Reporte zur Charge UJ598AAA ,U7091

Symptomtext

expired dose of PENTACEL was administered with no reported adverse event; Initial information was received on 13-Dec-2022 regarding an unsolicited valid non-serious case received via call center from a health professional. This case involves 7 months old female patient who experienced expired dose of pentacel was administered with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included hepatitis b vaccine (HEPATITIS B) for Immunisation. On 13-Dec-2022, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine at a dose of 0.5 ml (lot: UJ598AAA ,U7091AA, Expiry date: 05-Dec-2022) via intramuscular route in the left thigh for prophylactic vaccination. On 13-Dec-2022 the patient developed a non-serious event of expired dose of pentacel was administered with no reported adverse event (expired product administered) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine. Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, ipv and HIB VACCINE (Pentacel) was not applicable. At time of reporting, the outcome was Unknown for the 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 guidelines. 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.