Received Feb 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU4 | INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
vaccination failure; Developed Influenze A; This serious case was reported by a medical representative via sales rep and described the occurrence of vaccination failure in a adult male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2024-2025 season) for prophylaxis. In SEP-2024, the patient received the 1st dose of FluLaval Quadrivalent 2024-2025 season. In JAN-2025, between 4 and 5 months after receiving FluLaval Quadrivalent 2024-2025 season, the patient experienced vaccination failure (Verbatim: vaccination failure) (serious criteria GSK medically significant) and influenza a virus infection (Verbatim: Developed Influenze A). The outcome of the vaccination failure was not reported and the outcome of the influenza a virus infection was not resolved. It was unknown if the reporter considered the vaccination failure and influenza a virus infection to be related to FluLaval Quadrivalent 2024-2025 season and Flulaval Tetra Pre-Filled Syringe Device. It was unknown if the company considered the vaccination failure and influenza a virus infection to be related to FluLaval Quadrivalent 2024-2025 season and Flulaval Tetra 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: 15-JAN-2025 The reporter stated that the patient received FluLaval Quadrivalent vaccine. The patient had a purchased rapid test that showed he had developed Influenza A on January 2025. The reporter was not his doctor.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description) is considered unrelated to GSK vaccine FluLaval Quadrivalent 2024-2025 season and FluLaval Tetra PRE-FILLED SYRINGE DEVICE. Influenza is a listed event which, due to the following criteria (insufficient information provided about the clinical description) is considered unrelated to GSK vaccine FluLaval Quadrivalent 2024-2025 season and FluLaval Tetra PRE-FILLED SYRINGE DEVICE.
Test Date: 202501; Test Name: rapid test; Result Unstructured Data: (Test Result:Influenza A,Unit:unknown,Normal Low:,Normal High:) had Influenza A