<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-2025-708
Date of Submission: 2025-08-03

This report was submitted by a Physician from Edwards-Dennis Medical Center concerning patient ANON-PX-7311. The subject is a 81-year-old female with a significant medical history including 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): Atorvastatin (Statin) administered via the Subcutaneous route at a dosage of 55mg, initiated on 2025-05-14 for Hypercholesterolemia and discontinued on 2025-07-04; Lisinopril (ACE inhibitor) administered via the Topical route at a dosage of 371mg, initiated on 2025-05-14 for Hypertension and discontinued on 2025-07-04.

On approximately 2025-06-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Hepatotoxicity. The Vomiting was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed who and advised rule. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 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: Into occur hear stock me. Could arrive animal film. Never prepare add yourself human exist center.</data>
report_id: ADR-2025-708
report_date: '2025-08-03'
patient_details:
  patient_id: ANON-PX-7311
  gender: Female
  relevant_history:
  - coronary artery disease
  - migraines
  age_at_reaction: 81
suspected_drugs:
- drug_name: Atorvastatin
  dosage: 55mg
  route_of_administration: Subcutaneous
  start_date: '2025-05-14'
  indication_for_use: Hypercholesterolemia
  drug_class: Statin
  end_date: '2025-07-04'
- drug_name: Lisinopril
  dosage: 371mg
  route_of_administration: Topical
  start_date: '2025-05-14'
  indication_for_use: Hypertension
  drug_class: ACE inhibitor
  end_date: '2025-07-04'
adverse_reactions:
- symptom_name: Vomiting
  onset_date: '2025-06-25'
  severity: Severe
  outcome: Unknown
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2025-06-25'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed who and advised rule.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 7
reporting_facility: Edwards-Dennis Medical Center
reporter_type: Physician
notes: Into occur hear stock me. Could arrive animal film. Never prepare add yourself
  human exist center.
