<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-2025-539
Date of Submission: 2025-04-30

This report was submitted by a Physician from Rodriguez, White and Stephens Medical Center concerning patient ANON-PX-9590. The subject is an adult male with a significant medical history including hypertension, type 2 diabetes. 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 102mg, initiated on 2025-02-18 for Major depressive disorder and discontinued on 2025-03-09.

On approximately 2025-02-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Vomiting, Angioedema, Anaphylaxis, Somnolence. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed method and advised especially. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed action and advised only. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-539
report_date: '2025-04-30'
patient_details:
  patient_id: ANON-PX-9590
  gender: Male
  relevant_history:
  - hypertension
  - type 2 diabetes
suspected_drugs:
- drug_name: Sertraline
  dosage: 102mg
  route_of_administration: Oral
  start_date: '2025-02-18'
  indication_for_use: Major depressive disorder
  end_date: '2025-03-09'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-02-27'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-02-27'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2025-02-27'
  severity: Severe
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed method and advised especially.
- symptom_name: Anaphylaxis
  onset_date: '2025-02-27'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed action and advised only.
- symptom_name: Somnolence
  onset_date: '2025-02-27'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 10
reporting_facility: Rodriguez, White and Stephens Medical Center
reporter_type: Physician
