Symptomtext
patient was administered the liquid component (DTAP-IPV) of vaccine without being reconstituted with the powder component (lyophilized ACTHIB vaccine), with no reported adverse event; patient was administered the liquid component (DTAP-IPV) of vaccine without being reconstituted with the powder component (lyophilized ACTHIB vaccine), with no reported adverse event; Initial information received on 16-Sep-2022 regarding an unsolicited valid non-serious case received from a physician. This case involves a 6 months old female patient who was administered the liquid component (dtap-ipv) of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] without being reconstituted with the powder component (lyophilized acthib vaccine), 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 7V (CRM197) (Prevnar); rotavirus vaccine live reassort oral 5V (Rotateq) and influenza vaccine (INFLUENZA VACCINE) all for Immunisation. On 13-Sep-2022, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine at a dose of 0.5 ml total (lot UJ641AAA, expiry date: 28-Feb-2023) via intramuscular route in the thigh nos for immunisation. On 13-Sep-2022 the patient was administered the liquid component (dtap-ipv) of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine without being reconstituted with the powder component (lyophilized acthib vaccine), with no reported adverse event (product preparation error, single component of a two-component product administered, latency: same day for both). Reporter also wanted to know where to find the 0.4% NaCL diluent to mix with the ACTHIB portion. Action taken: Not applicable. Outcome: Unknown for both 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.