Received Aug 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TD | TD ADSORBED (TENIVAC) | SANOFI PASTEUR | UNK | — | OT |
patient under their care had experienced an adverse event while taking Tenivac.; one of a patient under their care had experienced an adverse event while taking Tenivac; Initial information received on 10-Jul-2025 regarding an unsolicited valid non-serious case received from other health care professional. This case involves an unknown age and unknown gender patient who was administered with Diphtheria-2/Tetanus-5 adsorbed toxoids no preservative adult [Tenivac] experienced an adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection lot number not reported (dose, strength, lot/batch number and expiration date: not provided) for prophylactic vaccination (immunization) and experienced an adverse event (poor quality product administered) and (adverse event). Reportedly, Reason: Misplaced probes, Max /low temperature reached: She said that the previous reported temperature was 30°F but she said that she told one of her workmates that day to place it on the correct spot: new temperature: 32°F. Duration: Half-day after they got the previous temperature gauge. He was not sure of the whole duration.Previous Excursion- None, Human error- Yes, Administered post-excursion- No, Does extended stability data cover the excursion- No. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event of (no adverse event). At time of reporting, the outcome was Unknown for the event of (no adverse 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. Additional information was received on 17-Jul-2025 from Other Health Care Professional: Case validity updated from non case to non valid case; text amended accordingly. Additional information was received on 30-Jul-2025 from other healthcare professional: Case updated from non-valid to valid. Based on data previously received, the following information has been amended (removed the case classification Non valid case and follow on deleted the initial justification, updated the number of patient from 0 to 1)