Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | 1 | U8847AA | OT / LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | OT |
administered fluzone hd instead of fluzone np to a patient with no reported adverse event; Initial information received on 03-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 61 years old female patient who was administered influenza USP trival A-B high dose subvirion vaccine [Fluzone High Dose] instead of influenza USP trival A-B subvirion no preservative vaccine [Fluzone] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Oct-2025, the patient received a dose of 0.5 ml (dose 1) once of suspect influenza USP trival A-B high dose subvirion vaccine (Suspension for injection in pre-filled syringe) (lot: U8847AA; expiry date: 30-Jun-2026) via intramuscular route in the left upper arm for Immunisation instead of influenza USP trival A-B subvirion no preservative vaccine (Suspension for injection) with no reported adverse event (wrong product administered) (latency: same day). The patient had no other immunizations. 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.