Received Nov 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | 1 | B5NJ9 | IM |
had a sore arm; a little hot; stiffness; had a little pain; fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 71-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number B5NJ9, expiry date 05-DEC-2026) for prophylaxis. Concurrent medical conditions included heart disorder (heart condition). On 25-OCT-2025, the patient received the 1st dose of Arexvy (intramuscular). In OCT-2025, less than a week after receiving Arexvy, the patient experienced pain (Verbatim: had a little pain), extremities hot feeling of (Verbatim: a little hot) and stiffness (Verbatim: stiffness). On 25-OCT-2025, the patient experienced pain in arm (Verbatim: had a sore arm). On 26-OCT-2025, the patient experienced fever (Verbatim: fever). The outcome of the pain, extremities hot feeling of and stiffness were unknown and the outcome of the fever was resolved (duration 2 days) and the outcome of the pain in arm was not resolved. It was unknown if the reporter considered the pain, fever, pain in arm, extremities hot feeling of and stiffness to be related to Arexvy. It was unknown if the company considered the pain, fever, pain in arm, extremities hot feeling of and stiffness to be related to Arexvy. Additional Information: GSK Receipt Date: 29-OCT-2025 The patient that received Arexvy between noon and 1PM, had a little pain in his arm (unknown arm) that started that same evening and it still hurts a little at the time of reporting. The patient had a little fever, about 99-degree F, that started 24 hours after receiving Arexvy, lasted two days, and was now gone. The patient had a sore arm that started the evening of 25th OCT 2025. The patient arm got little hot and he experienced stiffness. The reporter stated that the husband had a heart condition (pre-existing Arexvy) and was looking at having surgery for his heart valve. This case was linked with US2025140793, reported by same reporter different patient.; Sender's Comments: US-GSK-US2025140793:Same reporter
Heart disorder (heart condition)
Test Date: 20251026; Test Name: Body temperature; Result Unstructured Data: (Test Result:99,Unit:degree F,Normal Low:,Normal High:)