Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Tinnitus every single day; This spontaneous case, initially received on 21-Oct-2025 (including additional information received 22-Oct-2025), was reported by a non health professional and concerns a female patient. Concomitant Medications: Unknown, Medical History: Unknown Administration of company suspect drug: On an unknown date, the patient received Flucelvax (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 an unknown date, 14 days after the vaccine was administered, the patient experienced Tinnitus every single day (outcome: Not Reported). Patient took Flucelvax and 14 days later, she started experiencing tinnitus every single day. The patient did not had tinnitus in the past. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter (Consumer) did not provided the seriousness assessment and considered the event Tinnitus every single day as related to the administration of Flucelvax (TIV).; Reporter's Comments: Due to the spontaneous nature of the case, the event Tinnitus is considered related for reporting purposes.