Symptomtext
medication error due to use of invalid vaccine since it was reconstituted with wrong diluent with no reported adverse event; Initial information received on 03-May-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old female patient who was administered an invalid vaccine since it was reconstituted with wrong diluent with no reported adverse 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. Concomitant medications included diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (Pediarix); pneumococcal vaccine conj 7V (CRM197) (PREVNAR); and Rotavirus vaccine. On 02-May-2022, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE (lot UJ588AAA, expiry date: 24-Oct-2022) via intramuscular route in the left thigh for immunization. On 02-MAY-2022 the patient was administered an invalid vaccine since it was reconstituted with wrong diluent with no reported adverse event (product preparation error). Action taken was not applicable. At time of reporting, the outcome was Unknown for the 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.