Reporte zur Charge LUJ660AAA

Symptomtext

patient receiving only the liquid portion of PENTACEL, did not receive the lyophilized powder portion with no reported adverse event; Initial information received on 04-Aug-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a 6 months old male patient who received only the liquid portion of pentacel, did not receive the lyophilized powder portion with no reported adverse event, after receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Prophylactic vaccination. On 04-Jun-2022, the patient received a dose number 1 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE ( lot LUJ660AAA and expiration date: 25-Feb-2023) at a dose of 0.5ml once via unknown route in unknown administration site for immunization. On 04-Jun-2022 (latency: same day),the patient received only the liquid portion of pentacel, did not receive the lyophilized powder portion with no reported adverse event (Single component of a two-component product administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE. Action taken :not applicable. It was not reported if the patient received a corrective treatment for the event. 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.