Symptomtext
pentacel instead of acthib was administered in error with no reported adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 months old and unknown gender patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] instead of HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (yeast), pertussis vaccine acellular 3-component, polio vaccine Inact 3v (VERO), tetanus vaccine toxoid (Pediarix) and Rotavirus Vaccine for Prophylactic vaccination, chlorphenamine maleate, naphazoline hydrochloride (Flucur). On 14-Jun-2023, the patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection lot UJ805AA expiry date: 17-feb-2024 via intramuscular route in the right thigh for prophylactic vaccination (immunization) instead of HIB (PRP/T) VACCINE in error with no reported adverse event (wrong product administered) on the same day. Action taken was not applicable. At time of reporting, the outcome was Unknown for the event pentacel instead of acthib was administered in error with no reported adverse 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 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.