Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acute myocardial infarction, COVID-19, Lung opacity, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: ACUTE MYOCARDIAL INFARCTION; PNEUMONIA; LUNG OPACITY; SARS-COV-2 TEST POSITIVE; COVID-19; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAERS ID 2035903) on 28-JAN-2022 and concerned a 62 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, batch number: 041A21A expiry: unknown) dose was not reported, dose number in series was 01, 01 in total administered on 02-APR-2021 for unknown indication.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, it was unknown whether patient had any adverse events (dose number in series was 01). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient additionally received non-company suspect vaccine MRNA 1273 ( form and route of administration were not reported, batch number: 045C21A expiry: unknown) dose was not reported, dose number in series was 02, administered on 02-NOV-2021 for an unspecified indication.  On 05-JAN-2022, the patient experienced severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection. On the same day, coronavirus disease (Covid-19) polymerase chain reaction (PCR) test result was positive. On 09-JAN-2022, the patient had acute myocardial infarction, pneumonia, lung opacity. The patient was admitted on 11-JAN-2022 and she was discharged on 14-JAN-2022. She was hospitalized for 4 days. Patient was hospitalized for non-ST-elevation myocardial infarction (NSTEMI) suspected pneumonia in the anterior right upper lobe accounted for consolidative opacities. She consulted for positive COVID-19 and recommendations included a three day course of remdesivir (dose number in series was 02).  The outcome of the acute myocardial infarction, covid-19, lung opacity, pneumonia and SARS-CoV-2 test positive was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000214995. 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 was received from Central Complaint Vigilance Department on 03-FEB-2022. The following information was updated and incorporated into case narrative: Product Quality Complaint investigation result.; Sender's Comments: V2: Follow up information in this version updated Product quality complaint investigation result. The follow up information does not change the causality of the previous report   20220156997 - covid-19 vaccine ad26.cov2.s - acute myocardial infarction, pneumonia, covid-19, lung opacity, and 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).