Reporte zur Charge UJ112AA

Symptomtext

A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00489116) and transmitted to Sanofi on 23-Feb-2021. This case involves one-year-old male patient who received an expired 0.5 mL first dose HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ112AA and expiry date: 21-Jun-2020) via an intramuscular route in the left thigh for prophylactic vaccination on Monday, 22 Feb (year not reported) given by one of the Medical Assistants (Expired product administered). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX). This was a case of actual medication error due to expired vaccine used (latency same day). At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.