Received May 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TD | TD ADSORBED (TENIVAC) | SANOFI PASTEUR | 2 | U7745AA | OT |
patient got administered expired Tenivac vaccine with no reported adverse event; Initial information received on 22-May-2025 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves a 35 years old male patient who got administered expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] vaccine with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-May-2025, the patient got administered expired 0.5 ml dose 2 of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Strength- standard) Suspension for injection lot U7745AA and expiry date- 20-May-2025 via intramuscular route in the deltoid nos (not specified) for Immunization with no reported adverse event (expired product administered) (latency- same day). Action taken- 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.