Received Jun 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | OT |
whether there had been any specific instances of one Sanofi flu vaccine being mistaken for another and administered to a patient, she said that historically there may have been with no reported adverse event; Initial information received on 12-Jun-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient for whom influenza usp trival a-b subvirion no preservative vaccine [Fluzone], there had been any specific instances of one sanofi flu vaccine being mistaken for another and administered to a patient, she said that historically there may have been with no reported 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 received an unknown dose of suspect influenza usp trival a-b subvirion no preservative vaccine; Suspension for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for Immunization; whether there had been any specific instances of one sanofi flu vaccine being mistaken for another and administered to a patient, she said that historically there may have been with no reported adverse event (wrong product administered) (latency: same day) Reportedly: She states that they have some new staff that is coming on board in the near future, and they are putting together training materials for them related to flu vaccination. When the nurse was asked whether there had been any specific instances of one Sanofi flu vaccine being mistaken for another and administered to a patient, she said that historically there may have been, but she cannot say for sure, and she does not have any information on any specific instances Action taken was not applicable. Information on the batch number was requested corresponding to the one at time of event occurrence. 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.