Received Mar 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 72RF2 | — |
lightheadedness; phantom bruising all over the body; severe fatigue; malaise; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of light headedness in a patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 72RF2, expiry date 30-JUN-2025) for prophylaxis. On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced light headedness (Verbatim: lightheadedness), contusion (Verbatim: phantom bruising all over the body), fatigue (Verbatim: severe fatigue) and malaise (Verbatim: malaise). The outcome of the light headedness, contusion, fatigue and malaise were not reported. The reporter considered the light headedness, contusion, fatigue and malaise to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. The company considered the light headedness, contusion, fatigue and malaise to be related to Fluarix 2024-2025 season and Fluarix 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: 21-OCT-2024 and 28-OCT-2024 The health care professional reported that a patient received Fluarix and had phantom bruising all over the body, severe fatigue, malaise and lightheadedness and patient went to emergency department. The reporter stated that particular batch (Lot: 72RF2) was causing the adverse events. This case was one of the four linked cases, reported by the same reporter for different patient. Follow up information received on 04-NOV-2024 The case reported was an human safety information only with no defined quality defect and therefore this case does not qualify as a customer complaint as per GQP 8203 definitions and scope. Summary of changes: Event deleted and narrative were updated. Upon internal review case was updated on: 06-MAR-2025 The suspect was coded as Fluarix 2024-2025. Summary of changes: Product tab, event details and narrative were updated.; Sender's Comments: US-GSK-US2024AMR131526:Original Case : US2024129463 US-GSK-US2024AMR131525:Original Case : US2024129463 US-GSK-US2024133757:Same reporter