Reporte zur Charge U6789AA

Symptomtext

Expired ACTHIB was administered to patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00647532) and transmitted to Sanofi on 18-Jun-2021. This case involves a 15 months old male patient who received 0.5 mL expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot U6789AA and expiry date: 06-Jun-2021) via intramuscular route in right thigh (expired product administered) for prophylactic vaccination on 18-Jun-2021. The patient's medical history, past medical treatments, past vaccinations and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for immunization. The reporter asked does there need to be re-administered. The reporter also stated the Acthib, Diluent and Carton all had different expiration dates and asked why they are all different. It was an actual medication error case due to expired vaccine used (latency: same day). At the time of reporting, the patient experienced no adverse event. 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.