Reporte zur Charge UJ680AA

Symptomtext

administered pentacel to a 7 month old patient of only the liquid dtap/ipv portion and not the acthib component of pentacel with no reported adverse event; DTAP-IPV and ACTHIB components given as 2 separate injections with no reported adverse event.; Initial information received on 14-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7 months old female patient to whom administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] of only the liquid dtap/ipv portion and not the haemophilus type B (HIB) vaccine (HIB (PRP/T) vaccine) [ACT-HIB] component of pentacel with no reported adverse event and dtap-ipv and acthib components given as 2 separate injections 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 13V (CRM197) (Prevnar 13) for Prophylactic vaccination. On 01-Mar-2023, the patient received a dose 3 at 0.5 mL dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection, (strength and lot number: not reported) (expiry date: 09-Sep-2023) via intramuscular route in right leg and unknown dose of suspect HIB (PRP/T) vaccine , powder and solvent for solution for injection, (lot number: UJ680AA) (strength and expiry date: not reported) via unknown route in unknown administration site for immunization. On 01-Mar-2023, to the patient administered pentacel to a 7 month old patient of only the liquid dtap/ipv portion and not the acthib component of pentacel with no reported adverse event (single component of a two-component product administered) and dtap-ipv and acthib components given as 2 separate injections with no reported adverse event (wrong technique in product usage process) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine and HIB (PRP/T) vaccine. No lab data was reported. Action taken was not applicable. At time of reporting, the outcome was Unknown for the events. 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.