Received Mar 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Pericarditis; ASSESSMENT PROGRAM This is a solicited report received from Other HCPs and a Consumer or other non HCP, Program ID. A 72-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS (hospitalization, medically significant) with onset 03Oct2023, outcome "unknown". The patient was hospitalized for pericarditis (hospitalization duration: 5 day(s)). The event "pericarditis" required emergency room visit. Clinical course: The patient developed pericarditis a week and a half after getting Pfizer Covid vaccine. He went to Emergency room from which he was admitted to the hospital for 5 days. The reporter's assessment of the causal relationship of "pericarditis" with the suspect product(s) BNT162b2 omi xbb.1.5 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 OMI XBB.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and plausible temporal association the company considers that there was a reasonable possibility that the event Pericarditis was related to BNT162b2 omi xbb.1.5. 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.