Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8415MA | OT |
temperature excursion for Fluzone NP exposed to negative 13 F for 4 hours with no reported adverse event.; Initial information received on 07-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to US-SA-2025SA100631. This case involves an unknown age and unknown gender patient who administered influenza USP trival A-B subvirion vaccine [Fluzone] and that had temperature excursion exposed to negative 13 F 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 22-Jan-2025, the patient received an unknown dose of suspect influenza USP trival A-B subvirion vaccine, suspension for injection (lot UT8415MA and expiry date: 30-Jun-2025) via unknown route in unknown administration site for immunization and that had temperature excursion exposed to negative 13 F for 4 hours with no reported adverse event (poor quality product administered). Reportedly, Previous Excursion: 31-Dec-2024: 48 F for 30 minutes. Extended stability data did not cover the excursion. Human error was No. Reason: Fridge malfunction and product was administered. 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-2025SA100631: