Medical Review
Physician-level case review with AI-assisted coding and causality assessment
Source Documents
Email Report — Dr. Mitchell
Email • 2026-04-14
Patient Record Extract
PDF • 2026-04-14
Dear Safety Team,
I am writing to report an adverse event in my patient, J.D., a 54-year-old male with rheumatoid arthritis who has been receiving Adalimumab 40mg subcutaneously every two weeks since January 2026.
On April 10, 2026, approximately 4 hours after his scheduled injection, the patient developed injection site reaction with erythema, swelling, and pruritus.
The reaction was self-limiting and resolved within 48 hours with topical corticosteroid treatment. The patient is recovering.
Dr. Sarah Mitchell, MD
AI-Generated Narrative Draft
Structured OutputThis is an initial spontaneous report from a healthcare professional (physician) concerning a 54-year-old male patient (Patient ID: J.D.) with a medical history of rheumatoid arthritis.
The patient was treated with adalimumab (Humira) 40 mg subcutaneous injection every 2 weeks for rheumatoid arthritis, initiated on 05-Jan-2026.
On 10-Apr-2026, approximately 4 hours after the scheduled injection, the patient experienced injection site reaction characterized by erythema, swelling, and pruritus at the injection site (MedDRA PT: Injection site reaction; LLT: Injection site erythema, Injection site pruritus, Injection site swelling).
The event was assessed as non-serious. The event resolved within 48 hours with topical corticosteroid treatment. The outcome was reported as recovering. No dose modification was planned. The reporter assessed causality as possible.