Reporte zur Charge UJ182AA

Symptomtext

Patient received expired ActHIB vaccine with no adverse event; Initial information regarding an unsolicited valid non-serious was received from a Physician (Reference number- 00527706) and transmitted to Sanofi on 19-Mar-2021. This case involves a 16 months old female patient who received a fourth 0.5 mL expired dose HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ182AA and expiration date: 08-Mar-2021) via intramuscular route in the right thigh (right leg) (expired product administered) for prophylactic vaccination on 19-Mar-2021. Medical history, past medical treatments, past vaccinations and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation. It was actual medication error due to expired vaccine used (on same day). It was reported that after administration it was later discovered that the vaccine was expired by 11 days. The reporter would like to know if the patient must be revaccinated. At the time of report, the patients 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 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.