Reporte zur Charge UJ264AA

Symptomtext

expired dose of ACTHIB was inadvertently administered/ no AE; Initial information was received on 20-Jul-2021 regarding an unsolicited valid non-serious case received from an Other healthcare professional via Regulatory authority (Reference number- 00689723) and transmitted to Sanofi on 20-Jul-2021. This case involves a four-year-old female patient who inadvertently administered expired HIB (PRP/T) VACCINE [ACT-HIB] vaccine (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 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (KINRIX) for prophylactic vaccination and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for prophylactic vaccination. On 19-Jul-2021, the patient received 0.5 ml (total) dose of suspect HIB (PRP/T) VACCINE [lot UJ264AA expiry date 04-Jun-2021] via intramuscular route in right thigh for prophylactic vaccination. It was reported that, "Caller with question on whether dose needs repeating". 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.