Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19-2 | COVID19 (COVID19 (MODERNA BIVALENT)) | MODERNA | UNK | — | — |
found dead; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (found dead) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. Concurrent medical conditions included Diabetic. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Death occurred on 25-Dec-2022 The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Patient got the booster shot found dead in Christmas morning. Treatment drug was not reported. Company comment: This is a spontaneous case regarding a male patient of an unknown age, with concurrent medical condition of diabetes, who died after receiving mRNA-1273.222 bivalent vaccine (Original/Omicron BA.4/5). The event Death (seriousness criteria death and medically significant) occurred on an unknown latency from vaccination. The cause of death was not reported. It is unknown if an autopsy was performed. According to the report, patient received the booster shot and was found dead. No further details were disclosed. Concurrent medical condition of diabetes remains a confounding factor. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2022-692839, US-MODERNATX, INC.-MOD-2022-692969 (E2B Linked Report). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Upon internal review significant correction was performed on 01-Sep-2025 to update IB listedness, event onset date added, and Reference type updated from E2B Company Number to E2B Report Duplicate.; Sender's Comments: US-MODERNATX, INC.-MOD-2022-692839:Master case US-MODERNATX, INC.-MOD-2022-692969:same reporter; Reported Cause(s) of Death: unknown cause of death
Diabetic