Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | U8827AA | OT / LA |
Temperature excursion negative disposition with human error,refrigerator temperature knob was accidentality turned down with no reported adverse event; Initial information received on 08-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 8 years old male patient received Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone] that had a negative disposition with human error, refrigerator temperature knob was accidentality turned down with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Oct-2025, the patient received a 0.5ml dose of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine Suspension for injection standard strength, frequency once (lot U8827AA and expiry date-30-Jun-2026) via unknown route in the left arm for Immunization had a temperature excursion negative disposition with human error, refrigerator temperature knob was accidentality turned down with no reported adverse event (product storage error). Reportedly- extended stability data does not cover the excursion, human error was involved (refrigerator temperature knob was accidentality turned down), The product was administered. 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.