Reporte zur Charge UJ217AC

Symptomtext

received just the HIB portion powder vial and was reconstituted with sterile water, did not receive the DTAP IPV portion/no AE; Initial information was received on 14-Apr-2021 regarding an unsolicited valid non-serious case from a other health professional. This case involves a 15-month-old male patient who received just the HIB portion powder vial and was reconstituted with sterile water, did not receive the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5) portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product preparation issue). Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Immunisation. On 09-Apr-2021, the patient received a dose of 0. 5 ml suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ217AC, expiry date not reported) via an intramuscular route in the left thigh for prophylactic vaccination (product preparation issue). It was a case of actual medication error due to Inappropriate reconstitution technique (latency same day). This suspected adverse reaction report is submitted and classified as a medication error solely and 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 exclusively to ensure the 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.