Received Mar 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 946624 | LA |
Vaccination failure; Fever broke; Severe sore throat; Flu virus type A; This spontaneous case, initially received on 03-Mar-2025, was reported by a non health professional and concerns an adult male patient. Administration of company suspect drug: On 22-Oct-2024, the patient received Flucelvax (TIV) for Indication not reported. Dose regimen: Not reported, Route of administration: Not reported. Anatomical location: Left Deltoid. Lot number: 946624. No additional suspect drugs. Adverse reactions/events and outcomes: On 21-Feb-2025, the patient experienced Flu virus type A (Medically Significant, outcome: Not Reported). Associated symptoms included: Fever broke , Severe sore throat. On unknown date, the patient experienced Flu virus type A after receiving Flucelvax/Vaccination failure (Medically Significant, outcome: Not Reported) It was reported that 25-Feb-2025, severe sore throat subsided. Source of infection was not known for certain. Possibly obtained at a sporting event on 19-Feb-2025. Flu was verified by swab on 24-Feb-2025. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter did not provide the seriousness and causality of the events.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, the events are considered related for reporting purposes. For influenza and vaccination failure, patient tested positive within 21 to 180 day time period and also tested positive to Influenza A on swab. Furthermore, A lack of effect can generally be expected for any medicinal/drug product as a 100% success rate cannot be reasonably assumed in every patient treated.
Medical History/Concurrent Conditions: Influenza virus test; Comments: None