Received Jun 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
acute rheumatoid arthritis in R. thumb; rash extending 5 inches from injection site; rash turned into cellulitis; This serious case was reported by a consumer via interactive digital media and described the occurrence of rheumatoid arthritis in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, less than a week after receiving Arexvy, the patient experienced rheumatoid arthritis (Verbatim: acute rheumatoid arthritis in R. thumb) (serious criteria GSK medically significant), injection site rash (Verbatim: rash extending 5 inches from injection site) and injection site cellulitis (Verbatim: rash turned into cellulitis). The outcome of the rheumatoid arthritis, injection site rash and injection site cellulitis were not reported. It was unknown if the reporter considered the rheumatoid arthritis, injection site rash and injection site cellulitis to be related to Arexvy. The company considered the rheumatoid arthritis to be unrelated to Arexvy. It was unknown if the company considered the injection site rash and injection site cellulitis to be related to Arexvy. Additional Information: GSK Receipt Date: 13-JUN-2025 This case was reported by a patient via interactive digital media. The patient had rash extended 5 inches from injection site which appeared about 12 hours after Arexvy injection. Also, joint swelling, inflamed and extremely painful acute rheumatoid arthritis in right thumb. Then on day 5 and 6, rash turned into cellulitis.; Sender's Comments: Rheumatoid arthritis is an unlisted event which is considered unrelated to GSK vaccine Arexvy.