Received Dec 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
pericarditis; This spontaneous case was reported by a non-health professional and describes the occurrence of PERICARDITIS (pericarditis) in an 83-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Concomitant products included Colchicine and Ibuprofen for an unknown indication. On 17-Nov-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 24-Nov-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced PERICARDITIS (pericarditis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (pericarditis) had not resolved. The patient had no concomitant disease or risk factor. The patient had blood tests, echo and CT without any results provided. It was unknown if there were additional lab data/results available. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Colchicine; Ibuprofen