Received Nov 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLULAVAL) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 99H9A | — |
Patients pregnant; Vaccines administered after temperature excursion; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received Flu Seasonal TIV Quebec (FluLaval 2025-2026 season) (batch number 99H9A, expiry date 30-JUN-2026) for prophylaxis. On 10-OCT-2025, the patient received FluLaval 2025-2026 season. On an unknown date, an unknown time after receiving FluLaval 2025-2026 season, the patient experienced vaccine exposure during pregnancy (Verbatim: Patients pregnant) and incorrect storage of drug (Verbatim: Vaccines administered after temperature excursion). The outcome of the vaccine exposure during pregnancy and incorrect storage of drug were not applicable. Pregnancy exposure: Pregnancy Exposure (FluLaval 2025-2026 season): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing 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: 14-NOV-2025 Nurse reported that several patients were given Flulaval that had a high temperature excursion. Their refrigerator was out of range they found out it was broken and they were not receiving alerts that the temperatures were too high. So, while this was happening, they had given the Flulaval vaccine to their pregnant patients unknowingly. Problem started happening from 30 SEP 2025. Also, it was not confirmed whether all patients were affected as the time for excursion was yet to be determined but they believed few were affected during this time frame. This was 1 of 11 linked cases, reported by same reporter for different patients.; Sender's Comments: US-GSK-US2025AMR148674: US-GSK-US2025AMR148675: US-GSK-US2025AMR148676: US-GSK-US2025AMR148677: US-GSK-US2025AMR148673: US-GSK-US2025AMR148672: US-GSK-US2025AMR148678: US-GSK-US2025148281: US-GSK-US2025AMR148669: US-GSK-US2025AMR148671: