Received Feb 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT / LA |
cardiomyopathy; This is a spontaneous report received from an Other HCP from License Party. Other Case identifier(s): AE-022476 (BioNTech), 2026SA001152 (SANOFI Patient Safety & Pharmacovigilance). A 76-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) intramuscular, in left arm for covid-19 immunisation; influenza vaccine inact split 4v (FLUZONE HIGH DOSE QUADRIVALENT), on 09Sep2024 as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIOMYOPATHY (hospitalization, medically significant) with onset 19Sep2024, outcome "unknown". The patient was hospitalized for cardiomyopathy (start date: 19Sep2024, discharge date: 25Sep2024, hospitalization duration: 7 day(s)). Therapeutic measures were taken as a result of cardiomyopathy. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. Additional information: On 19Sep2024, the patient developed cardiomyopathy (latency of 10 days) following administration of Influenza USP Trivalent A-B High-Dose Subvirion vaccine and Pfizer-BioNTech COVID-19 vaccine. No action was taken with the suspected products. A defibrillator was given as corrective treatment for the event. The outcome of the event is unknown. This event was assessed as medically significant. The patient was hospitalized on the same day the event occurred and was discharged on 25Sep2024, with a hospitalization duration of 6 days. SUSPECT PRODUCT is under agreement with BIONTECH SE.; Sender's Comments: Based on the information available and plausible temporal association, the causal relationship between the reported event CARDIOMYOPATHY and suspect drug BNT162B2 cannot be 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.