Reporte zur Charge U6831AA/U7189AA

Symptomtext

patient was administered with expired TENIVAC with no reported adverse event; Initial information received on 21-Jan-2022 (Non-case) and follow up on 05-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 62 years old female patient where patient was administered with expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Oct-2023, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot U6831AA/U7189AA and expiration date- 30-Sep-2023) via intramuscular route in the right arm (strength: not provided) for Immunisation (expired product administered) (latency- same day). Action taken- 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. Additional information was received on 05-Oct-2023 from Other healthcare professional: Case was updated from Non case to valid case.