to inpatient hospice services for terminal wean from 15l/NRB and management of respiratory distress. Morphine drip initiated at 1mg/hr and titrated as appropriate per order. Decreased O2 2L per hour as tolerated by pt on 4/14. Discharged 4/14.
1589214 2307880 2022-06-03 MD DEATH; ANEURYSM; This spontaneous report received from a consumer concerned a 33 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered on an unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the reporter stated that the patient got the Johnson and Johnson vaccine. Then he got the booster and got aneurysm (dose number in series 2). The reporter also mentioned that the patient passed away at the age of 33 (dose number in series 2). On an unspecified date, the patient died from unknown cause of death. It was unknown if the autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death was fatal, and the outcome of aneurysm was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20220600785.; Sender's Comments: V0: 20220600703-covid-19 vaccine ad26.cov2.s- Death, Aneurysm. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
1589473 2308277 2022-06-03 78.00 Pfizer COVID vaccine #3 given 8/22/21, lot # FC3183; 2/5/22 pt had a positive COVID home test; 2/6/22 went to urgent care and was referred to hospital ED for low O2 sats (80s); admitted 2/6 - 2/8/22 and was given dexamethasone, remdesivir, O2; dc'd to home; since then has had watery diarrhea, fatigue, poor oral intake, more labored breathing; 2/15/21 pt back to ED; admitted with COVID pneumonia, AHRF, A Fib with RVR, AKI and supratherapeutic INR; ICU; was in DIC and received cryoprecipitate; given ABX; pt's condition continued to worsen and he was transitioned to comfort care; he passed away in the hospital
1589477 2308281 2022-06-03 MI 42.00 Pt admitted 2/26 with past medical history of hypertension, COPD, obesity, multisubstance drug abuse presented with acute respiratory distress, shortness of breath, which then led to cardiac arrest while she was in the emergency room. Pt was intubated, but the patient's weaning process was difficult. Pt was unresponsive and condition was worsened. Several diagnoses while pt was hospitalized including anoxic hypoxic encephalopathy, asthma, COPD exacerbation, poorly-controlled hypertension, as well as COVID-19 infection confirmed 3/6, Strep pneumoniae as well. Family elected to transition over hospice and she was transferred 3/9. Patient was placed on comfort measures, and expired on 3/12.
1589514 2308318 2022-06-03 TN 45.00 Moderna COVID vaccine #3 given 10/29/21, lot # 071F21A; pt had a positive COVID test in Rehab and Healing; medical records reviewed with no mention of COVID; last History and Physical was from Medical Center on 12/27/21 for fever, hypotension, bilateral pneumonia
1589609 2308414 2022-06-03 TX 77.00 During the hospitalization , patient was treated for following diagnosis 1. Acute hypoxic respiratory failure with ARDS secondary to COVID-19 bilateral pneumonia (POA): Patient was intubated on 09/12/2021 Patient was extubated on 09/18/2021 and within few minutes of extubation patient passed away comfortably with family members bedside Patient was pronounced dead at 12:31 p.m. on 09/18/2021
1589610 2308415 2022-06-03 TX 92.00 Pt readmitted from 10/16 - 10/21 stay for AKI & falls; returned d/t worsening creatinine of 5.0; admitted for AKI, acute bronchitis; pt COVID+ & xray showed pneumonia; tx w/Azithromycin, Cefipime, Vit C, steroids & zinc; 10/20 - started 5 day course of remdesivir; O2 status & creatinine worsened and pt started dialysis 10/30; Hgb dropped to 5.7 w/ no evidence of bleeding; 2 U PRBCs transfused; pt did not improve w/ dialysis & oxygenation status continued to deteriorate and required OptiFlow & BiPAP. Pt made DNR, went into asystole 11/4 and subsequently passed away.
1589850 2308660 2022-06-03 48.00 this patient died at home on 1/30/22; there was a post-mortem COVID test done on 1/31/22 that was positive; there are no medical records on this patient
1589912 2308722 2022-06-03 TN 76.00 Pfizer COVID vaccine #3 given 8/25/21, lot # FC3184; 1/12/22 pt went to dr's office with productive cough, negative COVID test, CXR showed pneumonia; treated with steroids, and ABX and sent home; later in the week, he developed chills and hypoxia (on 4L O2 via NC and O2 sats in 70s); 1/24/22 brought to ED via EMS and admitted; positive COVID test; increased O2 to 15 L; given remdesivir, ABX, and dexamethasone; increased O2 demands requiring ventilator; developed acute thromobosis; condition worsened; Atrial flutter; tracheostomy performed; G tube placed; continued encephalopathy; wife made pt a DNR but not to withdraw care; 3/5/22 pt transferred to Hospital where he passed away
1589690 2308497 2022-06-03 WI 74.00 This patient had an extensive past medical history including breast cancer, lymphoma, CAD s/p stents. Patient was vaccinated with Pfizer vaccine x3. She presented to the hospital with shortness of breath, hypoxia after being evaluated at urgent care. Patient had tested positive for COVID-19 approximately 3 weeks prior to Hospital on 5/15/2022. The patient had a prolonged and complex hospitalization, with numerous consultants during her stay including infectious disease, intensivist/pulmonology, nephrology, gastroenterology, palliative care teams. She was treated for COVID-19 pneumonia with steroids, duo nebs at the at the direction of infectious disease. This patient was also thought to have superimposed bacterial pneumonia and completed a course of ceftriaxone and doxycycline. She was suspected to have post COVID pneumonitis/pulmonary fibrosis as well contributing to worsening shortness of breath and respiratory decline. Patient was DNR. She was initially hesitant to be intubated but did elect intubation. Patient did not improve, and her respiratory status continued to decline. Hospitalization was complicated by acute on chronic normocytic anemia. She also had melena and underwent EGD with findings of slow oozing blood likely from NG tube gastric erosions. She was treated with APC. Of note, patient would not accept blood products. Nephrology followed closely and assisted with volume management during her stay. Patient had aggressive treatment by pulmonologist/intensivist, multiple consultants input, but patient respiratory continued to decline. Palliative care followed and family elected to transition the patient to comfort measures. Family was able to visit and she was compassionately extubated at 11 AM and given IV morphine for comfort. Time of death was 11:14.
1588091 2306038 2022-06-02 KY Death; This spontaneous case was reported by a health care professional and describes the occurrence of DEATH (Death) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment This is a spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the Fatal unexpected, event of death, which occurred on an unknown date, thus latency between vaccination and the event cannot be assessed. The patient received the second dose of mRNA-1273. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. No further information regarding the course of events, lab tests, imaging studies and treatment was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: Upon internal Review on 01-Jun-2022, significant correction was made to update report type, suspect product and narrative.; Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the Fatal unexpected, event of death, which occurred on an unknown date, thus latency between vaccination and the event cannot be assessed. The patient received the second dose of mRNA-1273. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. No further information regarding the course of events, lab tests, imaging studies and treatment was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: unknown cause of death
1588783 2306895 2022-06-02 40.00 pt had a positive COVID test on 12/16/21 and was in the hospital; dc'd to home on 12/20/21; pt returned to hospital on 12/26/21 with increase in abdominal swelling, abdominal pain, SOB, generalized weakness, anemic; in chronic renal failure, hepatic failure; fluid leaking from abdomen and legs; pt too large for the CT machine; pt passed away in the hospital on 12/29/21
1588606 2306586 2022-06-02 AL 79.00 attacked his kidneys(ANCA associated Vasculitis).; autoimmune disease; rash; psoriasis; he was very sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. A 79-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 79 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (FLU), (Batch/Lot number: unknown) for immunisation. Facility type vaccine: Hospital. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. His daughter is the reporter and has the batch info and can provide when contacted, Location of injection: Arm Left, Route of Administration: Intramuscular, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Daughter is reporter and has batch info to provide when contacted, Location of injection: Arm Left, Route of Administration: Intramuscular, Manufacturer unknown), for COVID-19 immunization. If other vaccine in four weeks: Unknown. If covid prior vaccination: Unknown. If covid tested post vaccination: Unknown. Known allergies: Unknown-daughter will know. The following information was reported: ANTI-NEUTROPHIL CYTOPLASMIC ANTI-BODY POSITIVE VASCULITIS (death, hospitalization, disability, medically significant, life threatening) with onset 25Oct2021 at 05:15, outcome "fatal", described as "attacked his kidneys(ANCA associated Vasculitis)."; AUTOIMMUNE DISORDER (death, hospitalization, disability, medically significant, life threatening) with onset 25Oct2021 at 05:15, outcome "fatal", described as "autoimmune disease"; ILLNESS (death, hospitalization, disability, life threatening) with onset 25Oct2021 at 05:15, outcome "fatal", described as "he was very sick"; PSORIASIS (death, hospitalization, disability, life threatening) with onset 25Oct2021 at 05:15, outcome "fatal"; RASH (death, hospitalization, disability, life threatening) with onset 25Oct2021 at 05:15, outcome "fatal". The patient was hospitalized for anti-neutrophil cytoplasmic antibody positive vasculitis, autoimmune disorder, rash, psoriasis, illness (hospitalization duration: 30 day(s)). The events "attacked his kidneys (anca associated vasculitis).", "autoimmune disease", "rash", "psoriasis" and "he was very sick" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Biopsy: Unknown results, notes: Doctor did 4 biopsies thinking that patient may have psoriasis; Biopsy kidney: Unknown results. Therapeutic measures were taken as a result of anti-neutrophil cytoplasmic antibody positive vasculitis, autoimmune disorder, rash, psoriasis, illness. The patient date of death was 16May2022. Reported cause of death: "attacked his kidneys (ANCA associated Vasculitis).", "autoimmune disease", "Rash", "psoriasis", "he was very sick". No autopsy was performed. Other medication in two weeks: He had his flu vaccine the day after receiving his 3rd dose on Pfizer's covid vaccine. his daughter reported this to me and does have the batch # information. Patient was 78 years old and received his 3rd vaccine at the end of October and 2 days later came down with a rash. Doctor did 4 biopsies thinking that patient may have psoriasis. Patient continued to get sicker and doctors finally diagnosed him with an autoimmune disease which attacked his kidneys (ANCA associated Vasculitis). They started him on dialysis and ended up giving him steroids and plasmapheresis, which did help temporarily but by that point he was very sick. They ended up having to intubate him and he passed away on 16May2022. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage, Patient died. No days hospitalization: 30. Date of death: 16May2022. Death cause: ANKA associated Vasculitis/Sepsis/pneumonia. If autopsy performed: No. If treatment ae: Yes. Ae treatment: 4 biopsies, Plasmapheresis, Kidney biopsy, steroids, Intubated Other medical history: He was perfectly healthy and working before he received his 3rd vaccine. He did have a bad reaction to first 2 vaccines but felt he still needed to get his 3rd vaccine. His daughter, (name), will be able to provide much more information The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Reported Cause(s) of Death: attacked his kidneys(ANCA associated Vasculitis).; autoimmune disease; Rash; psoriasis; he was very sick
1588731 2306842 2022-06-02 MI 70.00 Discharge Provider: MD Primary Care Physician at Discharge: DO Admission Date: 5/26/2022 PRESENTING PROBLEM: Hyperbilirubinemia [E80.6] Elevated liver enzymes [R74.8] Acute on chronic combined systolic and diastolic CHF (congestive heart failure) (HCC) [I50.43] Acute on chronic respiratory failure with hypoxia and hypercapnia (HCC) [J96.21, J96.22] COVID [U07.1] HOSPITAL COURSE: Patient is a 71-year-old male with a past medical history significant for recent COVID-19 infection status post treatment and completion of dexamethasone, oxygen-dependent chronic obstructive pulmonary disease, coronary artery disease, chronic systolic and diastolic heart failure who presented with difficulty breathing well as hypoxia. He is usually on 2 L of oxygen via nasal cannula. In the emergency department he was found to be hypoxic with sats 72 on 2 L and VBG showed pH of 7.24 with CO2 of 59. He was initially placed on non-rebreather and then placed on BiPAP. He has persistent atrial fibrillation which is rate controlled with metoprolol and amiodarone and is also on Xarelto. Patient felt to to have chronic combined hypoxic and hypercarbic respiratory failure due to CHF exacerbation and chronic obstructive pulmonary disease exacerbation. There was also concern that he had pneumonia due to infiltrates as well as leukocytosis. Patient was placed on vancomycin and Zosyn. MRSA screen came back negative and therefore vancomycin was discontinued. He was rapidly weaned off BiPAP and placed on 6 L of oxygen via nasal cannula. Patient's home torsemide was held and he was placed on IV Lasix. Cardiology was consulted who agreed with IV diuresis. Patient had improvement of his symptoms. Leukocytosis did improve. Blood cultures did not reveal any growth. He was initially placed on Solu-Medrol and then transitioned to prednisone. Patient had very little improvement in his symptoms with IV Lasix. He also had increase in his creatinine and therefore Nephrology was consulted. Nephrology place patient on Lasix infusion but he still did not have adequate diuresis. Patient's condition declined acutely the morning of 5/31 and he became increasingly short of breath with increased work of breathing. Prior to this he was a full code and when code status was discussed previously, patient stated that he did not wish to change it. However as his condition declined, patient stated that he wished to become a do not resuscitate. His condition declined even further and he was made comfort care late afternoon 5/31. Hospice was consulted and patient was made inpatient hospice.
1588748 2306860 2022-06-02 TN 80.00 Patient tested positive for Covid-19 on 01/19/2022. Patient was asymptomatic and afebrile, and was moved to isolation at facility. On 01/31/2022 patient noted to have a large amount of rectal bleeding in toilet, with abdominal pain and was transferred to ED for evaluation. Patient returned the following day with orders to set up a GI consult. Patient was noted to have unsteady gait, and felt dizzy. Patient was then transferred to Hospital. Patient expired on 03/07/2022.
1588759 2306871 2022-06-02 TN 71.00 Patient presented to ED with SOB while at a skilled nursing facility. The patient had a previous hospitalization with COVID PNA where she was treated on the COVID protocol, discharged on 1 L of oxygen PRN. Patient stated since discharged she ahs always been short of breath. In the ED CTA of chest had scattered infiltrates suggestive of worsening covid infiltrates. The patient was placed on 4.5 L of oxygen, saturation at 92% and tachypneic. The patient was admitted to ICU and was eventually intubated, she required multiple sedatives which also affected her blood pressure. She continued to require higher FiO2 until family decided to withdraw care. Patient expired on 04/26/2022.
1588769 2306881 2022-06-02 TN 77.00 Patient presented to ED via EMS due to decrease oxygenation at home. In the ED supplemental oxygen initiated. Chest xray shows changes consistent with COVID-19 PNA. Covid antigen positive, CRP elevated. Patient reports frequent nonproductive cough, ongoing dyspnea, increased lower extremity edema. Patient admitted to hospital and started on BiPap with oxygenation improvement. Patient then was found to be unresponsive with Bipap mask off, code was called and patient went through 2 rounds of ACLS with 2 doses of epi with ROSC on ventilator, patient on epi drip and transfer to ICU. Decision to withdraw care was made and patient passed on 9/13/2021.
1588776 2306888 2022-06-02 TN 77.00 Presented to ED by her husband because of multiple falls over the last week. She has had some progressive SOB over last week and has no home oxygen. EMS reported saturation of 87%, placed on 6 LNC. She c/o all over body pain and found to be covid positive. Chest xray shows infiltrates in both lungs. Patient had became bradycardic that progressed to asystole, and code blue was called in the ED. Patient had 5 rounds of CPR with epinephrine and hat ROSC. However, patient became bradycardic, atropine given, and patient coded again and was unable to regain a pulse. Patient expired on 09/07/2021.
1588780 2306892 2022-06-02 OK 93.00 Resident had received second covid-19 Moderna booster on 5/11/22; Resident has frequent history of UTIs, had VRE in urine on 3/25/22 , resident was taking amikacin 250 mg IM twice a day from 5/16-5/21 for different UTI. Resident was seeming to improve, alert and oriented to person and place. On 5/31 around 10 pm resident began reporting nausea and not feeling well, on 6/1 resident had emesis x 2 prior to am meal, refused meds, was able to eat some jello. No abdomen distention, some tenderness noted to left upper quadrant, VS stable for resident 136/88-98-14-97.1-96% on 2 L via nasal cannula. Later in the afternoon resident began having brown coffee colored liquid emesis on clear liquid diet, labs performed and sent to hospital. Residents oxygen began to drop to 86% so increased oxygen to 3L, resident complaining of abdomen and chest pain and sent to emergency department via ambulance. Medical Center later called to inform staff that resident had passed away and had a incarcerated hernia. Resident was a DNR.
1588896 2307009 2022-06-02 70.00 12/5/21 pt to ED due to husband not being able to awaken her; evidence of UTI in ED; positive COVID test in ED; O2 supplementation, 1 L via NC; admitted for UTI and altered mental state; started on ABX, Vitamin D, dexamethasone; DNR/DNI; husband desires to take pt home; dc'd to home 12/8/21, where pt passed away
1588808 2306920 2022-06-02 67.00 Patient had a positive COVID test on 1/18/22 at local Health Care and spent a week in the hospital; patient brought to ED at alternate Medical Center and was in respiratory distress; intubated; suffered cardiac arrest after intubation; CPR performed x 12 mins with success; 1/31/22 transferred patient to County General Hospital; no muscle or motor activity; pupils nonreactive; had a positive COVID test; pneumonia; DNR with limited therapy; found to have non-Hodgkin's lymphoma and heavy cell leukemia; suffered a prolonged hospital course; ventilator dependent; 2/18/22 tracheostomy; 2/24/22 PEG placement; developed AKI; staph bacteremia; Klebsiella pneumonia; NSTEMI; 3/6/22 seizures; 3/12/22 palliatively extubated and made comfort measures only; patient died in the hospital.
1588964 2307078 2022-06-02 TN 63.00 Patient tested positive with Covid-19 on 3/25/22. Patient had history of head and neck cancer. Brought to hospital per ENT for inpatient hospice services. Patient admitted with epistaxis, hemoptysis, right distal common carotid artery pseudoaneurysm. Patient continued to have more bleeding and was seen by palliative care, hospice and admitted to inpatient hospice service. Patient expired on 5/6/22.
1588975 2307090 2022-06-02 TN 66.00 Patient admitted to hospital on 02/11/2022 for acute encephalopathy, productive cough, dyspnea requiring use of his home oxygen tank, wheezing, subjective fevers, and was found at the time to be covid positive. Patient was not a candidate for Remdesivir d/t renal dysfunction. CXR showing cardiomegaly status post remote transcatheter aortic valve replacement with interval development of a large dependent left pleural effusion and hazy interstitial opacities present within the mid and lower lungs bilaterally. Patient was weaned from oxygen and mental status improved back to baseline. Patient was discharged home for quarantine x 10 days and dexamethasone x 10 days. Patient expired on 02/17/2022.
1588981 2307096 2022-06-02 FL 84.00 He received Covid vaccines on 1/30/21, 2/27/21, and 11/15/21. On 5/25/22, he was brought to ER due to weakness, SOB, and runny nose. He was recently involved MVC and was released from the other hospital. He tested positive COVID requiring oxygen therapy, so he was admitted to the hospital. He received Remdesivir and Steroid. On 5/28/22, he complained of chest pain. Echo shoed cardiomyopathy with EF 35-40%. He went to ventricular fibrillation. He was coded twice. He was able to achieve return of spontaneous circulation but was still hypotensive with maximum support. His family decided DNR and pronounced death at 13:51 on 5/28.
1589006 2307121 2022-06-02 TN 72.00 Patient presented to ED for SOB, Afib with RVR on arrival, rate improved with metoprolol. Solu-Medrol given, and tolerated home oxygen level, 3 LNC. RVP positive for Covid-19. ProBNP elevated, COPD and mild CHF exacerbation secondary to viral infection, UTI on urinalysis, Rocephin given. Recommended to patient admission to hospital, patient chose to go home. Patient was discharged home on steroids and antibiotics. Patient expired on 03/17/2022.
1589008 2307124 2022-06-02 75.00 pt had a positive COVID test on 1/24/22 as an out patient; 1/30/22 pt was brought to ED with worsening SOB, generalized weakness, productive cough that's worsened over past 2-3 days; O2 supplementation; tested positive again for COVID; chest x-ray shows COVID pneumonia; given Decadron and Remdesivir; ABX; O2 needs increased; transferred to MICU; pt required intubation with mechanical ventilation, requiring a paralytic; ran fever; EKG showed LBBB and Sinus Tachycardia; worsening kidney function; pt became a DNR and transitioned to comfort care; he passed away in the hospital
1589013 2307129 2022-06-02 TN 77.00 Patient tested positive for Covid-19 on 01/13/2022. Patient admitted to hospital on 02/26/2022 with c/o SOB and was found to have hypothermia along with AKI/CKD. Patient was placed on antibiotics and found to have E. Coli UTI with chronic indwelling foley and had issues with dysphagia, eventually suffering from aspiration PNA with worsening oxygen requirements requiring PAP support. Patients work of breathing continued to increase and palliative measures were introduced, he developed shock which worsening despite vasopressor support and decision was made to transition to comfort measures only. Patient expired on 03/04/2022.
