Reporte zur Charge UJ528AA

Symptomtext

Pentacel that only the diluent was used for the DTAP portion of the vaccine wih no AE; Patient administered 0.25 ml dose of Pentacel with no AE; Initial information received on 21-Sep-2021 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 6-month-old and unknown gender patient for whom it was reported "pentacel that only the diluent was used for the dtap portion of the vaccine" [product preparation issue] and patient administered 0.25 ml dose of pentacel while receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [incorrect dose administered]. The patient medical history, medical treatment(s), vaccination(s), concomitant medication, and family history were not provided. On an unknown date, the patient received a 0.25 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot UJ528AA and expiry date: not reported] via an intramuscular route in the right thigh for prophylactic vaccination. It was reported patient visit on 03-Sep-2021. No other vaccines were reported. It was a case of actual medication error due to incorrect dose administered and product preparation issue [Latency: on the same day]. It was not reported if the patient received any corrective treatment for the events. At time of reporting, the outcome was unknown for the events. 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.