Age: 1.75
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation issue
Clinical narrative: the two components of the vaccine, liquid DTaP-IPV component and the lyophilized Hib component, were not mixed together, but were administered as separate injections WITH NO REPORTED ADVERSE EVENT; Hib component is administered after reconstitution with sterile water instead of the supplied 0.4 percent saline diluent with no adverse event; Initial information received on 31-Mar-2022 regarding an unsolicited valid non-serious case was received from other health professional.  This case involves a 21 month old male patient for whom the two components of the diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel] vaccine, liquid dtap-ipv component and the lyophilized hib component, were not mixed together, but were administered as separate injections with no reported adverse event and hib component is administered after reconstitution with sterile water instead of the supplied 0.4 percent saline diluent with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included water for injection (Sterile water); hepatitis a vaccine for immunization; and hepatitis b vaccine for Immunization.  On 31-Mar-2022, the patient received third dose of 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine, once (lot Number: U7130AA (DTaP-IPV), Expiration Date :07-Dec-2022; Lot Number: UJ622AA (Hib), Expiration Date :07-Dec-2022; Lot Number: UJ622AAA (carton), Expiration Date :07-Dec-2022) via intramuscular route in unknown administration site for immunization.  It was reported that on 31-MAR-2022, latency: same day, the two components of the vaccine, liquid dtap-ipv component and the lyophilized hib component, were not mixed together, but were administered intramuscularly as separate injections with no reported adverse event (wrong technique in product usage process). The lyophilized Hib component was reconstituted with sterile water for injection. The Hib component was administered after reconstitution with sterile water instead of the supplied 0.4 percent saline diluent with no adverse event (product preparation issue). This was the patient's third dose in the series, on a catch-up schedule.   Action taken with diphtheria, tetanus, ac pertussis, ipv and hib vaccine (Pentacel) was not applicable.  It was not reported if the patient received a corrective treatment for the events (the two components of the vaccine, liquid DTaP-IPV component and the lyophilized Hib component, were not mixed together, but were administered as separate injections WITH NO REPORTED ADVERSE EVENT, Hib component is administered after reconstitution with sterile water instead of the supplied 0.4 percent saline diluent with no adverse event).  At time of reporting, the outcome was Unknown for the event the two components of the vaccine, liquid dtap-ipv component and the lyophilized hib component, were not mixed together, but were administered as separate injections with no reported adverse event and was Unknown for the event hib component is administered after reconstitution with sterile water instead of the supplied 0.4 percent saline diluent with no adverse 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 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.