Reporte zur Charge U6901AA/UJ423AA

Symptomtext

one patient received ACT-HIB after the diluent had expired with no adverse event; administering to a patient who is outside the approved ages of 2 months through 5 years with no adverse event; Initial information received on 27-Apr-2022 regarding an unsolicited valid non-serious case received from from a other health professional. This case involves a 18 years old male patient who received act-hib after the diluent had expired with no adverse event and administering to a patient who is outside the approved ages of 2 months through 5 years with no adverse event ,while receiving vaccine Hib (Prp/T) Vaccine [Act-Hib]. The patient's past medical history included Bone marrow transplant. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Tdap); Hepatitis B Vaccine (Hepatitis B Vaccine); Pneumococcal Vaccine Conj (Pneumococcal Conjugate Vaccine); and Polio Vaccine (Polio). On 04-Apr-2022, the patient received a dose of suspect Hib (Prp/T) Vaccine Powder and solvent for solution for injection( lot U6901AA and UJ423AA , expiration date: 07-Mar-2022 and 20-May-2022) at a dose of 0.25ml via intramuscular route in the right deltoid as prophylactic vaccination. On 04-APR-2022(latency: same day), the patient received act-hib after the diluent had expired with no adverse event (expired product administered) and administered vaccine who is outside the approved ages of 2 months through 5 years with no adverse event (Product use issue). Action taken: not applicable. It was not reported if the patient received a corrective treatment for the events . At time of reporting, the outcome was Unknown for both events 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.