<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-2025-809
Date of Submission: 2025-04-16

This report was submitted by a Other Healthcare Professional from Johnson-Hopkins Medical Center concerning patient ANON-PX-6701. The subject is a 33-year-old female with a significant medical history including type 2 diabetes, asthma, osteoarthritis, anxiety. 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 (Anticoagulant) administered via the Intramuscular route at a dosage of 361mg, initiated on 2025-03-24 for Thromboembolism prevention and discontinued on 2025-04-10; Levothyroxine (Thyroid hormone) administered via the Intramuscular route at a dosage of 65mg, initiated on 2025-03-24 for Hypothyroidism and discontinued on 2025-04-10.

On approximately 2025-04-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Stevens-Johnson syndrome, Diarrhea, Hepatotoxicity, Maculopapular Rash. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed approach and advised eight. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed value and advised head. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed expect and advised believe. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-809
report_date: '2025-04-16'
patient_details:
  patient_id: ANON-PX-6701
  gender: Female
  relevant_history:
  - type 2 diabetes
  - asthma
  - osteoarthritis
  - anxiety
  age_at_reaction: 33
suspected_drugs:
- drug_name: Warfarin
  dosage: 361mg
  route_of_administration: Intramuscular
  start_date: '2025-03-24'
  indication_for_use: Thromboembolism prevention
  drug_class: Anticoagulant
  end_date: '2025-04-10'
- drug_name: Levothyroxine
  dosage: 65mg
  route_of_administration: Intramuscular
  start_date: '2025-03-24'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
  end_date: '2025-04-10'
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2025-04-05'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: true
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-04-05'
  severity: Mild
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed approach and advised eight.
- symptom_name: Diarrhea
  onset_date: '2025-04-05'
  severity: Mild
  outcome: Recovering
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2025-04-05'
  severity: Severe
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed value and advised head.
- symptom_name: Maculopapular Rash
  onset_date: '2025-04-05'
  severity: Severe
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed expect and advised believe.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
reporting_facility: Johnson-Hopkins Medical Center
reporter_type: Other Healthcare Professional
