Reporte zur Charge UJ6353AA

Symptomtext

ACTHIB administered with sterile water instead of provided diluent, with no reported adverse event; Initial information received on 19-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old female patient who administered acthib with sterile water instead of provided diluent, with no reported adverse event after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Prophylactic vaccination. On 18-Aug-2022, the patient received a dose number 4 of suspect HIB (PRP/T) VACCINE (lot UJ6353AA and expiration date:27-Jan-2023) at a dose of 0.5ml via intramuscular route in the right thigh for immunization. On 18-Aug-2022 (latency: same day) ,the patient developed a non-serious event of act hib administered with sterile water instead of provided diluent, with no reported adverse event (product preparation error) . Action taken:not applicable. It was not reported if the patient received a corrective treatment for the event. Outcome: 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 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.