Reporte zur Charge UJ225AAA

Symptomtext

An expired dose of Pentacel was given to a consumer, no AE; Initial information was received on 28-Apr-2021 regarding an unsolicited valid non-serious case from a Nurse. This case involves a patient (demographics unknown) who was administered dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ225AAA, expiry date: 23-Apr-2021) via unknown route in unknown administration site on an unknown date for prophylactic vaccination (Expired product administered). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It was a case of an actual medication error due to Expired vaccine used (latency same day). The nurse called for recommendation after an expired dose of Pentacel was given to a consumer. 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.