Received Oct 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 407252 | — |
The total dose was not administered; There was a leakage between the insertion of the needle with the syringe.; This spontaneous case initially received on 07-Oct-2025, was reported by a health professional and concerns an elderly male patient. Administration of company suspect drug: On 07-Oct-2025, the patient received Fluad (TIV) for Flu prevention, Dose regimen: 0.5 ml, route of administration: not reported, Anatomical location: Not reported, Lot number: 407252. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced The total dose was not administered (outcome: Unknown), There was a leakage between the insertion of the needle with the syringe. (outcome: Unknown). A pharmacist reported that a Fluad vaccine (LOT: 407252, EXP: 05-May-2026) vaccine was given to a patient and the total dose was not administered. Pharmacist informed that during administration there was a leakage between the insertion of the needle with the syringe. The defect was noticed while the pharmacist was administering the vaccine, as it leaked from the connection point between the needle and the syringe. After administration, the pharmacist observed the vaccine dripping, indicating that only a partial dose had been administered. The plunger was depressed during the injection, and pharmacist stated that the shield was put back in place after pulling out the needle from the patient. The leak was specifically located at the needle insertion point with the syringe. There were no visible signs of damage on the syringe. Details regarding the needle used, its manufacturer or model, whether it was tightly attached, or if any attempts were made to tighten or replace it, remain unknown. It is also unknown whether a complaint sample was obtained or if there are any signs of damage on the needle. A picture of the complaint sample has not yet been provided and should be obtained. No information is available regarding treatment measures, outcome of the event, concomitant medications, or the patient's medical history. The patient was not hospitalized. Fluad (TIV) action taken: Not Applicable Reporter's assessment: The reporter did not provide the seriousness and causality of the events.; Reporter's Comments: The events are not related due to nature of event (special situation)