Symptomtext
administered Acthib, diluted incorrectly with a room temperature sterile water diluent with no reported adverse event; administered Acthib, diluted incorrectly with a room temperature sterile water diluent with no reported adverse event; Initial information received on 25-Aug-2022 regarding an unsolicited valid non-serious case received from health professional. 01250757 This case involves a 2-year-old female patient who was administered HIB (PRP/T) VACCINE [ACT-HIB] diluted incorrectly with a room temperature sterile water diluent 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 Pneumococcal Vaccine for Immunization; Hepatitis A Vaccine for Immunization; and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Daptacel) for Immunization. On 24-Aug-2022, the patient administered Suspect ACT-HIB vaccine with diluent sterile water at room temperature at dose 0.5ml once (lot: UJ647AAA, expiry date: 02-MAR-2023) via (unknown: formulation, strength, route) in the left thigh for prophylactic vaccination with no reported adverse event (product preparation error, Poor quality product administered) at same day latency. It was reported that "A staff member gave HIB vaccine that was diluted incorrectly to two sibling patients. The first patient received Act-HIB diluted with sterile water. The dose was diluted incorrectly with a room temperature sterile water diluent that is meant for live virus vaccines. Normally, the facility attaches vaccines to their diluents by a band when the vaccines are received, to prevent this type of error". Action taken: Not applicable for both suspects. 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 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.
