Reporte zur Charge UJ356AAB

Symptomtext

Patient was administered an expired vaccine/ no AE; Initial information was received on 26-Jul-2021 regarding an unsolicited valid non-serious case received from an Other healthcare professional via Agency (Reference number- 00697308) and transmitted to Sanofi on 26-Jul-2021. This case involves a two-year-old female patient reported that the patient was administered an expired HIB (PRP/T) VACCINE [ACT-HIB] vaccine with no adverse event (expired product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE INACT (VAQTA) for prophylactic vaccination and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for prophylactic vaccination. On 26-Jul-2021, the patient received 0.5 mL (once) fourth dose of suspect HIB (PRP/T) VACCINE [lot UJ356AAB and expiry date 25-Jul-2021] via intramuscular route in right thigh for prophylactic vaccination. It was reported that, "Clinical Supervisor called to report that ACTHIB was administered to a patient on 26JUL2021, but it expired on 25JUL2021. Caller would like to know if this dose is considered valid and whether the dose should be repeated? Product used: Used". It was a case of actual medication error due to expired vaccine used (latency was on 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.