Received Sep 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | UT8802MA | OT / RA |
patient received FLUZONE NP which was exposed to temperature excursion due to Storage in cooler with ice packs where Max/low temperature reached was unknown for 4 hours with no reported adverse event; Initial information received on 17-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 years old female patient who received Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] which was exposed to temperature excursion due to storage in cooler with ice packs where maximum/lowest temperature reached was unknown for 4 hours with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other immunizations On 13-Sep-2025, the patient received 0.5ml (Dose 1) of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine (once), Suspension for injection, Strength Standard, lot UT8802MA and expiry date 30-Jun-2026 via intramuscular route in the right deltoid for immunisation which was exposed to temperature excursion due to storage in cooler with ice packs where max/low temperature reached was unknown for 4 hours with no reported 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, Previous excursion none. 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.; Sender's Comments: US-SA-2025SA281965: