Received Feb 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Constrictive pericarditis; UNBRANDED AD TESTING This is a solicited report received from a Consumer or other non HCP, Program ID. A 70-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS CONSTRICTIVE (medically significant), outcome "not recovered", described as "constrictive pericarditis". Clinical course: The Pfizer vaccine was the reason that he have been dealing/treated for constrictive pericarditis. Reporter consider event as caused by suspect product reported as Unknown. The reporter considered "constrictive pericarditis" related to BNT162b2 omicron (lp.8.1). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on known disease pathophysiology, the reported serious event of PERICARDITIS CONSTRICTIVE is assessed as not related to the suspected drug - BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA), and more likely due to the patient's underlying medical condition or is an inter-current medical condition. 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. This case will be re-evaluated upon receipt of addition