Reporte zur Charge UJ8566AA

Symptomtext

used the HIB component of ACT-HIB with the diluent of PENTACEL and administered it to a patient with no reported adverse event; Initial information received on 08-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves 4 months old female patient for whom HIB component of HIB (PRP/T) vaccine [ACT-HIB] was used with the diluent of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] and administered it to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient was administered a standard dose 2 (0.5 ml) of HIB component of HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UJ8566AA, expiry date- 26-MAR-2024) with the diluent of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UJ851AA, expiry date- 04-JAN-2024) via intramuscular route in unknown administration site for Immunization with no reported adverse event (product preparation error) (latency- same day). Reportedly, Patient care supervisor called to ask if the HIB components of ACT-HIB and PENTACEL were the same because a medical assistant used the HIB component of ACT-HIB with the diluent of PENTACEL and administered it to a patient. Action taken was not applicable. At time of reporting, the outcome was Unknown for the 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 guidelines. 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.