Received Dec 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052549 | IM |
Sudden death, heart stopped; This spontaneous case was reported by a consumer and describes the occurrence of SUDDEN CARDIAC DEATH (Sudden death, heart stopped) in a 62-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052549) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3052549) for COVID-19 prophylaxis. No Medical History information was reported. On 25-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. The patient died on 01-Nov-2025. The reported cause of death was sudden death, heart stopped. It is unknown if an autopsy was performed. No concomitant medications were provided. The patient did not experience any additional symptoms/events. The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available. No treatment medication was provided.; Reporter's Comments: Very little information provided at this time. The benefit-risk relationship of product is not affected by this report.; Reported Cause(s) of Death: Sudden death, heart stopped