Received Dec 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8764DB | OT / RA |
The vaccine dripped on the patient arm, and not received the full dose with no reported adverse event; The vaccine dripped on the patient arm, and not received the full dose with no reported adverse event; The vaccine dripped on the patient arm, and not received the full dose with no reported adverse event; Initial information received on 25-Nov-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 73 years old male patient who received the influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] that dripped on the patient arm and not received the full dose with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Aug-2025, the patient received unknown dose of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe with lot U8764DB and expiry date 30-JUN-2026 via intramuscular route in the right arm for Influenza immunization that dripped on the patient arm and not received the full dose with no reported adverse event (accidental exposure to product) (exposure via skin contact) (incorrect dose administered) (Latency same day). 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.