Reporte zur Charge UU668AAA

Symptomtext

patient the liquid portion only of PENTACEL and did not give the lyophilized portion containing the Acthib with no reported adverse event; patient the liquid portion only of PENTACEL and did not give the lyophilized portion containing the Acthib with no reported adverse event; Initial information received on 14-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old female patient to whom the liquid portion only of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] and did not give the lyophilized portion containing the acthib 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 Prophylactic vaccination; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination. On 29-Aug-2022, the patient received 0.5ml (Dose 3) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (strength, formulation was unknown, lot UU668AAA and expiry date: 13-May-2023) via intramuscular route in vastus lateralis for Immunization. Patient was not using it for the first time. On 29-AUG-2022 the patient developed a non-serious event of patient the liquid portion only of pentacel and did not give the lyophilized portion containing the acthib with no reported adverse event (single component of a two-component product administered and product preparation error) (unknown latency). The reporter was inquiring how to proceed with this patient. This situation was reported as a medication error due to incorrectly not mixing both of the portions with this vaccine as directed. 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.