Received Jul 3, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Developed pericarditis after taking the 3rd dose (Booster) for the COVID; This is a spontaneous report received from an Other HCP from License Party. Other Case identifier(s): AE-024049 (BionTech), 2021SA299083 (Sanofi). A 67-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. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "Developed pericarditis after taking the 3rd dose (Booster) for the COVID". The information on the batch/lot number for [BNT162B2 OMICRON (LP.8.1)] will be requested and submitted if and when received. BNT162b2 omicron (lp.8.1) is under agreement with BIONTECH SE.; Sender's Comments: The event of pericarditis is assessed as related to BNT162b2 omicron (LP.8.1), supported by the reported temporal association after vaccination and the known association of pericarditis with COVID-19 mRNA vaccines. In the absence of reported relevant medical history or concomitant medications, no alternative contributory factors could be evaluated. 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