Received Jan 14, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
off-label (intentional by HCP) due to planning to use adacel to 9 year old patient with no reported adverse event; Initial information received on 08-Jan-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 9 years old and unknown gender patient who planned (intentional by hcp) to use Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] with no reported 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 was planned to use an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot number, expiry date and strength not reported) for Prophylactic vaccination [Immunisation] with no reported adverse event (off label use). Information on the batch number was requested corresponding to the one at time of event occurrence. It was reported "We had a 9-year-old patient who needed to catch up on their tetanus vaccine. Since they were past the age for DTaP, we planned to administer Tdap. However, upon reviewing the Adacel package insert, it states that Adacel is indicated for patients aged 10 to 64 years." Action taken was not applicable.