Received Dec 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUBLOK) | SANOFI PASTEUR | UNK | U8923AA | OT |
FLUBLOK that was no longer suitable to be used was administered to a patient with no reported adverse event; Initial information received on 12-Dec-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 59 years old female patient who was administered to Influenza Trivalent Recombinant Vaccine [Flublok] that was no longer suitable to be used, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 06-Dec-2025, the patient received 0.5mL of suspect Influenza Trivalent Recombinant Vaccine, Solution for injection (lot U8923AA, expiry date 30-Jun-2025, frequency once and strength standard) via unknown route in unknown administration site for Influenza (Influenza Immunisation) and that was no longer suitable to be used was administered to a patient with no reported adverse event (poor quality product administered) (latency same day). It was reported "Flublok that was administered after it was deemed unusable. She stated they ordered it through [withheld], who called them directly telling them to refuse the particular shipment due to it being out of temp range. The same box was re-delivered a day or two later and they refused it again. After that though, the caller stated [withheld] put a new label on it and re-delivered it again, and they accepted it since it was a new label. One of the doses form that shipment was administered, so they are asking what our guidelines are regarding readministering the vaccine an it was confirmed the shipping window is usually 1-2 days, and the product/delivery was accepted by mistake on the 5th day after it was shipped from [withheld]". 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.