Received Feb 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
heart valve closed after receiving COVID vaccine; This is a solicited report received from a Pharmacist and a Consumer or other non HCP, Program ID. A 71-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 12Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC VALVE DISEASE (hospitalization), outcome "unknown", described as "heart valve closed after receiving COVID vaccine". The event "heart valve closed after receiving covid vaccine" required physician office visit. Therapeutic measures were taken as a result of cardiac valve disease. Clinical course: Patient reported that his heart valve closed after receiving COVID vaccine. He had to have a heart surgery to correct it. His cardiologist suspected the vaccine was connected with the event. The reporter's assessment of the causal relationship of "heart valve closed after receiving covid vaccine" 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 temporal association, there is reasonable possibility of causal association between the Reported event CARDIAC VALVE DISEASE and the suspect drug The impact of this report on the benefit/risk profile of the Pfizer drug 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.