Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neurological symptom, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: ACUTE MYOCARDIAL INFARCTION; MYOCARDITIS; CHEST PAIN; COUGH; NEUROLOGICAL SYMPTOM; COVID-19; SARS-COV-2 TEST POSITIVE; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAERS ID 1365209), concerned a 76-year-old male patient of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included stenting in 2013/2014. The patient's concurrent conditions included coronary artery disease (CAD) [status/post (s/p) stenting], paroxysmal atrial fibrillation, aortic stenosis, carotid disease, bilateral renal artery stenosis, benign prostatic hyperplasia (BPH), anxiety, type 2 diabetes mellitus and depression. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry date: unknown) dose was not reported, 1 total, administered on 22-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included hydroxyzine for anxiety, glyceryl trinitrate for chest pain; sertraline, atorvastatin, dabigatran, metformin and tamsulosin, all drugs used for an unknown indication. On 20-MAY-2021, the patient experienced a burning chest pain, cough following which he got the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test done which was positive and was diagnosed with coronavirus disease (COVID-19 and suspected clinical vaccination failure), On the same day, he experienced new stroke symptoms (neurological symptoms), myocarditis/non-ST segment elevation myocardial infarction (NSTEMI), and acute myocardial infarction. On 27-MAY-2021, the patient was hospitalized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the acute myocardial infarction, chest pain, cough, myocarditis, SARS-CoV-2 test positive, suspected clinical vaccination failure, neurological symptom and covid-19 was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This report was associated with product quality complaint: 90000183223 The suspected product quality complaint had been confirmed to be not voided. The investigation had been reviewed and the root cause and disposition determinations were documented properly. The investigation was approved and closed based on the PQC evaluation/investigation performed.  Additional information was received from Central Complaint Vigilance on 22-JUN-2021. The following information was updated and incorporated into the case narrative: PQMS number and investigational result.; Sender's Comments: V1:The current version updates the narrative with additional information on PQC investigational result and PQMS number. The additional information provided does not alter the causality assessment of the reported medical events. 20210624636-covid-19 vaccine ad26.cov2.s -Acute myocardial infarction, Chest pain. 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, UNDERLYING DISEASE 20210624636-covid-19 vaccine ad26.cov2.s  Myocarditis, Cough, Neurological symptoms, COVID-19,  SARS-CoV-2 test positive. This event(s) is considered un-assessable. 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). 20210624636-covid-19 vaccine ad26.cov2.s -Suspected 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.