Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | TFAA2536 | OT / RA |
administration of FLUBLOK to a patient after the excursion took place with no reported AE; Initial information received on 19-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 62-year-old male patient who was administered with Influenza Trivalent Recombinant Vaccine [Flublok TIV] to a patient after the excursion with no reported ae (adverse event) The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other immunizations. On 19-Sep-2025, the patient received a dose of 0.5ml suspect Influenza Trivalent Recombinant Vaccine Solution for injection (lot TFAA2536 and expiry date-30-Jun-2026) standard-strength, frequency-once via intramuscular route in the right deltoid for Immunization after the excursion took place with no reported ae (poor quality product administered) (latency- same day). Reportedly- Human error was involved; extended stability data does not cover the excursion; There was no previous excursion. Power failure Max/low temperature reached: 29 F (negative 1.667 C) Duration: 30 minutes. 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.