Reporte zur Charge UJ29AAA

Symptomtext

patient received an expired Pentacel, no adverse event; Initial information was received on 26-May-2021 regarding an unsolicited valid non-serious case from a other health professional. This case involves a 4 month old female patient who received 0.5 ml first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot UJ29AAA, expiry date: 14-May-2021) via intramuscular route in left leg for prophylactic vaccination on 26-May-2021 Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination. It was a case of an actual medication error due to Expired product administered (latency same day) The reporter asked if the patient need to be revaccinated 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 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.