1589018 2307134 2022-06-02 MI 83.00 Deceased (5.28.22); Hospitalized (5.26.22); COVID-19 positive (5.21.22); Fully vaccinated. -moderna x2 HOSPITALS Discharged as Deceased Summary BRIEF OVERVIEW: Discharge Provider: medical doctor Primary Care Physician at Discharge: medical doctor Admission Date: 5/26/2022 Active Hospital Problems Diagnosis Date Noted POA ? Acute kidney injury 05/28/2022 Unknown ? Encephalopathy 05/27/2022 Unknown ? Acute on chronic respiratory failure with hypoxia 05/26/2022 Unknown ? Pneumonia 05/26/2022 Unknown ? Chronic obstructive pulmonary disease 05/26/2022 Unknown ? Narrow complex tachycardia 05/26/2022 Unknown ? Ischemic cardiomyopathy 05/26/2022 Unknown ? Ventricular tachycardia 03/29/2021 Yes ? Intracranial hematoma following injury 02/13/2020 Yes ? Chronic combined systolic and diastolic congestive heart failure 04/19/2016 Yes ? Hypothyroidism 01/15/2016 Yes ? Diabetes mellitus Discharge Disposition: Deceased DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute on chronic respiratory failure with hypoxia HOSPITAL COURSE: Patient is an 84 y/o M with pmhx of COPD, DMII, HTN, atrial fibrilllation, VT, CHF, CAD & ICM with ICD, hypothyroidism and dementia who presented on 5/21/22 to outside hospital ED with c/o dyspnea with cough over weeks time, aggravated by exertion. At that time patient had positive COVID 19 test with CXR showing left basilar consolidation with small left effusion. Troponin 0.023, BNP 1030, WBC 7.2 & Lactic 1.8. Admitted to medical center & treated with 3 days of remdezivir, decadron taper & was weaned back to 2L O2. Patient then sent to a sub-acute-rehab (SAR) facility on 5/24/22 where he had a reported sudden change in mental status with confusion, agitation, aggressive with staff. Patient was sedated. Per SAR documentation, concern for dementia prior to COVID 19 infection after discussion with son. 5/26/22 transferred to hospital ICU initiated d/t recurrence of respiratory distress in setting of post-COVID 19 pneumonia with oxygen dependent COPD and suspected fluid overload component. MRSA screen positive. Started on broad-spectrum antibiotics and required HFNC at 100% FIO2. Echo not well visualized, but systolic function appeared mildly reduced. Course complicated by intermittent V tach which self-terminated with no shocks delivered. Met with family 5/28/2022 and they were all in agreement to transition to comfort care. Patient was pronounced dead at 16:50 on 5/28/2022 5/26/22 H&P: CHIEF COMPLAINT: Acute on chronic respiratory failure with hypoxia ASSESSMENT / PLAN * Acute on chronic respiratory failure with hypoxia Assessment & Plan Current blood gas is acceptable on 60% high-flow Updated chest x-ray with dense left lower lobe consolidation Plan Titrate FiO2 as able Marginal candidate for BiPAP given depressed mental mental status Follow serial chest x-rays and fluid status closely Pneumonia Assessment & Plan Found to be COVID positive - however available current imaging is atypical for COVID pneumonia Is status post treatment with remdesivir and Decadron as well as CAP with rocephin and zithromax COVID vaccination x2 no booster Plan Noncontrast chest CT to evaluate pleural versus parenchymal consolidation Zosyn and vancomycin pending culture data Film array/ Panculture Chronic obstructive pulmonary disease Assessment & Plan Active tobacco abuse up until recently No recent PFTs Reportedly noncompliant with request for home O2 Plan Bronchodilators as ordered Systemic steroids for acute exacerbation Congestive heart failure Assessment & Plan Labeled chronic systolic CHF Last EF was 46% ICD is in place Plan is to update echo Monitor fluid status Diabetes mellitus Assessment & Plan On insulin as an outpatient Glycemic control in place NPO for now Intracranial hematoma following injury Assessment & Plan Noted following MVA in 2020 Currently with decreased level of consciousness thought to be due to toxic metabolic encephalopathy - noncontrast head CT pending Hypothyroidism Assessment & Plan On synthroid No recent TSH available - requested SUBJECTIVE: The patient is an 84-year-old male who originally presented to hospital on 05/21/22 with complaints of weakness. He was found to have a pneumonia as well as tested positive for COVID-19. In addition to routine community-acquired pneumonia coverage with antibiotics he was placed on Decadron and remdesivir. His pulmonary status improved and he was discharged on a 2 L of O2 on 05/24/2022 to subacute rehab. Shortly after arriving to rehab he had acute mental status change with confusion, agitation. The day of transfer to our facility described as having marked decrease level responsiveness. Relevant past medical history includes type 2 diabetes mellitus, chronic obstructive pulmonary disease with recent discontinuation of tobacco for which he is supposed to be on home O2, hypothyroidism, chronic systolic congestive Heart failure last EF 46%, status post ICD placement, history of intracranial hematoma after MVA in 2020 OBJECTIVE: BP 112/88 | Pulse 76 | Temp 36.7 �C (Oral) | Resp 18 | Ht 1.7 m | Wt 119.3 kg | SpO2 (!) 88% | BMI 41.28 kg/m� FIO2 (%): 60 % Physical Exam Constitutional: Comments: Somnolent Arouses to noxious stimuli HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Comments: Prolonged expiratory phase with marked decrease in breath sounds bilaterally Abdominal: General: There is no distension. Palpations: Abdomen is soft. Tenderness: There is no abdominal tenderness. Musculoskeletal: Right lower leg: No edema. Left lower leg: No edema. Skin: General: Skin is warm and dry. Neurological: Mental Status: He is disoriented. Comments: Moving all 4 extremities spontaneously Briefly interactive with noxious stimuli
1587558 2304952 2022-06-01 MN 89.00 admitted 5/12 for management of acute hypoxic respiratory failure secondary to COVID pneumonia.
1587596 2304992 2022-06-01 80.00 4/29/22 pt admitted to hosp; positive for COVID; extensive comorbidities; given O2 supplementation, dexamethasone, remdesivir; pt experienced A Fib with RVR; pt decided to become DNR/DNI; requesting comfort care and hospice; pt passed away in the hospital
1587612 2305008 2022-06-01 91.00 2/16/22 pt presents to hosp with lethargy and poor appetite; hx of positive COVID test on 1/22/22; admitted with encephalopathy metabolic secondary cellulitis vs in-patient delerium; probable cellulitis RUE vs septic joint; IV ABX; AKI; pt made DNR/DNI, no feeding tubes or artificial nutrition; transitioned to comfort care/hospice; pt passed away in the hospital
1587677 2305073 2022-06-01 90.00 Pfizer COVID vaccine #3 given 8/26/22, lot # FD8448; pt had a positive at home COVID test on 4/20/22; was given monoclonal antibodies the following day; 4/23/22 admitted to hospital with worsening hypoxia x past 4 days; pt placed on BiPAP; dexamethasone, ABX, DuoNeb, remdesivir; pt was transitioned to DNR/comfort care and passed away in the hospital
1587685 2305081 2022-06-01 MN 84.00 Dose 1 given 1/28/2021 Moderna, no lot # available. Pt tested positive for Covid 19, was admitted to the hospital and died from Covid pneumonia/respiratory failure.
1587686 2305082 2022-06-01 78.00 1/19/2022 pt admitted to hosp after being found laying in feces x 7days with maggots; acute metabolic/infectious encephalopathy secondary to pneumonia from gram positive cocci and COVID 19; positive COVID test on 1/20/22; DNR; developed melena, endoscopic evaluation offered but pt refused; experienced change in mental status and fever; IV ABX; MRSA bacteremia and pneumonia; poor kidney function; condition worsened; became hypoxic and nonresponsive; transitioned to inpatient hospice where he passed away
1587704 2305100 2022-06-01 WI 84.00 Tested Positive for Covid 04/13/2022, 04/18/2022, 05/18/2022 Died 05/22/2022
1587736 2305133 2022-06-01 52.00 11/6/21 Pt admitted to hosp as a transfer from another hospital for critical care management; was diagnosed positive for COVID on 11/1/21; pt in hypoxic respiratory failure and septic shock due to COVID pneumonia; given Baricitinib and dexamethasone; ABX; vasopressors and sedation; Right IJ vein DVT, on heparin drip; pt's condition quickly worsened; DNR; he passed away in the hospital.
1587757 2305154 2022-06-01 83.00 Pfizer COVID vaccine #3 given 10/06/2021, lot #30158A; pt had a positive COVID test on 2/22/22; 4/25/22 pt admitted to hospital with another positive COVID test, as a transfer from medical center; pt in respiratory failure, intubated; sepsis; hypotension; O2 sats 86% on 6 L via NC; on ABX, steroids; multi-organ failure; transitioned to comfort care/hospice; pt died in the hospital
1587837 2305235 2022-06-01 88.00 9/1/21 pt was seen in ED with a positive COVID test; recommended admission, but wife took pt home; 9/2/21 home health nurse found pt unresponsive; pt sent to ED; admitted; treated with ABX, decadron, remdesivir; wife wanted all care to be given to pt despite his DNR; intubated for airway protection; ICU; extubated; experienced grand mal seizure; given Keppra; on 100% O2 by NRB mask; wife passed away of COVID while pt in hospital; POA transitioned pt to DNR with palliative care; pt passed away in the hospital
1587858 2305257 2022-06-01 76.00 1/4/22 pt admitted to hosp with 4 days of SOB and cough; positive COVID test; hypoxic; on BiPAP; chest x-ray showed pneumonia; transferred to ICU; pt decompensated when off BiPAP x 20mins; alternating Vapotherm during the day and BiPAP at night; given dexamethasone, baricitinib, remdesivir; A Fib with RVR; pt continued to decline; respiratory distress requiring intubation followed by profound shock; condition worsened and pt passed away in the hospital
1587893 2305294 2022-06-01 84.00 12/07/2021 pt was admitted to hospital by a certificate of need; 12/27/21 pt began coughing; 12/28/21 CXR showed left lower pneumonia; given an antibiotic; persistent cough; COVID test was positive; transferred to another hospital; pt not in respiratory distress; no COVID treatment required; was put in COVID isolation room; 1/12/22 pt became less interactive and stopped eating; 1/13/22 psychiatric meds were stopped; 1/14/22 pt had a sudden hypoxia with hypotension; DNR/DNI; pt expired in the hospital
1587908 2305309 2022-06-01 95.00 8/16/21 pt admitted to hospital with dyspnea, weakness, and rhinorrhea; given O2 supplementation; had a positive COVID test; (pt had a previous positive COVID test ordered by Rehab Center on 8/6/21); pt passed away in the hospital the next day
1587255 2303498 2022-05-31 TN 77.00 Patient brought to ED shortly after testing positive for Covid-19 d/t increased confusion, vomiting, and decreasing oxygen saturation. Patient was admitted to hospital services with acute hypoxemic respiratory failure secondary to covid-9. Patient was unable to be on BiPap with vomiting. Patient started on Bronchodilator, dexamethasone and remdesivir and Baricitinib. Patient expired on 02/21/2022 with diagnosis of acute metabolic encephalopathy, Afib, AMS, aspiration PNA, CKD, Covid-19 virus infection, chronic combined systolic and diastolic CHF, Diabetes, Respiratory failure.
1586877 2303034 2022-05-31 TX 87.00 The callers Mother passed away from Cirrhosis of the Liver and Dementia; The callers Mother passed away from Cirrhosis of the Liver and Dementia; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HEPATIC CIRRHOSIS (The callers Mother passed away from Cirrhosis of the Liver and Dementia) and DEMENTIA (The callers Mother passed away from Cirrhosis of the Liver and Dementia) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Dementia and Liver cirrhosis. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEPATIC CIRRHOSIS (The callers Mother passed away from Cirrhosis of the Liver and Dementia) (seriousness criteria death and medically significant) and DEMENTIA (The callers Mother passed away from Cirrhosis of the Liver and Dementia) (seriousness criteria death and medically significant). The reported cause of death was cirrhosis of the liver and Dementia. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided. Company comment: This is a spontaneous case concerning a 87-year-old, female patient with concurrent medical conditions of cirrhosis of the liver and dementia and with vaccine history of receiving first, second and third dose of mRNA-1273 vaccine, who experienced the unexpected serious (medically significant and death) AESI event of hepatic cirrhosis and the unexpected serious (medically significant and death) event of dementia. The events hepatic cirrhosis and dementia occurred before the patient received first, second and third dose of mRNA-1273 vaccine administration. It was reported that the patient died from cirrhosis of the liver and dementia approximately 66 days after the patient received third dose of mRNA-1273 vaccine administration. It was unknown if autopsy was performed and if the cause of death was determined by a physician. The patient's age remain confounder for the event dementia. The concurrent medical conditions of cirrhosis of the liver and dementia remain confounders for the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-575845.; Sender's Comments: This is a spontaneous case concerning a 87-year-old, female patient with concurrent medical conditions of cirrhosis of the liver and dementia and with vaccine history of receiving first, second and third dose of mRNA-1273 vaccine, who experienced the unexpected serious (medically significant and death) AESI event of hepatic cirrhosis and the unexpected serious (medically significant and death) event of dementia. The events hepatic cirrhosis and dementia occurred before the patient received first, second and third dose of mRNA-1273 vaccine administration. It was reported that the patient died from cirrhosis of the liver and dementia approximately 66 days after the patient received third dose of mRNA-1273 vaccine administration. It was unknown if autopsy was performed and if the cause of death was determined by a physician. The patient's age remain confounder for the event dementia. The concurrent medical conditions of cirrhosis of the liver and dementia remain confounders for the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Cirrhosis of the Liver; Dementia
1586749 2302902 2022-05-31 those lovely shots killed my daddy; shed that spike protein; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included covid-19 (Family History) (the patient's son-in-law had covid-19) and shingles (Family History) (the patient's daughter had shingles). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and protein total increased. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the protein total increased was unknown. The reported cause of death was unknown cause of death. The reporter considered the unknown cause of death to be related to Shingles vaccine. It was unknown if the reporter considered the protein total increased to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 25-MAY-2022 Reporter's Comment: This case was reported by patient's daughter via interactive digital media. The patient took the jabs (Shingles vaccine) (though the reporter begged him not to) and he shed that spike protein and suddenly reporter's husband had Covid and reporter had shingles. The reporter stated that, if that was not enough, those lovely shots killed her daddy (patient). The reporter further stated that, all these little birds were chirping source, source would never believe they had been lied too and fooled. The doctors and so many others were kept ringing the alarm, but they would not listen. Additional Supportive Information: The follow up would not possible as no contact details were available. Note: As the information was not clear. Hence, all the information was retained, and case kept valid.; Reported Cause(s) of Death: Unknown cause of death
1587103 2303341 2022-05-31 86.00 pt tested positive for COVID on 10/24/21; 10/25/21 family brought pt to hosp requesting care, stating they were unable to care for him any longer; dx with COVID pneumonia; some dyspnea but not requiring O2 supplementation; started on ABX; began to prepare to transition him to hospice care; DNR; 10/29/21 dc'd pt to Hospice where he passed away; DC and med records sent to vaers website
1587122 2303361 2022-05-31 31.00 11/9/2021 pt tested positive for COVID at Urgent Care; came to Hospital on 11/15/21 for SOB; treated with remdesivir, Baricitinib, dexamethasone with no improvement; found to be positive for AIDS on 12/4/21; intubated; 12/9/21 transferred to Medical Center for ECMO evaluation; severe ARDS with opportunistic infections; pt required heavy sedation; grim prognosis; refractory shock; pt's condition continued to deteriorate and he passed away in the hospital; death certificate and med records sent
1587134 2303373 2022-05-31 76.00 pt had a positive COVID test on 1/10/22 at a Hospital; pt received from hospital on 1/21/22 to another HCF; pt with end-stage dementia; DNR; comfort measures only; admitted to a hospice; on O2 supplementation; pt passed away in the facility; death certificate and records sent to info@vaers.org
1587149 2303389 2022-05-31 AR 78.00 Pt was admitted to the hospital on 5/27 for a hip fracture following a fall, found to be positive for covid, pt died on 5/30
1587219 2303461 2022-05-31 WI 86.00 Patient is a 87 y.o. female, never smoker, no significant prior pulmonary history, other more comorbidities including anemia of chronic disease, chronic kidney disease on dialysis, diabetes mellitus, heart failure with preserved ejection fraction, presented from her nursing facility confusion, dyspnea and weakness.presented to the ED on 05/16/2022 after dialysis due to weakness and not feeling well, diagnosed with COVID. She had normal vital signs and she was prescribed antibiotics and sent back to the facility. She had worsening symptoms last night. She presented to the ED again today. She was found to be hypercapnic. She was placed on BiPAP.
1587239 2303481 2022-05-31 TN 81.00 Patient presented to ED on 02/09/2022 for chest pain and mild shortness of breath. The patient tested positive for Covid-19 on 02/08/2022. The patient required 2LNC in ED. Ddimer elevated, and patient was admitted to rule out a PE. Patient also presented with AMS. The ED started the patient on a heparin qtt. Patient expired on 02/23/2022. Death diagnosis include Respiratory Failure, Covid-19 PNA, Failure to Thrive, AKI, NSTEMI with elevated troponin.
1587411 2303656 2022-05-31 65.00 Pfizer COVID vaccine #3 given 12/17/2021, lot # FE3594; pt had a positive COVID test on 2/11/2022, ordering facility Hospital; 3/30/22 admitted to hosp with acute renal failure, acute hypercalcemia, acute encephalopathy, dx with multiple myeloma; took 3 rounds of chemotherapy; no renal failure improvement; suffered 2 PEA arrests and did not survive the second one.
1587279 2303522 2022-05-31 72.00 Pt had a positive COVID test on 12/29/21; pt was in the hosp and dc'd to home on 12/20/21 with gastroenteritis, COVID, AKI; presents back to hosp on 1/4/22 with c/o fever and chills; worsening hypoxia; O2 supplementation; chest x-ray shows COVID pneumonia; given "COVID directed therapies"; worsening PNA and delerium; pt is now a DNR/DNI; dc'd to home with a Hospice on 1/13/22; presuming pt died at home on 1/15/22; do not have access to death certificate; med records sent to info@vaers.org
1587378 2303623 2022-05-31 94.00 Moderna COVID vaccine #3 given 9/8/21, lot # 045C21A; pt had a positive COVID test on 4/18/22 while staying at Nursing Home; 4/24/22 pt sent to hospital due to being found unresponsive; CXR showed COVID pneumonia; CT of the brain showed chronic subdural; in acute renal failure; admitted; post acute respiratory failure; O2 supplementation; pt made comfort care only; septic shock; pt passed away in the hospital
1587424 2303669 2022-05-31 62.00 Pfizer COVID vaccine #3 given 10/22/21, lot # FF2593; pt had a positive COVID test on 5/2/21 when he was admitted to the hospital; AHRF secondary to pneumonia; presented with SOB, cough, nasal congestion; right pneumonia with effusion; ICU; ABX; thoracentesis; pt's condition worsened; placed on comfort care only and passed away in the hospital
1587396 2303641 2022-05-31 83.00 Moderna COVID vaccine #3 given 12/9/21, lot #058H21A; pt had a positive COVID test on 3/23/22 at Care and Rehab Center; on supplemental O2; pt passed away in the facility on 4/2/22
1587298 2303541 2022-05-31 TN 59.00 Presented on 1/28/2022 with inferior STEMI s/p PCI, DKA, and Covid-PNA. Hospital course complicated by acute hypoxic respiratory failure 2/2 PNA, volume overload, and new onset atrial fib. On admission to CC the patient was intubated and sedated. Patient tested positive for Covid on 1/28/22. Patient was not a candidate for Remdisivir because of being intubated. Patient was treated with steroids. For PNA he was started on antibiotics, and diuresis for volume overload and was extubated. Patient was transferred to step down and started on Remdesivir per ID. Patient with inferior STEMI who underwent emergent PCI/DES to the RCA, then developed VF arrest with inability to achieve ROSC.
1587346 2303591 2022-05-31 63.00 pt had a positive COVID test on 3/29/22; 4/12/22 pt had a laparoscopic left colectomy in the hospital; she developed hypotension; given IV fluids; appearance of generally ill; c/o nausea; 4/14/22 had abd CXR which showed underlying ileus; pt progressed to shock; became septic; transferred to ICU; DNR; pt's condition worsened and she died in the hospital
1587304 2303548 2022-05-31 TN 72.00 Patient was admitted to hospital on 02/20/2022 with complaints of SOB. He had progressive dyspnea and shortness of breath prior to admission. Patient was diagnosed with Covid-19 on 02/20/2022. He was immediately started on high-flow and admitted to the ICU. He was managed conservatively for several days however he did end up requiring intubation. He continued to decline on the ventilator and eventually required prone therapy. At this point, family decided to withdraw care and comfort measures were instituted. The patient was transferred to the medical -surgical floor. Patient expired on 03/02/2022.
1587334 2303579 2022-05-31 TN 78.00 Patient tested positive to Covid-19 on 02/27/2022 and admitted to hospital on 02/28/2022 for acute kidney failure, acute respiratory failure with hypoxia. Patient expired on 03/16/2022.
1586156 2301167 2022-05-28 I lost my little brother to a Pfizer heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "I lost my little brother to a Pfizer heart attack". The patient date of death was unknown. Reported cause of death: "I lost my little brother to a Pfizer heart attack". It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: I lost my little brother to a Pfizer heart attack
1584385 2298706 2022-05-27 93.00 pt had a positive COVID test on 8/23/21 from a facility; pt passed away in the facility; DC and med records sent to vaers website
1583335 2297615 2022-05-27 75.00 Parkinson's disease; Dementia due to Parkinson's disease; Interchange of vaccine products; Seizures; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PARKINSON'S DISEASE (Parkinson's disease), DEMENTIA (Dementia due to Parkinson's disease) and SEIZURE (Seizures) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065K21A and 030H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products CARBIDOPA, LEVODOPA (DUOPA) for Parkinson's disease and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. The patient's past medical history included Alcohol use in 2012 and Arterial stent insertion NOS. Concurrent medical conditions included Penicillin allergy, Non-smoker and Parkinson's disease. Concomitant products included LORAZEPAM for Anxiety, QUETIAPINE FUMARATE (SEROQUEL) for Anxiety and Prophylaxis, PARACETAMOL (TYLENOL) for Pain, TRAZODONE for Prophylaxis, VENLAFAXINE, MIDODRINE, MACROGOL 3350 (MIRALAX), VITAMIN D2 and LANSOPRAZOLE (PREVACID) for an unknown indication. On 16-Oct-2017, the patient started CARBIDOPA, LEVODOPA (DUOPA) (Percutaneous) at an unspecified dose. On 06-Feb-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 12-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2022, the patient experienced SEIZURE (Seizures) (seriousness criteria death and medically significant) and PYREXIA (Fever). On an unknown date, the patient experienced PARKINSON'S DISEASE (Parkinson's disease) (seriousness criteria death and medically significant), DEMENTIA (Dementia due to Parkinson's disease) (seriousness criteria death and medically significant) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was treated with Hospice care for Parkinson's disease; Hospice care for Dementia; Hospice care for Seizure and Hospice care for Pyrexia. The patient died on 12-May-2022. The reported cause of death was parkinson's disease and dementia due to parkinson's disease. It is unknown if an autopsy was performed. At the time of death, PYREXIA (Fever) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104.3 f 104.3 F. Company Comment: This spontaneous case concerns a 75-year-old old male patient with concurrent condition of Parkinson's Disease and relevant medical history of Arterial stent insertion who experienced the fatal unexpected, serious (medically significant) adverse event of special interest of Seizure and fatal, unexpected (medically significant) events of Parkinson's disease and Dementia which occurred after receiving a dose of mRNA-1273 vaccine taken as fourth dose of COVID-19 immunization. He previously received mRNA-1273 approximately five months prior to the current dose but with no information on adverse event. Interchange of vaccine products is noted in this case as he received Pfizer BIONTECH COVID-19 vaccine as primary series of COVID-19 immunization. Patient has been taking several central nervous system medications and was admitted to hospice care 10 months prior to the events. Two days after the last dose of mRNA-1273 administration, he developed high grade fever (104.7 degrees Fahrenheit) and seizure. The clinical course was not provided but reported that patient died at home 8 days after the onset of seizure. Death occurred 9 days after second dose of mRNA-1273 vaccine. The cause of death was reported as Parkinson's disease and Dementia due to Parkinson's disease. It is unknown if an autopsy was performed. Dementia is a common manifestation of Parkinson's disease. Concomitant use of Venflaxine and Trazodone and occurrence of high grade fever are confounders for the event Seizure. Advanced age, medical history and low body mass index are also considered confounders for the fatal outcome. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 75-year-old old male patient with concurrent condition of Parkinson's Disease and relevant medical history of Arterial stent insertion who experienced the fatal unexpected, serious (medically significant) adverse event of special interest of Seizure and fatal, unexpected (medically significant) events of Parkinson's disease and Dementia which occurred after receiving a dose of mRNA-1273 vaccine taken as fourth dose of COVID-19 immunization. He previously received mRNA-1273 approximately five months prior to the current dose but with no information on adverse event. Interchange of vaccine products is noted in this case as he received Pfizer BIONTECH COVID-19 vaccine as primary series of COVID-19 immunization. Patient has been taking several central nervous system medications and was admitted to hospice care 10 months prior to the events. Two days after the last dose of mRNA-1273 administration, he developed high grade fever (104.7 degrees Fahrenheit) and seizure. The clinical course was not provided but reported that patient died at home 8 days after the onset of seizure. Death occurred 9 days after second dose of mRNA-1273 vaccine. The cause of death was reported as Parkinson's disease and Dementia due to Parkinson's disease. It is unknown if an autopsy was performed. Dementia is a common manifestation of Parkinson's disease. Concomitant use of Venflaxine and Trazodone and occurrence of high grade fever are confounders for the event Seizure. Advanced age, medical history and low body mass index are also considered confounders for the fatal outcome. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Parkinson's disease; Dementia due to Parkinson's disease
1584380 2298701 2022-05-27 90.00 pt had a positive COVID test on 12/6/21; asymptomatic except for poor oral intake; pt stays in Health and Rehab facility; pt passed away in the facility; DC and med records sent.
