Received Dec 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No Batch number | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 40699 | — |
Syncopal event; This spontaneous case initially received on 26-Nov-2025, was reported by a non-health professional and concerns an adolescent male patient. Medical history and concomitant medications were reported as unknown. Administration of company suspect drug(s): On 18-Oct-2025, the patient received Flucelvax (TIV) for Prevention of Influenza Disease, Dose regimen: Not reported, Route of administration: Not reported, anatomical location: Not reported, Lot number: 40699. CSL Seqirus Batch number unable to be matched. Non-company suspect drugs: Hepatitis a vaccine (Hepatitis a vaccine), Indication: not reported. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Syncopal event (Medically Significant, outcome: Unknown). Patient had a syncopal event. Case was upgraded to serious upon company assessment of the reported event's (Syncopal event) clinical significance Flucelvax (TIV) action taken: Not Applicable Treatment measures associated with event: Unknown Reporter's assessment: The primary reporter did not provide causality assessment and seriousness reported as unknown.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, event is considered related for reporting purposes. However, there is insufficient information regarding the event for meaningful causal assessment (event onset date, temporality, relevant medical history, etc.). Of note, concomitant administration of Hepatitis A vaccine considered as confounder.