Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cerebrovascular accident, Pulmonary oedema, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: PULMONARY OEDEMA; COVID-19; COVID-19; CEREBROVASCULAR ACCIDENT; URINARY TRACT INFECTION; SARS-COV-2 TEST POSITIVE; SARS-COV-2 TEST POSITIVE; URINARY TRACT INFECTION; CEREBROVASCULAR ACCIDENT; PULMONARY OEDEMA; This spontaneous report received from a consumer by a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS), (VAER reference number 2413519) concerned a 92 year old female of unspecified race and ethnic origin. Initial information was processed along with the additional information received on 31-AUG-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, and cardiovascular disease or serious heart condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-JAN-2022 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 92 years old. No concomitant medications were reported.  On 01-JAN-2022, the patient experienced cerebrovascular accident. On 16-AUG-2022, the patient experienced pulmonary oedema, covid-19, urinary tract infection, and sars-cov-2 test positive and was hospitalized (date unspecified). The patient was hospitalized for 2 days and it was unsure if the patient was discharged from the hospital. Laboratory data included: COVID-19 PCR test Positive, and SARS-CoV-2 test Positive. The drug period for the events was reported as 0 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19, cerebrovascular accident, pulmonary oedema, sars-cov-2 test positive and urinary tract infection was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000248692. 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 05-SEP-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: This follow up adds information about Product quality complaint investigation result. This does not alter previous causality assessment of the reported events.   20220860025-covid-19 vaccine ad26.cov2.s-cerebrovascular accident, pulmonary oedema. 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, the event of pulmonary edema is confounded by the event of Covid 19 infection]   20220860025-covid-19 vaccine ad26.cov2.s-urinary tract infection. The case causality is considered NOT RELATED. Rationale: The age of the patient (elderly) and the female gender has more plausible explanation for the event than the vaccine.  20220860025-covid-19 vaccine ad26.cov2.s-covid-19, sars-cov-2 test positive. 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.