Reporte zur Charge UJ353AAA

Symptomtext

medical assistant gave an expired vaccine to a patient, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from other health care professional and a physician via Medical Information (MI) (Reference number- 00691414) and transmitted to Sanofi on 21-Jul-2021. This case involves a 01-year-old male patient for whom it was reported that medical assistant gave an expired vaccine to the patient (expired product administered) for HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ353AAA and expiration date: 16-Jul-2021) via intramuscular route for prophylactic vaccination on 20-Jul-2021. Medical history, past medical treatments, past vaccinations 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) and HEPATITIS A VACCINE INACT (HAVRIX). It was an actual medication error case due to expired vaccine used (latency: same day). At the time of reporting, the patient experienced 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 t in the Directive requirements set ou2001/83/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.