Received Mar 17, 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 |
patient received Fluzone HD yesterday instead of Fluzone Tri with no reported adverse event; Initial information received on 07-Mar-2025 (with live follow up processed together CSD: 07-Mar-2025) regarding an unsolicited valid non-serious case received from a other health professional. This case involves 29 years old (unknown gender) patient who received influenza USP trival A-B high dose subvirion vaccine [Fluzone high dose] yesterday 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 10-Mar-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 instead of influenza USP trival A-B subvirion no preservative vaccine, Suspension for injection both with (lot number, strength and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) with no reported adverse event (wrong product administered) (Latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, The caller would like to know if there are any next steps. The caller was asked for additional AE information and she states, that is all I have and that the patient was given the wrong dose. The caller called again to report that a 5/8 inch needle was used for administration instead of the recommended 1 inch needle. 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.