Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Myocarditis; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An 85-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in Oct2025 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: MYOCARDITIS (medically significant) with onset Oct2025, outcome "unknown". The patient received the shot 10 days ago and he develop Myocarditis - a condition in his heart. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.