Reporte zur Charge UJ327AAC

Symptomtext

expired dose of ACTHIB was given to a patient with no adverse event; Initial information received on 05-Aug-2021 regarding an unsolicited valid non-serious case from a other health professional via Medical Information (Reference number- 00712752). This case involves a one years old female patient who was vaccinated with the expired dose of suspect vaccine HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). The patient's medical history, past medical treatment, vaccination and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) [PREVNAR] for immunisation. On 05-Aug-2021, the patient received a 0.5ml fourth dose of suspect HIB (PRP/T) VACCINE (lot UJ327AAC and expiry date: 28-Jun-2021) (oral solution) via intramuscular route in the right deltoid for prophylactic vaccination. It was an actual medication error case due to expired vaccine used (latency: same day). The reporter "asking if patient will need to be revaccinated." At time of reporting, no adverse event was reported. 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.