Symptomtext
the powdered Hib portion of pentacel was administered, reconstituted with the wrong diluent with no reported adverse event; the powdered Hib portion of pentacel was administered, reconstituted with the wrong diluent with no reported adverse event; Initial information was received on 01-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient to whom the powdered Hib portion of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [PENTACEL (VERO)] was administered, reconstituted with the wrong diluent 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 rotavirus vaccine live reassort oral 5V (Rotateq) and pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination. On 30-Aug-2023, the patient received a 0.5 ml, total (once) (dose 2) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot UJ865AA, expiry date: 31-Mar-2024, strength: standard) via intramuscular route in the left thigh for Immunisation and the powdered hib portion of pentacle was administered, reconstituted with the wrong diluent with no reported adverse event (product preparation error) (single component of a two-component product administered) (Latency: same day). Reportedly, HCP asks if they can still use the liquid DTaP-IPV portion of the PENTACEL vaccine that was not initially used and then use a standalone ACT-HIB for the Hib component. Also, it was reconstituted with lidocaine HCl, sodium chloride 7mg. Action taken: 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 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.