Received Oct 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | 2 | AE435 | — |
A patient received 2 doses of Arexvy.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 77-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number AE435, expiry date 30-OCT-2025) for prophylaxis. Previously administered products included Arexvy (1st dose was given in 2023). On 13-SEP-2025, the patient received the 2nd dose of Arexvy. On 13-SEP-2025, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: A patient received 2 doses of Arexvy.). The outcome of the extra dose administered was not applicable. Additional Information: GSK receipt date: 16-SEP-2025 The reporter called to report that a patient received two doses of Arexvy. The reporter wanted to know was there any concerns and possible side effects.