Symptomtext
ACT-HIB was given to a patient without reconstituting with proper diluent and instead it was reconstituted with sterile water/ no adverse event; Initial information received on 26-Jul-2021 regarding an unsolicited valid non-serious case received from a physician and Other Health Care Professional. This case involves a 6 month-old male patient who received HIB (PRP/T) VACCINE [ACT-HIB] without reconstituting with proper diluent (reconstituted with sterile water) [product preparation error]. The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and 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. On 26-Jul-2021, the patient received third dose 0.5 mL (once) of suspect HIB (PRP/T) VACCINE (lot UJ405AAB and expiry date 08-Oct-2021) via an intramuscular route at the right thigh for prophylactic vaccination. It was reported that "Physician assistant student reports that he gave ACT-HIB to a patient without reconstituting with proper diluent. States he did not see diluent packaged with ACT-HIB and instead he reconstituted with sterile water". 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 was reported. Event outcome 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.