Received Mar 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TD | TD ADSORBED (TENIVAC) | SANOFI PASTEUR | UNK | U8303BA | OT / LA |
Max/low temperature reached Negative 1.5 F (NEGATIVE 18.6 C) for 48 hours and 45 minutes for and tenivac was administered after excursion occurred with no reported ae; Initial information received on 24-Feb-2025 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 58 years old female patient where max/low temperature reached negative 1.5 F (negative 18.6 c) for 48 hours and 45 minutes for Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] and was administered after excursion occurred with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 19-Feb-2025, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot- U8303BA and expiration date- 30-SEP-2026) via intramuscular route in the left deltoid (strength: not provided) for Immunization and max/low temperature reached negative 1.5 f (negative 18.6 c) for 48 hours and 45 minutes for and tenivac was administered after excursion occurred with no reported ae (poor quality product administered) (latency- same day). Reportedly, Previous Excursion, Yes; Does extended stability data cover the excursion, No. Action taken- not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. 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.