Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | U8827AA | OT / RA |
refg temp knob was accidentality turned downMax temperature reached: 25.7F Duration: 4 h17 with no ae; Initial information received on 08-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 years old female patient received Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone that had a temperature excursion where the refrigerator temperature knob was accidentally turned downmax temperature reached: 25.7f duration: 4 h17 with no ae (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 dose of 0.5ml of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine Suspension for injection (lot U8827AA and expiry date-30-Jun-2026) via intramuscular route in the right arm for Immunization that had a temperature excursion where the refrigerator temperature knob was accidentally turned down max temperature reached: 25.7f duration: 4 h17 with no ae (product storage error) (unknown latency). Reportedly- extended stability data does not cover the excursion, human error was involved (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.