Received Dec 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | No batch number | IM |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | IM |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | IM |
Rheumatoid arthritis; This spontaneous case initially received on 17-Dec-2025, was reported by a health professional and concerns an elderly female patient. Administration of company suspect drug: On 23-Sep-2023, the patient received Fluad (TIV) for indication not reported, Route of administration: Intramuscular, dose: not reported, anatomical location: not reported. Lot number: No batch number available and will be requested upon follow-up. Non-company suspect drugs: Pfizer BioNTech COVID-19 vaccine (Tozinameran), on 23-Sep-2023, Indication: Not reported, dose: not reported, anatomical location: not reported. Lot number: No batch number available RSV vaccine (RSV vaccine), on 23-Sep-2023, Indication: Not reported, dose: not reported, anatomical location: not reported. Lot number: No batch number available. Adverse reactions/events and outcomes: On 01-Dec-2023, the patient experienced Rheumatoid arthritis (Medically Significant, outcome: Not Reported). Fluad (TIV) action taken: Not Applicable Reporter's assessment: The reporter considered the event Rheumatoid arthritis as not related to the administration of Fluad (TIV) and serioussness was not provided. Patient attributes rheumatoid arthritis to the Covid vaccine.; Reporter's Comments: Causality: Not related. The event rheumatoid arthritis is considered coincidental with no biological and temporal plausibility (2 months 9 days after vaccination) for the product to cause/contribute. Co-suspect COVID-19 vaccine is considered as possible contributing factor.