Symptomtext
ACT-HIB has been reconstituted with sterile dilute instead of the appropriate one with no advese event; Initial information received on 04-Feb-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves an unknown age and unknown gender patient who reported act-hib has been reconstituted with sterile dilute instead of the appropriate one with no advese event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB]. 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 dose of suspect HIB (PRP/T) VACCINE (lot-UJ611AAB,30-Nov-2022) via unknown route in unknown administration site for immunization. On an unknown date the patient developed a non-serious event "act-hib has been reconstituted with sterile dilute instead of the appropriate one with no advese event" (product preparation error) (unknown latency) following the administration of HIB (PRP/T) VACCINE. It was reported "She thinks there may be three patients but she is not sure who they are as she is still investigating who gave the product". Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable. At time of reporting, the outcome was Unknown for the event act-hib has been reconstituted with sterile dilute instead of the appropriate one 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 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.