Reporte zur Charge UJ474888

Symptomtext

supposed to administer Pentacel- gave the DTAP and IPV but didn't reconstitute with the HIB powder/ was given only the diluent portion of the Pentacel vaccine with no reported adverse event; Initial information was received on 18-Nov-2021 regarding an unsolicited valid non-serious case from an other health professional via a consumer via phone call (under Medical Information (MI) Inquiry Number: 00864370). This case involves a 2 years old male patient who was supposed to administer DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] he was given the dtap and ipv but didn't reconstitute it with the hib powder and was given only the diluent portion of the pentacel vaccine with no reported adverse event (product preparation issue). The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided. On 02-Nov-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number: UJ474888 and expiry date: 18-Jul-2022) via intramuscular route in the left deltoid for prophylactic vaccination. It was reported "What are the next steps for handling?" It was case of an actual medication error due to inappropriate reconstitution technique (latency was on same day). 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 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.