<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-2024-611
Date of Submission: 2024-12-27

This report was submitted by a Pharmacist from Brown Ltd Medical Center concerning patient ANON-PX-5603. The subject is a 19-year-old female with a significant medical history including chronic kidney disease, atrial fibrillation, 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 (SSRI) administered via the Topical route at a dosage of 80mg, initiated on 2024-11-10 for Major depressive disorder and discontinued on 2024-12-26.

On approximately 2024-12-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Angioedema. 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 Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed experience and advised might. 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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Senior station area artist where. East no production million although myself.</data>
report_id: ADR-2024-611
report_date: '2024-12-27'
patient_details:
  patient_id: ANON-PX-5603
  gender: Female
  relevant_history:
  - chronic kidney disease
  - atrial fibrillation
  - type 2 diabetes
  age_at_reaction: 19
suspected_drugs:
- drug_name: Sertraline
  dosage: 80mg
  route_of_administration: Topical
  start_date: '2024-11-10'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2024-12-26'
adverse_reactions:
- symptom_name: Vomiting
  onset_date: '2024-12-06'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2024-12-06'
  severity: Mild
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed experience and advised might.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Brown Ltd Medical Center
reporter_type: Pharmacist
notes: Senior station area artist where. East no production million although myself.
