Symptomtext
Medical assistant called stating that diluent or liquid portion of PENTACEL is missing so lyophilized portion was diluted with a normal saline diluent with no reported adverse event; Initial information received on 11-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 years old female patient to whom administered the diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/Hib(PRP/T) Vaccine [Pentacel (Vero)] and reporter stating that diluent or liquid portion of pentacel is missing so lyophilized portion was diluted with a normal saline diluent with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a unknown dose of suspect diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/Hib(PRP/T) Vaccine Suspension for injection (strength: not reported, Expiry date: 09-Oct-2023, lot UJ790AA) via unknown route in unknown administration site as Immunization and medical assistant called stating that diluent or liquid portion of pentacel is missing so lyophilized portion was diluted with a normal saline diluent with no reported adverse event (product preparation error) (latency: same day). 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.