Reporte zur Charge UJ645AAA

Symptomtext

received an extra dose of ACTHIB with PENTACEL with no reported adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid non-serious case via health professional. GMI number: 01228386 This case involves a 2-month-old male patient received an extra dose of HIB (PRP/T) VACCINE [ACT-HIB] with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunization; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunization. On 02-Aug-2022, the patient received 1st dose of suspect ACT-HIB vaccine at dose 0.5 ml once (lot UJ645AAA) via unknown route in the right thigh and received 1st dose of suspect Pentacel Vaccine at dose 0.5ml once (lot UJ673AAA) via unknown route in the left thigh both for prophylactic vaccination with no reported adverse event (extra dose administered) latency same day. It was reported that "health care professional (HCP) called to report that a patient received an extra dose of ACTHIB. Caller states that a 2-month-old patient received PENTACEL and ACHIB at the same visit. Caller would like to know what the new dosing schedule for the patient would be. Caller reported that the patient has not shown any signs of an adverse event from the two doses of Hib received." Action taken: Not applicable. At time of reporting, the 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 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.