Received Nov 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLULAVAL) | GLAXOSMITHKLINE BIOLOGICALS | UNK | AH2G4 | — |
Leaking syringe; Leaking syringe; Underdose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number AH2G4, expiry date 30-JUN-2026) for prophylaxis. This case was associated with a product complaint. On 17-OCT-2025, the patient received FluLaval 2024-2025 season. On 17-OCT-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced accidental underdose (Verbatim: Underdose). On an unknown date, the patient experienced syringe leak (Verbatim: Leaking syringe) and pharmaceutical product complaint (Verbatim: Leaking syringe). The outcome of the accidental underdose, syringe leak and pharmaceutical product complaint were 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: 17-OCT-2025 The health care professional reported that one Flulaval syringe leaked out at the plunger while administering the vaccine. The patient had to receive another full dose. The defect discovered during administration of the product. The product was partially administered, with most of the product running out of the syringe. The leak occurs at the first stopper, at the bottom of the stopper rings. 25 G size gauge needle was used.