Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute myocardial infarction, COVID-19, Dyspnoea, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: ACUTE MYOCARDIAL INFARCTION; COVID-19; DYSPNOEA; SARS-COV-2 TEST POSITIVE; This spontaneous report received from a health care professional by a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) concerned a 67 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, diabetes, coronary artery disease, and congestive heart failure. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-APR-2021 for an unspecified indication. Age at time of vaccination 67 years old. Concomitant medication included oxygen for drug used for unknown indication (wears oxygen 4 liters at night.). The drug was associated with Batch and lot tested and found within specifications.  On 30-JUN-2022, patient experienced dyspnoea (patient stated that patient started having trouble breathing), acute myocardial infarction (patient was admitted for an non-ST-elevation myocardial infarction (NSTEMI) and found to be COVID positive), covid-19 and SARS-COV-2 (severe acute respiratory syndrome coronavirus-2) test positive. Laboratory data included: SARS-CoV-2 test Positive (Dose number in series 1). On an unspecified date, the patient was hospitalized. Number of days of hospitalization was not reported. Latency was 450 days. The patient received second dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855191, expiry: UNKNOWN) dose was not reported, 1 total, administered on an unspecified date for an unspecified indication. It was unknown whether patient had any adverse events following vaccination with second dose of covid-19 vaccine ad26. cov2.s (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dyspnoea, acute myocardial infarction, covid-19 and SARS-COV-2 test positive was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint 90000242636 (for batch number 043A21A) and 90000242637 (for batch number 1855191). The suspected product quality complaint has been confirmed to be for PQC-90000242636 (batch number 043A21A) 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 PQC evaluation/investigation performed. The suspected product quality complaint has been confirmed to be voided (PQC-90000242637, batch number 1855191) (did not meet PQC criteria as this reporter received a Janssen vaccine both as primary and a booster dose series vaccination. This case indicates that infection occurred at a timing interval of less than 14 days post the booster dose. Therefore the reported symptomatic covid infection will be processed against the primary dose only. PQC 90000242636 captures the report for the primary dose, based on the PQC evaluation/investigation performed.  Additional information was received from department on 04-AUG-2022. The following information was updated and incorporated into the case narrative: Added product quality complaint result for PQC no: 90000242636.; Sender's Comments: V4: The additional information in this version is  product quality complaint result for PQC no: 90000242636.This doesnot alter causality of previously reported events.  20220732603-covid-19 vaccine ad26.cov2.s-Covid-19,Sars-cov-2 test positive . The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.   20220732603-covid-19 vaccine ad26.cov2.s- Acute myocardial infarction, Dyspnoea. 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 ( hypertension, diabetes, coronary artery disease, and congestive heart failure.) . Therefore, this event(s) is considered not related.