Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | UT8514KA | OT / LA |
Patient received expired FLUZONE TRIVALENT, with no reported adverse event; Initial information received on 18-Sep-2025 (With live follow attached on same day) regarding an unsolicited valid non-serious case received from other health professional. This case involves a 8 years old male patient received expired influenza USP trival A-B subvirion NO preservative vaccine [Fluzone], with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Sep-2025, the patient received Dose 1 of 0.5 ml of suspect influenza USP trival A-B subvirion NO preservative vaccine Suspension for injection Strength: standard, Frequency; Once with lot UT8514KA and expiry date 30-Jun-2025 via intramuscular route in the left arm for Immunization with no reported adverse event (expired product administered) (latency same day) Reportedly, did not return a box of expired fluzone trivalent, which led to it being used for administration to a patient. 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.