Received May 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TD | TD ADSORBED (TENIVAC) | SANOFI PASTEUR | UNK | U80218A | IM / RA |
administering an expired dose of tenivac, expired on 16mar2026 but it was administered on 30mar2026 with no reported adverse event; Initial information received on 31-Mar-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves an 81-year-old male patient who received an expired dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac], expired on 16-Mar-2026 but it was administered on 30-Mar-2026 with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), family history were not provided. On 30-Mar-2026, the patient received an expired 0.5 mL dose (dose 1), Once of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult, Suspension for injection of standard strength [Batch/Lot Number: U80218A, Expiration Date: 16-Mar-2026] via intramuscular route in the right deltoid for immunisation with no reported adverse event [(Expired product administered) (Latency: same day)]. Action taken: No specific action was documented. 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.
Comments: NONE