Received Dec 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT / LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT / LA |
cardiomyopathy; TARGETED IMMUNIZATION ENGAGEMENT (TIE) This is a solicited report received from an Other HCP, Program ID. A 76-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 09Sep2024 as dose number unknown, single intramuscular, in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIOMYOPATHY (hospitalization) with onset 19Sep2024, outcome "unknown". The patient was hospitalized for cardiomyopathy (start date: 19Sep2024, hospitalization duration: 6 day(s)). Therapeutic measures were taken as a result of cardiomyopathy. Clinical course: Patient was hospitalized for 6 days starting on 19Sep2024 for cardiomyopathy. Patient received a defibrillator while hospitalized. The reporter's assessment of the causal relationship of "cardiomyopathy" with the suspect product(s) BNT162b2 omicron (kp.2) 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 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Based on the temporal relationship, the association between the event cardiomyopathy with COMIRNATY (2024-2025 FORMULA 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.