Reporte zur Charge UJ329AB

Symptomtext

expired ACT-HIB was accidentally given to a 1-year-old female patient/ no AE; Initial information was received on 30-Jun-2021 regarding an unsolicited valid non-serious case received from a Other health care professional via Agency (Reference number- 00663874) and transmitted to Sanofi on 30-Jun-2021. This case involves a one-year-old female who was mistakenly vaccinated with expired dose of 0.5 mL of (total) HIB (PRP/T) VACCINE [ACT-HIB] (lot number UJ329AB and expiry date 06-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination on 30-Jun-2021 (expired vaccine used).] Diluent batch number U6789AA and expiry date 21-Oct-2021. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination, PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) 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 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.