Received Jun 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TD | TD ADSORBED (TENIVAC) | SANOFI PASTEUR | UNK | U7183AA | OT / RA |
administration of an expired product with no reported adverse event; Initial information received on 29-May-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 83 years old male patient who received an expired dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] with no reported adverse. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 29-May-2025, the patient received an expired, 0.5ml dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult, Strength Standard, (Once) Suspension for injection, (Unknown strength) lot U7183AA and expiry date 23-Sep-2024 via intramuscular route in the right deltoid for immunization with no reported adverse event (expired product administered) (Latency Same day). Action taken was not applicable. 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.