Reporte zur Charge UJ162ABA

Symptomtext

an expired Pentacel dose was given to a patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious was received from a Physician via Medical Information (Reference number- 00616586) and transmitted to Sanofi on 26-May-2021. This case involves a 7 months old male patient who received a 0.5 mL expired dose (second dose) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot UJ162ABA and expiry date: 24-Apr-2021) via intramuscular route in the right thigh (expired product administered) for prophylactic vaccination on 26-May-2021. The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided. The reporter wanted to know wanted to know if it should be counted as a valid dose or if patient needs revaccination. 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.