<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-2024-805
Date of Submission: 2024-12-25

This report was submitted by a Patient from Miller-White Medical Center concerning patient ANON-PX-6098. The subject is a 71-year-old female with a significant medical history including osteoarthritis, anxiety, coronary artery disease, atrial fibrillation. 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): Sertraline administered via the Oral route at a dosage of 415mg, initiated on 2024-10-17 for Major depressive disorder and discontinued on 2024-12-02; Warfarin administered via the Subcutaneous route at a dosage of 367mg, initiated on 2024-10-17 for Thromboembolism prevention and discontinued on 2024-12-02.

On approximately 2024-10-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Stevens-Johnson syndrome, Hepatotoxicity, Maculopapular Rash, Diarrhea. The Pruritus was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Life-threatening 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 none and advised own. The current patient status regarding this symptom is 'Recovering'. The Maculopapular Rash was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed itself and advised single. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-805
report_date: '2024-12-25'
patient_details:
  patient_id: ANON-PX-6098
  gender: Female
  relevant_history:
  - osteoarthritis
  - anxiety
  - coronary artery disease
  - atrial fibrillation
  age_at_reaction: 71
suspected_drugs:
- drug_name: Sertraline
  dosage: 415mg
  route_of_administration: Oral
  start_date: '2024-10-17'
  indication_for_use: Major depressive disorder
  end_date: '2024-12-02'
- drug_name: Warfarin
  dosage: 367mg
  route_of_administration: Subcutaneous
  start_date: '2024-10-17'
  indication_for_use: Thromboembolism prevention
  end_date: '2024-12-02'
adverse_reactions:
- symptom_name: Pruritus
  onset_date: '2024-10-30'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-10-30'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2024-10-30'
  severity: Severe
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed none and advised own.
- symptom_name: Maculopapular Rash
  onset_date: '2024-10-30'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2024-10-30'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed itself and advised single.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 8
reporting_facility: Miller-White Medical Center
reporter_type: Patient
