Received Sep 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | UT8802MA | OT / RA |
Received fluzone np which was stored in a cooler with frozen ice packs, separated by a "barrier layer" of refrigerated packs to prevent freezing for 4 hours with human error 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 was linked to US-SA-2025SA281885, US-SA-2025SA281863 and US-SA-2025SA281892 This case involves a 13 years old female patient who received Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] which was stored in a cooler with frozen ice packs, separated by a barrier layer of refrigerated packs to prevent freezing 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 concomitant therapy was administered. 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 (once), (strength standard) lot UT8802MA and expiry date via intramuscular route in the right deltoid for immunisation, which was stored in a cooler with frozen ice packs, separated by a barrier layer of refrigerated packs to prevent freezing for 4 hours with human error with no reported adverse event (product storage error) (Latency Same day). Reportedly, this excursion occurred due to a human error, it was unknown if extended stability data cover the excursion, since the highest temperature reached was unknown. 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-2025SA281885: US-SA-2025SA281863: US-SA-2025SA281892: