Received Jun 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 4b22t | SYR / LA |
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 4B22T | IM / LA |
pad of right thumb black and blue; pain associated with spasm; Spasm in right thumb; This non-serious case was reported by a consumer via call center representative and described the occurrence of spasms in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4B22T) for prophylaxis. On 29-MAY-2025, the patient received Arexvy (intramuscular, left arm) .5 ml. On 29-MAY-2025, 5 min after receiving Arexvy, the patient experienced spasms (Verbatim: Spasm in right thumb) and muscle pain (Verbatim: pain associated with spasm). On 30-MAY-2025, the patient experienced skin discoloration (Verbatim: pad of right thumb black and blue). On 29-MAY-2025, the outcome of the spasms and muscle pain were resolved. The outcome of the skin discoloration was not resolved. It was unknown if the reporter considered the spasms, skin discoloration and muscle pain to be related to Arexvy. It was unknown if the company considered the spasms, skin discoloration and muscle pain to be related to Arexvy. Additional Information: GSK receipt date: 30-MAY-2025 The patient was vaccinated with Arexvy on 29th May 2025 in the left arm. Within 5 minutes she felt a spasm in her right thumb. The spasm resolved fairly quickly but reported today the pad of her right thumb is black and blue. There was some pain associated with the spasm. No further information was obtained/provided.