Received Nov 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | IM |
Vomiting; Shivering; Shaking; This spontaneous case, initially received on 23-Oct-2025, was reported by a Non-Health Professional and concerns a child female patient. Weight: 35.28 kg; Height: 142.2 cm Administration of company suspect drug: On 22-Oct-2025 17:30, the patient received Flucelvax (TIV) for Indication not reported, Dose regimen: Not reported, Route of Administration: Not Reported, Anatomical location: Not reported, Lot number: No batch number available will be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On 23-Oct-2025 04:30, the patient experienced Vomiting (outcome: Recovered / Resolved, stop date: 23-Oct-2025 06:30), Shivering (outcome: Recovered / Resolved, stop date: 23-Oct-2025 06:30), Shaking (outcome: Recovered / Resolved, stop date: 23-Oct-2025 06:30). Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter considered the events Shaking, Shivering, Vomiting related to the administration of Flucelvax (TIV) and seriousness reported as non-serious; Reporter's Comments: Due to the spontaneous nature of the case, events Vomiting, Shivering and Shaking were considered related for reporting purposes
Comments: None