Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | UT8802MA | OT / RA |
Temperature excursion: Stored in cooler with ice packsMax/low temperature reached: UnknownDuration: 4 hours,with no reported adverse event; Temperature excursion: Stored in cooler with ice packs-Max/low temperature reached: Unknown, Duration: 4 hours and product was administered 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 15 years old male patient who was administered to Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] which went under temperature excursion: negative disposition- stored in cooler with ice packs- max/low temperature reached: unknown, duration: 4 hours with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Sep-2025, the patient received 0.5mL (dose 1) of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (lot UT8802MA, expiry date 30-Jun-2026, strength standard and frequency once) via intramuscular route in the right deltoid for Immunisation - temperature excursion: stored in cooler with ice packs-max/low temperature reached: unknown, duration: 4 hours and product was administered with no reported adverse event (poor quality product administered) (latency same day) and (product storage error). Reportedly, Fluzone NP were stored in a cooler with frozen ice packs, separated by a barrier layer of refrigerated packs to prevent freezing. This storage condition lasted for 4 hours before the vaccines were transferred to a refrigerator with within-range temperature. The clinic supervisor also stated that they could not provide the exact highest temperature that the vaccines reached. No other immunizations. 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-2025SA281863:for FLUZONE NP US-SA-2025SA281965: 02658701: