Received Feb 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
cardiomyopathy; AFIB; Autoimmune disease; Plural effusion; This is a spontaneous report received from an Other HCP. A female 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: CARDIOMYOPATHY (medically significant), outcome "unknown"; ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "AFIB"; AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "Autoimmune disease"; PLEURAL EFFUSION (non-serious), outcome "unknown", described as "Plural effusion". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the available information the company considers that there was not a reasonable possibility that the events Cardiomyopathy, AFib, Autoimmune disorder and Pleural effusion were related to BNT162b2 omicron. There is no compelling evidence to implicate suspect drug with the events and more likely related to underlying/intercurrent medical conditions. 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