Received Feb 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Seasonal influenza; This spontaneous case, initially received on 07-Feb-2025, was reported by a non health professional and concerns a male patient with unknown age. Medical history and concomitant medications were reported as unknown. Administration of company suspect drug: On an unknown date in Oct-2024 or Nov-2024, the patient received Flucelvax (TIV) for Influenza vaccination, Dose regimen: 0.5 ml, route of administration and anatomical location: not reported. Lot number: not reported but would be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On 29-Jan-2025, the patient experienced Seasonal influenza (Medically Significant, outcome: Not Reported, stop date: 29-Jan-2025). It was reported that In October or November of 2024, the patient received the Flucelvax vaccine and he diagnosed with seasonal influenza on 29-Jan-2025. 'Case was upgraded to serious upon company assessment of the reported event Seasonal influenza clinical significance' Flucelvax (TIV) action taken: Not Applicable Reporter assessment: The reporter considered the event as non-serious and did not provide a causality assessment for event; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Causal association cannot be completely ruled out for the events in view of insufficient information (events onset date, temporality, relevant medical history,nclear etiology).
Comments: None