Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Heart injury, Investigation, Myocardial infarction, Stress echocardiogram
Clinical narrative: Heart attack; she might have a little bit of heart cell damage; tired; This is a spontaneous report from a contactable nurse (patient). A 73-year-old female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EN6207, Expiration date: Jul2021, NDC number was unknown), via an unspecified route of administration, in right deltoid on 10Mar2021 14:10 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Family medical history relevant to adverse event was not provided. The patient received historical vaccine of first dose bnt162b2 (Lot number: EL9267, Expiration date: May2021) right deltoid on 12Feb2021 for covid-19 immunisation. Patient did not receive prior Vaccinations (within 4 weeks). Caller is a retired Registered Nurse who states she felt it was important to report, that she had a heart attack 70 hours after receiving the Covid vaccine on 13Mar2021. Her doctor informed her she probably should report it. Caller states she's not 100 % sure it's the Covid vaccine. Informs she has no other cardiac issues, health issues or problems with medications, stating they narrowed it down. Patient was taken by ambulance and then to the Emergency Room. States she was admitted to the hospital and had testing done on heart, stress test echo, on heparin IV drip, aspirin. Hospitalized for 4 days. Patient states supposedly she will have a complete recovery, right now she is just tired. Was told she might have a little bit of heart cell damage on an unspecified date in Mar2021, but not anything really significantly. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available. As per the reporter for the heart attack seriousness criteria reported as Life threatening and Caused/prolonged hospitalization. patient was in hospital for Heart attack from 13Mar2021 to 16Mar2021. As per the reporter drug result reporter as related. The patient underwent lab tests and procedures which included testing done on heart and stress test echo with unknown results in 2021. Therapeutic measures were taken as a result of heart attack. The outcome of the events was unknown.; Sender's Comments: Based on known drug safety profile, there is possibility of causal association between the reported events Heart attack,Heart injury and the suspect vaccine BNT162B2 cannot be Excluded.Also there is limited information in the case provided,Consider also possible contributory effects from patient's medical history and surgical history.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate