Received Jun 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Getting the flu; This spontaneous case initially received on 31-May-2026, was reported by a health professional and concerns a male patient of unknown age. The patient had no relevant medical history. Administration of company suspect drug: On an unknown date, the patient received INN Flu Vaccine Seasonal for an indication not reported, Dose regimen: Not reported, Route of administration: Unknown, Anatomical location: Not reported, Lot Number: No batch number available and would not be requested for follow-up as consent not obtained. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Getting the flu (Medically Significant, outcome: Unknown). Case was upgraded to serious upon company assessment of the reported event (Getting the flu) clinical significance. What patient did know was this- when patient stopped getting the flu shot each year, he stopped getting the flu and it had been over 15 years. INN Flu Vaccine Seasonal action taken: Not Applicable Reporter's assessment: The reporter assessed the event as non-serious and causality was reported as unknown.; Reporter's Comments: Due to the spontaneous nature of the case, it is considered related for reporting purposes. However, the information is insufficient (event onset date, latency/temporality, last dose prior to event onset, clinical course ,relevant medical history, lab investigations, treatment details and concomitant medications) to perform in-depth analysis.
Comments: None