Received Nov 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 5R4CY | — |
Vaccine stored outside recommended conditions and administered to patient; 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 Flu Seasonal TIV Dresden (Fluarix 2025-2026 season) (batch number 5R4CY, expiry date 30-JUN-2026) for prophylaxis. On 18-NOV-2025, the patient received Fluarix 2025-2026 season. On an unknown date, an unknown time after receiving Fluarix 2025-2026 season, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 18-NOV-2025 The nurse reported that the Fluarix vaccine had been activated on 17-NOV-2025, and one day after activation, the vaccine was administered to the patient. The nurse mentioned it had not been a temperature excursion as the vaccine had been activated and then given the next day, whereas it should have been discarded by the end of the activation day. The nurse enquired whether the patient needed to be revaccinated or not.