Received Dec 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
drowsiness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (drowsiness) and FATIGUE (fatigue) in a 30-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 13-Dec-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 13-Dec-2025, the patient experienced SOMNOLENCE (drowsiness) and FATIGUE (fatigue). On 14-Dec-2025, SOMNOLENCE (drowsiness) and FATIGUE (fatigue) had resolved. The action taken with mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) was unknown. Concomitant medication was not reported. It was reported that the events fatigue and drowsiness resolved within one day. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.