Reporte zur Charge UJ54ABA

Symptomtext

A patient received a expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from consumer/non-healthcare professional via Medical Information (Reference number- 00710323) and transmitted to Sanofi on 04-Aug-2021. This case involves a one-year-old male patient who received an expired HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 28-Jul-2021, the patient received a 0.5 mL dose of expired suspect HIB (PRP/T) VACCINE (solution, lot UJ54ABA and expiry date: 18-Jul-2021) via an unknown route in an unknown administration site for prophylactic vaccination (expired product administered). It was reported that "Medical office manager reporting that an expired ACTHIB vaccine was given to a patient on 28Jul2021, she is inquiring if the dose is valid." This was a case of actual medication error due to Expired vaccine used (latency same day). At time of reporting, no adverse events were reported. 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 the 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.