Received Oct 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052741 | — |
sore arm; feeling hot; sweating overnight; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING HOT (feeling hot), NIGHT SWEATS (sweating overnight) and MYALGIA (muscle aches) in a 45-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052741) for COVID-19 prophylaxis. Patient had no current or past health conditions. On 27-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (unknown route) .5 milliliter. On 27-Sep-2025, the patient experienced PAIN IN EXTREMITY (sore arm), FEELING HOT (feeling hot), NIGHT SWEATS (sweating overnight) and MYALGIA (muscle aches). On 28-Sep-2025, FEELING HOT (feeling hot) and MYALGIA (muscle aches) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved and NIGHT SWEATS (sweating overnight) outcome was unknown. No concomitant medication was reported. Patient had no other vaccines in the four weeks before getting the Moderna product. No results from medical tests or lab tests reported. It was stated that he experienced sore arm the same day as receiving the vaccine on 27-Sep-2025, followed by muscle aches, feeling hot, and sweating overnight, but it was not a serious event. Patient had the sore arm, muscle aches and feeling hot into the next day (28-Sep-2025). The muscle aches and feeling hot resolved 28-Sep-2025, but the sore arm continued. Patient was not treating by physician. No treatment or medicine taken by patient in response to the adverse event. Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2025: Live significant follow-up received: Onset date for events (Muscle ache, feeling hot, Pain in arm) was updated. Outcome for events Muscle ache, feeling hot updated to recovered. Outcome for event Pain in arm updated to not recovered. On 29-Sep-2025: Live non-significant follow-up received: Dosage information updated.