Symptomtext
QUADRACEL and mixed it with the ActHib portion of the PENTACEL with no reported adverse event; Initial information was received on 21-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 14 months old female patient to whom was given diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [Quadracel] and mixed it with the hib (prp/t) vaccine [ACT-HIB] portion of the Pentacel 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 hepatitis b vaccine and pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Immunisation. On 12-Sep-2022, the patient received a (dose 1) of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine, suspension for injection (lot C5970AA; Expiry: 27-Apr-2023) via intramuscular route in unknown administration site and dose 2 of suspect hib (prp/t) vaccine, powder and solvent for solution for injection (lot UJ672AA; Expiry: 27-Apr-2023) via intramuscular route in unknown administration site both for immunization. It was reported that Quadracel and mixed it with the Acthib portion of the Pentacel with no reported adverse event (product preparation error) (Latency: on same day). 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.