Reporte zur Charge UJ579AAA

Symptomtext

administered ACT-HIB to a patient using an alternate diluent with no reported adverse event.; Initial information received on 06-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center. This case involves a 1 years old male patient who was administered act-hib using an alternate diluent 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) and family history were not provided. Concomitant medications included pneumococcal vaccine conj 13v (CRM197) (Prevnar 13) for Prophylactic vaccination; hepatitis a vaccine (Hepatitis a) for Prophylactic vaccination; and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for Prophylactic vaccination. On 10-Mar-2022, the patient received a 0.5 ml dose of suspect hib (prp/t) vaccine lot UJ579AAA frequency: once (dose, route, strength: unknown) in unknown administration site for Prophylactic vaccination. On 10-MAR-2022 the patient developed a non-serious event administered act-hib to a patient using an alternate diluent with no reported adverse event. (Wrong diluent used) following the administration of hib (prp/t) vaccine. Action taken: not applicable. It was not reported if the patient received a corrective treatment for the event (Wrong diluent used). At time of reporting, the outcome was Unknown for the event Wrong diluent used. 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.