Received Apr 14, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
sore arm; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and FATIGUE (fatigue) in a 75-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 07-Oct-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. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown. Relevant medical history (vaccines within the past 4 weeks, medical conditions) was reported as unknown. No concomitant medication was reported. Patient had side effects after taking the shot. Other than that, the patient was satisfied. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2026-794798 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2026-794798:Master case, Reporter's case