Received Mar 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TD | TD ADSORBED (TENIVAC) | SANOFI PASTEUR | UNK | U7679AA | OT / RA |
60 year old patient received an expired dose of TENIVAC today with no reported adverse event; Initial information received on 25-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 60 years old male patient received an expired dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] today with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) ,concomitant medications and family history were not provided. On 25-Mar-2025, the patient received a dose of 0.5 ml of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult (Suspension for injection) lot U7679AA, Expiry date : 21-Mar-2025 (expired product administered) via intramuscular route in the right deltoid for Immunization with no reported adverse event (strength was unknown) (latency : same day). Reportedly, Caller requested information regarding any detrimental effects to the patient for administration of TENIVAC 4 days post expiration date. The caller was not aware of any adverse reactions at the time of the call. 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.