Received Oct 8, 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 female 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) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. The patient was in her 70s. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789812, US-MODERNATX, INC.-MOD-2025-789815 (E2B Linked Report). This case was linked to MOD-2025-789817 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2025: Live follow up received that contains non-significant information includes reference numbers were added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789812:Husband case (Moderna COVID-19 Vaccine) US-MODERNATX, INC.-MOD-2025-789815:Husband case (SPIKEVAX NOS)