Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8792LA | OT / RL |
5 & 1/2 month old was administered Fluzone in the right thigh with no reported adverse event; Initial information received on 29-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 and ½ months old female patient who was administered with Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] in the right thigh with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Nirsevimab (Beyfortus [Nirsevimab]). On 14-Oct-2025, the 5 and ½ months old female patient received an unknown dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine Suspension for injection (lot UT8792LA and expiry date-30-Jun-2026) via unknown route in the right thigh for Immunization (product administered to patient of inappropriate age) (latency-same day). Information on the batch number was requested corresponding to the one at time of event occurrence. 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.
BEYFORTUS [NIRSEVIMAB]