Received Jan 8, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | UT8829AA | OT |
Vaccine (FLUZONE HD) was administered after a temperature excursion with a negative disposition with no reported adverse event; Initial information received on 05-Jan-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 58 years old female patient who was administered with Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] post excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-Dec-2025, the patient received an unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe, lot UT8829AA, expiry date: 30-Jun-2026, strength not reported via unknown route in unknown administration site for Influenza, post excursion with no reported adverse event (poor quality product administered) (latency: same day). It was reported "human error was not involved; refrigerator malfunction. Duration of temperature excursion: 13 minutes Maximum/minimum temperature reached: (negative) -0.4° Celsius for 13 minutes. Product was administered post excursion. The extended stability data did not cover the excursion". 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.