Received Nov 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | 1 | — | OT |
administering fluzone hd intravenously instead of intramuscularly with no reported adverse event; Initial information received on 18-Nov-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who received influenza USP trival A-B high dose subvirion vaccine [fluzone HD] intravenously instead of intramuscularly with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Nov-2025, the patient received Dose 1 of 0.5 ml of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe, frequency once (Unknown lot and expiry date) via iv NOS (Not otherwise specified) route in unknown administration site for Immunization instead of intramuscularly with no reported adverse event (incorrect route of product administration) (Latency same day. Information on the batch number requested corresponding to the one at the time of reporting. 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.