Received Nov 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
When injecting the Fluad there was a needle error, she got some of it; some leaked but it was not where the needle hooks; This spontaneous case, initially received on 24-Oct-2025, was reported by a health professional and concerns an female patient. Administration of company suspect drug: On 09-Oct-2025, the patient received Fluad (TIV) for Active immunization for the prevention of influenza disease, Dose regimen: 0.5 ml, Route of administration: not reported, Anatomical location: Not reported, Lot numbers: not reported and will be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On 09-Oct-2025, the patient experienced When injecting the Fluad there was a needle error, she got some of it (outcome: Not Reported), some leaked but it was not where the needle hooks (outcome: Not Reported). The registered pharmacist (RPh) stated that when they were injecting the Fluad, there had been a needle error. They mentioned that the patient received some of the dose, but it was unclear how much, and they were trying to determine whether the patient needed to be revaccinated. The Registered Pharmacist (RPh) clarified that it was a needle error and not related to the company or the product itself, noting that the Fluad had worked well. They added that some of the vaccine had leaked, but not from where the needle connects, and asked whether it was recommended to administer a second shot. Fluad (TIV) action taken: Not applicable. Reporter's assessment: The reporter considered the events as non-serious and did not provide causality assessment.; Reporter's Comments: The events were considered as not related due to nature of event (special situation).