<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-2025-361
Date of Submission: 2025-01-03

This report was submitted by a Other Healthcare Professional from Nunez Group Medical Center concerning patient ANON-PX-5875. The subject is a 33-year-old male with a significant medical history including hypertension, asthma, seasonal allergies, coronary artery 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 Subcutaneous route at a dosage of 204mg, initiated on 2024-12-25 for Major depressive disorder and discontinued on 2024-12-28; Metformin (Biguanide) administered via the Subcutaneous route at a dosage of 417mg, initiated on 2024-12-25 for Type 2 diabetes and discontinued on 2024-12-28.

On approximately 2024-12-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Stevens-Johnson syndrome. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed nice and advised way. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Off lead skill piece a eight. Card should campaign. Not street race position. Free behind accept movie beat international imagine city.</data>
report_id: ADR-2025-361
report_date: '2025-01-03'
patient_details:
  patient_id: ANON-PX-5875
  gender: Male
  relevant_history:
  - hypertension
  - asthma
  - seasonal allergies
  - coronary artery disease
  age_at_reaction: 33
suspected_drugs:
- drug_name: Sertraline
  dosage: 204mg
  route_of_administration: Subcutaneous
  start_date: '2024-12-25'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2024-12-28'
- drug_name: Metformin
  dosage: 417mg
  route_of_administration: Subcutaneous
  start_date: '2024-12-25'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2024-12-28'
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2024-12-28'
  severity: Severe
  outcome: Unknown
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-12-28'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed nice and advised way.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 6
reporting_facility: Nunez Group Medical Center
reporter_type: Other Healthcare Professional
notes: Off lead skill piece a eight. Card should campaign. Not street race position.
  Free behind accept movie beat international imagine city.
