Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | OT |
Accidental use in 1mo year old patient with no reported adverse event; Initial information received on 26-Feb-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves a 1 month old and unknown gender patient who received with no reported adverse event while receiving vaccine influenza USP trival A-B subvirion NO preservative vaccine [Fluzone]. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On 26-Feb-2025, the patient received 0.5 ml of suspect influenza USP trival A-B subvirion NO preservative vaccine Suspension for injection lot number not reported via intramuscular route in unknown administration site for Influenza vaccination (Influenza immunisation) (product administered to patient of inappropriate age) (Latency same day) Information on the batch number could not be 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.