Reporte zur Charge UJ637AAA

Symptomtext

extra dose of ACTHIB was administered to a patient on the same date with no reported adverse event; Initial information received on 14-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old female patient who was administered extra dose of acthib on the same date with no reported adverse event while 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. On 13-Oct-2022, the patient received a once booster dose of suspect HIB (PRP/T) VACCINE (lot UJ637AAA and expiration date: 30-Nov-2022) at a dose of 0.5ml (twice)via intramuscular route in the left thigh for prophylactic vaccination. On 13-Oct-2022 (latency: same day), the patient was administered extra dose of acthib on the same date with no reported adverse event (extra dose administered) Action taken :not applicable. It was not reported if the patient received a corrective treatment for the event. Outcomes: 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.t