Symptomtext
just administered the diluent portion of the ACTHIB without reconstituting it with the lyophilized vaccine component with no reported adverse event; Initial information received on 27-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 16 months old female patient who was just administered the diluent portion of the HIB (PRP/T) Vaccine [ACT-HIB] without reconstituting it with the lyophilized vaccine component with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Jan-2023, the patient received a 0.6 ml dose of suspect diluent portion of the HIB (PRP/T) Vaccine without reconstituting it with the lyophilized vaccine component with no reported adverse event (product preparation issue) (Powder and solvent for solution for injection) (lot UJ677AAB, Expiry date: 07-Apr-2023 with strength unknown) via intramuscular route in the left thigh for immunization. Action taken: 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.