Received Dec 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT |
heart failure; This is a spontaneous report received from an Other HCP and a Consumer or other non HCP, Program ID. A 79-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 at 11:28 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC FAILURE (disability, medically significant) with onset 2023, outcome "unknown", described as "heart failure". The event "heart failure" required emergency room visit. Therapeutic measures were taken as a result of cardiac failure. Clinical Course: Date and time adverse event started: 01Apr2024. Patient states post covid vaccine 2023 she eventually developed breathing problems, left bundle branch block discovered , and eventually diagnosed with heart failure within 6 months if 2023 vaccine. A subquential Pfizer COVID vaccine was given the following year. Multiple medications added to medication regimen post heart failure diagnois in 2023. Result or outcome of adverse event(s): Emergency room/department or urgent care: checked. Disability or permanent damage: checked. The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] will be requested and submitted if and when received.; Sender's Comments: Based on limited information available and temporal association, there is reasonable possibility of causal association between the event heart failure and the suspect drug BNT162b2 omi xbb.1.5. 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.