1584287 2298599 2022-05-27 90.00 Moderna COVID vaccine # 3 given 11/29/2021, lot #027H21B; 1/3/22 pt admitted to hosp with worsening altered mental state and back pain; found to be positive for COVID; treated with dexamethasone, remdesivir, supportive care; no improvements; transitioned to comfort care and pt passed away in the hosp; DC and med records sent.
1584409 2298730 2022-05-27 86.00 COVID 19 that lead to pneumonia and hospitalization
1584450 2298773 2022-05-27 MI 65.00 Patient was recently admitted to hospital from 01/13-1/16 with COVID PNU, was treated with empiric antibiotics and Decadron, was subsequently discharged home on about 6 L home oxygen. His condition worsened and he presented back to the ER on 01/17 with worsening shortness of breath. Was hypoxic and was placed on high-flow oxygen. CTA showed right-sided PE, echo did not show any evidence of right heart strain. He was started on Eliquis, Decadron and empiric antibiotics and was admitted to hospitalist service. He remained on high-flow oxygen. He was weaned to nasal cannula on 01/27 and currently on 6L, and wanted to go to specialty hospital. At hospital he spent 26 days, hewas deemed safe for discharge to the inpatient rehab facility by myself and the specialist(s) on 2/25/2022. subsequently Rehabilitation Hospital from 2/25-3/4. Patient subsequently experienced increased WOB and LOC with declining mental status and was then transferred to hospital. Initially admitted to mod care with high O2 requirements. On 3/7, CCM consulted for increasing O2 requirement that decompensated overnight requiring intubation. On 3/16/22 Patient became bradycardic and subsequently was found to be in PEA arrest. Family elected to make patient DNR at that time. TOD: 1250.
1584530 2320202 2022-05-27 81.00 Narrative: Fully COVID vaccinated, positive on admission, passed away due to hypoxic respiratory failure secondary to COVID
1582917 2296413 2022-05-26 TN 82.00 Patient was recently discharged from Hospital on July 30, 2021 after receiving treatment for community acquired PNA and pleural effusion. Sent home on ABX and completed that course on August 5th. Daughter reports since discharge patient has been very fatigued with no energy and sleeps most of day, with increasing bilateral lower extremity weakness and has fallen which prompted a call to EMS. On arrival to ED patients BP was 79/42 and HR in 50's. A sepsis bundle was initiated and was started on Levophed with an ICU admission. Patient tested positive for Covid 19 on 8/11/2021. Patient expired on 08/19/2021.
1582795 2296285 2022-05-26 81.00 pt staying in hospital; admitted on 12/17/21; had a positive COVID test on 1/27/22; planned to stay through quarantine period, but pt expired on 2/5/22; DC and med records being sent to info@vaers.org
1582800 2296290 2022-05-26 65.00 pt admitted to hospital on 12/3/21 for acute encephalopathy, acute right MCA stroke, cerebral edema; pt had a positive COVID test on 1/17/22; found without breath and pulseless on 2/5/22. DC and med records sent to info@vaers.org
1582805 2296295 2022-05-26 42.00 1/4/22 admitted to hosp for generalized weakness, body aches, sore throat, SOB, Cough, N/V/D x 2 days; poor oral intake; found to be positive for COVID; currently being worked up for heart transplant list; AKI secondary to hypovolemia/hypotension; suffered cardiac arrest; intubated; revived; pt self extubated and made himself a DNI; pt passed away in the hospital
1582814 2296305 2022-05-26 85.00 PFIZER COVID Booster (#3) given 10/4/21, lot # FF2587; pt admitted to hosp 1/15/22 with SOB; found to be positive for COVID and have COVID pneumonia; family wanted comfort care; pt admitted to GIP hospice for end of life care; pt passed away in the hospital; DC and med records sent to vaers
1582419 2295570 2022-05-26 BLOOD CLOT; This spontaneous report received from a consumer via media via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced blood clot. The reporter stated that, "I finally know of someone who died of a blood clot from the vaccine". It was unspecified if an autopsy was performed. On an unspecified date, the patient died from blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0-20220547817-covid-19 vaccine ad26.cov2.s-Blood clot. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: BLOOD CLOT
1582838 2296330 2022-05-26 82.00 pt had a positive COVID test from Hospital on 1/13/22; requested med records but only received GIP hospice records from Hospice; pt was DNR; admitted with ARF; on O2; pt passed away inpatient hospice; DC and med records sent to vaers
1582851 2296345 2022-05-26 74.00 pt had a positive COVID test on 1/3/22 while in local Healthcare facility; pt died at the hospital on 1/5/22; DC and med records sent to info@vaers.org
1582866 2296361 2022-05-26 86.00 pt had a positive COVID test on 1/14/22 while in nursing home asymptomatic initially except for sleeping a lot; later became congested, non-productive cough; O2 supplementation, dexamethasone, ABX and cough syrup; pt passed away in the nursing home; DC and med records sent to info@vaers.org
1582876 2296371 2022-05-26 48.00 pt had a positive COVID test on 9/1/2021, ordered by Health Department; pt died at home with COD being COVID 19; DC and record from medical examiner sent to vaers
1582829 2296320 2022-05-26 54.00 pt admitted to hosp 12/24/21 with SOB; had a recent dx on 12/23/21 with a positive COVID test; given O2 supplementation; condition worsened and he was transferred to CCU; intubated and sedated; given dexamethasone, remdesivir, baricitinib, ABX; renal function worsened; pt was made comfort care; palliatively extubated and passed away in the hosp
1582919 2296415 2022-05-26 TN 78.00 Patient tested positive for Covid-19 on 1/12/2022, was transferred to hospice facility with diagnosis of HTN, Hyperlipidemia, Scoliosis, GERD, Hx of femur fracture, overactive bladder, chronic pain, and Covid. Patient expired on 1/24/2022.
1583006 2296505 2022-05-26 84.00 pt had a positive COVID test on 9/8/21 ordered from nursing home; pt passed away at hospice facility; DC and med records sent to info@vaers.org
1582941 2296439 2022-05-26 MT 42.00 Case Completed primary Covid series in March 2021, then died of Covid in January 2022. Case sought medical care for cough, respiratory symptoms, fever and chills at local ER on 1/14/2022, but left Against Medical Advise the same day. He died somewhere out of the facility, where the coroner's report included that Covid contributed to his death on 1/16/2022.
1583064 2296565 2022-05-26 MT 84.00 Case was vaccinated and boosted x1 as of November 2021, then was hospitalized for several hours and died of COvid in APril 2022. Case self-tested at home 2 days prior to seeking care at the ER for acute on chronic respiratory failure. She was admitted for a few hours, but died the same day she sought care.
1583034 2296534 2022-05-26 85.00 Moderna COVID #3 vaccine given 11/11/21, lot #004F21A; pt had a positive COVID test on 11/22/21 while staying at a Home; pt also fell and had poor oral intake; 12/7/21 came to hospital with left hip fx; due to pt's fragile state, surgery was not attempted; placed on comfort care only; inpatient hospice; pt died in the hospital
1583032 2296532 2022-05-26 MT 90.00 Case received primary vaccine series in January 2021, and died of Covid in October 2021 Case was a resident of a long-term care facility. He tested positive for Covid, and died the same day before he could be taken to the hospital. The facility was experiencing an outbreak at the time.
1582849 2296343 2022-05-26 89.00 1/5 - 1/11/22 recent hospitalization for right hip fx; had a positive COVID test on 1/11/22, pt asymptomatic; and was dc'd to a nursing home; 1/15/22 pt readmitted to hosp for acute encephalopathy; UTI discovered; ABX; DNR/DNI; dexamethasone given with O2 supplementation; worsening condition; made comfort measures only and pt passed away in the hospital; DC and med records sent to info@vaers.org
1582992 2296490 2022-05-26 80.00 11/5/21 pt admitted to hosp with altered mental status, lethargy, hypoxia, found to be positive for COVID, A Fib with RVR, UTI, respiratory failure; per daughter, pt had a positive COVID test also in September 2021 (9/3/21 and 9/7/21) but did not require hospitalization but did isolate in a nursing home; pt this time given decadron; pt's condition deteriorated and she passed away in the hospital; DC and med records sent to vaers
1582962 2296460 2022-05-26 TX 68.00 Presented with AMS/confusion x2 days; Covid + in ED; Admit ICU 9/15 Covid PNA; tx 9/16 zinc, singulair, merrem, steroids, eliquis, 9/17 vanc,; with High K+ and AKI with admit..not candidate for remdesivir or baricitinib; O2 initially on 6 LPM NC; transitioned to HF O2 within 24 hours; 9/20 pt intubated; 10/2 CRRT started; 10/7 Currently; pt on 1 pressor, 100% FiO2, High CO2 values and unresponsive >24 hours off sedation and paralytics; Discussing comfort measures with family. Patient has been made DNR by family members,and was pronounced dead on 10/15/2021
1582960 2296458 2022-05-26 47.00 pt had hosp admission 9/3 - 9/8/21 for positive COVID test and COVID pneumonia; dc'd to home; continued to have SOB; came to ED with AHRF secondary to pneumonia, left pneumothorax and thrombocytopenia; transferred to Medical Center for higher level of care; O2 given; IV ABX; poor oral intake; transitioned to comfort care and pt died in the hospital
1582972 2296470 2022-05-26 TX 60.00 presented with AMS, n/v, Upper GI bleed?; Initial Covid test negative but + Influenza B; + covid 9/21; tx with : 9/17 rocephin, 9/22 steroids, 9/23 actemra; Pt had GI bleed throughout visit; Initially no O2 needed; 9/23 resp decline and dx with covid PNA; began Covid tx; 9/24 intubated 0200.010201.010202.010203.010204.010205.010206.010207.010208.01Patient developed multiorgan failure, along with ARDS/DIC. Family decided withdrawal of care. And she is pronounced dead at 1803.
1582154 2294517 2022-05-25 MI 85.00 Patient presented to the ED on 5/22/22 from her LTC facility for altered mental status. On initial presentation to the ED was unresponsive and seizing. Intubated in the ED. Found to be septic, febrile, +COVID. She underwent work up for meningitis and was treated with broad spectrum antibiotics plus antiviral on admission. Neurology was consulted and she was started on keppra. EEG showed no seizure activity. Patient was admitted to the ICU, at that time further discussions had with the patient's husband. He states that she would not have wanted aggressive care, she has advanced dementia at baseline and he did not want to escalate care. He did want to wait to move to comfort measures on 5/23/22 so that he could notify family and have family see her, but did not want any additional therapy including no pressors. On 5/23/22 family was able to come see the patient, and decision was made to move to full comfort care. Patient was extubated 1743. Comfort measures maintained, and patient passed at 2003 on 5/23/2022 with her husband at bedside. Preliminary cause of death sepsis with acute respiratory failure in +COVID pneumonia patient.
1581929 2294252 2022-05-25 IL She received one dose of the Pfizer COVID-19 vaccine and died ten days later; This is a literature report. A 90-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "major neurocognitive disorder" (unspecified if ongoing); "asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "home hospice" (unspecified if ongoing); "significantly deteriorated" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), 10 days after the suspect product(s) administration, outcome "fatal", described as "She received one dose of the Pfizer COVID-19 vaccine and died ten days later". The patient date of death was unknown. Reported cause of death: "She received one dose of the Pfizer COVID-19 vaccine and died ten days later". It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, Death cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: She received one dose of the Pfizer COVID-19 vaccine and died ten days later
1582032 2294392 2022-05-25 74.00 wife found pt down in the home and started CPR; EMS contacted; EMS also performed CPR, gave O2, Epinephrine, Bicarbonate, intubated; preceding sx was SOB; pt had been recently admitted to the hosp with COVID pneumonia (positive COVID test on 12/27/21) and was dc'd to home; wife requested CPR be stopped and pt passed away in the ED; DC and med records sent per VAERS request
1582048 2294408 2022-05-25 75.00 pt passed away at home; positive COVID test from Family Medical; sent per VAERS request
1582082 2294442 2022-05-25 75.00 pt died at home; no med records; pt had a positive COVID test on 8/14/22, ordering facility: Medical Center; DC sent per request
1582084 2294444 2022-05-25 69.00 pt had a positive COVID test on 8/16/21; post-mortem testing from Medical Education Research Institute; pt died at Hospital.
1582087 2294447 2022-05-25 68.00 pt died at home; no medical records; pt had a positive post mortem COVID test on 8/19/21; DC sent per VAERS request
1582098 2294458 2022-05-25 77.00 pt died at hospice; positive COVID test on 8/30/21 from medical center; DC and med records sent per request.
1582145 2294508 2022-05-25 74.00 1/17/22 pt presented to hosp after multiple falls, weakness, worsening cognitive function, poor oral intake; previous ED visits for same sx on 1/17/22 and 1/24/22 at the local Medical Center; 1/17/22 found to be positive for COVID; COVID pneumonia; outside the window for remdesivir; given O2 supplementation; Decadron; experienced GI bleed; transferred to another unit; code blue was called for pt and she was intubated; another code blue occurred and the pt passed away in the hospital; DC and med records sent to info@vaers.org per VAERS request
1582171 2294534 2022-05-25 55.00 recent hospital admission for BKA; sent to rehab then back to hospital on 12/7/21 with necrosis of right stump; spiked fever; cultures done; ABX started; found to have upper extremities DVTs and right PE; on 12/30/21 pt had a positive COVID test; steroids given; pt became unresponsive at some point, hypoxic, tachycardia; code blue called; ROSC never obtained; pt expired in the hospital; DC and med records sent, per request
1582200 2294565 2022-05-25 74.00 Pfizer COVID vaccine #3 given 10/1/21, lot # FF8841; 1/29/22 pt presents to hosp with generalized weakness, nausea and cough; found to be positive for COVID; given O2, remdesivir, baricitinib, dexamethasone; blood cultures positive for MRSA; multi-organ failure; pt conditioned to worsen; DNR; condition deteriorated; made comfort care only; pt passed away in the hospital; DC and med records sent.
1582261 2294628 2022-05-25 76.00 pt had a positive COVID test on 1/3/22 taken to Hospital; 1/15/22 pt presents to hospital from facility with SOB; O2 sats in 70s on RA; pt has a UTI; given ABX; sent to ICU; another positive COVID test on 1/15/22; pt died in the hospital; DC and med records sent per VAERS request
1582278 2294779 2022-05-25 SD 75.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 02/05/2021 and 02/26/2021. They first tested positive for COVID-19 on 09/18/2021 at an Urgent Care Clinic. They presented to Emergency Department via ambulance on 09/22/2021 with primary complaint of general weakness that had been happening for about the past 6 days. They were admitted to hospital on 09/22/2021. They were found to having multiple complications and co-occurring conditions, including ESBL E. coli and Enterococcus faecalis, a subdural hematoma, severe encephalopathy attributable to COVID-19, acute kidney injury, COVID-19 pneumonia, and Acute Respiratory Distress Syndrome (ARDS) with Acute Hypoxic Respiratory Failure. The individual lapsed into unresponsiveness and was intubated. Given poor prognosis for recovery, the family agreed to comfort care only and the individual was extubated and they died in the hospital on 10/23/2021. A second COVID-19 test on a specimen collected 10/23/2021 was also positive, but was not resulted out until 10/25/2021.
1582282 2294783 2022-05-25 60.00 pt had a hosp admission in January 2022 for CHF exacerbation, HTN, mild AKI, and positive for COVID; on 2/3/22 pt admitted to hospital with sciatica type lower back pain; given dexamethasone to improve back sx; worsening AKI; pt had a drop in hemoglobin after a melanotic stool; EGD done; pt intubated; found duodenal ulcer; pt's condition worsened; experienced asystole; ACLS protocol CPR x 3 rounds with meds, ROSC achieved; metabolic status worsened; pt was made comfort care and passed away in the hospital; DC and med records sent to info@vaers.org
1582302 2294932 2022-05-25 MT 71.00 Case completed primary Covid vaccine in February 2021, then was hospitalized and died of Covid in September 2021. Hospitalized at: Hospital. Initially hospitalized for Covid pneumonia for 4 days. Treated with Dexamethasone and remdesivir, and discharged home. Readmitted 5 days later with worsening hypoxia, kidney injury and pneumonia. Also treated with tocilizumab, yet respiratory condition worsened, and case died.
1582311 2294941 2022-05-25 MT 83.00 Case completed primary Covid vaccine series in March 20212, then was hospitalized for and died of Covid in September 2021. Case was admitted to hospital with severe respiratory conditions, in the presence of recently deteriorating health and advanced dementia. Comfort care was provided, and patient died soon after admit.
1582219 2294584 2022-05-25 52.00 1/29/22 pt presents to ED via EMS with c/o dyspnea that's worsening; has been falling at home; hx of DM and HTN; placed on CPAP; high blood glucose; DKA; transferred to ICU; found to be positive for COVID; asymptomatic; given ABX; suffered strokes and cerebral edema; condition worsened; determined brain dead by flow study; DC and med records sent t per VAERS request
1581125 2292622 2022-05-24 MN 83.00 Dose 1 given 2/10/2021 Moderna Lot # 024M20A Patient tested positive for Covid on 5/22/2022, died on 5/23/2022 at hospital.
1581186 2292683 2022-05-24 81.00 Pt staying in facility; Pt had a positive COVID test on 10/24/21; received monoclonal antibodies; still has increasing SOB; on supplemental O2 and BiPAP, but pt pulls BiPAP off frequently; decrease in appetite; weak; pt in severe respiratory distress, family refused hospitalized; comfort care with pain management; pt died in the facility; death certificate and med records sent per VAERS request
1581126 2292623 2022-05-24 MI 83.00 Pt had become increasingly short of breath over the last 2 days. He had a history of cardiac and pulmonary disease. He had newly diagnosed A. fib. He was found to be COVID positive with possible secondary bacterial pneumonia. Prior to admission he went into PEA arrest and was pronounced dead.
1581141 2292638 2022-05-24 77.00 Moderna COVID vaccine #1 given 01/02/2021, lot # 025L20A; Moderna COVID vaccine #2 given 01/30/2021, lot # 012M20A; pt stays at Rehab Center; pt had a positive COVID test on 1/14/22 and was placed in a COVID unit; pt passed away in the facility; death certificate and med records sent per VAERS request
1581161 2292658 2022-05-24 87.00 Moderna COVID vaccine #3 given 11/12/2021, lot # 002C21A; pt stays in a local facility; pt had a positive COVID test on 9/19/2021; DNR; per death certificate, pt died in the facility with coronavirus pneumonia being a condition contributing to death; death certificate and med records sent to info@vaers.org per VAERS request
1581175 2292672 2022-05-24 82.00 7/2021 pt had a hospital admission for pneumonia after a fall with fractured ribs; was dc'd to Nursing Home; 8/11/2021 presents to ED after exposure to COVID and a positive COVID test on 8/1/22; c/o increase in SOB, fever, productive cough, chills; steroids, ABX, remdesivir, dexamethasone, O2 supplementation; pt did well and was weaned off O2; dc'd to nursing facility before going home; per death certificate, pt died at home with hx of COVID being a condition contributing to death; death certificate and med records sent per VAERS request
1581183 2292680 2022-05-24 TN 74.00 Patient at hospital for long duration due to complications of covid pneumonia. Patient became hypoxic and refused Bipap therapy. Patient was transferred to hospice care and expired on 11/11/2021.
1581207 2292704 2022-05-24 77.00 pt had a positive COVID test on 1/28/2022 and was hospitalized; did not need O2; dx with COVID pneumonia and A Fib with RVR; dc'd to home on 2/3/22; 2/4/22 pt presents with extreme weakness and inability to ambulate; requesting PT rehab placement; O2 supplementation 1 L via NC; 2/8/22 admitted to facility; 2/22/22 pt was found pulseless and breathless; CPR started, EMS called; EMS stated pt remains in asystole; pt died in the facility
1581195 2292692 2022-05-24 TN 83.00 Patient presented to ED on 09/09/2021 with fever, covid positive, and shortness of breath with increased cough. In ED creatinine, BNP, troponin elevated and chest xray showing viral pneumonia. Patient expired on 9/17/22 due to Sepsis secondary to Covid PNA.
1581250 2292749 2022-05-24 60.00 PFIZER COVID vaccine #1 given 04/08/2021, lot #ER8729; Pfizer COVID vaccine #2 given 05/20/2021, lot #EW0169; pt had a previous hosp admission from 12/22/21 - 1/7/22 for left calf pain and found to be positive for COVID on 12/26/21; received monoclonal antibodies and dc'd to home; back to ED on 1/11/22 with c/o dyspnea; O2 sats in 70s on RA; EMS called; O2 supplementation given; ABX and dexamethasone; transferred to hospital; O2 demands increased requiring intubation; worsening ventilatory and pressor requirements; worsening shock; pt passed away in the hosp; DC and med records sent, per VAERS request.
1581309 2292808 2022-05-24 85.00 11/3/21 pt presents to hosp with c/o LLQ and RLQ abdominal pain, worsening with some nausea, also saw dentist today for an abscessed molar; 11/4/21 pt had an appendectomy; later had a cough with increasing SOB; initial COVID test was negative; was given dexamethasone; repeat COVID test on 11/11/21 was positive; treated with remdesivir; respiratory problems worsened; DNR/DNI; pt was using CPAP; pt's condition worsened and she passed away in the hosp; death certificate and med records sent to info@vaers.org per VAERS request
1581350 2292849 2022-05-24 88.00 pt presented to ED with wheezing, SOB, cough; tested positive for COVID; admitted; O2 supplementation; dexamethasone; baricitinib; severe sepsis; multiorgan failure; intubated; experienced cardiac arrest with ROSC; no clinical improvements; severe brain injury; DNR; palliatively extubated and pt passed away in the hosp; DC and med records sent per request
1581445 2293121 2022-05-24 SD 102.00 This is an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated with the Pfizer product on 01/04/2021 and 01/25/2021. They tested positive for COVID-19 three times on 09/30/2021 at the nursing home at which they were a resident. They had encounters at a hospital on 09/29/2021, 09/30/2021, 10/03/2021, 10/04/2021, 10/07/2021, 10/08/2021, 10/11/2021, and 10/19/2021 but it doesn't seem that any of these resulted in a hospital admission. The encounter on 10/11/2021 admit/discharge times are about 10 hours apart. The individual died on 10/22/2021.
1581225 2292722 2022-05-24 89.00 pt presents to ED with increasing hypoxia x 2 days, more lethargic; placed on BiPAP; positive test for COVID; given remdesivir, Tocilizumab, dexamethasone, ABX, O2 demands increased; pt was made comfort care; DNR; pt passed away in the hospital; DC and med records sent per VAERS request
1580512 2290580 2022-05-23 MI 68.00 COVID vaccine breakthrough case. Patient vaccinated on 2/25/21 Moderna 024M20A, 3/25/21 Moderna 017B21A and boosted on 10/28/21 Moderna 939903 (lot number stated in system).
1580238 2290270 2022-05-23 NY 71.00 12/9/2021 - Sent to ER from Oncology for SOB/hypoxia and immunocompromised due to 3/5 chemo completed for stage IV lung Ca. POC Covid test positive. On arrival temp 37, RR 18, SpO2 94 on supp O2, BP 131/87, WBC 7.7. Chest xray revealed bilateral infiltrates concerning for Covid 19. Admitted to Telemetry for covid pneumonia. Started on Vancomycin, Cefepime, Decadron, Lovenox, and Remdesivir. 12/10 - Baricitinib added to treatment. On high flow NC for O2, FiO2 65% with 40L flow. BP 152/95, HR 123. 12/11 - having asymptomatic runs of V tach and dissiculty swallowing. Kept NPO. O2 requirements not improving but not worsening. Changed steriod to Solu-medrol on 12/12. mech diet initiated 12/14- 5 day course Remdesivir complete. Baricitinib d/c 12/13 - WBC trending down. increasing hypoxia/HR - Hypoxia/tachycardia increasing -placed on BiPAP 100% FiO 12/15 - Decision for Palliative /comfort care vs aggressive treatment. 12/18 - Patient expired @1220.
1580275 2290337 2022-05-23 74.00 Pfizer COVID vaccine #1 given 02/09/2021, lot # EN9581; Pfizer COVID vaccine #2 given 03/02/2021, lot # EN6198; pt tested positive for COVID on 12/15/21; pt came to hospital 12/17/21 c/o SOB (increasing) and diarrhea; placed on O2 supplementation; chest x-ray showed COVID pneumonia; given ABX; O2 needs increased resulting in BiPAP; transferred to ICU; during the nigh pt experienced multiple cardiac arrests, mostly PEA; pt did not survive; death certificate and med records sent to info@vaers.org per VAERS request
1580381 2290446 2022-05-23 67.00 pt admitted to hospital with delerium secondary to hypoxia, COVID 19 encephalitis; given Decadron, O2 supplementation; admitted to hospice as GIP hospice; dc'd to home with hospice where he passed away; death certificate and med records sent per VAERS request
1580404 2290469 2022-05-23 65.00 Moderna COVID vaccine #1 given 03/04/2021, lot #010A21A; Moderna COVID vaccine #2 given 04/07/2021, lot #030B21A; pt had an admission to Medical Center from 11/1/21 - 11/6/21 and was treated for COVID pneumonia; had a positive COVID test 11/1/21; was given dexamethasone, remdesivir, and O2 supplementation; transferred to Hospital where she had an increase in O2 demands; intubated, steroids, and ABX given; transferred back to Medical Center for further care; experienced recurrent A Fib; AKI; sputum culture with S. Aureus and GNR; on ABX; DNR; pt's condition worsened and she went into cardiac arrest and passed away in the hospital
1580427 2290492 2022-05-23 92.00 pt had a positive COVID test on 1/24/22; brought by EMS to ED on 2/2/22 with c/o increasing SOB and generalized weakness; EMS placed NRB on pt and gave a breathing tx; in ED found to have COVID pneumonia; poor oral intake cough; O2 supplementation given; ABX given; DNR; pt refuses blood transfusions and platelets; desires to go home; dc'd to home with home health care scheduled (no mention of the name of home health in med records); pt passed away at home; death certificate and med records sent to info@vaers.org per VAERS request
1580519 2290587 2022-05-23 58.00 pt brought to ED via EMS; pt unresponsive when EMS arrived; found to have low blood sugar; given IV D5W; had an episode like a seizure before getting to ED, shaking and pink, frothy sputum noted; intubated in ED; admitted; experienced hypertensive crisis; found to be positive for COVID; given ABX, steroids; AKI on CKD stage III; hemodialysis; suffered PEA arrest; poor prognosis; inpatient hospice GIP; palliatively extubated and pt passed away in the hospital; med records and death certificate sent per VAERS request
1580535 2290603 2022-05-23 82.00 pt had been at home on hospice; had a positive COVID test on 1/8/22; came to hospital on 1/9/22 for sever hypoxia; family elected to restart GIP hospice due to poor prognosis; pt passed away in the hospital; med records and agency sent to specific website per VAERS request
1580563 2290631 2022-05-23 63.00 2/3 - 2/5/22 pt admitted to the Hospital with sepsis and COVID pneumonia; pt had a positive COVID test on 2/2/22; was dc'd to home feeling better; pt went back to the hospital on 2/9/22 with worsening dyspnea, dry cough, fatigue; hypoxic (77% O2 sat on RA); O2 given; transported to the medical center for further care; given IV Decadron and ABX; O2 demands increased; pt's condition worsened with hypotension, bradycardia, became unresponsive and pulseless; code blue called and pt passed away in the hospital; DC and med records sent to info@vaers.org per their request
1580627 2290696 2022-05-23 98.00 pt lived in SNF, from 3/31/21 - 11/21/21; pt expired in the facility after having a positive COVID test 11/10/21 with severe hydration; death certificate and med records have been sent per VAERS request
1580671 2290742 2022-05-23 66.00 12/20/21 pt seen at Medical Center ED with c/o cough and diarrhea x 2days; found to be positive for COVID; no O2 supplementation needed; was dc'd to home; 1/9/22 pt presents to ED in Medical Center with c/o cough, diarrhea, nausea and chest pain; hypoxic (O2 sats 65% on RA); O2 supplementation; admitted; worsening respiratory and renal failure; family requested desire for intubation but DNR; on 1/21/22 pt became tachypneic, but saturating reasonably well; became pulseless and passed away in the hospital; med records and death certificate sent per VAERS request
1580784 2290907 2022-05-23 SD 74.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 01/27/2021 and 02/17/2021. They first tested positive for COVID-19 on 09/14/2021 at a clinic. They presented to emergency department on 09/17/2021 but it seems they were not admitted to hospital at that time. They were admitted to hospital on 09/28/2021 and an additional COVID-19 test was positive on this day. They were found to be having multiple complications and co-occurring conditions, including COVID-19 pneumonia, Psudomonas Pneumonia, Enterococcus Pneumonia, Acute Kidney Failure, and A-fib. A third COVID-19 test on 10/15/2021 was also positive. They remained hospitalized until their death on 10/22/2021.
1580048 2290037 2022-05-22 IL 90.00 COVID Vaccine Breakthrough Case Pfizer Dose 1 3/30/21 (EN6205 Pfizer Dose 2 4/20/21 (EM9809) COVID Positive 11/22/21 11/22/21: Patient is a 91 year male from home and recently discharged. He presents to the ER today with complaints of shortness of breath and generalized weakness. Patient's past medical history significant with CKD 3, diastolic CHF, anemia of CKD hyperlipidemia, hypertension and Hashimoto thyroiditis. Patient is fully vaccinated for COVID-19. He had stable vital signs upon arrival to the ER. Chest x-ray showed cardiomegaly with mild pulmonary venous congestion and early pulmonary edema. Blood work in ER showed proBNP 4305, creatinine 1.5, troponin positive x1 and hemoglobin 8.2. Patient was treated with 40 mg IV 1 time, aspirin and Nitro-Bid. Patient was transfer to the medical unit. I met with the patient and the he was resting in bed and denies any discomfort at this time. Patient is currently 2 L oxygen nasal cannula with sats around 92%. Patient denies fever chills, abdominal pain, constipation, chest pain, palpitation, dizziness, headaches. Patient will be admitted and treated for CHF at exacerbation. And discussed the plan of care with the patient and she is agreeable to stay for further management. Patient reports having a caregiver twice a week 11/29/21: Patient is a 91 year male from home who presents to the ER today with complaints of shortness of breath and generalized weakness. Patient's past medical history significant with CKD 3, diastolic CHF, anemia of CKD hyperlipidemia, hypertension and Hashimoto thyroiditis. Patient is fully vaccinated for COVID-19. He had stable vital signs upon arrival to the ER. Chest x-ray showed cardiomegaly with mild pulmonary venous congestion and early pulmonary edema. Blood work in ER showed proBNP 4305, creatinine 1.5, troponin positive x1 and hemoglobin 8.2. Patient was treated with 40 mg IV 1 time, aspirin and Nitro-Bid. Patient was transfer to the medical unit and treated for CHF exacerbation, Covid 19 pneumonia, acute kidney injury and hyperkalemia. He was treated with Remdesivir, dexamethasone and IV antibiotics. Nephrology was consulted for AKI and hyperkalemia. The patient's symptoms improved and he was able to transfer to Allure in Moline for skills nursing. Today patient denies fever chills, abdominal pain, constipation, chest pain, palpitation, dizziness, and headaches. he has stable vitals and will be transferred by EMS services.
1580030 2290018 2022-05-22 IL 85.00 COVID Vaccine Breakthrough CAse Moderna Dose 1 11/15/21 (033F21A) COVID Positive 11/30/21 12/1/21: Patient has dementia. He also has myasthenia gravis and hypothyroidism.Not a very reliable historian. He reportedly tested positive for SARS-CoV-2 10 days ago. Having cough with yellowish expectoration. Family think that he may have aspirated in a.m. Family noticed increased work of breathing in last 1 day. He had temperature of 100.3� F in emergency department. Was hypoxic and was requiring up to 5 L of oxygen in emergency department. Had elevated lactic acid level. CRP was 16.25. His D-dimer was very very high at 35.2. CT pulmonary angiogram showed bilateral pulmonary emboli. 12/10/21: 85-year-old male patient with a history of severe dementia, myasthenia gravis and hypothyroidism was admitted the hospital with complaints of cough. The patient was diagnosed with COVID-19 infection obtained side to admission to the hospital on 12/2/2021. Patient was noted to have some shortness of breath and elevated body temperature is 100.3� F. He was also hypoxic requiring 5 L of oxygen in the emergency room on admission. CT of the chest showed evidence of bilateral PE E the patient was admitted for further care. Acute hypoxic respiratory failure the the -secondary due to COVID-19 and pneumonia -patient maintained on oxygen -patient completed treatment with steroids, remdesivir and antibiotics treating COVID-19 infection Bilateral PE with right lower extremity superficial thrombus -patient nt on ay medications as he is discharged home on no medication -Pt under palliative care at home now and then hospice care eventually after d/c to home per the son Dysphagia -patient followed by dietitian, recommend puree diet with honey thickened fluids, continue Severe dementia -patient son is the power of attorney Catheter associated trauma, off antibiotics at the time of discharge. Discussed the patient's case with care coordination again this morning. The son, power of attorney wishes for the patient to be transferred home. Patient will have a 24 hour attendant/nurse at home. Outpatient palliative care to follow the patient at home. The son will consider hospice at a later point after the patient is discharged home. All questions answered. 12/13/21: Patient deceased
1579312 2289295 2022-05-21 MI 77.00 Patient died of COVID infection in May 2022
1577996 2287100 2022-05-20 101.00 per death certificate, one of the causes of death was acute encephalopathy with COVID 19 viral infection; faxed for med records from Dr. who signed the death certificate, but never received records; death certificate sent to info@vaers.org per VAERS request
1577427 2286395 2022-05-20 DIED; COULD NEVER WALK AGAIN; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown, and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient could never walk again. On 25-APR-2022, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of could never walk again was not reported. This report was serious (Death).; Sender's Comments: V0-20220519096-covid-19 vaccine ad26.cov2.s-.Died The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
1577780 2286767 2022-05-20 Passed away; Respiratory failure; Congestive heart failure; Rash; Erythrodermic psoriasis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: DEATH (death), outcome "fatal", described as "Passed away"; RESPIRATORY FAILURE (death, medically significant), outcome "fatal"; CARDIAC FAILURE CONGESTIVE (death, medically significant), outcome "fatal", described as "Congestive heart failure"; RASH (non-serious), outcome "unknown"; ERYTHRODERMIC PSORIASIS (non-serious), outcome "unknown". The patient date of death was unknown. Reported cause of death: "Congestive heart failure". It was not reported if an autopsy was performed. Clinical course: Patient passed away as a result of respiratory failure, due to congestive heart failure, due to a reaction from covid 19 vaccine. (That is from his death certificate). He apparently had a rash that was diagnosed as erythrodermic psoriasis, a rare psoriasis that his doctors said was a reaction to the vaccine. He had just had his second dose of the pfizer vaccine when the rash started. He had no pre existing conditions, no other health issues. He was 73 when he passed away. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Congestive heart failure
1577974 2287078 2022-05-20 84.00 pt had a positive COVID test on 9/14/2021; requested med records; the wrong pt's records were sent; refaxed for records and they were not received by this time; per death certificate, a positive COVID test was listed as a contributing factor; death certificate sent per VAERS request
1577426 2286394 2022-05-20 GASTROPARESIS; HUNG HERSELF WITH BATHROBE BELT(SUICIDE); This spontaneous report received from a consumer via a company representative via media concerned an 81 years old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced gastroparesis (which had blown up in her and suffered from the same for 5 months). On 18-AUG-2021, the patient had hung herself with bathrobe belt (suicide) and died from the same. It was unspecified if an autopsy was performed. It was reported by consumer that, "My 81 year old mom committed suicide on August 18th after suffering a blowup of incurable gastroparesis after her poison shots". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of hung herself with bathrobe belt(suicide) on 18-AUG-2021, and the outcome of gastroparesis was not reported. This report was serious (Death, and Other Medically Important Condition). This case is a duplicate of 20220527077. This case, from the same reporter is linked to 20220126450, 20220126177, 20220126708, 20220126582, 20220130063 and 20220528171. Additional information was received from consumer on 12-MAY-2022. It was determined that Manufacturer Case Number 20220527077 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20220126211. The following information was updated and incorporated into the case narrative: Added reporter (company representative). Upon review following information was amended: The case was made valid, batch number statement updated in narrative and social media captured in source.; Sender's Comments: V1:Follow up information in this version updated It was determined that Manufacturer Case Number 20220527077 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20220126211. The following information was updated: reporter. Upon review following information was amended: The case was made valid, batch number statement updated in narrative and social media captured in source.The follow up information does not change the causality of the previous reported event. 20220126211-Covid-19 vaccine ad26.CoV-2.s. Hung herself with bathrobe belt (suicide), Gastroparesis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: SUICIDE
1578035 2287140 2022-05-20 IA 64.00 COVID Vaccine Breakthrough Case Pfizer Dose 1 4/7/21 (lot NA) Pfizer Dose 2 5/5/21 (lot NA) COVID Positive 11/17/21 11/17/21: Patient is a 65 year old female with past history of diabetes mellitus, obesity, and depression who was admitted with respiratory failure secondary to COVID-19 pneumonia. History is obtained from chart review as well as discussion with the patient and the outside hospitalist. Patient denies any underlying history of heart or lung disease. She does not using inhalers. She started feeling poorly approximately 2 weeks ago. Has had fatigue and weakness and then started developing a cough with chest congestion about 5 days ago. She then started becoming more short of breath over last few days as well. She is not having any nausea or vomiting or diarrhea but does admit to a decreased appetite. She presented to the ER yesterday after her daughter checked her pulse ox and was found to be 67% on room air. She was placed on 2 L and admitted to that hospital. She does state that she received 2 doses of the Pfizer COVID-19 vaccine. Oxygen requirements increased overnight and was transferred to this facility for higher level of care. Was on 15 L earlier today but currently on 10 L. She states she does have obstructive sleep apnea for which she uses a CPAP at night. She was given remdesivir as well as Decadron and started on ceftriaxone and azithromycin. She is currently afebrile. She denies any chest pain or abdominal pain. 12/19/21: 65-year-old female with obstructive sleep apnea on CPAP, cirrhosis with esophageal varices, type 2 diabetes mellitus, hypertension admitted for acute hypoxemic respiratory failure secondary to COVID-19 and pneumonia. Patient was treated with remdesivir, Decadron, Actemra, broad-spectrum antibiotics. Patient's oxygen requirement was persistently elevated with progressive worsening hypoxia and ended up intubated on 12/15/2021, developed right-sided pneumothorax pneumomediastinum and subcutaneous emphysema which was treated with chest tube. Right-sided Pneumothorax has expanded, 2nd chest tube was placed with resolution of pneumothorax. Patient's condition continued to deteriorate with persistent hypoxia despite being on full ventilator support with 100% FiO2. Patient's family has decided on comfort care and care had been withdrawn and patient died on 12/19/2021 at 1642. Cause of death COVID 19.
1578441 2287550 2022-05-20 SD 84.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Janssen product on 03/31/2021. They tested positive for COVID-19 on 10/14/2021 at the nursing home at which they were a resident. The individual died on 10/19/2021 after a rapid decline in health. The individual was on hospice care at the nursing home for underlying medical conditions.
1578760 2287890 2022-05-20 WI 82.00 1 week after third Covid 19 vaccine shot she developed Shingles. Approx 1 week later had a ruptured cholecystitis which required multiple surgeries. After surgery she was unable to be extubated for an extended period. Once extubated was on high flow oxygen and could not maintain sats on room air. Was too weak to swallow or stand. Had a feeding tube placed. Never regained strength and on April 13 she chose to go on hospice and care was withdrawn. She died on April 16th, 2022.
1578045 2287150 2022-05-20 IA 67.00 COVID Vaccine Breakthrough Case J&J Dose 5/10/21 (lot NA) COVID Positive 12/3/2021 12/3/21: Patient is a 68-year-old male with history of peripheral neuropathy, COPD, chronic pain, present to the emergency department with a complaint of worsening shortness of breath since Tuesday. Prior to Tuesday patient has been in his usual state of health. Denies any fever or chills, since Tuesday he has been having some shortness of breath, reported cough, patient has been getting weaker, no fever or chills, symptoms keep getting worse hence his wife brought him to the emergency department. He received COVID-19 vaccine Johnson Johnson in April, received flu shot, smokes half pack per day, history of COPD in uses inhaler as needed but no oxygen or. No obstructive sleep apnea. Close contact with COVID-19 patient at home. Patient was very tachypneic in distress, could not provide much history however his wife was present at bedside and was able to help. He is full code. In ED, Anion gap 20, lactic acid 3.7, proBNP 4883, troponin 0.05, fever, tachycardia, severe hypoxia requiring BiPAP. Chest x-ray showed right upper lobe pneumonia. Patient was given 1 dose of Solu-Medrol, Rocephin and DuoNeb nebulizer treatment. 12/23/21: Patient is very comatose and noncommunicative, and respiratory distress. His wife is on bedside. His condition has not been changing since yesterday. Patient deceased later that day.
1576716 2284758 2022-05-19 84.00 pt presents to ED with shallow breathing and unresponsive; O2 supplementation; family did not want BiPAP to be used; DNR/DNI; pt in respiratory distress; found to be positive for COVID; COVID pneumonia; pt experienced hypoperfusion, hypokalemia; comfort care; pt trasferred to in hospital hospice care where she passed away
1576542 2284487 2022-05-19 FL INSTANTLY DIED; MASSIVE HEART ATTACK; This spontaneous potential legal report received from a parent via a company representative concerned a 55 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received with covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) 1 total, first dose, dose, start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient previously received with covid-19 vaccine ad26. cov2.s (dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) 1 total, second dose, dose, start therapy date were not reported for prophylactic vaccination, which was an off label use, and inappropriate schedule of vaccine administered (dose number in series 2). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) 1 total, booster dose, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Parent said that his son had a massive heart attack 2 weeks after receiving his covid booster. He was on his way home from basketball game when he pulled off the side of the road and instantly died. Parent was considered calling a lawyer to file a wrongful death case (dose number in series 3). On an unspecified date, the patient died from unknown cause of death. It was unspecified if autopsy was done. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of instantly died on an unspecified date, and the outcome of massive heart attack was not reported. This report was serious (Death, and Other Medically Important Condition). This case, involving the same patient is linked to 20220526608 (dose series 2 case).; Sender's Comments: V0: 20220529749-COVID-19 VACCINE AD26.COV2.S- instantly died, massive heart attack . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
1576551 2284497 2022-05-19 FL 74.00 mass on her lungs; lesion in the lungs metastasized to the brain / mass on her brain; blood clots in the shin to the hip; she passed /death; Covid-19 after 2 doses of the vaccine; Covid-19 after 2 doses of the vaccine; sore arm at the injection site for a day or two; a lot of pain from the lesions of the shingles; Shingles developed and the lesions were found on her left upper arm, shoulder and spread to her chest and back left upper shoulder; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (she passed /death), PULMONARY MASS (mass on her lungs), METASTASES TO CENTRAL NERVOUS SYSTEM (lesion in the lungs metastasized to the brain / mass on her brain), THROMBOSIS (blood clots in the shin to the hip), HERPES ZOSTER (Shingles developed and the lesions were found on her left upper arm, shoulder and spread to her chest and back left upper shoulder) and COVID-19 (Covid-19 after 2 doses of the vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Latex allergy. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced INJECTION SITE PAIN (sore arm at the injection site for a day or two). In 2021, the patient experienced PULMONARY MASS (mass on her lungs) (seriousness criteria hospitalization and medically significant), METASTASES TO CENTRAL NERVOUS SYSTEM (lesion in the lungs metastasized to the brain / mass on her brain) (seriousness criteria hospitalization and medically significant), THROMBOSIS (blood clots in the shin to the hip) (seriousness criteria hospitalization and medically significant), HERPES ZOSTER (Shingles developed and the lesions were found on her left upper arm, shoulder and spread to her chest and back left upper shoulder) (seriousness criterion medically significant) and PAIN (a lot of pain from the lesions of the shingles). In February 2022, the patient experienced COVID-19 (Covid-19 after 2 doses of the vaccine) (seriousness criterion medically significant) and DRUG INEFFECTIVE (Covid-19 after 2 doses of the vaccine). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Shingles, at an unspecified dose and frequency. The patient died on 23-Mar-2022. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PULMONARY MASS (mass on her lungs), METASTASES TO CENTRAL NERVOUS SYSTEM (lesion in the lungs metastasized to the brain / mass on her brain), THROMBOSIS (blood clots in the shin to the hip), HERPES ZOSTER (Shingles developed and the lesions were found on her left upper arm, shoulder and spread to her chest and back left upper shoulder), COVID-19 (Covid-19 after 2 doses of the vaccine), DRUG INEFFECTIVE (Covid-19 after 2 doses of the vaccine), PAIN (a lot of pain from the lesions of the shingles) and INJECTION SITE PAIN (sore arm at the injection site for a day or two) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that all hell broke loose after the 2nd dose. Caller reported that her bother who lived on and off with their mother noticed that she was having several falls. Her sister also noticed that when she spoke with her on the phone she was not making sense, could not complete her sentences, could not remember things, would mumble and not speak clearly and they were surprised because she was a very sharp lady. Everyone suspected that she might have a stroke. Her mother withheld this information from her until one day in Jul2021, she fell and no one was around to help her. Caller had to call the police to do a welfare check on her and they found her lying on the bathroom floor. She was taken to the hospital where they found a mass on her brain and her lungs. They were told that the mass needed to be removed immediately. They moved her to another state where caller would be able to take care of her. She was prescribed with Valacyclovir for Shingles developed around that time. The lesions on her left upper arm, shoulder and spread to her chest and back left upper shoulde were eventually scabbed over but she was still in a lot of pain. Brain surgery was done in another hospital. They were told that the lesion was from the mass in her lungs and it had metastasized to the brain. She underwent radiation after the brain surgery. This was somewhere in Sep2021 or Oct2021. She was hospitalized 3 more times due to blood clots that were seen on her shin to the hip. The patient spent more days in various hospitals than out after getting the 2nd dose of the vaccine. She did not have any concomitant vaccination with the Covid-19 vaccine. She contracted Covid-19 approximately 6 weeks (feb2022) before she passed on 23Mar2022 in a hospice across the hospital where she was confined last. No concomitant product use was provided by the reporter. Company comment- This spontaneous case concerns a 75-year-old female patient with no relevant medical history, who experienced Fatal, unexpected, serious (Hospitalization) events of Pulmonary mass, Metastases to brain, unexpected, serious (Medically significant) event of Herpes zoster and unexpected, serious (Hospitalization, Medically significant) adverse event of special interest Thrombosis and unexpected, serious (Medically significant) adverse event of special interest Covid-19. After getting the 2nd dose of vaccination, the patient complained that she could not walk and talk. She was noted to have several falls, was not making sense when she speaks, could not complete her sentences, and could not remember things. She would mumble and could not speak clearly. In July 2021, the patient fell, and no one was around to help her. She was found lying on the bathroom floor. She was taken to the hospital where they found a mass on her brain and lungs. They were told that the mass needed to be removed immediately. Shingles developed around this time. It was severe and the lesions were found on her left upper arm, shoulder and spread to her chest and back left upper shoulder. She was prescribed with Valacyclovir, and it eventually scabbed over but she was still in a lot of pain due to the lesions. Brain surgery was done in another hospital and they were told that the lesion was from the mass in her lungs and it had metastasized to the brain. She underwent radiation after the brain surgery. She was hospitalized 3 more times due to blood clots that were seen on her shin to the hip. The patient contracted Covid-19 approximately 6 weeks before she passed on in a hospice across the hospital where she was confined last. No autopsy result was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-565162 (Patient Link).; Sender's Comments: This spontaneous case concerns a 75-year-old female patient with no relevant medical history, who experienced Fatal, unexpected, serious (Hospitalization) events of Pulmonary mass, Metastases to brain, unexpected, serious (Medically significant) event of Herpes zoster and unexpected, serious (Hospitalization, Medically significant) adverse event of special interest Thrombosis and unexpected, serious (Medically significant) adverse event of special interest Covid-19. After getting the 2nd dose of vaccination, the patient complained that she could not walk and talk. She was noted to have several falls, was not making sense when she speaks, could not complete her sentences, and could not remember things. She would mumble and could not speak clearly. In July 2021, the patient fell, and no one was around to help her. She was found lying on the bathroom floor. She was taken to the hospital where they found a mass on her brain and lungs. They were told that the mass needed to be removed immediately. Shingles developed around this time. It was severe and the lesions were found on her left upper arm, shoulder and spread to her chest and back left upper shoulder. She was prescribed with Valacyclovir, and it eventually scabbed over but she was still in a lot of pain due to the lesions. Brain surgery was done in another hospital and they were told that the lesion was from the mass in her lungs and it had metastasized to the brain. She underwent radiation after the brain surgery. She was hospitalized 3 more times due to blood clots that were seen on her shin to the hip. The patient contracted Covid-19 approximately 6 weeks before she passed on in a hospice across the hospital where she was confined last. No autopsy result was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
1576552 2284498 2022-05-19 NJ 69.00 Two heart attacks/Leg stents failed after hearth attacks; Cardiogenic shock; Acute renal failure; ischemic cardiomyopathy; Phlegm/Cough; Lack of drug effect; tested positive for Covid 19; This spontaneous case was reported by a consumer and describes the occurrence of CARDIOGENIC SHOCK (Cardiogenic shock), ACUTE KIDNEY INJURY (Acute renal failure), ISCHAEMIC CARDIOMYOPATHY (ischemic cardiomyopathy), MYOCARDIAL INFARCTION (Two heart attacks/Leg stents failed after hearth attacks) and COVID-19 (tested positive for Covid 19) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052C21A and 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Stent placement (stent put in her leg) on 16-Jun-2021, Stent placement (she also had stents put in her legs and because suffered the 2 heart attacks) in July 2021, Bypass surgery (leg bypass surgery) in September 2021 and Amputation above knee on 24-Dec-2021. Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (Amoxicillin), Allergy (Aspirin) and Diabetes. Concomitant products included INSULIN for Diabetes. On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDIAL INFARCTION (Two heart attacks/Leg stents failed after hearth attacks) (seriousness criteria hospitalization and medically significant). On 31-Dec-2021, the patient experienced COVID-19 (tested positive for Covid 19) (seriousness criterion medically significant). On an unknown date, the patient experienced CARDIOGENIC SHOCK (Cardiogenic shock) (seriousness criteria death and medically significant), ACUTE KIDNEY INJURY (Acute renal failure) (seriousness criteria death and medically significant), ISCHAEMIC CARDIOMYOPATHY (ischemic cardiomyopathy) (seriousness criteria death and medically significant), PRODUCTIVE COUGH (Phlegm/Cough) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with SACUBITRIL, VALSARTAN (ENTRESTO) at an unspecified dose and frequency; RANOLAZINE at an unspecified dose and frequency; METOPROLOL at an unspecified dose and frequency; CLOPIDOGREL at an unspecified dose and frequency and ATORVASTATIN at an unspecified dose and frequency. The patient died on 23-Feb-2022. The reported cause of death was Ischemic cardiomyopathy, Cardiogenic shock and Acute renal failure. An autopsy was not performed. At the time of death, MYOCARDIAL INFARCTION (Two heart attacks/Leg stents failed after hearth attacks), COVID-19 (tested positive for Covid 19), PRODUCTIVE COUGH (Phlegm/Cough) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 test: positive (Positive) positive. This case was linked to MOD-2022-566930 (Patient Link). Company Comment: This spontaneous case concerns a 69-year-old old female patient with relevant concurrent condition of diabetes mellitus and medical history of stent placement for unspecified peripheral condition who experienced the fatal, unexpected, serious (medically significant) adverse events of special interest of Cardiogenic shock, Ischaemic cardiomyopathy and Acute kidney injury and twice reported unexpected, serious (hospitalization, medically significant) adverse event of special interest of Myocardial infarction and unexpected, serious (medically significant) adverse event of special interest of COVID-19 which occurred after receiving the second dose of mRNA-1273 vaccine. Patient developed chest pain a day after the second dose of vaccination. She was admitted in a hospital and diagnosed to have two episodes of Myocardial infarction. She was discharged and prescribed with Entresto, Ranolazine, Metoprolol, Clopidogrel and Atorvastatin. Her leg stents failed on the same month of vaccination thus she underwent peripheral vascular bypass surgery two months after. Approximately 5 months after vaccination, she underwent above the knee leg amputation for unknown indication. She was started on physical rehabilitation since then. Patient developed COVID-19 (with a positive SARS-CoV-2 test) approximately five months after the second dose of mRNA-1273 vaccine. Drug ineffective was also considered (COVID-19 occurred approximately five months post-completion of primary vaccination of mRNA-1273 and within the recommended dosing interval). It was mentioned that COVID-19 is contributory to the patient demise however the clinical presentation, diagnostic evaluation and treatment details was not reported in this case. Death occurred approximately seven months after second dose of mRNA-1273 vaccine. The cause of death was reported as Cardiogenic shock, Ischemic cardiomyopathy, and Acute renal failure. It is unknown if an autopsy was performed. Patient�s advanced age and concurrent condition remain as confounders for the events Myocardial infarction, Cardiogenic shock, Ischaemic cardiomyopathy and Acute kidney injury and the fatal outcome. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69-year-old old female patient with relevant concurrent condition of diabetes mellitus and medical history of stent placement for unspecified peripheral condition who experienced the fatal, unexpected, serious (medically significant) adverse events of special interest of Cardiogenic shock, Ischaemic cardiomyopathy and Acute kidney injury and twice reported unexpected, serious (hospitalization, medically significant) adverse event of special interest of Myocardial infarction and unexpected, serious (medically significant) adverse event of special interest of COVID-19 which occurred after receiving the second dose of mRNA-1273 vaccine. Patient developed chest pain a day after the second dose of vaccination. She was admitted in a hospital and diagnosed to have two episodes of Myocardial infarction. She was discharged and prescribed with Entresto, Ranolazine, Metoprolol, Clopidogrel and Atorvastatin. Her leg stents failed on the same month of vaccination thus she underwent peripheral vascular bypass surgery two months after. Approximately 5 months after vaccination, she underwent above the knee leg amputation for unknown indication. She was started on physical rehabilitation since then. Patient developed COVID-19 (with a positive SARS-CoV-2 test) approximately five months after the second dose of mRNA-1273 vaccine. Drug ineffective was also considered (COVID-19 occurred approximately five months post-completion of primary vaccination of mRNA-1273 and within the recommended dosing interval). It was mentioned that COVID-19 is contributory to the patient demise however the clinical presentation, diagnostic evaluation and treatment details was not reported in this case. Death occurred approximately seven months after second dose of mRNA-1273 vaccine. The cause of death was reported as Cardiogenic shock, Ischemic cardiomyopathy, and Acute renal failure. It is unknown if an autopsy was performed. Patient�s advanced age and concurrent condition remain as confounders for the events Myocardial infarction, Cardiogenic shock, Ischaemic cardiomyopathy and Acute kidney injury and the fatal outcome. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: ischemic cardiomyopathy; cardiogenic shock; acute renal failure
1576648 2284598 2022-05-19 Pfizer COVID-19 Vaccine killed his mother and lawsuits are coming.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (002191). A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "Pfizer COVID-19 Vaccine killed his mother and lawsuits are coming.". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Additional information: The caller mentioned that the Pfizer COVID-19 Vaccine killed his mother and lawsuits are coming. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Pfizer COVID-19 Vaccine killed his mother and lawsuits are coming.
1576712 2284754 2022-05-19 WI 70.00 Death related to COVID-19 infection
1576537 2284481 2022-05-19 DEAD; This spontaneous report received from a consumer via a company representative via Social media concerned 14 patients of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the reporter stated that, " thanks to the poison vaccines I have 14 dead relatives and friends ". On an unspecified date, the patients died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case is a duplicate of 20220527210. This case, from the same reporter is linked to 20220126450, 20220126177, 20220126174, 20220126211, 20220126582, 20220126614 and 20220126701. Additional information was received from consumer on 12-MAY-2022. It was determined that Manufacturer Case Number was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number. The following information was updated and incorporated into the case narrative: social media added as source, reporter added, patients number updated from 12 to 14 in narrative.; Sender's Comments: V1: Additional information received is regarding Manufacturer Case Number was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number and social media added as source, reporter added, patients number updated from 12 to 14 in narrative. This follow up information received does not alter the assessment of prior company causality of previously reported event. 20220126708-COVID-19 VACCINE AD26.COV2.S-Dead. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
1576727 2284769 2022-05-19 102.00 pt moved from LTC to SNF (Rehab Center) due to testing positive for COVID; diarrhea and confusion; moved to isolation for treatment on 1/8/22; 1/17/22 pt became more lethargic, chest congestion, cough, decreasing O2 sats; general decline in condition; family declined hospitalization transfer; pt given O2 supplementation and IV ABX; pt passed away in the SNF; death certificate and med records sent per VAERS request
1576830 2284872 2022-05-19 86.00 Moderna COVID vaccine #1 given 1/13/2021, lot #029L20A; Moderna COVID vaccine #2 given 2/11/21, lot #024M20A; pt transferred from dialysis to ED due to O2 sats being 65% and pt c/o difficulty breathing with tachycardia; in ED pt developed A Fib with RVR; found to be positive for COVID; given ABX, O2 supplementation, Decadron; while pt was hooked up to dialysis, she became hypotensive, dialysis not started; in the afternoon she developed respiratory distress, lost pulse, CPR started, pt intubated on mechanical ventilation; lost pulse 2 more times with ROSC achieved; prognosis extremely poor; family made pt a DNR but not to withdraw mechanical ventilator or vasopressors; pt passed away in the hospital; death certificate and med records sent to VAERS per VAERS request
1576988 2285034 2022-05-19 TN 82.00 Pfizer vaccine x 3. Tested positive for Covid on 05/03/2022. Admitted to a local Hospital on 4/30/2022. Expired on 05/14/2022 while still hospitalized.
1577000 2285046 2022-05-19 TN 79.00 Moderna x 3. Tested positive for COVID 19 on 02/01/2022. Admitted to Medical Center on 05/13/2022. Expired on 05/17/2022 while still hospitalized.
1577097 2285145 2022-05-19 MT 67.00 Case received primary Covid series in February 2021, and was hospitalized for Covid in February 2022. Hospitalized at: Hospital. Case had multiple medical issues, and Covid added to his overall disease burden. He was unable to tolerate treatment for Covid, survived his isolation period and was hospitalized for 39 days, at which point he died. He had multiple contributing factors listed on his death certificate, but Covid was not one of them.
1577364 2321751 2022-05-19 79.00 Narrative: The patient received three doses of Pfizer COVID 19 Vaccine in Jan,Feb,Oct 2021. The patient tested positive for COVID 19 on 8 Feb 2022. The patient presented to the ED with shortness of breath and weakness. The patient was admitted on 8 Feb 2022 with covid pneumonia, afib, and anemia. The patient was treated with remdesivir and dexamethasone. The patient's condition did not improve. The patient was referred to hospice care on 4 March 2022. The patient died on 14 March 2022 of respiratory failure and covid pneumonia. Reported per EUA.
1575925 2282686 2022-05-18 BLOOD CLOT; This spontaneous report received from a consumer via other manufacturer (Pfizer) concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient died of a blood clot from the Johnson and Johnson vaccine. It was reported as reporter's pharmacist had a patient whose husband died of a blood clot from the Johnson and Johnson vaccine. It was unknown if an autopsy performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220530466-Covid-19 vaccine ad26.cov2.s-blood clot . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: BLOOD CLOT
1576107 2282884 2022-05-18 TN 63.00 Patient presented to the ED with altered mental status, shortness of breath and urine incontinence. Patient was given fluids, antibiotics and started on Bipap. Patient tested covid positive. Chest xray revealed advanced chronic interstitial disease with hyperinflation with opacities. Patient was transferred to the ICU. Patient was started on Remdesivir, Decadron and lovenox. Patient was made a hospice patient and expired due to acute respiratory failure on 02/23/2022.
1576217 2282997 2022-05-18 86.00 pt presents to ED with increasing SOB, cough, congestion, decrease in appetite, and weakness; admitted for respiratory failure secondary to COVID infection (positive test on 8/21/21); course was complicated by sepsis and multiorgan failure; pt's condition worsened; O2 supplementation; DNR/DNI; pt experienced cardiac arrest and did not survive; death certificate and medical records sent per VAERS request
1576233 2283013 2022-05-18 77.00 COVID Moderna #1 given 1/13/21, lot #025L20A; COVID Moderna #2 given 2/10/21, lot #030L20A; pt had a positive COVID test on 11/9/21; pt presented to the Hospital 1/14/22 with altered mental status, O2 sats 51% on 2L O2; placed on BiPAP; pt had a DNR/DNI but family overturned that and pt was intubated in ED; pneumonia, UTI, AHRF; pt given ABX; admitted to inpatient hospice where he was extubated on 1/16/22 and he passed away on 1/19/22; death certificate and medical records sent to info@vaers.org per VAERS request
1576252 2283033 2022-05-18 81.00 COVID vaccine, Pfizer #1 given on 12/30/2021, lot # EL3246; COVID vaccine, Pfizer #2 given on 01/20/2021, lot # EL3302; 02/05/2022 pt presented to ED via EMS to be treated for COVID Pneumonia; had a positive test on 02/01/2022; pt continued to decline; was given remdesivir, zithromax, baricitinib, O2 supplementation; continued to worsen; DNR; had an episode of SVT, responded to metoprolol but was not able to maintain O2 sats above 80%; reverted back to SVT; went into respiratory arrest and asystole; he never recovered; death certificate and med records sent to VAERS website per VAERS request
1576312 2283094 2022-05-18 83.00 1/27/22 pt admitted from nursing home for SOB; O2 sats in 70s% on RA; given O2 supplementation; positive COVID test; first positive COVID test on 1/3/22; CXR showed bilateral infiltrates; CTA chest showed bilateral PE; pt had respiratory distress and became pulseless, ACLS performed with ROSC achieved; intubated; transferred to ICU, experienced 2 other cardiac arrests; after the 3rd cardiac arrest and multiple rounds of CPR done, ROSC was not achieved; family decided to make pt a DNR and he passed away in the hospital; DC and medical records sent per VAERS request
1576324 2283106 2022-05-18 MN 75.00 HOSPITALIZATION AND DEATH RELATED TO COVID-19 FOLLOWING COMPLETION OF PRIMARY VACCINE SERIES
1576332 2283116 2022-05-18 65.00 12/23/2021 pt presents to ED with weakness and history of passing out, positive COVID test ; on 12/16/21, pt was found to be positive for COVID (asymptomatic) when in Hospital for urinary retention, foley catheter placed; in ED pt found to have hyponatremia and UTI; given ABX, O2 supplementation, decadron, remdesivir, albuterol; AHRF secondary to COVID 19 PNA; DNR/DNI; transferred to comfort care; pt passed away in the hospital; DC and med records sent to info@vaers.org per VAERS request
1576430 2283266 2022-05-18 SD 92.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 01/28/2021 and 02/18/2021. They presented to emergency department on 10/11/2021 with primary concerns of shortness of breath and fever which had been happening for about 2 days (symptom onset approx. 10/09/2021). They were admitted to hospital on 10/11/2021 and tested positive for COVID-19 upon admission. They experienced complications of COVID-19 pneumonia, septic shock, and pancytopenia. They remained hospitalized until their death on 10/16/2021.
1576452 2283435 2022-05-18 SD 107.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 01/07/2021, 01/28/2021, and 10/11/2021. The individual also received a HighDoseQ influenza vaccine on 10/11/2021. They tested positive for COVID-19 on 09/21/2021 via antigen test at the hospital and were hospitalized twice around the time of the positive test: 09/06/2021-09/08/2021 and again from 09/15/2021-09/17/2021. The individual had a negative COVID-19 test on 10/06/2021 at the retirement home at which they were a resident. They presented to emergency department via ambulance on 10/13/2021, 2 days after receiving the third dose of the Pfizer product and an influenza vaccine on the same day. Primary complaints were swelling in leg, weakness, loss of appetite, and "not coming out of [their] room for 3 days." They were put on comfort care and died on 10/19/2021 in the hospital. Clinical notes indicate they had "severe COVID related CVA" prior to death, and COVID-19 pneumonia is on the death certificate, even though there was a negative COVID-19 test between the positive test and the person's death.
1575644 2280956 2022-05-17 CA 0.42 Patient was born at 37 weeks considered a preemie. He had COVID-19 at 2 months old and tested positive on 1/6 in the ER. The virus lasted for about 4 weeks. He fought hard and guaranteed he had lingering Covid in his system when he passed on 4/28. He received his first round of shots on 2/9 (DTaP/ Hep B/ IPV, HiB, Pneumococcal Conjugate (PCV-13), and Rotavirus Pentavalent). Later that week he developed a cough/ temperature of 100. He did not feel well which I have documented on video. He had the 2nd dose of the same vaccinations listed above on 4/19. I have photos of a rash that showed up on Friday 4/22 and continued throughout the weekend. He was clammy, weak, fussy, irritable and not himself after the second round of shots. The vaccinations played a role in my son losing lack of oxygen and not being able to cry out or get his head up when I found him on 4/25. I believe he had a delayed reaction VERY possible considering his circumstances. Patient is not going to be framed as a SIDS baby; there are reasons behind his death and the truth needs to be addressed. I want justice for my son and the head of the Health Department to own up to the pressures they push on doctors when all babies are not the same. Babies are not a number or a medical study. There needs to be FDA guidelines for vaccinations for babies who are preemies or have experienced COVID-19 or any sickness for that matter. No reason why we couldn?t have spread his shots. He was only 5 months way TOO much for a baby to handle. Where is the common sense in all this??? I had questioned the doctor and trusted the medical field. Now I am left with a dead son. No one else is suffering the pain my husband and I get to face everyday. If we had waited longer he would still be here today. There should be compensation from the vaccination companies to my husband and I. They need to be held accountable and so does the board of immunizations. Looking forward to a response with truthful answers. This is my son?s life, not some political cover up or pay out.
1575128 2280410 2022-05-17 FL 77.00 falling face first on the floor/collapsed; This spontaneous case was reported by an other health care professional and describes the occurrence of FALL (falling face first on the floor/collapsed) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Multiple myeloma (IgG multiple myeloma) on 01-Mar-2008, Hypertension (HTN) on 09-Aug-2015, Gait abnormal (Impaired Gait) on 11-Jul-2010, Cardiac arrhythmia (Cardiac arrhythmia- Pacemaker dependent) on 09-Aug-2015, DVT on 09-Aug-2015 and Pacemaker insertion (cardiac) (Cardiac arrhythmia- Pacemaker dependent). Concomitant products included POMALIDOMIDE from 21-May-2021 to an unknown date, DEXAMETHASONE from 21-May-2021 to an unknown date, GABAPENTIN (NEURONTIN) from 21-May-2021 to an unknown date and LACTULOSE for an unknown indication. On 25-Oct-2021 at 8:49 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2022, the patient experienced FALL (falling face first on the floor/collapsed) (seriousness criterion death). The patient died on 30-Apr-2022. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered FALL (falling face first on the floor/collapsed) to be not related. No treatment medication was reported by reporter. It was reported that patient was involved in a study. Patient took third dose of Moderna vaccine on 25-Oct-2021. It was reported that study staff contacted patient on 3-May-2022 for month 6 blood withdraw per protocol and came to know that patient passed away on 30-Apr-2022. Patient wife already informed clinical team of her husband at medical center. patients wife reported that she left the patient home alone for few hours, when she retuned she found that patient had fallen face first in the bathroom. she called EMT for assistance but first responder did not proceed with any intervention. she stated that the cause of death had not yet been released. she reported that the death certificate was pending. Company comment: This spontaneous case concerns a 77 year old male patient with relevant medical history of Multiple myeloma, Hypertension, Cardiac arrhythmia, Cardiac pacemaker insertion and Deep vein thrombosis who met with the unexpected fatal (seriousness criteria-death) event of Fall, about 6 months, 4 days after receiving the third dose with mRNA-1273 vaccine in the COVID-19 vaccination series. Patient was at home and collapsed falling face first on the floor; could not be revived by the rescue team. The cause of death was not known. No further information on autopsy details and details pertaining to the previous doses was available in the report. Elderly age of the patient and multiple co morbidities could be risk factors for the fatal outcome. The causality for the fatal event was 'not related' as per the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 77 year old male patient with relevant medical history of Multiple myeloma, Hypertension, Cardiac arrhythmia, Cardiac pacemaker insertion and Deep vein thrombosis who met with the unexpected fatal (seriousness criteria-death) event of Fall, about 6 months, 4 days after receiving the third dose with mRNA-1273 vaccine in the COVID-19 vaccination series. Patient was at home and collapsed falling face first on the floor; could not be revived by the rescue team. The cause of death was not known. No further information on autopsy details and details pertaining to the previous doses was available in the report. Elderly age of the patient and multiple co morbidities could be risk factors for the fatal outcome. The causality for the fatal event was 'not related' as per the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
1575361 2280666 2022-05-17 TN 79.00 79-year-old male with a history of chronic obstructive pulmonary disease, atrial fibrillation, gastroesophageal reflux disease, oral cancer, lung cancer for Which he follows with his oncologist and status post chemotherapy with last treatment approximately 2 weeks prior to admission after which he reported he had progressively worsening shortness of breath and associated weakness, chills, productive cough with thick green sputum, for which he presented to the emergency room on 01/12/2022. He went to see his PCP on the day of admission when his symptoms did not improve and was found to be in atrial fibrillation with rapid ventricular response, and EMS was activated for transport to Medical center. Upon arrival to the emergency room; he was found to be hypoxic and placed on supplemental oxygen and tested positive for Covid-19. He was given diltiazem in the emergency room and admitted to the Covid step-down floor. He continued to require increasing amounts of oxygen despite being placed on remdesivir, steroids, vitamin C, and zinc. Transferred to the intensive care unit due to ongoing worsening respiratory failure. Pulmonology was consulted on 01/14/2022. Patient was intubated on 01/15/2022 and never came off the ventilator. He remained with low oxygen saturations in the 80s. He did get treated with baricitinib as well for the COVID-19. Patient expired on 1/23/22.
1575393 2280700 2022-05-17 TN 72.00 patient admitted on 1/25/22 after noted in dialysis with atrial flutter, given metoprolol and blood pressure became worse. She complains of SOB and palpitations. Patient on 2LNC 24/7. Patient tested positive for Covid 19 on 1/29/22. Patient expired on 1/31/22.
1575418 2280726 2022-05-17 TN 63.00 Death and COVID pos S/p COVID vaccination
1575448 2280756 2022-05-17 TN 68.00 68 year-old male recently diagnosed with dementia, presents emergency department with family concerning for worsening mental status over the last 2 weeks. According to family members, patient's blood pressure has been in decline over the last 1 month in duration has been having medications discontinued due to low blood pressure. Patient was having progressive worsening lower extremity edema and then had Lasix increased. According to family members, patient's mental status yesterday has been worse. Cardiopulmonary arrest in setting of progressive decline over 1 month. Cause of death uncertain. He appears to have been in cardiogenic shock occurring in the setting of multiple organ failure including AKI and liver failure. This may have by precipitated by acute cholangitis. The cause of his neurological decline is uncertain, but may relate to his COVID-19.
1575625 2280935 2022-05-17 SD 80.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Janssen product on 03/16/2021. They tested positive for COVID-19 on 08/17/2021. They presented to emergency department on 10/12/2021 with primary concern of GI bleed and anemia. They were not admitted to hospital, but discharged to nursing home for comfort care. They died on 10/13/2021.
1575841 2281416 2022-05-17 TN 93.00 Patient is a 93 year-old male, with past medical history significant for HTN, prior ICH, suspected CKD, meningioma and recent SARS Covid 19 infection. Prior to his hospitalization, patient was hospitalized, early September, 2021 when tested positive for COVID on admission on 09/02/21 . Reportedly his symptoms started on 08/30/21. He was found to have right upper lobe consolidation. He was treated With Rerndesivi rand ceftriaxone, which was transitioned to Cefdinir upon transfer to skilled nursing facility on 09/08/2021.. At that time, he was fully oriented and able to talk over the phone. Since then, he reportedly became increasingly confused. disoriented, with nonsensical speech without focal deficits. While at hospital, he was incidentally noted to have meningioma on head CT. Patient was seen at ED on 09/19/21 for reported acute respiratory distress. His oxygen saturation was reported to be in the 60% range. He was on NRB, which was slowly titrated down to 6L via NC. He was also hypotensive. Patient died 9/23/2021 at 2: 19 AM. Cause of death acute hypoxemic respiratory failure, bacterial pneumonia; nonSTEMI, severe aortic stenosis, recent COVID-19.
1575663 2280975 2022-05-17 TN 76.00 Patient has severe underlying fibrotic lung disease. Evaluations in the past suggested possibly hypersensitivity pneumonitis. There was concern she might also have severe pulmonary fibrosis. She has been on Ofev and oxygen at home. Her baseline oxygen is 5 Lat rest and 10 L with activity. Patient developed symptoms 1/17/2022. She was+ for COVID 1/24/2022. At that time chest x-ray showed severe pulmonary fibrosis. CT chest 1/25/2022 with extensive pulmonary fibrosis and bibasilar infiltrates as well as ascending aortic aneurysm 4.1 cm and pulmonary artery dilation consistent with pulmonary hypertension. She has been on a burst of high-dose Solu-Medrol per pulmonary. Patient is now transitioning to prednisone. She did receive tocilizumab. Patient required bipap, family decided to discharge on hospice. Patient expired on 2/4/22.
1575834 2281409 2022-05-17 TN 82.00 Patient with CLL admitted through the ED with hypoxemia and fever. She presented with decreased appetite, fatigue, and dyspnea on exertion. On 1/11/22 the patient acutely worsened, likely from sepsis due to Covid-19. She was transferred to ICU for increased oxygenation needs requiring high flow nasal cannula. Remdesivir and dexamethsone completed. Comfort care was initiated on 1/17/22 and the patient expired on 1/19/22.
1575843 2281418 2022-05-17 TN 66.00 Patient brought into the ED for unresponsiveness and found to be in severe metabolic acidosis and DKA. Patient was recently treated for Covid 19 at a Hospital. Patients condition decline and she could not protect her airway and was intubated the patient repeat CAT scan show diffuse white matter change discussed with the ramify the possibility that she might have severe stroke or severe encephalitis. Recommend hospice and family agree to proceed. Patient expired on 02/03/2022.
1575678 2280990 2022-05-17 TN 90.00 Patient reports to hospital from assisted living facility for altered mental status, with a positive covid test 10 days prior. Admitted to step down unit on 3 LNC. Chest Xray showing lungs under expand with atelectasis. She was started on dexamethasone. She was not a candidate for additional covid therapies due to significant renal failure. Patient made comfort care and expired on 12/27/21.
1575783 2281210 2022-05-17 SD 83.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 01/20/2021 and 02/10/2021. They presented to Emergency Department on 10/07/2021 with a primary complaint of chest pain. They were evaluated and discharged back to the nursing home at which they were a resident without being admitted to hospital. They tested positive twice on 10/11/2021 via antigen test at the nursing home at which they were a resident. They were hospitalized briefly on 10/14/2021 (admitted and discharge dates are the same day). The individual died on 10/16/2021.
1575693 2281005 2022-05-17 TN 67.00 Patient presents to ED with difficulty breathing, coughing, and dyspnea. Sepsis present upon admission secondary to Covid-PNA. Patient expired on 12/28/2021 due to cadiopulmonary arrest.
1574703 2278428 2022-05-16 TN 85.00 Patient presents to Hospital as a transfer from Hospital for PNA, hypoxia and anemia. Patient states went to outside hospital d/t worsening SOB. She was diagnosed with COVID 19 on 8/24/2021. The patient was admitted to hospital. CT scan showed viral PNA. She was in respiratory failure and required oxygen. Transfused with PRBC. She was given steroids. Patient began refusing all medications, palliative care consulted. Patient was transitioned to hospice and expired on 8/30/2021.
1574459 2278177 2022-05-16 MI 60.00 Patient with Moderna COVID vaccinations who admitted to hospital with COVID complications and ultimately died on hospice services. Hospitalist d/f note below: "61 YO year old male with a history of polycystic kidney disease s/p renal transplant, left breast cancer, T-cell leukemia, T2DM, and hypertension who presented to the ED on 5/1/2022 with generalized weakness. 2 weeks prior to admission had exposure to a sick contact, since then experiencing generalized weakness and fatigue with chills, lightheadedness, shortness of breath, and a productive cough or thick, clear sputum. His brother, went to check on him the day of admission and found him in his room covered and feces and confused. Labs and chest xray were consistent with COVID19 pneumonia and he was treated with steroids, remdesivir and supportive treatment. Pulmonology was consulted which suggested starting anti-biotics for concerns of superimposed bacterial pneumonia and aggressive diuresis. Fungal cultures revealed a reactive Coccidiodes ab and he was started on voriconazole given his immunocompromised state, though there can be cross reactivity with histoplasma ab. He is DNR/DNI aggressive care so bipap,cpap were used for his oxygen needs. Throughout his course his respiratory status continually declined and he developed worsening kidney failure. Palliative was consulted to discuss goals of care. Brother is the patients POA and as the patients status continued to decline, family decided to transition to comfort care and hospice was consulted for GIP status, and was accepted. Patient will transition to hospice inpatient care. " After admitting to hospice services patient died.
1574680 2278405 2022-05-16 TN 31.00 Patient tested positive for COVID 19 on 2/2/22. On 2/7/22 presented to Medical Center worsening symptoms of generalized muscle ache, altered mental status and sepsis of unknown origin. Patient was started on broad spectrum antibiotics with vancomycin and cefepime. During dialysis he was noted to have right upper extremity weakness and right-sided facial droop. STAT CT showed possible subarachnoid hemorrhage. on 02/9/22 patient had irregular heart rhythm and accelerated junctional rhythm, cardiology was notified, patient developed a wide-complex sinus wave pattern rhythm and lost pulse and suffered cardiac arrest. ROSC was obtained, arrived in MCC in extremis, right IJ CVL and right radial arterial lines placed, started on vasopressors, stress dose steroids', vas cath placed, CRRT started. Shortly after initial of CRRT patient suffered cardiac arrest, ROSC unable to be maintained.
1574689 2278414 2022-05-16 TN 91.00 Patient presented to ED on 8/26/2021 with difficulty breathing, the onset was 8/24/2021. Also complains of fever, chills, and cough. Chest Xray in ED showed pulmonary fibrosis and viral PNA. He was started on IVF, IV abx and covid 19 treatment protocols, he was placed on Bipap. The patient was DNR. He was admitted to step down unit and continued on Bipap. He was given tocilizumab and started on baricitinib, and IV steroids. The patient showed little improvement and started to get worse. Family placed patient on comfort measures and wanted to discontinue the bipap. The patient expired on 8/29/2021.
1574603 2278327 2022-05-16 MI 73.00 Discharge Provider: DO Primary Care Physician at Discharge: MD Admission Date: 5/11/2022 PRESENTING PROBLEM: Acute hypoxemic respiratory failure due to COVID-19 (HCC) [U07.1, J96.01] HOSPITAL COURSE: Patient is a 74 year old male with a pmhx of severe COPD with O2 dependent, recent throat cancer on tube feeds, CAD, HTN, HLD, pulmonary HTN, and smoker. Patient had been short of breath and fatigued for the past three days. He was taken to PCP today and found to have 70% O2 saturations on his home 2L. EMS was called placed him on non-rebreather, gave solumedrol, and duoneb. Patient was in respiratory distress upon arrival with RR into the high 30's. He was found to have COVID-19 and CXR was concerning for a superimposed RLL pneumonia. His initial VBG was ok and he was placed on bipap due to his respiratory distress. Patient then became lethargic, CO2 retention worsened and he became unresponsive. Daughter stated she feels he has just given up with all he has been through. She has been updating family and she notes that he has made it well known he is to be a DNR/DNI. This is evident from prior hospitalizations. ER provider discussed withdrawing care but more family would like to be present so the patient was admitted to the hospital. Family said goodbyes and bipap O2 therapy was withdrawn. The patient passed away later that evening with family at the bedside. HE was given medications for comfort measures and respiratory dyspnea. Patient passed at 2132.
1574711 2278436 2022-05-16 TN 78.00 Patient presents to medical center with complaints of dyspnea. On 1/17/2022 patient started having a nonproductive cough and fever and ongoing UTI, which she was prescribed antibiotics by PCP. During ED presentation she reports sweats, headache, body aches, dyspnea at rest and with activity and nonproductive cough, nausea, and vomiting. Patient received Zithromax 500 mg IV, cefepime 2 g IV, and Decadron 6mg IV. Admitted to COVID unit with acute respiratory failure. Started on dexamethasone, remdesivir, and oxygen. Pulmonary started patient on baricitnib. Patient did not respond to treatment favorably. Patient family decided to proceed with comfort care measures. Patient expired on 1/26/22
1574794 2278520 2022-05-16 74.00 pt presented to ED with altered mental state and coughing up bloody secretions; left pneumothorax, right lung mass; positive for COVID; given IVFs, ABX, dexamethasone; intubated, Chest tube placed; transferred to ICU; pt's condition declined; DNR; pt went into asystole and never recovered; death certificate and medical records sent per VAERS request
1574859 2278585 2022-05-16 58.00 12/7/21 pt transferred to hospital from Hospital with a positive COVID test and worsening SOB; placed in ICU; given tocilizumab, remdesivir, decadron, lovenox; O2 supplementation (initially BiPAP); code blue called due to O2 sats falling into the 40s; became pulseless, ACLS initiated; intubated; mechanical ventilation; pt continued to have low O2 sats; given ABX due to sputum positive for E. Coli; pt developed A Fib with RVR; condition declined; code blue called, pt briefly achieved ROSC; became pulseless, asystolic; pt never recovered; death certificate and medical records sent to per VAERS request
1574938 2278860 2022-05-16 SD 78.00 This is an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated with the Pfizer product on 01/30/2021 and 02/20/2021. They tested positive for COVID-19 on 09/29/2021 and again on 10/02/2021. They presented to emergency department via EMS on 10/06/2021 with a primary concern of shortness of breath. They were admitted to hospital same day. The individual was found to be having complications and co-occurring conditions including coagulopathy, encephalopathy, COVID-19 pneumonia, hypoxic respiratory failure, shock, and a Gastrointestinal Bleed. They remained hospitalized until their death on 10/12/2021.
1574151 2277643 2022-05-14 I know one person who died after the 2nd Pfizer COVID vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1 MANUFACTURER UNKNOWN), for COVID-19 Immunization.The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "I know one person who died after the 2nd Pfizer COVID vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.Clinical information: Reporter know one person who died after the 2nd Pfizer Covid vaccine and another who will be on anti-seizure medicine for the rest of their lives after taking the 2nd vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: I know one person who died after the 2nd Pfizer COVID vaccine
1574110 2277602 2022-05-14 MI develop cancer quickly and die after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (death, medically significant), outcome "fatal", described as "develop cancer quickly and die after receiving the vaccine". The patient date of death was unknown. Reported cause of death: "develop cancer quickly and die after receiving the vaccine". It was not reported if an autopsy was performed. This case is reported as non-serious. The reporter stated, "my sister was going on and on about deaths related to covid injections" later clarifying she was speaking about the Pfizer-Covid19 vaccine. She stated, "We've had several friends up and die. she's had 4 friends develop cancer quickly and die after receiving the vaccine. This one lady didn't have cancer and she was dead in three weeks." Later adding "I think she's worried about long-term side effects" not those close to administration but "5 months later they got sick and died, people who had cancer and it came back quickly". She stated her sister had been doing a lot of research online, but she's not sure what sources she's reading. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: develop cancer quickly and die after receiving the vaccine
1573494 2275697 2022-05-13 67.00 pt to ED with SOB, increased edema, confusion, fatigue and weight gain; COVID test negative; CHF exacerbation, acute renal failure and PNA with hypoxic respiratory failure; another COVID test done on 1/30/22 was positive; O2 supplementation; remdesivir not given due to solitary kidney; dexamethasone given; acute on chronic HRF secondary to COVID pneumonia/COPD; DNR; requesting hospice; comfort care; pt in Transitional Care Center; death certificate and med records sent per VAERS request.
1573119 2275258 2022-05-13 CA DIED; This spontaneous report received from a consumer via a company representative via media concerned a patient of an unspecified age, sex, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported and expiry: unknown) 1 total, dose and start therapy date were not reported administered for prophylactic vaccination. The batch number was not reported. Per Procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died from an unknown cause of death. It was unspecified if an autopsy was performed or not. The reporter stated that, "Unfortunately, my cousin took your Covid vaccine and died right after". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220520946-covid-19 vaccine ad26.cov2.s - died. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
1573261 2275409 2022-05-13 then got Covid and ignored it and they passed away; then got Covid and ignored it and they passed away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (death, medically significant), DRUG INEFFECTIVE (death, medically significant), outcome "fatal" and all described as "then got Covid and ignored it and they passed away". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Her friend was vaccinated (did not specify what vaccine) and then got Covid and ignored it and they passed away. The patient date of death was unknown. Reported cause of death: "then got Covid and ignored it and they passed away". It was not reported if an autopsy was performed. Clinical course: Caller stated she received Moderna vaccine, she tested positive for Covid 19 and has been taking Paxlovid for 4 days now. She has experienced water like diarrhea for 4 days now. She states that when she woke up in the morning she had to run from the bed to the toilet. and then she was fine the rest of the day. She had also experienced a metallic taste in her mouth. She would like to know if these two side effects were normal. Consumer was 78 year old female who described herself as a very healthy individual for her age and stated she did not have any breathing problems or anything. Caller also mentioned that her friend was vaccinated (did not specify what vaccine) and then got Covid and ignored it and they passed away. Proprietary medicinal product name was Paxlovid. The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Reported Cause(s) of Death: then got Covid and ignored it and they passed away; then got Covid and ignored it and they passed away
1573294 2275442 2022-05-13 MI This one lady didn't have cancer and she was dead in three weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "This one lady didn't have cancer and she was dead in three weeks". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical information: Caller is a consumer who states "my sister was going on and on about deaths related to covid injections" later clarifying she was speaking about the Pfizer-Covid19 vaccine. She states "We've had several friends up and die. she's had 4 friends develop cancer quickly and die after receiving the vaccine. This one lady didn't have cancer and she was dead in three weeks." Later adding "I think she's worried about long-term side effects" not those close to administration but "5 months later they got sick and died, people who had cancer and it came back quickly". She states her sister has been doing a lot of research online, but she's not sure what sources she's reading. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: This one lady didn't have cancer and she was dead in three weeks
1573401 2275604 2022-05-13 66.00 pt had a positive COVID test on 8/20/21 and again 9/7/21; was treated with monoclonal antibodies; pt entered Hospital on 9/21/22 with GI bleed; pt had a massive right MCA stroke and was moved to inpatient hospice status; was then transferred to Hospice where she passed away; death certificate and med records sent to vaers website per VAERS request -
1573418 2275621 2022-05-13 27.00 pt admitted to Hospice with anoxic brain injury; GIP agitation pt; pt had a positive COVID test on 12/23/21 Medical Center, after an asthma attack; hx of uncontrolled asthma, substance abuse, prior overdose, and seizures; poorly unresponsive; pt passed away in the hospice facility
1573439 2275642 2022-05-13 72.00 EMS called due to pt being unresponsive; O2 sats in the 80s on RA; hypotensive; in ED pt dx with septic shock from UTI, positive COVID test; COVID pneumonia; O2 supplementation; DNR/DNI but family wanted IVFs and ABX to see if pt improved; renal failure; severe thrombocytopenia; acute anemia with heme positive stool requiring transfusion; given IV Decadron; family made family comfort care; hospice where pt passed away
1573457 2275660 2022-05-13 78.00 pt brought to ED with heart failure exacerbation; initial COVID test was negative; treated with diuresis; pt then developed fevers and persistent hypoxia; on 8/24/21 the pt had a positive COVID test; treated with dexamethasone and remdesivir; O2 supplementation; increased need for O2; rapid respiratory response was called; pt transferred to SICU for BiPAP; pt intubated; pt status changed to DNR and transitioned to comfort care; he passed away in the hosital
1573128 2275268 2022-05-13 LA 70.00 brother passed away of unknown circumstances on 04Jan2022; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (brother passed away of unknown circumstances on 04Jan2022) in a 70-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on 04-Jan-2022 The patient died on 04-Jan-2022. The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. It was reported that patient was now deceased who was in a Moderna Covid-19 vaccine clinical study in 2020. The trial was conducted by the Medical Center. It was reported that the patient passed away due to unknown circumstances on 04Jan2022. The patient received a placebo injection in the study. After the trial ended, patient got unblinded and then received the Moderna Covid-19 vaccine. The reporter did not report any side effects or adverse reactions to Moderna Covid-19 vaccine. The reporter did not had dates of administration or lot numbers for the patient's Moderna Covid-19 vaccines. Deceased patient was listed as a contact in the case. On 05May2022 the reported answered the phone and said that he would try to call Moderna back with the information about vaccine lot numbers and dates of administration of the vaccine. Company comment: This Spontaneous case concerns a 70-year-old male patient, with no reported medical history, who had a serious, unexpected fatal outcome unspecified day, after receiving a dose of mRNA-1273 vaccine. Patient had passed away due to unknown circumstances and the cause of death was not reported. It is unknown if an autopsy was performed. The patient was reported to have been included in a clinical trial and have received a placebo injection while in the study. After the trial ended, the patient received a dose of mRNA-1273 vaccine on unknown date. Clinical course, circumstances surrounding the event and treatment details were not reported in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2022-56043.; Sender's Comments: This Spontaneous case concerns a 70-year-old male patient, with no reported medical history, who had a serious, unexpected fatal outcome unspecified day, after receiving a dose of mRNA-1273 vaccine. Patient had passed away due to unknown circumstances and the cause of death was not reported. It is unknown if an autopsy was performed. The patient was reported to have been included in a clinical trial and have received a placebo injection while in the study. After the trial ended, the patient received a dose of mRNA-1273 vaccine on unknown date. Clinical course, circumstances surrounding the event and treatment details were not reported in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: his brother passed away of unknown circumstances
1573653 2275861 2022-05-13 MN 60.00 Hospitalized long term for multiple issues. Pt positive for COVID 19 on 10/31/2021.
1573710 2275919 2022-05-13 85.00 8/9/21 pt admitted to hosp with AHRF secondary to COVID PNA; positive COVID test 8/9/21; treated with dexamethasone, O2 supplementation, remdesivir, zinc, Vitamins C/D; pt's condition worsened with no clinical improvement; O2 needs increased; DNR/DNI; transitioned to comfort measures; pt passed away in the hospital
1573727 2275936 2022-05-13 85.00 pt admitted to hosp on 9/1/21 with a positive COVID test; COVID pneumonia; dc'd to SNF on 9/13/21; was then dc'd to home; pt c/o increasing SOB and productive cough past 4 days; pt tachycardic; large left pneumothorax and bilateral interstitial lung disease; thoracostomy tube placed; pt's condition worsened; labored breathing; family decided to transition pt to comfort measures; the next day the son decided to not transition pt to comfort measures; treatments began again; the following day, pt's family decided to again transition pt to comfort measures only and he passed away; med records and death certificate submitted to info@vaers.org per VAERS request
1573730 2275940 2022-05-13 SD 88.00 This is an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated with the Janssen product on 05/06/2021. They tested positive via antigen test on 09/16/2021 at the nursing home at which they were a resident. They presented to emergency department on 09/24/2021 with primary complaint of low oxygen saturation. The individual reported no symptoms such as shortness of breath, etc. The individual was sent to emergency dept by their primary care provider, who had noted the low oxygen saturation. The individual's oxygen saturation was normal when it was checked in the emergency department. I see no indication the individual was admitted to hospital. The individual died on 09/29/2021, although some clinical notes have the death date as 10/01/2021. The death certificate has 09/29/2021 as date of death.
1573741 2275953 2022-05-13 SD 74.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 02/09/2021 and 03/02/2021. They presented to Emergency Department on 09/25/2021 after about 6 days of shortness of breath and increasing oxygen requirements.. The individual was admitted to hospital 09/25/2021 and tested positive for COVID-19 upon admission. The individual experienced complications of COVID-19 pneumonia and a cardiac arrest. They were transitioned to comfort care only and died in the hospital on 10/01/2021.
1573761 2276174 2022-05-13 SD 57.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 03/03/2021 and 03/31/2021. They tested positive for COVID-19 on 09/29/2021 and 09/30/2021. They were admitted to hospital 09/30/2021. They experienced several complications and co-occurring conditions, including: sepsis, hypoxic respiratory failure, severe acidosis, multiple organ dysfunction, coagulapathy (attributed to COVID-19), tension pneumothorax, low paltelet, thrombocytopenia, hyperglycemia, encephalopathy, and COVID-10 pneumonia. The individual remained hospitalized until their death on 10/06/2021. (some clinical documents have date of death as 10/05/2021 but the death certificate has 10/06/2021).
1573772 2276185 2022-05-13 SD 92.00 This is an instance of breakthrough COVID-19 after which death occurred. The indiviudal was vaccinated with the Pfizer product on 01/12/2021 and 02/02/2021. They tested positive for COVID-19 on 10/09/2021 at the nursing home at which they were a resident. I see no indication that the individual was hospitalized, but the nursing home healthcare provider may have more information. It was thought the only symptom the individual had was diarrhea. The individual died on 10/10/2021.
1573676 2275884 2022-05-13 75.00 9/7/21 pt admitted to the Hospital for hospice care; pt had a positive COVID test on both 8/25/21 and 9/3/21; pt passed away in the hospital; limited medical records received; death certificate and medical records sent to info@vaers.org per VAERS request
1572818 2273595 2022-05-12 74.00 pt had a positive COVID test on 9/23/21 and again showing positive on 10/10/21; pt passed away at home; attempted to get medical records from physician who signed death certificate, but received a phone call from the office stating the pt had never been seen by the dr prior to her passing; death certificate sent per VAERS request
1572369 2273058 2022-05-12 DEATH; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose and start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died from an unknown cause of death. The reporter stated that, "The covid vaccine killed my mother. Can I finally post this without being ostracized. I needed my mother more than she needed that shot". It was unspecified if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20220515166-covid-19 vaccine ad26.cov2.s-Death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
1572463 2273170 2022-05-12 have had 5 of my wife's friends who had miscarriages; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABORTION SPONTANEOUS (death, medically significant), outcome "fatal", described as "have had 5 of my wife's friends who had miscarriages". The patient date of death was unknown. Reported cause of death: "Death". It was not reported if an autopsy was performed. Clinical course includes, As per call with reporter: Reporter thinks the real world data right now, rather than just the data from Pfizer and early on, I mean, there its-its awful, is just awful, what they saw. Reporter started referring to a document that was regarding breast feeding and pregnant women. Reporter spoke for a while and then summarized and asked about information regarding breastfeeding and pregnancy with the Pfizer COVID19 vaccine. He mentioned both he and his wife are not vaccinated. Early on, Reporter had 5 of his wife friends who had miscarriages. They had the COVID vaccine. All of their friends who had no COVID vaccine had a normal, healthy baby. So 5 out of 5 that were vaccinated had miscarriages in their third trimester and then-well one had a still born birth so he guessed that's 4 out of 5. No doctor linked any of that to the COVID vaccine and all those doctors-all those women were told, cause we actually- there obviously were very mentally upset-but all their doctors, OBGYN, all of them recommended that they get the COVID vaccine because they were told that 'your baby is gonna get COVID or you could get COVID during it and your baby would die reporter meant, they didn't give any data and that scared those women into getting the shot. They didn't provide anything. So any questions that were asked, they said 'no you have to, you need to get it. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200677408 mother/baby case; Reported Cause(s) of Death: Death
1572464 2273171 2022-05-12 have had 5 of my wife's friends who had miscarriages; have had 5 of my wife's friends who had miscarriages; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). A female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABORTION SPONTANEOUS (death, medically significant), outcome "fatal", EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown" and all described as "have had 5 of my wife's friends who had miscarriages". The patient date of death was unknown. Reported cause of death: "have had 5 of my wife's friends who had miscarriages". It was not reported if an autopsy was performed. Clinical course: Early on, reporter have had 5 of wife's friends who had miscarriages. They had the COVID vaccine. All of reporter's friends who had no COVID vaccine had a normal, healthy baby. So 5 out of 5 that were vaccinated had miscarriages in their third trimester. No doctor linked any of that to the COVID vaccine. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200677408 mother/baby case; Reported Cause(s) of Death: have had 5 of my wife's friends who had miscarriages
1572797 2273571 2022-05-12 SD 97.00 This is an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated with the Pfizer product on 04/06/20221 and 04/27/2021. They tested positive for COVID-19 on 09/27/2021 x4. They were briefly admitted to hospital on 09/29/2021 after presenting to emergency department for shortness of breath, but were discharged back to the nursing home at which they were a resident. The individual was a DNR and on comfort care only. They died later on the same day, on 09/29/2021.
1572453 2273159 2022-05-12 his death was weeks after getting the vaccine; pneumonia; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "his death was weeks after getting the vaccine"; PNEUMONIA (medically significant), outcome "unknown". The date and cause of death for the patient were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: his death was weeks after getting the vaccine
1572845 2273622 2022-05-12 72.00 pt presents to ED with SOB, wheezing, nasal congestion/rhinorrhea, fever; pt had a positive COVID test; admitted; started on steroids and ABX; pt had brief periods of improvement then worsening oxygenation; transferred to CCU; continuous BiPAP; pt was DNI; pt passed away of hypoxia in the hospital
1573059 2328478 2022-05-12 64.00 Narrative: Wife reported that patient passed away in sleep at his house on 04/17/2022. Patient received EUA J&J COVID vaccination on 04/01/2021 and a Moderna booster 0.25 ml (11/18/2021). Patient called the triage nurse on 04/08/2022, one week prior to death, with complaints of loose stools, bowel urgency, and vomiting. Patient noted that since ankle surgery at Hospital on 03/15/2021, he has had intermittent LE swelling, and the swelling was also notable with the GI symptoms. Patient missed group therapy session and wife reported his death.
1573066 2328506 2022-05-12 50.00 Narrative: Patient was inpatient MICU and died inpatient. Death was caused by: Pneumocystis Pneumonia in setting of HIV/AIDS, along with Mycobacterium TB complex Pneumonia, Psuedomonas Pneumonia with resultant acute hypoxic respiratory failure. Patient had received J&J covid vaccine on 04/12/2021 assumed at clinic although not properly recorded in patient chart. This death is not related to the COVID vaccine.
1573067 2328507 2022-05-12 48.00 Narrative: Patient received COVID J&J vaccination on 08/26/2021 at clinic. Patient was outpatient with no remarkable comorbidities, but given the length of time, it is unlikely the event is related to vaccination unless undiagnosed upon death (04/14/2022)
1572885 2273662 2022-05-12 91.00 pt presented to ED with generalized weakness, diarrhea, vomiting, poor oral intake, mild cough, sore throat; CT scan showed acute cholecystitis; positive COVID test; COVID pneumonia; started on ABX, steroids, O2 supplementation; pt improved and was able to be sent home; she passed away at home; death certificate and med records sent to info@vaers.org per VAERS request
1572243 2271851 2022-05-11 SD 85.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 01/06/2021 and 01/27/2021. They tested positive for COVID-19 on 09/13/2021. They presented to emergency department on 09/19/2021 with primary complaints of chills/shaking. They were admitted to hospital and diagnosed with COVID-19 pneumonia. They continued to decompensate and remained hospitalized until their death on 09/27/2021.
1572230 2271837 2022-05-11 SD 89.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 02/02/2021 and 03/02/2021. They tested positive for COVID-19 on 09/19/2021. They presented to emergency department and were admitted to hospital on 09/21/2021. Two repeat COVID-19 tests was also positive on 09/21/2021. Primary complaints for hospital admission were increased agitation, decreased appetite, and general weakness. On second day of hospitalization, the individual stopped all oral intake. The family agreed to comfort care only. The individual remained hospitalized until their death on 09/26/2021. They were diagnosed with failure to thrive in an adult and hypokalemia.
1571914 2271117 2022-05-11 77.00 pt had a positive COVID test 1/3/22 in nursing home; 1/10/22 was transferred-Hospital for fever, cough, congestion; still positive for COVID; pt dc'd from hospital to home where she passed away; death certificate and med records sent to info@vaers.org per VAERS request
1571492 2270623 2022-05-11 Died days after receiving the COVID 19 shot; heart attack; Enlarged heart; Swelling of the throat; Chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 30-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Died days after receiving the COVID 19 shot"; MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack"; CARDIOMEGALY (non-serious), outcome "recovered", described as "Enlarged heart"; PHARYNGEAL SWELLING (non-serious), outcome "recovered", described as "Swelling of the throat"; CHEST PAIN (non-serious), outcome "recovered". The events "heart attack", "enlarged heart", "swelling of the throat" and "chest pain" required physician office visit. The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: Reporter was Aunt, states that now that the results are coming out from Pfizer and the young kids are being effected by the side effects. She states that patient was 30-years-old and died days after receiving the COVID 19 shot. Patient had chest pains, an enlarged heart and swelling of throat. Doctor said she was fine. Reporter states then patient's heart, she had that myo, whatever it's called and had a heart attack, and died at 30. Also reported that her 30-years-old niece died after being forced to get the Pfizer COVID-19 Vaccine to be able to get a job and her niece has 2 kids who are being forced to get a COVID-19 Vaccine in their school, so she wants to know if they will die too for having the vaccine. She stated her niece got just the first shot and then felt a swollen throat and went to see a doctor, but that the doctor told her that it was just a regular allergy and to go home. Reporter stated that Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) was related to a possible reaction to the vaccine, she stated that her niece's death was related to that. She wanted to know if a heart attack could be related to the Pfizer COVID- 19 Vaccine. We're pushing kids to get vaccine and kid have the most possibility of getting side effects. When referring caller to and HCP, she stated that all HCPs were being uncooperative. She also stated should she just go ahead and kill the kids. Are just experimenting with kids to see the results in the end. How many die. Because it is being pushed and enforced. Pray that nothing happens to this kids if they get the shot because you don't know what you're doing, you're just trying to make money. Reporter stated that we're pushing kids to get vaccine and kid have the most possibility of getting side effects. Reporter states now they are finding that kids with Pfizer were at the highest risk of side effects like seizures and enlarged hearts. Reporter states they are saying get the shot, get the kids shots and asked if their mother died immediately after the shot are the kids going to die since they share the same DNA. Reporter states that she has seen meth addicts live longer than some people who are getting the shot. She is concerned and declined to complete the report and stated that she thinks it would be best if her niece's husband did the report. States she is just calling to get the information about on how to do all things and help them out. She states the sad thing is they have to come up with money for her funeral and to take care of the kids. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Died days after receiving the COVID 19 shot
1571419 2270547 2022-05-11 FL PASSED AWAY; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total was administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-FEB-2022, the patient passed away from unknown cause of death. It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220513819 - Covid-19 vaccine ad26.cov2.s -Passed away. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
1570841 2268819 2022-05-10 63.00 pt saw PCP on 1/13/22 with sx of sore throat, decrease in appetite, fever, chills, sinus problems cough, SOB, nausea and vomiting; states has fallen twice in last few days due to vertigo; denies hitting head or LOC; strep test came back positive; COVID test done but results not ready at visit time; given Amoxicillin; COVID test did turn out to be positive; pt expired at home per death certificate; death certificate and med records submitted to VAERS per their request
1571017 2269002 2022-05-10 SD 63.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 02/02/2021 and 02/23/2021. They tested positive for COVID-19 on 09/16/2021 at the nursing home/rehab facility at which they were a resident. They were admitted to hospital on 09/23/2021 with primary complaints of hypoxia and respiratory failure, after not tolerating non-invasive ventilation at the nursing home. They tested positive again for COVID-19 on 09/24/2021. They then had a Pulseless electrical activity arrest for about 15 minutes. They were intubated, and they experienced cardiogenic shock. Bilateral pleural effusions were also discovered on CT scan. The individual remained hospitalized until their death on 09/24/2021.
1570998 2268983 2022-05-10 63.00 pt saw physician on 1/21/22 with c/o cough; positive COVID test; given zpack, prednisone, vitamin D and zinc; dc'd to home; pt died at home later that day; med records and death certificate emailed to VAERS per their request
1570991 2268976 2022-05-10 SD 73.00 This is an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated with the Moderna product on 05/05/2021 and 06/02/2021. They tested positive for COVID-19 via antigen text x2 on 09/12/2021. They presented to emergency department via ambulance on 09/20/2021 and were admitted to hospital. The individual experienced complications of COVID-19 pneumonia, a secondary bacterial pneumonia, hypoxia, and a UTI. Their condition continued to decline despite treatment. They remained hospitalized until their death on 09/23/2021.
1570979 2268964 2022-05-10 52.00 pt had been seen at hospital for laparoscopic cholecystectomy; pt had a positive COVID test on 2/1/22; pt was dc'd to home on dexamethasone and ABX for recent COVID pneumonia; pt was found unresponsive in hotel room; EMS notified; CPR; pt intubated; regained spontaneous circulation after a period of PEA; anoxic ischemic brain injury; drug screen positive for fentanyl, ETOH, THC; family desired hospice care for pt; DNR; pt passed away in hospice; death certificate and med records sent to per VAERS request
1570689 2268600 2022-05-10 MI Their mother died days after the first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team A 30-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Their mother died days after the first shot". The date and cause of death for the patient were unknown. Subject: Patient Assistance. Customer Verbatim: Is it ok for our children to get the COVID shot now that results show a high risk of serious side effects on children getting the shot? Their mother died days after the first shot. She was 30 yrs of age, healthy, energetic, great mom and wife. Now she is dead and the kids are motherless. Will the kids die too if the get the pfizer shot?. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Their mother died days after the first shot
1570830 2268808 2022-05-10 TN 74.00 Pfizer vaccine x 2. Tested positive for COVID 19 on 09/20/2021. Admitted to the Medical Center on 04/20/2022. Expired on 05/06/2022 while still hospitalized.
1570802 2268778 2022-05-10 78.00 pt had a recent hospital admission (facility unknown) for poor oral intake, cough, congestion; dx with UTI, non-STEMI; family opted to pursue hospice care with comfort as the goal; admitted to Facility on 1/25/22; pt tested positive for COVID on 1/26/22; given O2 supplementation, dexamethasone and doxycycline; pt expired in the nursing home; med records and death certificate submitted per VAERS request
1570771 2268746 2022-05-10 87.00 1/22/22 pt presents to hosp with c/o lethargy, SOB, weakness, mild productive cough, states tested positive for COVID 8 days prior (1/14/22); has had increasing weakness and SOB, poor oral intake, difficulty urinating; increased O2 to 6L via NC; severe sepsis with acute organ dysfunction; given ABX, IV fluids, dexamethasone; placed on BiPAP; pt's condition worsened; palliative care called in to see pt; pt expired in the hospital; med records and death certificate emailed per VAERS request.
1570725 2268699 2022-05-10 NY 71.00 12/20/2021 - Came to ER with worsening Covid symptoms- c/o weakness/sore throat/diarrhea. Previous inpatient stay from 12/9 - 12/18, in with cellulitis and later became symptomatic with covid pneum - tested on 12/14 - treated with Remdesivir-5 days, antibiotics, and steroid. Still Thrombocytopenic and anemic with severe Leukocytosis. CRP 7. PaO2 of 70. Vitals WNL. On 2L O2 NC. New diagnosis of AML. Continuing Cefepimine and Doxy. 12/21 - WBC 65.4/Platelets 22. Received 2U platelets. Heparin held due to Thrombocytopenia. 12/22 - CT scan of lung concerning for consolidation. Still on 2LNC. Continuing antibiotic/steroid. Received 2 additional U platelets and 1 PRBC. 12/23 - Bone biopsy complete. Thrombocytopenia likely due to underlying Leukemia. Treatment pending result. Worsening hepatic dysfunction AST- from 138 on adm to 270, ALT from 76 to 200. 12/24 - One IV ripped and bled significantly. Patient unresponsive for 30 seconds trying to move from commode to bed. Rapid called. 2U PRBC and 2U platelets ordered HCT 26.2/HGB 7.8. Moved to CVICU. O2 at 98 on 4LNC. GI consult indicates liver injury likely due to Covid liver, underlying sepsis, and potential drug induced from antibiotics. Indicates there is no specific treatment at this point for liver injury. Antibiotics continued for sepsis/pneumonia. 12/25 - Liver functions stable. Conservative management and supportive care contnued. Pulse 124, RR 29, all other vitals WNL. Transfusion support continued for AML. Biopsy report pending. 12/26 - NG tube attempted by nursing. Patient began to bleed and struggle. Attempted a 2nd time. Tip unable to be verified and left in place. Questionable blood aspiration. Developed fever overnight >104 - 103.2 - Tylenol given w/o relief. Transitioned to Palliative care for overall poor prognosis. 12/27 - Patient expired @2125
1571042 2269032 2022-05-10 64.00 1/10/22 pt presents to ED from a fall after being dizziness; mild displaced left greater trochanter; (pt recently hospitalized from 12/7/21 - 12/15/21 for SOB); pt has a cough; found to be positive for COVID; O2 supplementation; ABX; Vitamins C, D, and zinc; remdesivir and dexamethasone; pt's condition worsened and he passed away in the hospital
1571018 2269003 2022-05-10 102.00 pt lives in a nursing home; had a positive COVID test on 4/17/21; per death certificate, pt died in the nursing home with the causes being: Cardiac Arrest, Respiratory Failure, COVID 19; death certificate and med records emailed to info@vaers.org per VAERS request
1571049 2269039 2022-05-10 85.00 Pfizer COVID #1 GIVEN 01/07/2021, lot #EL3246; Pfizer COVID #2 given 01/28/2021, lot #EL9261; minimal medical records received from hospital; pt had a positive COVID test on 1/28/22 with ordering facility being Hospital; was admitted to Hospital on 2/17 - 2/26/22 where pt expired; per death certificate, pt died of COVID 19 illness, Olgilvie's Syndrome with persistent pseudo-obstruction and colonic perforation with peritonitis; medical records and death certificates sent per VAERS request
1571341 2328596 2022-05-10 96.00 Narrative: Documenting VAER as required for pt who died and received COVID vaccine months before
1571187 2269340 2022-05-10 GA 95.00 Transverse myelitis. Contracted covid in January 2022. Passed away on February 08, 2022 from covid.
1571253 2328475 2022-05-10 86.00 Narrative: Documenting VAER as required for pt who died and received COVID vaccine months before.
1571274 2328513 2022-05-10 69.00 Narrative: Patient received two doses of Moderna COVID 19 Vaccine in Mar/Apr 2021. The patient tested positive for COVID 19 on 12 Jan 2022. The patient presented to the ED with weakness. The patient was admitted to the hospital on 12 Jan 2022 with DKA, Acute kidney injury, and covid infection. The patient's covid symptoms turned into sepsis. The patient was treated with antibiotics, was intubated, and the patient's condition worsened. The patient died on 22 Jan 2022 due to intracranial bleed, Sepsis, due to COVID pneumonia and hyper-coagulopathy. Reported per EUA.
1571282 2328529 2022-05-10 71.00 Narrative: Patient received two doses of Pfizer COVID 19 Vaccine in March 2021. The patient tested positive for COVID 19 on 5 February 2022. The patient presented to the ED on with general malaise and weakness, dry cough, headache, and shortness of breath. The patient was admitted with a diagnosis of COVID/hypoxia. The patient was treated with remdesivir and dexamethasone. The patient's conditioned worsened with acute pneumonia and sepsis. The patient died on 12 February 2022 due to COVID pneumonia and sepsis. Reported per EUA
1571318 2328571 2022-05-10 74.00 Narrative: Vaccinated, not boosted pt admitted for AHRF requiring intubation 2/2 COVID. Extubated but eventually worsened requiring BIPAP. Transition to palliative care and ultimately deceased.
1571319 2328572 2022-05-10 89.00 Narrative: Documenting VAER as required for pt who died and received COVID vaccine months before.
1571325 2328578 2022-05-10 72.00 Narrative: Vaccinated, not boosted pt admitted for COVID PNA requiring intubation ultimately palliatively extubated and deceased
1571330 2328585 2022-05-10 79.00 Narrative: Documenting VAER as required for pt who died and received COVID vaccine months before.
1571344 2328600 2022-05-10 71.00 Narrative: Documenting VAER as required for pt who died and received COVID vaccine months before.
1571347 2328604 2022-05-10 85.00 Narrative: Documenting VAER as required for pt who died and received COVID vaccine months before.
1570242 2267688 2022-05-09 TX 78.00 Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Rec'd Pfizer Vaccines 1/26/2021, 2/20/2021 and 9/13/2021. Prior hospitalization for bilateral community-acquired PNA and acute hypoxic respiratory failure from 4/4/2022 - 4/11/2022 at same facility and was Covid neg. Presented to ED 5/1/2022 with c/o productive cough and SOB, and tested POSITIVE for COVID. Admitted w/acute on chronic hypoxemic resp failure due to Covid PNA, placed on BIPAP. Also found to have a RLL PE on CTA at presentation. Condition deteriorated despite tx w/vanc, dexamethasone, zinc sulfate, and ascorbic acid. Expired on 5/8/2022.
