Received Sep 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLULAVAL) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 4GR2B | — |
vaccine was leaking where needle is screwed to the syringe; pharmaceutical product complaint; Incomplete dose due to prefilled syringe leakage; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 55-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 4GR2B, expiry date 30-JUN-2026) for prophylaxis. This case was associated with a product complaint. On 10-SEP-2025, the patient received FluLaval 2024-2025 season. On 10-SEP-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced incomplete dose administered (Verbatim: Incomplete dose due to prefilled syringe leakage). On an unknown date, the patient experienced syringe leak (Verbatim: vaccine was leaking where needle is screwed to the syringe) and pharmaceutical product complaint (Verbatim: pharmaceutical product complaint). The outcome of the incomplete dose administered, syringe leak and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the syringe leak to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device. It was unknown if the company considered the syringe leak to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device. 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: 10-SEP-2025 Reporter stated that during Prefilled Syringe FluLaval administration to a patient, they noticed vaccine was leaking where needle was screwed to the syringe.