Johnson & Johnson

Pt received vaccine on 03/17/2021. Pt's wife stated that pt never felt well after receiving the vaccine. Per hospital notes, pt lost his balance and fell at home approximately 12 hours prior to admission. By report, he laid on the floor for around 12 hours before emergency services were activated and he was brought to the ED. Primary diagnosis was a closed left hip fracture with other hospital problems of the fall at home, bradycardia, coronary artery disease, hypokalemia, protein calorie malnutrition, type 2 myocardial infarction and essential hypertension.

Wife reports patient was vaccinated on 3/30/21. She stated patient only had blurred vision following vaccination which lasted a about 2 days. On 4/4 family members visited and it was noted that 1 member tested positive for Covid on 4/5/21 and her spouse was home sick on 4/4/21 and was later positive on 4/5/21. Around 4/5/21 patient began having more frequent episodes of delusion and confusion. Speech slurred and slouched in chair. Patient would be demanding when asking for water when water was in his hand. Talking to her but looking at the ceiling. She stated she thought he was having "mini strokes." Increased weakness with standing. Slid to floor multiple times from chair. She reports loss of appetite and trembling. Saw MD on 4/12. "Could hardly breathe." MD ordered doxycycline and an inhaler. Patient to Hospital on 4/13/21. Diagnosed with Covid on 4/13/21 via PCR. Discharged from hospital to Skilled Nursing Facility on 4/16/21. Sent back to Hospital on 4/18/21 and passed away on 5/1/21. Wife states that death certificate indicates "Utonic Hypercapnic respiratory failure, acute/chronic CHF, hypoxemic respiratory failure and HTN, DM, prostate CA and COVID PNA. No autopsy performed. Medical PCP.

death 13 days following receipt of vaccination. Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Cause of death not documented. Significant comorbidities include dementia with neuropsychiatric behaviors including anxiety.

Pt had AFIB and was on ELIQUIS 2.5 mg BID. He began to bleed, a lot. We stopped DOAC, disussed possibility pt might die form blood clot without the DOAC. He had vaccine after stopping DOAC (stopped DOAC 2/24/21). On 3/8 he had the Janssen Vaccine. On 3/15 he awoke w weakness, inability to speak. Transferred to hospital where he was diagnosed w having major stroke, admitted to hospital. They decided NOT to use anticoagulant because he had too great a risk of bleeding.

Patient received the COVID 19 vaccine on 3/30/21. He died at home on 5/10/2021. Per his daughter, he began to decline approximately 2 weeks prior to his death (poor po intake, weight loss, increased sleep) and had not been dx or treated for an acute illness prior to his death.

Presented to ED with history of chronic respiratory failure with COPD and CHF- presented with shortness of breath, he was found to have no rhonchi or wheezing but he was found to have pulmonary edema from left ventricular heart failure. Patient admitted. He was diuresing watching his kidney function and urine output, his oxygen requirement has come to his baseline-that is treated per minute. He has no chest pain or shortness of breath, no reason to suspect PE. Troponin negative. Patient stable for discharge.

Suffered from a stroke on 4/3/21 from a blood clot in his brain stem. Prior to vaccine he was healthy and 100% independent, still drove, did grocery shopping, yard work, etc. Now he cannot move his left side and was placed on hospice as he has lost his will to eat, drink, or live.

Presented with 3 days of dizziness and shortness of breath, 3 weeks bilateral leg swelling without pain, redness, or warmth. No headaches, no bloody stool, no change in bruising patterns. Patient afebrile, stable vital signs, CBC remarkable for a platelet count of 2000 with immature platelet fraction of 69.8, hemoglobin 10.9, hematocrit 34.1. Diagnosis ITP.

Contracted COVID-19 ~1 month later, tested positive on 5/16/21. Died 6/9/2021 at 94 years old. Had CLL diagnosed during final hospitalization, thought to have caused poor vaccine response and susceptibility to COVID.

death Narrative: Patient with consistent decline over the last year; March 2021- increased confusion related to dementia, falls, hospitalizations wt loss. Enrolled in home hospice on 3/26 family's goal was to keep patient home and comfortable. Patient received J&J vaccine in the home through agency on 4/6/2021, Patient had a fall on 4/7/2021, Patient with rib pain after the fall no other injury noted. Patient passed away on home hospice on 4/11/2021.

On 5/12/2021 patient was complaining of generalized body aches, later in the morning when going to a pain management clinic, patient subsequently became nauseous and vomited several times during the course of the day. Reportedly had episode of dark emesis as well. Patient was then found by family around 10pm unresponsive, pale, w/ difficulty breathing, EMS was called, patient was found to be in cardiac arrest in asystole. Patient possibly had v-fib during transport and was defibrillated twice before becoming asystolic again. Patient was subsequently pronounced dead in the Emergency Department on 5/12/21 at 11:04pm.

STroke April 6 at hospital I am PCP, not admitting doctor I wanted to be sure you were aware of thromboembolic event

PNEUMONIA; INJECTION SITE ITCHINESS; RASH AT INJECTION SITE; This spontaneous report received from a consumer concerned a 97 year old male. 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 not reported, batch number: Unknown) dose was not reported, 1 total dose administered on 07-APR-2021 in left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient developed an itchy rash at the site of the vaccine, 5 days after receiving the vaccine. Her husband did not said anything and it had started to dry up. Consumer said her husband picked up pneumonia about 3 weeks after the vaccine on 27-APR-2021 and was hospitalized. He was on antibiotics for a long time. might be 2 weeks or more. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pneumonia, injection site itchiness, and rash at injection site. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 - 20210557955-covid-19 vaccine ad26.cov2.s-Pneumonia. 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).

Patient received the COVID 19 vaccine on 3/30/21 as part of the homebound program. Per the obituary, he died at home on 6/12/2021.

Death Narrative: Patient has been admitted to a home hospice program since approximately 11/12/20 with an initial terminal diagnosis of dysphagia which was later changed in February 2021 to vascular dementia. Patient with significant past medical history of several CVA's which led to aphasia and vascular dementia.