Received Jan 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | U8854AA | OT |
fluzone was exposed to Temperature reached: 25.9?Duration out of labelled range: 2 hours 29 minutes with Human Error with no reported adverse event; Initial information received on 09-Jan-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a Child and unknown gender patient who had administered Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone] and was exposed to temperature reached: 25.9?duration out of labelled range: 2 hours 29 minutes with human error with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine Suspension for injection (strength: STD (standard) except for Fluzone HD Quad, expiry date: 30-Jun-2026 and lot U8854AA) via unknown route in unknown administration site for influenza and was exposed to temperature reached: 25.9?duration out of labelled range: 2 hours 29 minutes with human error with no reported adverse event (product storage error) (unknown latency). Reportedly, Previous excursion: None, they said that their vaccines did not freeze, so they're trying to make sure that they gave the correct information. The vaccines were also exposed to previous excursions on 11Oct2025 at 31.5°F for 15 minutes and 50.5°F for 10 minutes and another one on 23Oct2025 at 32.2°F for around 15 minutes or less. 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.