Received Feb 17, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
administration of the Fluarix vaccine on 10-DEC-2025 after and above temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a elderly male patient who received Flu Seasonal TIV Dresden (Fluarix 2025-2026 season) for prophylaxis. On 10-DEC-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: administration of the Fluarix vaccine on 10-DEC-2025 after and above temperature excursion). 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: 15-DEC-2025 The health care professional informed that the Fluarix vaccine arrived to the facility on 05-NOV-2025, since then the vaccine was in temperature range until the 1st excursion on 04-DEC-2025. Before 04-DEC-2025 health care professional mentioned that there was no other prior excursion. The batch number was not provided and a request for this information has been made. This was 1 of the 5 cases, reported by the same reporter. Upon internal review case was updated on 17-FEB-2026 The country of occurrence was updated. Summary of changes: General tab and narrative were updated.; Sender's Comments: GSK-US2025AMR162503:Same reporter GSK-US2025AMR162501:Same reporter US-GSK-US2025AMR162504:same reporter US-GSK-US2025AMR162500:same reporter