Symptomtext
Pentacel was not reconstituted properly with no reported adverse event; Lyophilized portion was not given with no reported adverse event; Initial information received on 07-Jan-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old male patient who experienced pentacel was not reconstituted properly with no reported adverse event and lyophilized portion was not given with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Jan-2022, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ580AA via intramuscular route in unknown administration site. First time product used : No On 07-JAN-2022 the patient developed a non-serious pentacel was not reconstituted properly with no reported adverse event (product preparation issue) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. On 07-JAN-2022 the patient developed a non-serious lyophilized portion was not given with no reported adverse event (incorrect dose administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. It was reported "from reporting manager office that PENTACEL was not reconstituted properly, and the lyophilized portion was not given. It was questioned that what should be done now. This was an potential AE because of medication error. The patient has been Still using product". 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 events (Pentacel was not reconstituted properly with no reported adverse event, Lyophilized portion was not given with no reported adverse event). At time of reporting, the outcome was Unknown for the event pentacel was not reconstituted properly with no reported adverse event and was Unknown for the event lyophilized portion was not given with no reported adverse event. 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.