Reporte zur Charge UJ120AAB

Symptomtext

patient received an expired dose of ACT-HIB, no AE; Initial information regarding an unsolicited valid non-serious case was received from the other healthcare professional via Medical Information (Reference number- 00585968) and transmitted to Sanofi on 03-May-2021. This case involves a 15 month old female patient who was administered a 0.5 ml expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot number:UJ120AAB; expiry date: 22-Jan-2021; Strength: standard) via intramuscular route in left thigh site for prophylactic vaccination on 06-Apr-2021(expired product administered). Medical history, medical treatment(s), past vaccination(s) and family history were not provided. The patient's concomitant vaccinations included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) in left thigh for prophylactic vaccination. It was a case of an actual medication error due to expired vaccine used (latency same day). The reporter wanted to know what to do. 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.