Received Jul 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
with off label diagnosis s61.012A; Initial information received on 22-Jul-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 39 years old with unknown gender patient who had off label diagnosis s61.012A (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 had an intentional off label prescription by hcp as Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (with an unknown lot number, expiry date and strength) (frequency once; dose 0.5ml) via intramuscular route in unknown administration site was prescribed with off label diagnosis s61.012A Laceration without foreign body of left thumb without damage to nail, initial encounter (Skin laceration) (with no reported adverse event) had off label diagnosis s61.012A (Off label vaccine use) (latency same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. No follow up possible since reporter denied to respond to Sanofi PV.