Received Nov 4, 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 |
administration of fluzone hd to a patient whose age is not approved for the vaccine, with no reported adverse event; needed the regular dose of FLUZONE 0.5 mg but were administered FLUZONE HD with no reported ae; Initial information received on 23-Oct-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional). This case involves a 50 years old female patient who was administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] instead of Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] which is not approved for the patient age group, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Oct-2025, the patient received an unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (once), Strength Standard (unknown expiry date) lot number not reported via unknown route in unknown administration site for influenza immunisation instead of Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone], whose age is not approved for the vaccine, with no reported adverse event (product administered to patient of inappropriate age) (Latency Same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. 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.