Received Nov 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Felt terrible; Fever for a long time; This spontaneous case, initially received on 24-Oct-2025, was reported by a non health professional and concerns a patient of an unknown age/gender. The patient had no relevant medical history. Administration of company suspect drug: On an unknown date, the patient received INN Flu Vaccine Seasonal for Not reported indication, Dose regimen: not reported, Route of administration: Unknown, Lot number: No batch numbner available and would not be obtained due to no follow-up consent. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Felt terrible (outcome: Unknown), Fever for a long time (outcome: Unknown). When patient injected to self with the flu vaccine, patient felt terrible, had a fever for a long time. It had been years since patient had done it more. INN Flu Vaccine Seasonal action taken: Not Applicable Reporter's assessment: The reporter considered the events as non-serious and causality assessment was reported as unknown.; Reporter's Comments: Due to the spontaneous nature of the case, the events (Felt terrible, Fever for a long time) are considered related for reporting purposes.
Comments: None