Received Nov 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLULAVAL) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
shortness of breath; chest pain; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of shortness of breath in a specified number of patients who received Flu Seasonal TIV Quebec (Flulaval) for prophylaxis. On an unknown date, the patients received Flulaval. On an unknown date, an unknown time after receiving Flulaval, the patients experienced shortness of breath (Verbatim: shortness of breath) and chest pain (Verbatim: chest pain). The outcome of the shortness of breath and chest pain were unknown. It was unknown if the reporter considered the shortness of breath and chest pain to be related to Flulaval and Flulaval Pre-Filled Syringe Device. It was unknown if the company considered the shortness of breath and chest pain to be related to Flulaval and Flulaval 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: 09-OCT-2025 Healthcare professional reported 2 cases where 2 individuals (patients) experienced shortness of breath and chest pain following the administration of FluLaval. HCP said these adverse events were reported to VAERS already and HCP did not want to report again. The batch number was not provided, and unable to contact the reporter.