Received Nov 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Itchy circular type bruise; It was very itchy; This spontaneous case, initially received on 12-Nov-2025, was reported by a non-health professional and concerns an patient of unknown age/gender. There was no patient history and no allergy information. Medical history reported as unknown. There was no product complaint associated with the case. Administration of company suspect drug: On an unknown date in Nov-2025, the patient received Fluad (TIV) for Unknown indication, Dose regimen: Not reported, Route of administration: Not reported, Anatomical location: Arm, Lot number: No batch number available, and will be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date in Nov-2025, the patient experienced Itchy circular type bruise (outcome: Unknown), It was very itchy (outcome: Unknown). Consumer called and stated patient got the high dose flu vaccine about a week previous this report. That was way high on patient's arm, there was a circular type bruise and it was itchy, very Itchy. Fluad (TIV) action taken: Not Applicable Reporter's assessment: The primary reporter (patient) did not provide a seriousness or causality assessment.; Reporter's Comments: Due to the spontaneous nature of the case, the events are considered related for reporting purposes