Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
myocarditis; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDITIS (myocarditis) in a female patient of an unknown age 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 (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications were reported. It was reported that, one of the reporter's nieces had myocarditis. No treatment information was provided. Company comment: Reportedly, it was stated that the patient developed 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 at the time of this report. 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 included reference number added.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-307118:master case