Received Sep 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8802MA | OT / RA |
temperature excursion for fluzone np vaccines with maximum\lowest temperature reached :unknown 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 involves a 13 years old female patient who administered Influenza Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] which were stored in a cooler with maximum\lowest temperature reached :unknown 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. On 13-Sep-2025, the patient received 0.5 ml dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection, lot UT8802MA, expiry date:30-Jun-2026, frequency: once, strength: standard, via intramuscular route in the right deltoid for Immunization were exposed with temperature excursion with maximum\lowest temperature reached :unknown freezing for 4 hours with human error with no reported adverse event (latency: same day). Reportedly, human error was involved, previous excursion: none, Reason: Storage in cooler with ice Packs and product was administered. The extended stability data cover the excursion was unknown.They explained that FLUZONE NP vaccines 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. 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:for FLUZONE NP US-SA-2025SA281965: