Received Jun 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | OT |
| FLU3 | INFLUENZA (SEASONAL) (FLUAD) | SEQIRUS, INC. | UNK | — | OT |
heart attack; feeling weak; tired; overall unwell; RETAIL PHARMACY TARGETED IMMUNIZATION ENGAGEMENT (TIE) This is a solicited report received from an Other HCP, Program ID:. A 79-year-old male patient received BNT162b2 (BNT162B2 NOS), on 18Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 79 years intramuscular, in arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUAD), on 18Oct2022 as dose number unknown, single intramuscular, in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (hospitalization, life threatening) with onset 01Nov2022, outcome "unknown", described as "feeling weak"; MYOCARDIAL INFARCTION (hospitalization, medically significant, life threatening) with onset 01Nov2022, outcome "unknown", described as "heart attack"; MALAISE (hospitalization, life threatening) with onset 01Nov2022, outcome "unknown", described as "overall unwell"; FATIGUE (hospitalization, life threatening) with onset 01Nov2022, outcome "unknown", described as "tired". The patient was hospitalized for myocardial infarction, asthenia, fatigue, malaise (start date: Nov2022, discharge date: Nov2022, hospitalization duration: 7 day(s)). The events "heart attack", "feeling weak", "tired" and "overall unwell" required emergency room visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (2022) Unknown results. Clinical course: Vaccines were administered at the same time in the same arm. Two weeks later the patient had a heart attack. A couple days leading up the heart attack the patient reported feeling weak, tired, and overall unwell. Patient was taken to the emergency department mid-morning and stayed overnight while waiting for a room to open up at (withheld). Stayed at (withheld) Hospital for a week. Patient had to undergo an MRI. The reporter's assessment of the causal relationship of "heart attack", "feeling weak", "tired" and "overall unwell" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on the limited information provided, the causal association between the Reported events Myocardial infarction, malaise, fatigue and asthenia and the suspect drug BNT162b2 cannot be excluded as there is no concrete evidence available to eliminate the causal association. 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.
Test Date: 2022; Test Name: MRI; Result Unstructured Data: Test Result:Unknown results