Reporte zur Charge UJ513AD

Symptomtext

received a dose of expired ACTHIB with no reported adverse event; Initial information received on 22-Jun-2022 regarding an unsolicited valid non-serious case received from a physician. This case involves a 1 years old male patient who received a dose of expired acthib with no reported adverse event while receiving vaccine HIB (PRP/T) vaccine [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) and pneumococcal vaccine CONJ 13V (CRM197) (PREVNAR 13) for immunisation. On 22-Jun-2022, the patient received suspect HIB (PRP/T) vaccine at a dose of 0.5 ml (lot UJ513AD, expiry date, form) via unknown route in the left thigh for immunisation. On 22-Jun-2022 the patient developed a non-serious received a dose of expired acthib with no reported adverse event (expired product administered) following the administration of HIB (PRP/T) vaccine. Reporter wanted to know if the patient need to be revaccinated. Action taken: not applicable. Outcome: 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 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.