Received May 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TD | TD ADSORBED (TENIVAC) | SANOFI PASTEUR | 1 | U7920AA | OT |
off-label use as per local labelling due to administration of tenivac to a 6 year old patient with no reported ae; Initial information received on 15-May-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 6 year old male patient who received diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Teniva] with no reported AE (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-May-2025, the 6 years old male patient received an unknown dose (dose 1) of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection standard strength (lot U7920AA) (expiry date-unknown) via unknown route in unknown administration site for Immunization with no reported AE (off label use) (latency-same day). Reportedly-Nurse reported that the patient was 6 years old when they got their first dose of TENIVAC in the hospital and it was approved by their physician because the patient cannot get a pertussis shot. Action taken was not applicable.