Received Sep 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Flu; Flu; Lack of efficacy; This spontaneous case, initially received on 16-Sep-2025, was reported by a non health professional and concerns a patient of unknown age/gender. Administration of company suspect drug: On an unknown date, the patient received INN Flu Vaccine Seasonal for Not reported, Dose regimen: not reported, Route of administration: unknown, 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 Flu (Medically Significant, outcome: Unknown), Flu (Medically Significant, outcome: Unknown), Lack of efficacy (Medically Significant, outcome: Unknown). Case was upgraded to serious upon company assessment of the reported event's (Flu and Lack of efficacy) clinical significance. When the patient taught, the flu shot was highly recommended, so the patient received it twice, and both times the patient got the flu. When the patient did not get the vaccine, the patient never got the flu. INN Flu Vaccine Seasonal action taken: Not Applicable Reporter's assessment: The primary reporter assessed the event as non-serious with causality was reported as unknown.; Reporter's Comments: Due to the spontaneous nature of the case, the events influenza and drug ineffective are considered related for reporting purposes. Of note, there is limited information on temporality, age, medical history, suspect indication, lab test for flu and vaccine details to perform in depth analysis. A lack of effect can generally not be excluded for any medicinal/drug product as a 100% success rate cannot be reasonably assumed in every patient treated.
Comments: None