Received Dec 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLULAVAL) | GLAXOSMITHKLINE BIOLOGICALS | 1 | FH4YR | — |
Out of age range administration/4-month-old patient got the Flu vaccine (Flulaval); This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2025-2026 season) (batch number FH4YR, expiry date 02-JUN-2026) for prophylaxis. On 25-SEP-2025, the patient received the 1st dose of FluLaval 2025-2026 season. On 25-SEP-2025, an unknown time after receiving FluLaval 2025-2026 season, the patient experienced inappropriate age at vaccine administration (Verbatim: Out of age range administration/4-month-old patient got the Flu vaccine (Flulaval)). The outcome of the inappropriate age at vaccine administration 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 reporter reported that back on 25 Sep 2025, then a 4-month-old patient got the Flu vaccine (Flulaval) and it was discovered until this day of the reporting. The reporter wanted to know if need to administer the 2nd dose.