Reporte zur Charge UJ259AAA

Symptomtext

An expired dose of Pentacel was given to a patient, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Global Medical Information (GMI) (Reference number- 00611112) and transmitted to Sanofi on 21-May-2021. This case involves a 6 months old male patient who was administered 0.5 ml second dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ259AAA, expiry date: 14-May-2021, powder vial- Lot: UJ259AA and liquid vial-lot: UJ331AA, expiry date: 14-May-2021) once via intramuscular route in the left vastus lateralis for prophylactic vaccination on 20-May-2021 (Expired product administered). Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE 13V, HEPATITIS B VACCINE and ROTAVIRUS VACCINE for prophylactic vaccination. It was a case of an actual medication error due to Expired vaccine used (latency same day) The reporter stated that yesterday (20-May-2021) an expired Pentacel was given to a patient and wanted to know what needs to be done now. The reporter asked whether another dose can be given to the patient. The Pentacel had expired 1 week ago. It was reported that they will call the patient's parents 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.