Symptomtext
ACTHIB diluted with a sterile diluent from a different manufacturer and not with approved sterile diluent provided with the ACTHIB with no adverse event; Initial information received on 13-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves a 2 months old male patient who was administered acthib diluted with a sterile diluent from a different manufacturer and not with approved sterile diluent provided with the acthib with no adverse event w, after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB]. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Prophylactic vaccination; DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Prophylactic vaccination. On 24-Aug-2022, the patient received a dose number 1 of suspect HIB (PRP/T) VACCINE( lot UJ650AAA and expiration date: 05-Mar-2023) at a dose of 0.5ml once via intramuscular route in the right vastus lateralis for immunization. On 24-Aug-2022(Latency: same day), the patient was administered acthib diluted with a sterile diluent from a different manufacturer and not with approved sterile diluent provided with the acthib with no adverse event (product preparation error). Action taken :not applicable. It was not reported if the patient received a corrective treatment for the event . Outcome: unknown 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.