Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8874CA | OT |
Instead of delivering the dose, the vaccine leaked from the needle hub onto the patient's arm with no reported adverse event; Instead of delivering the dose, the vaccine leaked from the needle hub onto the patient's arm with no reported adverse event; Initial information received on 30-Oct-2025 regarding an unsolicited valid non-serious case received from a Other Health Care Professional. This case involves a 69 years old male patient and the nurse was administering influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone HD] instead of delivering the dose, the vaccine leaked from the needle hub onto the patient's arm with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-Oct-2025, the nurse was administering influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength- unknown, expiry date- 30-JUN-2026 and lot U8874CA) via unknown route in an unknown administration site for Influenza (Influenza immunisation) instead of delivering the dose, the vaccine leaked from the needle hub onto the patient's arm with no reported adverse event (accidental exposure to product) (exposure via skin contact) (latency- same day). It was reported that, "the leakage occur when administering the dose. The needle hub appears to be intact but here are dents around it. Caller was asked to callback to provide a few more information. Previous case was about FLUZONE HD. Caller noted that the area where the needle meets the tip, the top part, seemed to be chipped . Caller asked the nurse if the product was dropped but the nurse said that it was not. Product was taken out of the box and it leaked down on the patient's arm. Caller was requesting for a replacement." Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.