Reporte zur Charge U6265A

Symptomtext

expired DT vaccine was administered with no reported adverse event; Initial information received on 30-Jun-2022 regarding an unsolicited valid non-serious case received from medical assistant. Number: 01170883 This case involves a 66-year-old female patient to whom expired (Diphtheria and Tetanus Toxoids) TENIVAC vaccine was administered with no reported adverse event. The patient presented with a laceration on her right foot (Skin laceration). The patient's past medical treatment(s), vaccination(s) and family history were not provided. On 20-Jun-2022, the patient received a dose of suspect TENIVAC vaccine at dose of 0.5ml once with (lot: U6265A, expiry date: 19-Apr-2021) via intramuscular route in unknown administration site for Immunization (expired product administered, latency same day). It was reported that "HCP reports about a patient of the practice presented with a laceration on her right foot. She was administered a DT vaccine which was later noted to have expired 4/19/2021. No adverse events have been reported." 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 guidelines. 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.