Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
A kid died from myocarditis; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDITIS (A kid died from myocarditis) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (A kid died from myocarditis) (seriousness criteria death and medically significant). The reported cause of death was died from myocarditis. It is unknown if an autopsy was performed. Not Provided No concomitant medications were reported. No treatment medications were reported. Company comment: Reportedly, it was stated that the patient died from myocarditis after vaccination, however, no additional details regarding medical history of the patient, clinical course of the event, treatment details, as well as temporal relationship between vaccination and the event of myocarditis were provided. It remained unknown if an autopsy was performed. The benefit-risk relationship of the product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2021-307118 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 21-Mar-2025: Live non-significant follow up received: reference numbers were added.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-307118:Master case; Reported Cause(s) of Death: Died from myocarditis