Received Nov 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TD | TD ADSORBED (TENIVAC) | SANOFI PASTEUR | UNK | U7920AA | OT / LA |
Nurse states that they gave an expired TENIVAC to a pregnant patient with no reported adverse event; Nurse states that they gave an expired TENIVAC to a pregnant patient with no reported adverse event; Initial information received on 17-Nov-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 30-year-old female patient and nurse states that they gave an expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] to a pregnant patient with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported adverse events occurred at 7 weeks of pregnancy, during first pregnancy trimester. The date of last menstrual period was reported as 26-Sep-2025. The estimated due date is 05-Jul-2026. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant: no other immunizations The patient had unknown previous pregnancy/ies. On 17-Nov-2025, nurse states that they gave an expired 0.5 ml dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection frequency: once, strength: standard of lot U7920AA and expiry date: 25-Oct-2025 via intramuscular route in the left deltoid for Immunization to a pregnant patient with no reported adverse event (expired product administered) (exposure during pregnancy) (latency: on 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.