Received Jun 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
Intentional Off Label Prescription by HCP: Adacel is prescribed with off label diagnosis code S31.31XA Laceration without foreignbody of scrotum and testes, initial encounter with no reported adverse event; Initial information received on 03-Jun-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 32 years old and unknown gender patient for whom diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] intentional off label prescription by hcp with off label diagnosis code s31.31xa laceration without foreign body of scrotum and testes, initial encounter 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 received an unknown dose (0.5ml) of suspect diphtheria-2/tetanus/5 ac pertussis vaccine; Suspension for injection in pre-filled syringe (lot number, strength and expiry date not reported) via intramuscular route in unknown administration site for Laceration without foreign body of scrotum and testes, initial encounter (Scrotal injury) and (Testicular injury); intentional off label prescription by hcp with off label diagnosis code s31.31xa laceration without foreign body of scrotum and testes, initial encounter with no reported adverse event (off label use). (latency: same day) Information on the batch number cannot be requested corresponding to the one at time of event occurrence. Action taken was not applicable.