Reporte zur Charge UJ837AAA

Symptomtext

received pentacel, daptacel and act-hib so the dtap and hib portion is doubled with no reported adverse event; Initial information received on 25-Aug-2023 regarding an unsolicited valid non-serious case received via other health professional. This case involves a 2-year-old female patient received pentacel, daptacel and HIB (PRP/T) vaccine [ACT-HIB] so the dtap and hib portion is doubled 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 diphtheria vaccine toxoid, HIB vaccine CONJ (TET TOX), pertussis vaccine acellular 5-component, polio vaccine INACT 3V (MRC 5), tetanus vaccine toxoid (Pentacel) for Prophylactic vaccination; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Prophylactic vaccination; and hepatitis A vaccine INACT (HEP A IN VAC) for Prophylactic vaccination. On 22-Aug-2023, the patient received a 0.5 ml dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength: unknown) (lot: UJ837AAA, expiry date: 30-Oct-2023) via intramuscular route in unknown administration site for Immunization and patient received pentacel, daptacel and act-hib so the dtap and hib portion is doubled with no reported adverse event (extra dose administered) (latency: same day). It was unknown if any lab data/test results available. Action taken with haemophilus type B (HIB) vaccine (ACT-HIB) was 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 Directive. 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.