Received Apr 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLULAVAL) | GLAXOSMITHKLINE BIOLOGICALS | UNK | J5T9Z | — |
Underage; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number J5T9Z, expiry date 06-JUN-2025) for prophylaxis. On 17-APR-2025, the patient received FluLaval 2024-2025 season. On 17-APR-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage). 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: 18-APR-2025 Registered nurse called to report an Adverse Event regarding an underage administration and they just gave out a dose to a four month old patient, which led to inappropriate age at vaccine administration. The registered nurse wanted to have Medical Information advise on this situation. The vaccination date, vaccine detail and patient demographics were obtained in this call. No further detail was obtained in this call. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.