Received Jun 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | — |
myocardial infarction; This is a spontaneous report received from an Other HCP from a sales representative. A 45-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, medically significant, life threatening), 24 hrs after the suspect product(s) administration, outcome "recovered". Therapeutic measures were taken as a result of myocardial infarction. Clinical course: It was unknown if the patient had any other vaccine on the same date or in four weeks. It was also unknown if the patient took other medications in 2 weeks. The providers husband experience a myocardial infarction within 24 hours after the 2nd dose of the original Pfizer BioNTech COVID-19 vaccine.; Sender's Comments: Based on the close temporal relationship, the association between the event myocardial infarction with BNT162b2 can not be fully excluded. 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.