Reporte zur Charge LUJ401AA

Symptomtext

Patient recieved expired vaccine with no reported adverse event; Initial information was received on 23-Sep-2021 regarding an unsolicited valid non-serious case received from a other healthcare professional and non-healthcare professional via MI (Medical Information- 00782588). This case involves a 1-years old female patient who was vaccinated with an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (Expired product administered). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination. On 22-Sep-2021, the patient received a 0.5ml fourth {total} dose of suspect HIB (PRP/T) VACCINE (lot number LUJ401AA and expiry date 23-Aug-2021) via intramuscular route in the left thigh for prophylactic vaccination. It was reported "they would like to know if they need to revaccinate or can that vaccine count towards the series of shots for the patient?" It was a case of an actual medication error due to expired vaccine used (latency was on same day). At the time of report, no adverse event reported. Event outcome was unknown. 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.