Received Oct 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Fever; Aches; Sore throat; Headache; Cough; This spontaneous case, initially received on 09-Oct-2025, was reported by a non-health professional and concerns a patient of unknown age/gender. Concomitant medication and medical history was reported as unknown. Administration of company suspect drug: On 08-Oct-2025, the patient received Flucelvax (TIV) for not reported indication, 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 08-Oct-2025, the patient experienced Fever (outcome: Unknown), Aches (outcome: Unknown), Sore throat (outcome: Unknown), Headache (outcome: Unknown), Cough (outcome: Unknown). The patient had reaction: fever, aches, sore throat, headache, cough. It could be weather changes as well or kids but received the flu vaccine on 08-Oct-2025. Treatment measures associated with event was reported as unknown. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter did not provide seriousness and causality assessment for the events.; Reporter's Comments: Due to the spontaneous nature of the case, the event were considered related for reporting purposes.
Comments: None