Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Essential hypertension, Myocarditis, SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; SARS-COV-2 TEST POSITIVE; ACUTE MYOCARDIAL INFARCTION; MYOCARDITIS; COVID-19; CHEST PAIN; ESSENTIAL HYPERTENSION; CHEST X-RAY NORMAL; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER ID 1963286) concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: history of hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805018 expiry: unknown) dose was not reported, dose number in series 01, 01 total was administered on 02-APR-2021 for an unspecified indication. No concomitant medications were reported.  On 15-DEC-2021, the patient experienced chest pain and presented to the ED (emergency department) along with essential hypertension. On the same day, he was diagnosed with acute myocardial infarction non-ST segment elevation myocardial infarction (NSTEMI), myocarditis and coronavirus disease (COVID-19). The patient's chest x-ray was normal, saturating well on RA-CXR (Room air- Chest X-ray) - clear lung fields, no pneumonia on 15-DEC-2021. On 16-DEC-2021, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test was positive, and had confirmed clinical vaccination failure (dose number in series 01). Patient was hospitalized on an unspecified date for 3 days and discharged was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acute myocardial infarction, myocarditis, COVID-19, chest x-ray normal, chest pain, essential hypertension, and SARS-CoV-2 test positive, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report is associated with product quality complaint: 90000210098. 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 based on the Quality evaluation/investigation performed.  Additional information received from Department on 11-JAN-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result. Upon review following information was amended: age at the time of vaccination added.; Sender's Comments: V2. This follow up version was created to update Quality investigation results and age of the patient. This updated information doesn't alter previous causality assessment made for the events in this case. 20220100169-COVID-19 VACCINE AD26.COV2.S-Acute myocardial infarction, Myocarditis, COVID-19, Chest pain, Chest x-ray normal, SARS-CoV-2 test positive. 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). 20220100169-COVID-19 VACCINE AD26.COV2.S- Essential hypertension. 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: MEDICAL HISTORY 20220100169-COVID-19 VACCINE AD26.COV2.S-Confirmed 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