Symptomtext
only the liquid portion of PENTACEL was administered to a patient and the Acthib portion (lyophilized) was not reconstituted or used with no reported adverse event; Initial information received on 29-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old female patient who was administered only the liquid portion of pentacel and the acthib portion (lyophilized) was not reconstituted or used with no reported adverse event while 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 PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL), both for Prophylactic vaccination. On 27-Sep-2022, the patient received 0.5 mL dose of dose 4 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (formulation and strength not reported; lot U7256AB and expiry: 13-May-2023) via intramuscular route in vastus lateralis for prophylactic vaccination. On 27-Sep-2022, (latency: same day) only the liquid portion of pentacel was administered to a patient and the acthib portion (lyophilized) was not reconstituted or used 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 was not applicable. 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.