Received May 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | DL32D | — |
Administration after a below temperature excursion of 29.9 degree Fahrenheit; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number DL32D) and (batch number 44TR9) 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: Administration after a below temperature excursion of 29.9 degree Fahrenheit). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK receipt date: 15-MAY-2025 The nurse reported after giving several vaccines that were exposed to a temperature of 29.9 degree Fahrenheit as the lowest reached for Boostrix, which led to incorrect storage of drug. The Vaccine Administration Facility was the same as Primary Reporter.; Sender's Comments: US-GSK-US2025061548: US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061538:same patient,Different suspect US-GSK-US2025061545: