Received Sep 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
inappropriate use due to the administration of FLUZONE HD to a patient intended to receive FLUZONE NP with no adverse event; Initial information received on 10-Sep-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to this case US-SA-2025SA276446. This case involves an unknown age and unknown gender patient who was inappropriately administered with Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] who was intended to receive Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient inappropriately received an unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot number, expiry date and strength not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization) who was intended to receive fluzone np with no 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,In addition, the specialist reported that a medication error occurred due to the mix-up discovered on 09-Sep-2025. They appeared upset when explaining that a patient received the FLUZONE HD instead of the FLUZONE NP. The specialist also reported that they discovered another similar mix-up in another clinic, wherein 2 doses of FLUZONE HD were located in a box of FLUZONE NP. 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.; Sender's Comments: US-SA-2025SA276446: