Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUBLOK) | SANOFI PASTEUR | UNK | TFAA2546 | OT |
received the vaccine outside of the cold chain guideline and did dispense/administered two vaccinations from the box with no reported adverse event; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Infant and unknown gender patient who received Influenza Trivalent Recombinant Vaccine [Flublok] which was outside of the cold chain guideline and did dispense/administered two vaccinations from the box with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in Oct-2025, the patient received an unknow dose of suspect Influenza Trivalent Recombinant Vaccine, Solution for injection (lot TFAA2546, expiry date and strength not reported) via unknown route in unknown administration site for Influenza and it was outside of the cold chain guideline and did dispense/administered two vaccinations from the box with no reported adverse event (poor quality product administered) (latency same day). Reportedly, vaccine that was received late and was no longer viable. Pharmacy was closed on Saturday morning so maybe the delivery service was trying to deliver the vaccine on the 11th according to her. They were informed by a representative that if they haven't received it by the end of the Sunday, it was no longer a viable product. They got it first thing on Monday. Timestamp was 9:14 and it wa sconfirmed that it was non-viable after 12-Oct-2025. Their technician states that there was nothing in the box as sometimes there was the cold chain markers that can tell that it was outside of the temperature. It was just one box of Flublok. 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.