Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | U8827AA | OT / RA |
fluzone np that was administered post temperature excursion, refrigerator temperature knob was accidentality turned down, temperature reached: 25.7f wih 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 was linked to US-SA-2025SA301769. This case involves a 6 years old male patient who received Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] which was exposed to temperature excursion due to refrigerator temperature knob was accidentality turned down and maximum temperature reached was 25.7 degree Fahrenheit for 4 hours and 17 minutes with no 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 0.5ml dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine (once), Suspension for injection, Strength Standard, lot U8827AA and expiry date 30-Jun-2026 via unknown route into Right arm for immunisation, which was exposed to temperature excursion due to refrigerator temperature knob was accidentality turned down and maximum temperature reached was 25.7 degree Fahrenheit for 4 hours and 17 minutes with no adverse event (product storage error) (Latency Same day). Reportedly, this excursion occurred due to a human error, extended stability data did not cover the excursion. Vaccine did not have any previous excursion. Action taken : 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.; Sender's Comments: US-SA-2025SA301769: