Reporte zur Charge UJ147AAC

Symptomtext

ActHIB was administered to a patient 1 day after the expiration date/ NO AE; Initial information received on 18-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional via call-center. This case involves a 16-months-old male patient who administered a vaccine HIB (PRP/T) VACCINE [ACT-HIB] 1 day after the expiration date (batch number: UJ147AAC and expiry date: 17-Feb-2021 via an unknown route in right vastus lateralis) (expired product administered) on 18-Feb-2021 for prophylactic vaccination. The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and booster INFLUENZA VACCINE (FLU) for prophylactic vaccination. It was an actual medication error case due to expired vaccine used (latency: same day). The reporter would like to know if the patient must be revaccinated. vaccine was accidently used the expiration date on the diluent initially which was 22-Apr-2021. At the 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 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.