<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-2025-616
Date of Submission: 2025-06-11

This report was submitted by a Nurse from Knight-Barnes Medical Center concerning patient ANON-PX-2981. The subject is a 25-year-old female with a significant medical history including chronic kidney disease, hypertension, seasonal allergies. 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 Oral route at a dosage of 378mg, initiated on 2025-04-18 for Thromboembolism prevention with the course ongoing.

On approximately 2025-04-26, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Diarrhea, Pruritus, Headache. The Somnolence was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Diarrhea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed thousand and advised experience. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 4 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: Huge tough keep example drop require. Onto member build think. Price blood middle discover bar practice.</data>
report_id: ADR-2025-616
report_date: '2025-06-11'
patient_details:
  patient_id: ANON-PX-2981
  gender: Female
  relevant_history:
  - chronic kidney disease
  - hypertension
  - seasonal allergies
  age_at_reaction: 25
suspected_drugs:
- drug_name: Warfarin
  dosage: 378mg
  route_of_administration: Oral
  start_date: '2025-04-18'
  indication_for_use: Thromboembolism prevention
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2025-04-26'
  severity: Mild
  outcome: Unknown
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2025-04-26'
  severity: Mild
  outcome: Unknown
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2025-04-26'
  severity: Severe
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed thousand and advised experience.
- symptom_name: Headache
  onset_date: '2025-04-26'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 4
reporting_facility: Knight-Barnes Medical Center
reporter_type: Nurse
notes: Huge tough keep example drop require. Onto member build think. Price blood
  middle discover bar practice.
