Received Dec 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | OT |
accidental administration of Fluzone Np instead of Fluzone HD that is intended for patients with ages below 65 years with no reported adverse event; Initial information received on 25-Nov-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 87 years old male patient reporter reported accidental administration of fluzone np (Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone]) instead of Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose] that is intended for patients with ages below 65 years with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 25-Nov-2025, there was accidental administration of Influenza Usp Trival A-B Subvirion No Preservative Vaccine Suspension for injection (strength, dose, batch and expiry date unknown) via unknown route in unknown administration site for Immunization instead of fluzone hd that is intended for patients with ages below 65 years with no reported adverse event (wrong product administered) (latency same day). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. Action taken- 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.