Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
sore arm; minor side effects/other small things; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and IMMUNISATION REACTION (minor side effects/other small things) in an 8-decade-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and IMMUNISATION REACTION (minor side effects/other small things). At the time of the report, PAIN IN EXTREMITY (sore arm) and IMMUNISATION REACTION (minor side effects/other small things) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Concomitant medication was not provided. Patient was at high risk and had never had a problem with health. It was reported that patient and the patient's husband received constantly the Moderna vaccine since the beginning of the pandemic from 2021 and was very satisfied as they had only some minor side effects, like sore arm and other small things that were tolerable. Treatment information was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789812 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2025: Live follow-up received and updated narrative and references.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789812:Same patient with different product (husband case)