Received Feb 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Diagnosed with Influenza A; Fatigue; Fever; Coughing; Congestion; This spontaneous case, initially received on 21-Jan-2025, was reported by a non health professional and concerns a female patient with unknown age. No medical history or concomitant medications were reported. Administration of company suspect drug: On 24-Oct-2024, the patient received Flucelvax (TIV) for Active immunization for the prevention of influenza disease, dose, route of administration and route of administration: not reported, Lot number: not reported and wont be requested due to no follow-up consent. No additional suspect drugs. Adverse reactions/events and outcomes: On 19-Jan-2025, the patient experienced Diagnosed with Influenza A (Medically Significant, outcome: Unknown). Associated symptoms included: Standard symptoms of the flu - Fatigue, Fever, Coughing, Congestion. The patient reported that wanted to report an adverse event, with a special situation. She was vaccinated with Flucelvax on 24-Oct-2024. She was diagnosed with Influenza A on 19-Jan-2025 at Urgent Care, The patient was experiencing standard symptoms of the flu, including fatigue, fever, coughing, congestion etc. The patient has no other medical conditions. Non-drug treatment/Other action taken: Flucelvax (TIV) action taken: Not Applicable Reporter assessment: the reporter did not provide a seriousness and causality assessment for the event; Reporter's Comments: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Of note, Influenza A occurred 2 months and 27 days post vaccination with Flucelvax. But, there is limited information regarding the laboratory tests for the confirmation of Influenza A.
Comments: None