Reporte zur Charge UJ165AAA

Symptomtext

expired dose of Act-HIB given, stated that on the component or powder it say 29-May-2021 and the dilute stated 01-Mar-2021 with no reported adverse event; Initial information received on 04-Mar-2021 regarding an unsolicited valid non-serious case received from a physician and consumer/ non health care professional. This case involves a 3 year-old female patient who was vaccinated with expired dose of HIB (PRP/T) VACCINE [ACT-HIB], stated that on the component or powder would expired on 29-may-2021 and the dilute expired on 01-Mar-2021 (Expired Product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for prophylactic vaccination. On 03-Mar-2021, the patient received 0.5 mL (once) dose of suspect HIB (PRP/T) VACCINE (strength- standard) [lot UJ165AAA and expiry date 01-Mar-2021) via intramuscular/right vastuslaterallus route in unknown administration site for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (latency was on same day). At the time of report, 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.