Received Feb 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 946624 | RA |
Diagnosed with the flu A; This spontaneous case initially received on 30-Jan-2025, was reported by a non health professional and concerns a child female patient. Medical history or concomitant medications were reported as unknown. No allergy information provided. There was no product complaint associated with this case. Administration of company suspect drug: On 26-Oct-2024, the patient received Flucelvax (TIV) for Flu immunization, Dose regimen: 0.5 ml, Route of administration: not reported, anatomical location: right deltoid Lot number: 946624. No additional suspect drugs. Adverse reactions/events and outcomes: On 28-Jan-2025, the patient experienced Diagnosed with the flu A (Medically Significant, outcome: Unknown). The reporter informed that her child was diagnosed with the flu during a trip to her pediatrician then. Vaccination was given at Health Services Clinic. Flu was verified by nasal swab. Flu virus was Flu A. Onset date was 28-Jan-2025 and Recovery date was 20-Jan-2025 (as reported). Source of infection was unknown (likely a peer at her school). Flucelvax (TIV) action taken: Not Applicable Treatment measures associated with event: Unknown Reporter assessment The reporter provide the seriousness of the event as unknown and did not provide a causality assessment.; Reporter's Comments: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Causal association could not be completely ruled out in view of insufficient information, hence causality assessed as related.(relevant medical history, concomitant medications, diagnostic report)
Comments: None