Reporte zur Charge U766GAA

Symptomtext

2 doses of ADACEL was administered to a patient 6 weeks apart with no adverse event; Initial information received on 16-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who was administered 2 doses of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] 6 weeks apart with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Aug-2023, the patient received Dose 1 of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (lot number: U766GAA) (Expiry date: 08-Mar-2025) (with an unknown strength) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). On 29-Sep-2023 he/she also received Dose 2 of the same vaccine (lot number: U766GAA) (Expiry date: 08-Mar-2025) via unknown route in unknown administration site. On 29-Sep-2023, the patient was administered 2 doses of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine 6 weeks apart with no adverse event (extra dose administered) (latency: 1 month 14 days). It was reported, Pharmacy director asks for safety data and recommendations following the administration of 2 doses of ADACEL to a patient 6 weeks apart, first dose was given on 15Aug2023, the second one was given on 29Sep2023. This situation is reported as a medication error due to 2 doses of ADACEL was administered to a patient 6 weeks apart. Action taken: not applicable. Outcome: 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.