Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | No batch number | — |
Vaccine leaked during administration; Partial dose administered; This spontaneous case, initially received on 17-Oct-2025, was reported by a health professional and concerns a patient of unknown age/gender. Concomitant medication and Medical history were reported as unknown. Administration of company suspect drug: On an unknown date, the patient received Fluad (TIV) for an indication not reported, Dose regimen: Not reported, Dose 1, Route of administration: Not reported, Anatomical location: Not reported, Lot number: No batch number available and requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient had Vaccine leaked during administration (outcome: Unknown), Partial dose administered (outcome: Unknown). They had a patient who was going to need their Fluad vaccine repeated as the first vaccine leaked during administration. Partial dose administered. Treatment measures associated with event were unknown. Fluad (TIV) action taken: Not Applicable Reporter's assessment: The primary reporter provided seriousness assessment for events Vaccine leaked during administration, Partial dose administered as unknown and did not provide the causality assessment.; Reporter's Comments: Events Vaccine leaked during administration, Partial dose administered are not related due to nature of events (special situation).