Received Nov 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Anginas on her face; Minor allergy after the administration of Flucelvax; Hives on her face; This spontaneous case, initially received on 03-Nov-2025, was reported by a health professional and concerns an child female patient. Medical history and concomitant medications was reported as unknown. Administration of company suspect drug: On an unknown date in Oct-2023, the patient received Flucelvax (TIV) for unknown indication, Dose regimen: not reported, route of administration: 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, the patient experienced Anginas on her face (Medically Significant, outcome: Unknown), Hives on her face (outcome: Unknown), Minor allergy after the administration of Flucelvax (outcome: Unknown). Case was upgraded to serious upon company assessment of the reported event (Anginas on her face) clinical significance. The physician called and asked about a list of ingredients for the Flucelvax vaccine. The physician stated that a child had experienced a minor allergy after the administration of Flucelvax. The physician specified that the child had developed hives and anginas on her face within 5 to 10 minutes after the administration. The physician referred that Flucelvax was the only vaccine the child had received that day. The physician provided the NDC (sic!) Number and asked about the Gelatin constituent and requested a list of vaccine constituents. The physician informed that she was the mother of the child, and the HCP who administered the vaccine was another physician who was no longer following the case. Flucelvax (TIV) action taken: Not Applicable Treatment measures associated with event: Unknown Reporter's assessment: The reporter did not provide the seriousness and causality of assessment for the events.; Reporter's Comments: Due to the spontaneous nature of the case, all events are considered related for the reporting purposes. Related for all events considering close temporal relationship ( 5 to 10 minutes after the vaccine administration) and biological plausibility.