Received Jan 5, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Allergic reaction; This spontaneous case initially received on 11-Dec-2025, was reported by a non-health professional and concerns an female patient. Administration of company suspect drug: On an unknown date in 2024, the patient received Flucelvax (TIV) for an unknown indication., Dose regimen: Unknown, Route of administration: Unknown, 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 an unknown date in 2024, the patient experienced Allergic reaction (outcome: Unknown). It was reported that, the previous year from the day of report (2024), she received the vaccine and had an allergic reaction. Therefore, patient inquired for the composition of the vaccine Flucelvax in terms of the ingredients. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter provided the seriousness of the event as unknown and causality assessment was not reported.; Reporter's Comments: Due to the spontaneous nature of the case, the event is considered related for reporting purposes