Reporte zur Charge UG856AC

Symptomtext

accidently mixing together a standalone ACTHIB and PENTACEL and administering part of the doses to a patient with no reported adverse event; Initial information received on 18-Aug-2023 regarding an unsolicited valid non-serious case received from a physician. This case involves a 2 months old male patient who experienced accidently mixing together a standalone HIB (PRP/T) vaccine [ACT-HIB] and Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] and administering part of the doses with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Aug-2023, the patient received a dose 0.5 ml of suspects of standard strength Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine suspension for injection (lot: UJ859AA) with saline diluent of HIB (PRP/T) vaccine [ACT-HIB] Powder and solvent for solution for injection (lot: UG856AC) and combined with diluent (Expiry date: unknown) via intramuscular route in unknown administration site for Immunization with no reported adverse event (product preparation error) (latency: same day). It was reported that " HCP states that today was the first day of vaccine administration. She gave the PENTACEL to a patient but states that it was reconstituted with the HIB's saline diluent and then she combined it with the diluent. But she mentioned that the patient was only suppose to be given 0.5, and she administered more than that and most of it was saline. What should she do? UJ859AA Expiration date is unknown. A Physician reporting a medication error described as accidently mixing together a standalone ACTHIB and PENTACEL and administering part of the doses to a patient. The Physician realized the error when injecting such a larger volume of fluid; that the dose was stopped part way through administration; that this is the first time the Physician has administered vaccines; that in the past the supportive staff were the ones performing the administration; that this is their new clinic and the role falls on the Physician; that the error was due to the misinterpretation of the ten vials she saw in the PENTACEL box, thinking they were just the liquid portion and not reading they were 5-dose vials with both the liquid and the powder portion. Information is limited and unknown due to the caller was not in the office with all of the information". Action taken: not applicable. At time of reporting, the outcome was Unknown. 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.