Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 406981 | — |
Fever; Fatigue; This spontaneous case, initially received on 25-Sep-2025, was reported by a non health professional and concerns an adult female patient. Administration of company suspect drug: On 22-Sep-2025, the patient received Flucelvax (TIV) for Indication not reported, Dose regimen: 0.5 ml, Route of Administration: Not Reported, Anatomical location: Not reported, Lot number: 406981. Non-company suspect drugs: COVID-19 vaccine (COVID-19 vaccine) Adverse reactions/events and outcomes: On 24-Sep-2025, the patient experienced Fever (outcome: Unknown), Fatigue (outcome: Unknown). The non health professional reporter reported that Flucelvax was given to patient on 22-Sep-2025 shown adverse reactions as fever and fatigue on 24-Sep-2025 and not sure it was related or not and also received a COVID vaccine on the same day as the Flu vaccine on 22-Sep-2025 Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter did not provide causality assessment and seriousness was unknown; Reporter's Comments: Causality: Due to the spontaneous nature of the case, events considered related for reporting purposes
Comments: None