Received Oct 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
acute diverticulitis; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (acute diverticulitis) in a 64-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 11-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In October 2025, the patient experienced DIVERTICULITIS (acute diverticulitis) (seriousness criterion medically significant). At the time of the report, DIVERTICULITIS (acute diverticulitis) outcome was unknown. No concomitant medication was reported. Approximately three weeks later, she was diagnosed with acute diverticulitis, a condition she had never experienced before. The reporter inquired whether this could be a reported side effect of the Moderna COVID-19 vaccine. The reporter sought advice on this matter. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.