Received Feb 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Flu while being vaccinated; This spontaneous case, initially received on 04-Feb-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 indication not reported, dose, route of administration and anatomical location: not reported. Lot number: No batch number available but will be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Flu while being vaccinated (Medically Significant, outcome: Not Reported). It was reported that, the patient got flu while being vaccinated. It was unknown which influenza vaccine the patient received. INN Flu Vaccine Seasonal action taken: Not Applicable Reporter assessment: the reporter did not provide seriousness and causality assessment for the event.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Furthermore, due to lack of more detailed information (e.g. temporal relationship, patients risk factors, diagnostic reports and brand name of vaccine) causality cannot be excluded.
Comments: None