Received Feb 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLULAVAL) | GLAXOSMITHKLINE BIOLOGICALS | 4 | 4S5YG | — |
| FLU3 | INFLUENZA (SEASONAL) (FLULAVAL) | GLAXOSMITHKLINE BIOLOGICALS | 3 | — | — |
4th dose of FluLaval administered; 3rd dose of FluLaval administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 19-month-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 4S5YG, expiry date 30-JUN-2025) for prophylaxis. Co-suspect products included Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis. Previously administered products included Flulaval (patient had 1st dose on December 18th, 2023) and Flulaval (patient had 2nd dose on January 20th, 2024). On 12-DEC-2024, the patient received the 4th dose of FluLaval 2024-2025 season. On 09-SEP-2024, the patient received the 3rd dose of FluLaval 2024-2025 season. On 09-SEP-2024, not applicable after receiving FluLaval 2024-2025 season and an unknown time after receiving FluLaval 2024-2025 season, the patient experienced extra dose administered (Verbatim: 3rd dose of FluLaval administered). On 12-DEC-2024, the patient experienced extra dose administered (Verbatim: 4th dose of FluLaval administered). The outcome of the extra dose administered and extra dose administered were unknown. 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: 13-JAN-2025 The patient received 4 dose of Flulaval which led to extra dose administered.