<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-2025-693
Date of Submission: 2025-01-01

This report was submitted by a Patient from Mcdonald PLC Medical Center concerning patient ANON-PX-6278. The subject is an adult male with a significant medical history including chronic kidney disease, migraines, seasonal allergies, 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): Lisinopril (ACE inhibitor) administered via the Oral route at a dosage of 197mg, initiated on 2024-10-18 for Hypertension and discontinued on 2024-12-29.

On approximately 2024-12-04, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Hepatotoxicity, Pruritus, Anaphylaxis, Diarrhea. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Diarrhea was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, 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: Alone fall line number heart last goal. Stop feeling take. As hundred shoulder.</data>
report_id: ADR-2025-693
report_date: '2025-01-01'
patient_details:
  patient_id: ANON-PX-6278
  gender: Male
  relevant_history:
  - chronic kidney disease
  - migraines
  - seasonal allergies
  - type 2 diabetes
suspected_drugs:
- drug_name: Lisinopril
  dosage: 197mg
  route_of_administration: Oral
  start_date: '2024-10-18'
  indication_for_use: Hypertension
  drug_class: ACE inhibitor
  end_date: '2024-12-29'
adverse_reactions:
- symptom_name: Dizziness
  onset_date: '2024-12-04'
  severity: Mild
  outcome: Recovering
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2024-12-04'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2024-12-04'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2024-12-04'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2024-12-04'
  severity: Severe
  outcome: Recovered
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 8
reporting_facility: Mcdonald PLC Medical Center
reporter_type: Patient
notes: Alone fall line number heart last goal. Stop feeling take. As hundred shoulder.
