Symptomtext
patient was only given the liquid component of Pentacel, it was not reconstituted with Acthib with no reported adverse event; patient was only given the liquid component of Pentacel, it was not reconstituted with Acthib with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. (GMI number: 01213528) This case involves a 3-month-old female patient was only given the liquid component of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel], it was not reconstituted with acthib 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 Hepatitis B vaccine for Prophylactic vaccination; Rotavirus Vaccine for Prophylactic vaccination; and Pneumococcal Vaccine CONJ (pcv 13) for Prophylactic vaccination. On 20-Jul-2022, the patient received suspect Pentacel vaccine only liquid component at dose 0.5ml once (lot U6970bb) via intramuscular route in the left thigh for Immunization no reported adverse event (product preparation error, single component of a two-component product administered, same day latency). It was reported that "Caller states that a patient was only given the liquid component of Pentacel. It was not reconstituted with Acthib. Do we give a repeat dose or just give Acthib?" Action taken: Not applicable. At time of reporting, the outcome was Unknown for both 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.