Received Feb 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUARIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 9cc9k | LA |
Rash on arms legs and stomach; She was itchy; This serious case was reported by a other health professional via sales rep and described the occurrence of rash in a 60-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2025-2026 season) (batch number 9cc9k, expiry date 30-JUN-2026) for prophylaxis. Concurrent medical conditions included hypertension. Concomitant products included hydrochlorothiazide and losartan. On 14-JAN-2026, the patient received the 1st dose of Fluarix 2025-2026 season (left deltoid). In JAN-2026, less than a week after receiving Fluarix 2025-2026 season, the patient experienced pruritus (Verbatim: She was itchy). On 18-JAN-2026, the patient experienced rash (Verbatim: Rash on arms legs and stomach) (serious criteria other: Serious as per reporter). The outcome of the rash was not resolved and the outcome of the pruritus was not reported. It was unknown if the reporter considered the rash and pruritus to be related to Fluarix 2025-2026 season and Fluarix Pre-Filled Syringe Device. The company considered the rash to be unrelated to Fluarix 2025-2026 season and Fluarix Pre-Filled Syringe Device. It was unknown if the company considered the pruritus to be related to Fluarix 2025-2026 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: 20-JAN-2026 The patient was itchy.; Sender's Comments: A case of Rash (BCWG Level 3), 4 days after vaccination with 1st dose of Fluarix 2025-2026 season and Flu Seasonal TIV Dresden PRE-FILLED SYRINGE DEVICE, in a 60-year-old female patient. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received
Hypertension
HYDROCHLOROTHIAZIDE; LOSARTAN