Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 407268 | — |
Did not receive all the dosage, he received only about half the dosage; During the vaccination the product leaked from the needle; This spontaneous case, initially received on 03-Oct-2025, was reported by a health professional and concerns an elderly male patient. Concomitant medications and medical history were unknown. Administration of company suspect drug: On 03-Oct-2025, the patient received Fluad (TIV) for Immunization for the prevention of influenza disease, Dose regimen: Not reported, Route of Administration: Not Reported, Anatomical location: Not Reported, Lot number: 407268. No additional suspect drugs. Adverse reactions/events and outcomes: On 03-Oct-2025, same day of vaccination, the patient Did not receive all the dosage, he received only about half the dosage (outcome: Unknown, stop date: 03-Oct-2025), During the vaccination the product leaked from the needle (outcome: Unknown, stop date: 03-Oct-2025). The pharmacist tried to vaccinate patient with Fluad at the time of vaccination the product leaked from the needle and the patient did not receive all the dosage, he received only about half the dosage. Pharmacist reported this could happen because or needle was not well attached or it was defective. How many defective units? 1 Was the dose administered? Yes, partially Is the complaint sample available? unknown The defect was noticed during the administration. It was unknown if the plunger was depressed/not depressed. It was unknown if the needle shield was in place. The location of the leak was unknown. It was unknown if there were any signs of damage on the syringe and on the needle. The needle used was the pre-filled syringe (PFS) manufacturer. It was unknown if the needle appeared tightly attached. Fluad (TIV) action taken: Not Applicable Reporter's assessment: The primary reporter (pharmacist) did not provide a seriousness or causality assessment for events Did not receive all the dosage, he received only about half the dosage, During the vaccination the product leaked from the needle.; Reporter's Comments: Events Did not receive all the dosage, he received only about half the dosage, During the vaccination the product leaked from the needle assessed not related due to events nature (special situation).