Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: DEATH; ATRIAL FIBRILLATION; ATRIAL FIBRILLATION; COVID-19; CEREBROVASCULAR ACCIDENT; COVID-19; DEATH; SARS-COV-2 TEST POSITIVE; VACCINE BREAKTHROUGH INFECTION; This spontaneous report received from a health care professional by a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID) concerned an 88 year old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: stroke, and concurrent conditions included: hypertension, vascular dementia, chronic kidney disease, kidney carcinoma, combined heart failure, coronary artery disease, obstructive sleep apnea, multiple episodes of pulmonary embolism, and drug allergy (Meperidine Atorvastatin). The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN, and expiry date: Unknown) dose was not reported, 1 total administered on 13-SEP-2021 for an unspecified indication.  It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient received dose 2 with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin not reported, batch number: 213D21A expiry: UNKNOWN and expiry date: Unknown) dose was not reported, 1 total administered on 01-DEC-2021 to right arm for an unspecified indication. Age at time of vaccination 88 years old. No concomitant medications were reported.  On 25-JUL-2022, the patient had tested positive for sars-cov-2 (severe acute respiratory syndrome coronavirus 2) and experienced covid-19 (vaccine breakthrough infection) (Dose number in series 2), and had complications of cerebrovascular accident and atrial fibrillation (Dose number in series 2). The patient was briefly hospitalized for 1 day and died on 30-JUL-2022 (Dose number in series 2). It was unspecified if an autopsy was performed On 30-JUL-2022, the patient died from atrial fibrillation, covid-19, cerebrovascular accident, death, sars-cov-2 test positive, and vaccine breakthrough infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death and Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000253952. 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 received from Central Complaint Vigilance department on 07-NOV-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V3: This follow up adds information about Product quality complaint investigation result. This does not alter the previous company causality of the reported events.  20220951234-covid-19 vaccine ad26.cov2.s-Death, Atrial fibrillation, Cerebrovascular accident. 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(Patient age- 88 years, past medical history of stroke and concurrent conditions of hypertension, chronic kidney disease, kidney carcinoma, combined heart failure, coronary artery disease, multiple episodes of pulmonary embolism are considered as confounding factors). Therefore, this event(s) is considered not related.  20220951234-covid-19 vaccine ad26.cov2.s- Covid-19, Sars-cov-2 test positive, Vaccine breakthrough infection. 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: ATRIAL FIBRILLATION; COVID-19; CEREBROVASCULAR ACCIDENT; DEATH; SARS-COV-2 TEST POSITIVE; VACCINE BREAKTHROUGH INFECTION