Symptomtext
PENTACEL was not reconstituted and the lyophilized vial without the lid was stored at the appropriate temperature range with no ae; Initial information received on 26-Jan-2022 regarding an unsolicited valid non-serious case was received from an other health professional. This case involves an intercepted product storage error which involved diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (Pentacel) which was not reconstituted and the lyophilized vial without the lid was stored at the appropriate temperature range with no adverse event (ae). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient was supposed to receive a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (lot UJ523AAA and U6986AA, expiry date: 22-Jul-2022; ) via unknown route in unknown administration site to be given as prophylactic vaccination. It was reported that on 21-Jan-2022 the diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine was not reconstituted and the lyophilized vial without the lid was stored at the appropriate temperature range with no adverse event (intercepted product storage error). The reporter enquired if she could still reconstitute and administer the vaccine and if she should wipe off the top of the vial. Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable. It was not reported if the patient received a corrective treatment for the event (PENTACEL was not reconstituted and the lyophilized vial without the lid was stored at the appropriate temperature range with no ae). At time of reporting, the outcome was Unknown for the event pentacel was not reconstituted and the lyophilized vial without the lid was stored at the appropriate temperature range with no ae. 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.