Received Nov 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
Intentional Age Prescription by HCP: The patient is 72 years old. Per package insert, Adacel is approved for use in persons 10 through 64 years of age with no reported adverse event; Initial information received on 21-Oct-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 72 years old male patient who had prescription for Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] which is approved for use in persons 10 through 64 years of age 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 prescribed with 0.5 dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, solution for injection (lot number, expiry date and strength not reported) frequency: once, via intramuscular route in unknown administration site for protection against tetanus, diphtheria, and pertussiss [Immunisation] which is approved for use in persons 10 through 64 years of age with no reported adverse event (off label use). Information on the batch number cannot be requested corresponding to the one at time of event occurrence Action taken was not applicable.