Reporte zur Charge UJ183AA

Symptomtext

Patient received expired ACT-HIB vaccine/ NO AE; Initial information was received on 18-Aug-2021 regarding an unsolicited valid non-serious case from other health professional via call center via Medical Information (reference number- 00730100). This case involves a 1-years-old female patient who administered expired vaccine (expired product administered) HIB (PRP/T) VACCINE [ACT-HIB]. The patient's medical history, past medical treatment, vaccination and family history were not provided. On 19-Jul-2021, the patient received a 0.5 ml first dose of suspect HIB (PRP/T) vaccine (frequency: once, strength: standard, lot number: UJ183AA and expiry date: 12-Feb-2021) via an intramuscular route in the right thigh for prophylactic vaccination. It was of actual medication error due to expired vaccine used (latency: same day). It was reported as "patient received an expired ACTHIB vaccine; asking if patient will need to be revaccinated. Event Information -Treatment: patient did not receive treatment for this event ". At the time of reporting, 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 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.