Received Nov 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
She had a allergic reaction to; From the neck down she was red, so she had a pretty severe reaction; This spontaneous case, initially received on 10-Nov-2025, was reported by a health professional and concerns an elderly female patient. There was no patient history and no allergy information. Concomitant medication reported as unknown. There was no product complaint associated with this case. Administration of company suspect drug: On an unknown date in Dec-2024, the patient received Fluad (TIV) for active immunization for the prevention of influenza disease, Dose regimen: 0.5 ml, Route of Administration: Not Reported, Anatomical location: Not Reported, Lot number: No batch number available, and would be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On Dec-2024, the patient experienced She had a allergic reaction to (outcome: Unknown), From the neck down she was red, so she had a pretty severe reaction (outcome: Unknown), (Intensity: Severe). It was reported that the pharmacist reported they had a patient who got the Fluad 2023-2024 in unknown date in 2024, and then they got the 2024-2025 in unknown date in Dec-2024, however, the one in Dec-2024, she had an allergic reaction too. She was on prednisone and some other items. From the neck down she was red, so she had a pretty severe reaction, so pharmacist guessed and wanted to know what the differences were so that the pharmacist could put on her file about what was the difference. Fluad (TIV) action taken: Not Applicable Treatment medication: Prednisone Reporter's assessment: The reporter did not provide seriousness and causality assessment.; Reporter's Comments: Due to the spontaneous nature of the case, all events are considered related for the reporting purposes. Related for both events considering implied temporal relationship (she had an allergic reaction too in dec-2024) and biological plausibility.