Received Aug 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Some patients might have received Arexvy after a temperature excursion (below the recommended storage range); This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incorrect storage of drug (Verbatim: Some patients might have received Arexvy after a temperature excursion (below the recommended storage range)). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 29-JUL-2025 A senior medical assistant called to ask about the stability of Arexvy, after a temperature excursion of 31.3 degree fahrenheit for 10 minutes. The healthcare professional mentioned that some patients might have received Arexvy after this temperature excursion but she was not sure, which led to incorrect storage of drug. She did not provide any patient information and she did not provide any lot number or expiration date. The reporter wanted to know if they have to revaccinate the patients who possibly received the vaccine after a temperature excursion.