Reporte zur Charge UJ135ABA

Symptomtext

expired vaccine was administered to a patient with no adverse event; Initial information was received on 17-Dec-2020 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 45 year old male patient who was administered with expired Haemophilus type B (HIB) vaccine (ACT-HIB). (Expired product administered). Caller said the diluent and powder had different expiration dates and she didn't realize that the diluent expired on 26-Nov-2020. The powder was what she checked and it would expire on 26-Feb-2021 so she by mistake used the diluent to mix the powder and gave this patient a dose. Caller was asking how to proceed if they gave an expired ActHIB yesterday. At the time of the event, the patient had ongoing lung cancer. Had spleen removed in a month (Splenectomy) Concomitant medications included Meningococcal Vaccine a/c/y/w conj (dip tox) (Menactra); Men b and Pneumococcal Vaccine conj 7v (crm197) (Prevnar). On 16-Dec-2020, the patient received a once dose of suspect HAEMOPHILUS TYPE B (HIB) VACCINE (single dose vials) at a dose of 0.5 ml via intramuscular route at the right deltoid (lot UJ135ABA and expiry date 26-Nov-2020) (Powder lot UJ135AB expiry was 26-Feb-2021, Liquid part lot U6477AA expiry was 26-Nov-2020) for prophylactic vaccination. It was also a case of actual medication due to expired vaccine used (Latency: same day) At the time of reporting, patient had no adverse 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 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