Received Nov 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | UT8804AA | OT |
INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] administered that had a temperature excursion of negative 0.9 Celsius, duration 9 hours and 23 minutes with no ae while; Initial information received on 20-Nov-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 72 years old male patient who received Influenza USP Trival A-B High Dose Subvirion Vaccine [Fluzone HD] that had a temperature excursion of negative 0.9 Celsius, duration 9 hours and 23 minutes with no ae (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 19-Nov-2025, the patient received a dose of 0.5ml of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (lot UT8804AA, standard strength, frequency-once and expiry date-30-Jun-2026) via intramuscular route in the deltoid nos for Influenza that had a temperature excursion of negative 0.9 Celsius, duration 9 hours and 23 minutes with no ae (adverse event) (poor quality product administered) (latency-same day). It was reported "human error was not involved, extended stability does not cover the data of excursion, 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.