Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
Pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (Pericarditis) in a 72-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included Cardiac disorder and Mitral valve repair on 18-Jul-2025. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (Pericarditis) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Concomitant medication was not reported. Patient had pericarditis short-term after the surgery. Patient had never reacted to a Moderna vaccine. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.; Reporter's Comments: Past medical history of Cardiac disorder and Mitral valve repair are contributors for the event. Due to nonsuggestive temporal association and recent cardiac surgery as alternative explanation, the event was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.
Medical History/Concurrent Conditions: Cardiac disorder; Mitral valve repair