Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
Intentional Off Label Prescription by HCP: Adacel prescribed with off label diagnosis Z22.3 Carrier of other specified bacterial diseases with no reported adverse event; Initial information received on 17-Sep-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 61 years old and unknown gender patient who was prescribed Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] for carrier of other specified bacterial diseases 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 0.5ml dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, (once)Solution for injection, (unknown strength and expiry date) lot number not reported via intramuscular route in unknown administration site for Carrier of other specified bacterial diseases [bacterial infection], with no reported adverse event (off label use) (latency Same day). Information regarding batch number corresponding to the one at time of event occurrence will not be available. Reportedly, Intentional Off Label Prescription by HCP (healthcare professional). Action taken was not applicable.