Symptomtext
ACT-HIB reconstituted with sterile water instead of 0.4% NaCl saline diluent with no reported adverse event; Initial information was received on 30-Sep-2021 regarding an unsolicited valid non-serious case received from a other health professional via the [Reference Information (MI) - 00793063]. This case involves a 13 month-old male patient who was vaccinated with HIB (PRP/T) VACCINE [ACT-HIB] which reconstituted with sterile water instead of 0.4% NaCl saline diluent (Product preparation error). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and HEPATITIS A VACCINE for prophylactic vaccination. On 29-Sep-2021, the patient received first dose 0.5 mL suspect HIB (PRP/T) VACCINE (strength: standard; lot UJ383ABA and expiry date 11-Oct-2021) via an intramuscular route in the right vastus lateralis for prophylactic vaccination. It was reported "Caller reports that a patient was administered ACT-HIB; states ACT-HIB was reconstituted with sterile water instead of the provided 0.4% NaCl saline diluent. Caller asks if this dose would be considered valid. Caller also asks, since ACT-HIB would not be considered valid, if patient should be revaccinated right away or if there is a waiting period. Caller states that patient did not receive treatment for adverse events related to ACTHIB". It was a case of an actual medication error due to wrong solution used in drug reconstitution (latency was on same day). At the time of report, no adverse event reported. Outcome of event was 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 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.