Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | U8881CA | OT / LA |
patient was inadvertently administered the Fluzone prefilled syringe, , intramuscularly into the left deltoid, rather than the intended Fluzone High-Dose with no reported adverse event; Initial information received on 09-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 73 years old female patient who was inadvertently administered the Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone], intramuscularly into the left deltoid, rather than the intended Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose] with no reported adverse event while receiving vaccines and. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Oct-2025, the patient received 0.5mL dose of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine, once, Suspension for injection in pre-filled syringe (unknown strength), lot U8881CA and expiry date 30-Jun-2026 via intramuscular route in the left deltoid for immunisation rather than the intended Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunisation), with no reported adverse event (wrong product administered) (latency Same day). Reportedly, The patient received no concomitant vaccines. This error was the result of an order error, and not the result of confusing the two products. 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.