Reporte zur Charge UJ190AAA

Symptomtext

expired dose of PENTACEL was inadvertently administered/no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional. This case involves a patient with unknown demographics who inadvertently received expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ190AAA, expiry date- 22-Feb-2021 via unknown route in unknown administration site for prophylactic vaccination on 17-Mar-2021. Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It was a case of an actual medication error due to expired vaccine used (latency same day). Office manager reporting an expired dose of PENTACEL was inadvertently administered. Caller did not have any patient data available, requested caller to call back to provide. At the time of report there was 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.