Reporte zur Charge UJ524AAB

Symptomtext

medical assistant attempted to administer ActHib to patient, MA was able to administer only half of the dose, and other half shot out of the needle when the patient jerked away, so the patient got only about 0.25 mL with no reported adverse event; Initial information was received on 13-Apr-2021 regarding an unsolicited valid non-serious case received from other health professional (Inquiry number: 00559199). It was reported that a medical assistant was able to administer only half of the dose, and other half shot out of the needle when the patient jerked away, so the patient got only about 0.25 ml of HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ524AAB, expiry date not reported) (Suspension For Injection) via an intramuscular route for prophylactic vaccination (underdose). It was a case of actual medication error due to vaccine underdose. At the time of report, no adverse event reported. 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 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.