<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-2025-427
Date of Submission: 2025-01-18

This report was submitted by a Nurse from Bowers, Armstrong and Chavez Medical Center concerning patient ANON-PX-3858. The subject is a 19-year-old male with a significant medical history including coronary artery disease, 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 Subcutaneous route at a dosage of 28mg, initiated on 2024-10-25 for Major depressive disorder with the course ongoing.

On approximately 2024-12-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Nausea, Somnolence, Vomiting. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Nausea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed then and advised really. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed cold and advised she. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed ask and advised green. 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: Edge within exist value democratic carry view not. Week spring I whole behavior individual he. Cause she century performance may. Campaign play responsibility wrong age practice.</data>
report_id: ADR-2025-427
report_date: '2025-01-18'
patient_details:
  patient_id: ANON-PX-3858
  gender: Male
  relevant_history:
  - coronary artery disease
  - type 2 diabetes
  age_at_reaction: 19
suspected_drugs:
- drug_name: Sertraline
  dosage: 28mg
  route_of_administration: Subcutaneous
  start_date: '2024-10-25'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2024-12-02'
  severity: Severe
  outcome: Recovered
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2024-12-02'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed then and advised really.
- symptom_name: Somnolence
  onset_date: '2024-12-02'
  severity: Severe
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed cold and advised she.
- symptom_name: Vomiting
  onset_date: '2024-12-02'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed ask and advised green.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
reporting_facility: Bowers, Armstrong and Chavez Medical Center
reporter_type: Nurse
notes: Edge within exist value democratic carry view not. Week spring I whole behavior
  individual he. Cause she century performance may. Campaign play responsibility wrong
  age practice.
