Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | U8827AA | OT / RL |
Fluzone trivalent(unopened) refrigerator temperature knob was accidentality turned down/ max temperature reached: 25.7f degrees for 4 hours and 17 minutes, human error involve 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 7 months old male patient who had Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] (unopened) refrigerator temperature knob was accidentality turned down/ max temperature reached: 25.7f degrees for 4 hours and 17 minutes, human error involve 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 dose (0.5ml) of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine (unopened); Suspension for injection (lot U8827AA with expiry date 30-JUN-2026) via unknown route in the right thigh for Immunization; refrigerator temperature knob was accidentality turned down/ max temperature reached: 25.7f degrees for 4 hours and 17 minutes, human error involve with no reported adverse event (product storage error) (latency: same day). Reportedly: refrigerator temperature knob was accidentality turned downmix temperature reached: 25.7F DEGREES Duration: 4 hours and 17 minutes Previous Excursion? No Human error? Administered post-excursion? Yes Does extended stability data cover the excursion? NOT 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.