Symptomtext
inadvertently administered an expired ACT-HIB dose to a patient earlier today with no reported adverse event; Initial information was received on 27-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 8 months old female patient who received inadvertently administered an expired hib (prp/t) vaccine [ACT-HIB] dose to a patient earlier today with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (Pentacel) 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; influenza vaccine INACT SPLIT 4V (Fluzone QUADRIVALENT) for Prophylactic vaccination; and pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination. On 27-Oct-2023, the patient received a dose of 0.5 ml of suspect hib (prp/t) vaccine (Powder and solvent for solution for injection) (lot UJ801AA, Expiry date : 05-Oct-2023, Frequency : once, strength was unknown) via unknown route in unknown administration site for Immunization and inadvertently administered an expired act-hib dose to a patient earlier today with no reported adverse event (expired product administered) (latency : same day). Action taken with haemophilus type b (hib) vaccine (ACT-HIB) was not applicable. At time of reporting, the outcome was Unknown for the event inadvertently administered an expired act-hib dose to a patient earlier today with no reported 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.