<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-629
Date of Submission: 2025-05-09

This report was submitted by a Physician from Smith and Sons Medical Center concerning patient ANON-PX-7540. The subject is an adult male with a significant medical history including chronic kidney disease, type 2 diabetes, osteoarthritis. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities. 

Current medication review revealed the following suspected agent(s): Warfarin administered via the Intravenous route at a dosage of 57mg, initiated on 2025-04-08 for Thromboembolism prevention and discontinued on 2025-05-03; Amoxicillin (Penicillin antibiotic) administered via the Intramuscular route at a dosage of 426mg, initiated on 2025-04-08 for Bacterial infection and discontinued on 2025-05-03.

On approximately 2025-05-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Somnolence, Stevens-Johnson syndrome. The Pruritus was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Cell every professional. Personal cause charge cultural. Result tonight far arm.</data>
report_id: ADR-2025-629
report_date: '2025-05-09'
patient_details:
  patient_id: ANON-PX-7540
  gender: Male
  relevant_history:
  - chronic kidney disease
  - type 2 diabetes
  - osteoarthritis
suspected_drugs:
- drug_name: Warfarin
  dosage: 57mg
  route_of_administration: Intravenous
  start_date: '2025-04-08'
  indication_for_use: Thromboembolism prevention
  end_date: '2025-05-03'
- drug_name: Amoxicillin
  dosage: 426mg
  route_of_administration: Intramuscular
  start_date: '2025-04-08'
  indication_for_use: Bacterial infection
  drug_class: Penicillin antibiotic
  end_date: '2025-05-03'
adverse_reactions:
- symptom_name: Pruritus
  onset_date: '2025-05-01'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-05-01'
  severity: Severe
  outcome: Recovering
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-05-01'
  severity: Mild
  outcome: Unknown
  intervention_required: true
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 3
reporting_facility: Smith and Sons Medical Center
reporter_type: Physician
notes: Cell every professional. Personal cause charge cultural. Result tonight far
  arm.
