Reporte zur Charge UU357AAB

Symptomtext

gave expired dose of ACT-HIB to a patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician via Medical Information (Reference number- 00708771) and transmitted to Sanofi on 03-Aug-2021. This case involved 3-month-old male patient gave expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered) Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for prophylactic vaccination. On 30-Jul-2021, the patient received first dose of suspect HIB (PRP/T) VACCINE (lot: UU357AAB and expiry date: 26-Jul-2021) (Frequency = once) (Strength = standard) (Form: solution for injection) via intramuscular route in the left thigh for prophylactic vaccination (expired product administered) It was reported that, "doctor is calling to see what they need to do and reported the event". This was an actual medication error due to expired vaccine used (latency: same day) At the time of reporting, 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 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.