Received Mar 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8514NA | OT / RL |
FLUZONE PFS NP if it was given to a 1-month-old with no reported adverse event; Initial information received on 25-Feb-2025 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 1-month-old of unknown gender patient whom influenza USP trival A-B subvirion no preservative vaccine [Fluzone] was given with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-Feb-2025, the 1-month-old patient received a 0.5 ml dose of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine Suspension for injection strength: standard of lot UT8514NA and expiry date: 30-Jun-2025 via intramuscular route in the right thigh for immunization with no reported adverse event (product administered to patient of inappropriate age) (latency: on same day). Action taken was not applicable. Reportedly, Nurse clarified that no adverse event has been reported 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.