Reporte zur Charge U7013AB

Symptomtext

lyophilized component of pentacel being reconstituted with sterile water, rather than with the liquid component of the pentacelvaccine with no reported adverse event; Initial information received on 22-Aug-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, while giving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lyophilized component being reconstituted with sterile water, rather than with the liquid component of the pentacelvaccine 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 WATER FOR INJECTION (STERILE WATER); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and HEPATITIS B VACCINE (VACCINE, HEPATITIS B) for Immunisation. On 17-Aug-2022, the patient received 0.5ml, dose: 3 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (formulation, strength: unknown) lot U7013AB, (expiry date:15-Oct-2022) via intramuscular route in the left vastus lateralis (left thigh) for iimmunisation. On 17-Aug-2022 (latency: same day), the patient had a non-serious event "lyophilized component of pentacel being reconstituted with sterile water, rather than with the liquid component of the pentacelvaccine with no reported adverse event" (product preparation error). Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. 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.