Reporte zur Charge UJ28AA

Symptomtext

The patient was vaccinated with expired vaccine ACT-HIB/No AE; Initial information regarding an unsolicited valid non-serious case received from an other health professional via Information (Reference number: 00467939) and transmitted to Sanofi on 09-Feb-2021. This case involves a 16 month old patient who patient who received an 0.5 mL expired dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] [lot UJ28AA and expiry date: 07-Feb-2021] via an unknown route in the right thigh for prophylactic vaccination on 08-Feb-2021 [Expired product administered]. Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for prophylactic vaccination.; HEPATITIS A VACCINE (HEPATITIS A VACCINE) for prophylactic vaccination.; and INFLUENZA VACCINE (INFLUENZA VACCINE) for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used [Latency: on the same day]. Product used : Used. Still using product : No. At the time of report, 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.