Received Dec 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19-2 | COVID19 (COVID19 (PFIZER-BIONTECH BIVALENT)) | PFIZER\BIONTECH | 1 | — | — |
myocarditis; catching Covid; catching Covid; cardiac arrest; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-022008 (BioNTech SE). A 32-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY OMICRON XBB.1.5), 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: CARDIAC ARREST (death, medically significant) with onset 2023, outcome "fatal"; MYOCARDITIS POST INFECTION (death, medically significant), outcome "fatal", described as "myocarditis"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "catching Covid". The patient date of death was unknown. Reported cause of death: "Myocarditis", "cardiac arrest". Clinical course: a fit and healthy patient from the [withheld country] suffered a cardiac arrest in 2023 at age 32. After her death, she was diagnosed with myocarditis. Her family suggested her 'unknowingly catching Covid had this effect on her heart". Anti-vaxxers have been urging for Covid shots to be withdrawn from the market for years over heart damage fears, arguing that, in some groups, the risk is greater than if they had been infected instead. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. COMIRNATY is under agreement with BIONTECH SE.; Reported Cause(s) of Death: Myocarditis; cardiac arrest