<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-2025-526
Date of Submission: 2025-01-25

This report was submitted by a Physician from Gutierrez, Ross and Campbell Medical Center concerning patient ANON-PX-2538. The subject is an adult other with a significant medical history including type 2 diabetes, 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): Atorvastatin (Statin) administered via the Oral route at a dosage of 387mg, initiated on 2024-11-22 for Hypercholesterolemia and discontinued on 2025-01-24; Sertraline (SSRI) administered via the Intravenous route at a dosage of 454mg, initiated on 2024-11-22 for Major depressive disorder and discontinued on 2025-01-24.

On approximately 2025-01-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Pruritus, Nausea, Dizziness, Vomiting. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed here and advised threat. The current patient status regarding this symptom is 'Recovered'. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed gas and advised film. The current patient status regarding this symptom is 'Unknown'. The Dizziness was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-526
report_date: '2025-01-25'
patient_details:
  patient_id: ANON-PX-2538
  gender: Other
  relevant_history:
  - type 2 diabetes
  - migraines
suspected_drugs:
- drug_name: Atorvastatin
  dosage: 387mg
  route_of_administration: Oral
  start_date: '2024-11-22'
  indication_for_use: Hypercholesterolemia
  drug_class: Statin
  end_date: '2025-01-24'
- drug_name: Sertraline
  dosage: 454mg
  route_of_administration: Intravenous
  start_date: '2024-11-22'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-01-24'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-01-16'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed here and advised threat.
- symptom_name: Pruritus
  onset_date: '2025-01-16'
  severity: Severe
  outcome: Unknown
  intervention_required: true
- symptom_name: Nausea
  onset_date: '2025-01-16'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed gas and advised film.
- symptom_name: Dizziness
  onset_date: '2025-01-16'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-01-16'
  severity: Severe
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
reporting_facility: Gutierrez, Ross and Campbell Medical Center
reporter_type: Physician
