Reporte zur Charge U70938A

Symptomtext

expired dose of adacel was given to the patient with no reported adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 years old male patient who was administered an expired dose of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] 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 HPV vaccine and meningococcal vaccine for Prophylactic vaccination (immunization). On 19-Jun-2023, the patient received a dose of 0.5 ml (dose 1) of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: U70938A; expiry date: 18-Jun-2023; strength: standard; frequency: once) via intramuscular route in left deltoid for immunization. On 19-Jun-2023 the patient was administered an expired dose of diphtheria-2/tetanus/5 AC pertussis vaccine with no reported adverse event (expired product administered) (latency: same day). 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.