Reporte zur Charge UJ3581AA

Symptomtext

The patient was administered an expired ACTHIB with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via physician via Global Medical Information (Reference number- 00718353) and transmitted to Sanofi on 10-Aug-2020. This case involves a 1-year-old patient (unknown gender) who was administered an expired HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (Expired product administered). Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID;PERTUSSIS VACCINE ACELLULAR;POLIO VACCINE INACT;TETANUS VACCINE TOXOID for prophylactic vaccination. On 10-Aug-2021, the patient received a 0.5 ml fourth dose of suspect HIB (PRP/T) VACCINE (lot UJ3581AA, expiry date: 09-Aug-2021) via intramuscular route in left vastus lateralis for prophylactic vaccination. It was a case of an actual medication error due to Expired vaccine used (latency same day). It was reported "Caller reports that today she administered ACTHIB to a patient, ACTHIB expired yesterday, 09AUG2021. Caller asking if patient needs to have another dose of ACTHIB" 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 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.