Received Sep 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 3042647 | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
headache; Nausea; rheumatoid arthritis this year (2025); This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (rheumatoid arthritis this year (2025)) in an 8-decade-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042647) 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 13-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. In 2025, the patient experienced RHEUMATOID ARTHRITIS (rheumatoid arthritis this year (2025)) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) and NAUSEA (Nausea). The patient was treated with Methotrexate sodium (Methotrexate) in 2025 for Rheumatoid arthritis, at an unspecified dose and frequency. In 2025, RHEUMATOID ARTHRITIS (rheumatoid arthritis this year (2025)) had resolved. At the time of the report, HEADACHE (headache) and NAUSEA (Nausea) outcome was unknown. No concomitant medication was reported. The patient got diagnosed with rheumatoid arthritis in year 2025 and she had taken Moderna Covid vaccines before, she was on methotrexate, and she did not believe there was a correlation between the vaccine and arthritis. She said that the diagnosis came later after taking the vaccines. She also experienced 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. This case was linked to MOD-2025-789529, MOD-2025-789528, MOD-2025-789530 (Patient Link). Reporter did not allow further contact; Reporter's Comments: Co-suspect product Influenza vaccine is a confounder for the events. The benefit -risk relationship of product is not affected by this report.