Received Jan 1, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | TFAA2547 | OT / RA |
FLUBLOK was frozen and then administered to a patient with no reported adverse event; Initial information received on 22-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 89 years old male patient who experienced INFLUENZA TRIVALENT RECOMBINANT VACCINE [FLUBLOK TIV]. was frozen and then administered to a patient with no reported adverse event The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TD) for Prophylactic vaccination (Immunisation). On 22-Dec-2025 at 11:30 hours, the patient received frozen 0.5 ml of suspect INFLUENZA TRIVALENT RECOMBINANT VACCINE, Solution for injection (lot TFAA2547 and expiry 30-Jun-2026) (strength standard) with no adverse event (poor quality product administered) (latency same day) via intramuscular route in the right deltoid for immunization. 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.
TD