1570025 2267460 2022-05-09 85.00 pt had a positive COVID test on 12/15/21, 1/16/22, 1/23/22, 2/11/22 and 2/16/22; 2/11/22 pt admitted to a local medical center with common bile duct stones, anemia, GI bleed, acute/chronic renal failure; 2/15/22 pt transferred to another Medical Center; physician unclear on what the goals are; states pt has finished COVID quarantine; DNR; comfort measures only; no invasive procedures to be done; pt passed away in the hospital; COVID IS NOT listed as cause of death on death certificate; med records and death certificate submitted to info@vaers.org per their request
1569986 2267420 2022-05-09 75.00 pt sent to local Medical Center on 1/14/22 for possible CVA; dx with UTI and hyperglycemia; dc'd to nursing home, found to be positive for COVID on 1/17/22 in nursing home; comfort measures; pt more confused, hallucinating, poor oral intake, increasing SOB, malaise, non-productive cough, O2 sats worsening; O2 supplementation on pt; pt continued to decline and passed away in the nursing home; medical records and death certificate sent to VAERS.
1569985 2267419 2022-05-09 TN 82.00 Presented with covid symptoms, having chills, dry cough and nausea, loss of appetite. Tested positive for Covid-19 on 7/28/2021. IV steroids was initiated, and Lovenox. Patient expired on 8/17/2021.
1569957 2267390 2022-05-09 73.00 Pfizer COVID vac #1 given on 2/10/21, lot # EL3246; Pfizer COVID vac #2 given on 3/3/21, lot #EN5318; pt had a positive COVID home test 3 days before coming to ED; 2/3/22 pt presents to ED with SOB the night before, decreased UOP, even though drinking the same amount of fluids, fever, non-productive cough, dyspnea; admitted; 2/4/22 positive COVID test; acute on chronic renal failure; at first, did not need O2 supplementation, but later needed O2 was required; code blue called due to pt being unresponsive and pulseless, asystole; CPR and ACLS protocol; intubated; remained asystole and pt expired in the hospital
1569925 2267358 2022-05-09 KY 77.00 Resident had no po intake or urinary output on 4/21-22/2022. Resident unable to comprehend using a straw or chewing food. Slept for over 24 hours and unable to hold up her head. Resident was transported to hospital at that time where she was diagnosed with Covid, pneumonia and sepsis. Discharge noted septic shock, hyernatremia, dehydration, weakness & metabolic encphalopathy overlying advance dementia. Prior to be sent to hospital on 4/22/2022, resident was having increased confusion and tearfulness. Increased behaviors noted on 4/4/22, with increase in Depakote. Fall on 3/30/22.
1570458 2271861 2022-05-09 82.00 Narrative: 81yo male patient in home based primary care - geriatrics died at home of unknown cause on 4/16/2022. Pt had the following problem list in his chart: Hyperlipidemia 12/17/2021 Anxiety 12/17/2021 Benign prostatic hypertrophy without outflow 12/17/2021 obstruction GERD - Gastro-esophageal reflux disease (12/17/2021), HTN - Hypertension (12/17/2021) OA - Osteoarthritis (12/17/2021) Obesity 12/17/2021 Sleep Apnea 12/17/2021, Pulmonary hypertension (12/17/2021) Venous statis 12/17/2021 Lymphedema 12/17/2021 Chronic back pain 12/17/2021, Lumbar spondylosis (12/17/2021) Glaucoma 12/17/2021 Insomnia 12/17/2021 Restless Legs 12/17/2021 Seen by palliative care medicine service Gout 02/24/2016 Depression 08/20/2021 Brief history and current status: Patient dependent on continuous O2 and co-morbidities including Pulmonary HTN, Obesity, Lymphedema, Venus Stasis. Last hospital discharge 1/18/22. DISCHARGE DIAGNOSIS was - Acute on Chronic Hypoxic/hypercapnic Respiratory failure due to COPD. Pt received a covid vaccine (J&J) on 6/10/2021. This death likely is not related to the covid vaccine given the pt's advanced age, long length of time between death and date he received the vaccine and the pt's comorbidities.
1570342 2268064 2022-05-09 MT 55.00 Case completed 2 series of Moderna vaccine in March 2021, then was hospitalized in March of 2022. Hospitalized at: Hospital. She was admitted on the date noted above with hypercapnic respiratory failure requiring BiPAP. She had severe CO2 narcosis and was very obtunded. When she started becoming more awake she removed her BiPAP and promptly went into cardiac arrest. She was resuscitated and placed on mechanical ventilation. Further evaluation found her to have a severe left-sided pneumonia, probably on the basis of an aspiration event. She required high levels of PEEP and FiO2 for oxygenation. Discussions with the family ensued as she had failed multiple spontaneous breathing trials. Tracheostomy was suggested due to her body size and habitus. The family realized that she would never want to be placed on artificial life support for prolonged amount of time nor go to a nursing home. They opted for comfort care. She was given morphine infusion, extubated and then passed away with family at her side. WHILE CASE WAS HOSPITALIZED FOR COVID CARE, AND SUBSEQUENTLY DIED DURING THIS HOSPITALIZATION, COVID WAS NOT NOTED ON HER DEATH CERTIFICATE AS CONTRIBUTING TO HER DEATH. SHE HAD MULTIPLE COMORBIDITIES, AND COVID DID NOT MAKE THE LIST ON HER DEATH CERTIFICATE.
1570482 2273222 2022-05-09 101.00 Narrative: 101 year old male admitted on 3/25/22 with dyspnea on exertion. He had previously tested positive for COVID on 3/11/2022 and received monoclonal antibodies at an outside institution, unclear where. He was found to have NSTEMI on admission. He had been vaccinated x 3, Pfizer in the community (1/7/2021, 1/28/2021, and 10/6/2021). He did receive dexamethasone during admission. Date of death was 4/1 which was attributed to COVID-19, NSTEMI, Lung mass, Heart failure with reduced ejection fraction and Peripheral arterial disease on documentation of death.
1570467 2273140 2022-05-09 69.00 Narrative: Hospitalization - pt admitted on 1/9/22 for SOB. Prolonged hospital course for PNA, human metapneumovirus, COPD exacerbation. Found to be COVID-19 positive on 2/8/22 (while admitted), fully vaccinated (not boosted). Patient died on 2/15/22 of hypoxic respiratory failure.
1570473 2273212 2022-05-09 89.00 Narrative: Patient COVID positive despite 3 doses of vaccine.
1570480 2273220 2022-05-09 81.00 Narrative: Patient died on 4/8/2022 at home in hospice care. COMMUNITY AGENCY: Pt had received a covid vaccine on 7/20/21 (J&J). Likely vaccine not related to pt's death given advanced age (80yo) & multiple comorbidities & in hospice care. See pt's problem list below: Problem List: Full care by hospice Seen by palliative care medicine service BP - High blood pressure History of deep vein thrombosis Vitamin B6 deficiency Essential tremor Seen by palliative care service Closed fracture of greater trochanter of left femur Debility Dementia of the Alzheimer type with behavioral disturbance OA - Osteoarthritis Vitamin D Deficiency Serum vitamin B12 low Seen by palliative care medicine service Dementia Mild Cognitive Impairment, so stated Depressive disorder Lipoma Chronic post-traumatic stress disorder (Hypercholesterolemia Abnormal Urinalysis Alcohol dependence Tobacco user Finding of increased blood pressure H/O: gout Anemia Prostate cancer Localized swelling, mass and lump, lower limb Preventive Counseling, Unspec
1570481 2273221 2022-05-09 90.00 Narrative: Patient received a J&J covid vaccine first dose on 3/17/2022 at hospital facility. On 4/2/22 pt died at private hospital. This information found in pt's chart regarding pt's death. Death does not seem to be related to the covid vaccine given pt's advanced age and multiple comorbidities. "Brief Hospital Course: 90M found down by neighbor who normally lives alone with only the neighbor periodically checking on him for assistance. Patient brought in after being found down, confused, and found to have hyperkalemia, hypernatremia, troponemia and aki on ckd4. Patient had worsening encephalopathy and suspected underlying dementia, developed new afib, and unfortunately despite adjusted diet per speech had an episode of aspiration. No family was available and the listed emergency contacts had passed away. Nephrology and pulmcrit assisted with evaluation. Unfortunately patient had continued declined despite interventions and given the wishes listed in his advanced directives was transitioned to comfort measures only. Final Diagnosis: AKI vs progression of CKD4 to CKD5 Uremia Hypernatremia Hyperkalemia Metabolic Acidosis Acute metabolic encephalopathy/hospital delirium Aspiration Pneumonia New pAfib NSTEMI type 2 suspect demand ischemia in setting of aki/ckd rhadbo AOCD Rhabdomyolysis RLE Superficial thrombophlebitis in small saphenous vein Suspect underlying vascular dementia Time of Death: 2255 on 4/2/22 Electronically signed by MD at 04/03/22 1439"
1570483 2273223 2022-05-09 61.00 Narrative: Patient received his COVID Moderna booster on 2/17/22 and on 3/14/22, he reported to his PC provider that he had been experiencing sever pain with his trigeminal nerve to the right side of his face for approx. 2-3 weeks. He had pregabalin, diazepam, tramadol and quetiapine already prescribed that he took in attempts to alleviate his pain. He declined to go the the ER for further workup. PC provider did prescribe him hydromorphone 2mg q4-6h PRN and a Naloxone kit. On 3/16/22, notes indicate that he went to a non facility where he passed away from a massive GI bleed. No notes from that facility are available. There were 27 days from time of booster vaccine to date of death. Noted diagnosis of trigeminal nerve pain was first documented in 2018. No documentation of adverse events to first 2 vaccines.
1570504 2273260 2022-05-09 74.00 Narrative: Hospitalization - admitted for right-side weakness and found to have left occipital lobe intraparenchymal hemorrhage. Incidentally found to be COVID-positive on admission, asymptomatic. Fully vaccinated (not boosted). Pt died on 2/7/22 2/2 CVA.
1569921 2267354 2022-05-09 80.00 pt was seen by an urgent care doctor in the patient's home and was dx with COVID and UTI; given doxycycline; no improvements; sx worsened; more weak and confused, fever, a lot of secretions in oropharynx; wife concerned and brought him to ED; was intubated due to excess secretions and concern of aspiration; started on remdesivir and dexamethasone; DNR; pt passed away in the hospital; death certificate and med records submitted to info@vaers.org
1569482 2266791 2022-05-07 CA 50.00 Massive heart attack; blood clot; Pulmonary embolism; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Massive heart attack), THROMBOSIS (blood clot) and PULMONARY EMBOLISM (Pulmonary embolism) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039a21a and 027ia21a) for COVID-19 vaccination. No Medical History information was reported. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Massive heart attack) (seriousness criteria death and medically significant), THROMBOSIS (blood clot) (seriousness criteria death and medically significant) and PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria death and medically significant). The patient died on 08-Apr-2021. The reported cause of death was massive heart attack, Pulmonary embolism and blood clot. An autopsy was not performed. No concomitant medications were reported. 6 days after the second dose the patient had a massive heart attack a blood clot pulmonary embolism, and died in three hours. The patient did not have allergies. The patient never had COVID positive test or diagnosis. The patient did not experience any medical history relating to mentioned AE and both acute and chronic illnesses at the time of vaccination. The patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. The patient did not experience a similar event in the past and no history heart disease. The symptoms were not improved or worsened. No treatment information was reported. Company Comment: This spontaneous case concerns a 50-year-old old female patient with no medical history reported who experienced the fatal, unexpected, serious (medically significant) adverse events of special interest of Myocardial infarction, Thrombosis and Pulmonary embolism which occurred six days after receiving the second dose of mRNA-1273 vaccine. It was reported that patient had a massive heart attack a blood clot pulmonary embolism and died after three hours. Information about the clinical presentation, diagnostic evaluation and treatment details was not reported in this case. Death occurred six days after receiving the second dose of mRNA-1273 vaccine. The cause of death was reported as Myocardial infarction, Pulmonary embolism, and Thrombosis. Autopsy was not performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 50-year-old old female patient, with no medical history reported who experienced the fatal, unexpected, serious (medically significant) adverse events of special interest of Myocardial infarction, Thrombosis and Pulmonary embolism which occurred six days after receiving the second dose of mRNA-1273 vaccine. It was reported that patient had a massive heart attack a blood clot pulmonary embolism and died after three hours. Information about the clinical presentation, diagnostic evaluation and treatment details was not reported in this case. Death occurred six days after receiving the second dose of mRNA-1273 vaccine. The cause of death was reported as Myocardial infarction, Pulmonary embolism, and Thrombosis. Autopsy was not performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Massive heart attack; Pulmonary embolism; blood clot
1569556 2266869 2022-05-07 CA 93.00 Developed leg swelling; Had ascites; CT scan in Feb2022 showed liver cirrhosis; This is a spontaneous report received from a contactable reporter(s) (Other HCP). A 93-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 93 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (previous dose product=COVID 19, brand=Pfizer, brand unknown=False, lot unknown=True, lot unknown reason=Not available/provided to reporter at the time of report completion, dose number=2), for COVID-19 immunization; Bnt162b2 (product=COVID 19, brand=Pfizer, brand unknown=False, lot unknown=True, lot unknown reason=Not available/provided to reporter at the time of report completion, dose number=1), administration date: 2020, for COVID-19 Immunization. The following information was reported: HEPATIC CIRRHOSIS (death) with onset Feb2022, outcome "fatal", described as "CT scan in Feb2022 showed liver cirrhosis"; PERIPHERAL SWELLING (death), outcome "fatal", described as "Developed leg swelling"; ASCITES (death), outcome "fatal", described as "Had ascites". The patient underwent the following laboratory tests and procedures: Computerised tomogram: (Feb2022) liver cirrhosis, notes: CT scan in Feb2022 showed liver cirrhosis; SARS-CoV-2 test: (09Feb2022) Positive, notes: covid test type post vaccination=Nasal Swab. Therapeutic measures were not taken as a result of hepatic cirrhosis, peripheral swelling, ascites. The patient date of death was 13Apr2022. Reported cause of death: "Liver cirrhosis". No autopsy was performed. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202200655288 similar report from same reporter; Reported Cause(s) of Death: Liver cirrhosis
1569590 2266905 2022-05-07 She died reactions from the COVID Shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 72-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "She died reactions from the COVID Shot". The patient date of death was unknown. Reported cause of death: "She died reactions from the COVID Shot". Clinical information: "I have two, have some friend, two of our friends, one was 51 the other one 72, post night after they had the COVID shot, one had a heart attack and the other one, she was told totally healthy, she run five miles a day, only walk five miles a day, never had nothing wrong with her, she died reactions from the COVID Shot." No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: She died reactions from the COVID Shot
1569376 2266530 2022-05-06 SD 75.00 This is an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated with the Moderna product on 09/03/2021 and 04/06/2021. They presented to emergency department on 11/10/2021 after about a week of "cold-like symptoms." Primary complaint was respiratory distress, with oxygen levels 80% or lower on their normal 4 L of oxygen. They were admitted to hospital and required intubation. Intubation did not raise oxygen level above 70%. The individual was re-intubated but this also did not raise oxygen level. Decision was made to transfer to a different hospital for higher level of care via air ambulance. Pulse was lost during flight. CPR initiated and continued for about an hour after arrival at the destination hospital. Pulse was recovered, but prognosis was poor to due length of time of low oxygen levels. Family opted to discontinue aggressive measures and the individual died on 11/11/2021.
1569367 2266520 2022-05-06 SD 80.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 02/09/2021, 03/08/2021, and 08/25/2021. They had a symptom onset of approx 10/08/2021 with shortness of breath. They presented to emergency department on 10/09/2021. They were admitted to hospital from the emergency department and tested positive for COVID-19 upon admission. Their condition rapidly deteriorated and the individual was transitioned to comfort care only. They died on 10/10/2021.
1569360 2266513 2022-05-06 SD 74.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 01/28/2021 and 02/18/2021. They became symptomatic on approx 09/11/2021 with shortness of breath. They tested positive for COVID-19 on 09/16/2021, at the hospital. They were in palliative care at a care facility since May 2021. They died on 09/21/2021. I see an admit/discharge for the hospital indicated below for 09/08/2021-09/21/2021 but clinical notes dated 09/21/2021 indicate the induvial was receiving care at the care facility indicted in the address portion of this form on the day of their death (09/21/2021).
1569312 2266228 2022-05-06 SD 99.00 This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 12/30/2020 and 01/26/2021. They tested positive for COVID-19 on 09/30/2021. They were admitted to hospital on 10/01/2021. Primary complaint was assessment after a fall. The individual was a resident of an assisted living facility. The individual was described as being asymptomatic. However, the individual died on 10/11/2021. COVID-19 is listed on the death certificate.
1569151 2266066 2022-05-06 NV 80.00 Patient transported to Hospital via ambulance from his home on 3/6/2022 and died at the hospital same day from myocardial infarction. Had not felt well since 1/11/22 when he was seen in clinic at Health Facility by Dr. for UTI, dyspnea, fatigue. Treated for UTI and pneumonia. EKG was done at the time as well as a chest X ray . His wife believes that his death was due to side affects from the Covid-19 vaccine.
1569053 2265964 2022-05-06 KY 69.00 Presented to hospital ER on 12/21/2021 with 10 day history of shortness of breath. Upon arrival, diagnosed with acute COVID19 pneumonia with acute hypoxemic respiratory failure, with O2 sat of 84% on room air. Also reported weakness, fatigue, fever. Was admitted to hospital and remdesivir and dexamethasone started. 12/22/2021 required increase from 2L O2 via NC to 8L mini-high flow O2. Placed on Baracitinib. 12/23/21 placed on high flow O2 35L/min with 100% FiO2. Patient refuses to prone as it is too painful. 12/24/21 placed on bipap 100% overnight with continued sat in 70s-80s. Only managed 2 hours prone. Transferred to ICU for monitoring and probable intubation. Rocephin and Azithromycine added for possible concomitant bacterial pneumonia. 12/25/21 placed on mechanical ventilation. Remdesivir 5 day treatment completed.. 12/27/21 patient paralyzed and proned. 1/1/22sedation stopped for weaning trial. 1/2/22 remains off sedation but no response yet. Now febrile with temp 100.9 Continued to decline and on 1/4/22 patients sister decided to withdraw care. Expired 1/4/22.
1569013 2265923 2022-05-06 83.00 pt had a positive COVID test on 1/21/22 when seen at hospital; 1/25/22 transferred to hospital for worsening respiratory failure and altered mental status secondary to COVID pneumonia; required BiPAP; little improvement from medical management; pt made comfort care and expired in the hospital
1569005 2265914 2022-05-06 94.00 pt lives in nursing home (Healthcare and Rehab Center); was routinely tested for COVID and found to be positive on 12/13/22; no sx initially; slowly developed some congestion and was given Geri-Tussin Syrup; pt was refusing to eat or drink; decrease in UOP; pt was found deceased in her bed
1568347 2264443 2022-05-05 friends parents took the COVID vaccine and passed away; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "friends parents took the COVID vaccine and passed away". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: Case reported as non serious. Caller has not had the COVID vaccine and is concerned. She wants to know how does the vaccine works with new variants of COVID. She wants to understand the biochemistry. She compares it to the flu vaccine and how the influenza virus changes yearly. She states COVID is on the 7th mutation & Pfizer created a vaccine that was for the 1st variant. She notes that Omicron has 47 different mutations and how one would make a vaccine that is effective against the other variants. She states there are no vaccines that they are aware of that can do this but yet Pfizer "claims" that the vaccine does. Caller states that unless they "created this robotic vaccine, there is no way." She states that they are in the medical feild and they do not feel as though it makes sense how the biochemistry works for the product. Caller stated that her father did not feel as though it makes any sense and thus they have not received the vaccine at this time. Caller queried the biochemistry of the product and wants to know if they are taking the mRNA from the "crown." She states the only thing that does change is the crown and wants to know if this is where it is coming from. Caller notes that the news is stating that the product is only 10% effective with the "new variant." She states that is "bearly making it." She states they do not understand how it is working and they are confused and despite their medical back ground, they do not feel as though it makes sense from a biochemistry standpoint. Caller stated her friends parents took the COVID vaccine and passed away. She states they were mad because they followed "all the things" and they still passed away. She wants to know how come Pfizer is not liable for putting a product like this on the market and patients passing away. She states she spoke with a lawyer and the lawyer advised them that Pfizer was not liable. Caller wants to know who cannot take the product. She wants to know if there is an allergy test that can be done prior to taking the product. She spoke with her provider regarding this and they advised to contact either Pfizer or Moderna. Advised the caller that she would have to speak with the HCP regarding testing available for such request, Pfizer MI does not have guidance on said testing or availability of such. Advised that we would be able to provide her with a list of ingredients to then further review with her HCP. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200650352 Same reporter/vaccine/event, different patient; Reported Cause(s) of Death: friends parents took the COVID vaccine and passed away
1568333 2264428 2022-05-05 friends parents took the COVID vaccine and passed away; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) from medical information team. A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "friends parents took the COVID vaccine and passed away". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: Question: Call received from. Caller has not had the COVID vaccine and is concerned. Caller wants to know how does the vaccine works with new variants of COVID. She wants to understand the biochemistry. Caller compares it to the flu vaccine and how the influenza virus changes yearly. Caller states COVID is on the 7th mutation & Pfizer created a vaccine that was for the 1st variant. Caller notes that Omicron has 47 different mutations and how one would make a vaccine that is effective against the other variants. Caller stated that there are no vaccines that they are aware of that can do this but yet Pfizer claims that the vaccine does. Caller states that unless they created this robotic vaccine, there is no way. Caller states that they are in the medical field, and they do not feel as though it makes sense how the biochemistry works for the product. Caller states that her father does not feel as though it makes any sense and thus, they have not received the vaccine at this time. Caller questions the biochemistry of the product and wants to know if they are taking the mRNA from the crown. Caller states the only thing that does change is the crown and wants to know if this is where it is coming from. Caller notes that the news is stating that the product is only 10% effective with the new variant. Caller states that is bearly making it. Caller states they do not understand how it is working and they are confused and despite their medical background, they do not feel as though it makes sense from a biochemistry standpoint. Caller states they were mad because they followed all the things and they still passed away. Caller wants to know how come Pfizer is not liable for putting a product like this on the market and patients passing away. Caller states she spoke with a lawyer and the lawyer advised them that Pfizer is not liable. Caller wants to know who cannot take the product. Caller wants to know if there is an allergy test that can be done prior to taking the product. Caller spoke with her provider regarding this and they advised to contact either Pfizer or Moderna. Advised the caller that she would have to speak with the HCP regarding testing available for such request, Pfizer MI does not have guidance on said testing or availability of such. Advised that we would be able to provide her with a list of ingredients to then further review with her HCP. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200651970 Same reporter/vaccine/event, different patient; Reported Cause(s) of Death: friends parents took the COVID vaccine and passed away
1568387 2264526 2022-05-05 OH 75.00 Pt. presented with hypoxia and cough and was tested positive for Covid. During hospital stay pt was diagnosed with Covid PNA and acute hypoxic respiratory failure. She was given supplemental oxygen, rocephin and azythromicin for CAP.
1568355 2264479 2022-05-05 NC Severe COVID-19; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (Severe COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Liver transplant (Time since liver transplant was reported less than one year). Concomitant