Received Dec 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUBLOK) | SANOFI PASTEUR | UNK | U8790BA | OT / LA |
temperature excursion at negative 2.1°C and was administered to a patient with no reported adverse event; Initial information received on 04-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 48 years old female patient who was administered INFLUENZA TRIVALENT RECOMBINANT VACCINE [FLUBLOK] that had temperature excursion at negative 2.1°c with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines at the time of vaccination. On 04-Dec-2025 at 10:36AM, the patient received a 0.5 ml dose of suspect INFLUENZA TRIVALENT RECOMBINANT VACCINE Solution for injection (lot U8790BA, Expiry: 30-Apr-2026, strength: standard) via intramuscular route in the left deltoid as Influenza immunization that on an unknown date had temperature excursion at negative 2.1°c with no reported adverse event (poor quality product administered) (Latency: same day). 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.