<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-2024-548
Date of Submission: 2024-11-15

This report was submitted by a Other Healthcare Professional from Martinez-Ellison Medical Center concerning patient ANON-PX-5228. The subject is an adult male with a significant medical history including type 2 diabetes, asthma, coronary artery disease, chronic kidney disease. 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 (SSRI) administered via the Oral route at a dosage of 378mg, initiated on 2024-10-24 for Major depressive disorder with the course ongoing.

On approximately 2024-11-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Maculopapular Rash, Somnolence, Dizziness, Stevens-Johnson syndrome. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed appear and advised black. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Dizziness was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. 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 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. 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: Medical save cup myself rich kitchen.</data>
report_id: ADR-2024-548
report_date: '2024-11-15'
patient_details:
  patient_id: ANON-PX-5228
  gender: Male
  relevant_history:
  - type 2 diabetes
  - asthma
  - coronary artery disease
  - chronic kidney disease
suspected_drugs:
- drug_name: Sertraline
  dosage: 378mg
  route_of_administration: Oral
  start_date: '2024-10-24'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2024-11-12'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed appear and advised black.
- symptom_name: Maculopapular Rash
  onset_date: '2024-11-12'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2024-11-12'
  severity: Mild
  outcome: Recovered
  intervention_required: true
- symptom_name: Dizziness
  onset_date: '2024-11-12'
  severity: Severe
  outcome: Recovered
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-11-12'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
reporting_facility: Martinez-Ellison Medical Center
reporter_type: Other Healthcare Professional
notes: Medical save cup myself rich kitchen.
