Reporte zur Charge UJ8768A

Symptomtext

administered reconstituted pentacel along with another non-sanofi hib vaccine to a patient concurrently with no reported adverse event; Initial information received on 28-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4-year-old female patient for whom reconstituted Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] was administered along with another non-sanofi hib vaccine HIB vaccine CONJ (OMPC) [Pedvaxhib] concurrently with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-Aug-2023, the patient received a dose of 0.5 ml (Frequency: twice) dose 1 of suspect Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine of standard strength suspension for injection (lot: UJ8768A, Expiry date: 19-Mar-2024) via intramuscular route in left administration site for Immunization along with another non-sanofi hib vaccine PEDVAXHIB not produced by Sanofi Pasteur with unknown strength, batch number & expiry date to a patient concurrently with no reported adverse event (product preparation error) (latency: same day). Action taken: not applicable. At time of reporting, the outcome was 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.