Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | AU3238B | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
soreness and tenderness in the arm; soreness and tenderness in the arm; headache; muscle ache; nausea; tiredness/Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (soreness and tenderness in the arm), PAIN IN EXTREMITY (soreness and tenderness in the arm), HEADACHE (headache), MYALGIA (muscle ache) and NAUSEA (nausea) in an 8-decade-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch nos. AU3238B and 062120) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Influenza vaccine for an unknown indication. No Medical History information was reported. On 30-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 16-Jun-2024, received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (soreness and tenderness in the arm), PAIN IN EXTREMITY (soreness and tenderness in the arm), HEADACHE (headache), MYALGIA (muscle ache), NAUSEA (nausea) and FATIGUE (tiredness/Fatigue). At the time of the report, TENDERNESS (soreness and tenderness in the arm), PAIN IN EXTREMITY (soreness and tenderness in the arm), HEADACHE (headache), MYALGIA (muscle ache), NAUSEA (nausea) and FATIGUE (tiredness/Fatigue) outcome was unknown. No concomitant medication was reported. She had fatigue, headache, muscle ache, soreness and tenderness in the arm, nausea, and tiredness after her previous Covid vaccines and Flu vaccine. However, she noted that those side effects were not severe enough to require medical assistance or hospitalization. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported. No treatment medication was reported. This case was linked to MOD-2025-789525 (Patient Link). Reporter did not allow further contact