Received Nov 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUBLOK) | SANOFI PASTEUR | UNK | U8864AA | OT / LA |
administration of a minuscule amount of FLUBLOK to a patient resulting from a defective syringe flange with no reported adverse event; Initial information received on 24-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 65 years old female patient who was administered a minuscule amount of Influenza Trivalent Recombinant Vaccine [Flublok] resulting from a defective syringe flange with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-Oct-2025, the patient received a minuscule amount of Influenza Trivalent Recombinant Vaccine Solution for injection (unknown strength) lot U8864AA and expiry date 30-Jun-2026 via intramuscular route in the left arm for resulting from a defective syringe flange with no reported adverse event (incorrect dose administered) (Latency Same day). Reportedly, The syringe's flange (referred to by the caller as the "glass at the bottom") shattered and partially detached (or remained "hanging") during administration. The dose remained mostly full, although the caller stated that a minuscule portion may have been administered to the patient. 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.