<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-2024-167
Date of Submission: 2024-11-05

This report was submitted by a Patient from Gordon-Short Medical Center concerning patient ANON-PX-8856. The subject is a 48-year-old male with a significant medical history including type 2 diabetes, coronary artery disease, migraines. 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 450mg, initiated on 2024-09-07 for Major depressive disorder with the course ongoing; Atorvastatin administered via the Oral route at a dosage of 359mg, initiated on 2024-09-07 for Hypercholesterolemia with the course ongoing.

On approximately 2024-09-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Hepatotoxicity, Angioedema, Vomiting. The Anaphylaxis was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed condition and advised service. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed avoid and advised expert. The current patient status regarding this symptom is 'Unknown'. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. 

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. 

</data>
report_id: ADR-2024-167
report_date: '2024-11-05'
patient_details:
  patient_id: ANON-PX-8856
  gender: Male
  relevant_history:
  - type 2 diabetes
  - coronary artery disease
  - migraines
  age_at_reaction: 48
suspected_drugs:
- drug_name: Sertraline
  dosage: 450mg
  route_of_administration: Subcutaneous
  start_date: '2024-09-07'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
- drug_name: Atorvastatin
  dosage: 359mg
  route_of_administration: Oral
  start_date: '2024-09-07'
  indication_for_use: Hypercholesterolemia
adverse_reactions:
- symptom_name: Anaphylaxis
  onset_date: '2024-09-17'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2024-09-17'
  severity: Severe
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed condition and advised service.
- symptom_name: Angioedema
  onset_date: '2024-09-17'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed avoid and advised expert.
- symptom_name: Vomiting
  onset_date: '2024-09-17'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Gordon-Short Medical Center
reporter_type: Patient
