<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-2025-516
Date of Submission: 2025-03-20

This report was submitted by a Patient from Gonzales PLC Medical Center concerning patient ANON-PX-7542. The subject is a 64-year-old female with a significant medical history including type 2 diabetes, osteoarthritis, seasonal allergies. 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 Intramuscular route at a dosage of 459mg, initiated on 2025-02-06 for Hypertension and discontinued on 2025-02-28.

On approximately 2025-02-20, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Diarrhea, Somnolence, Maculopapular Rash, Vomiting. The Hepatotoxicity was classified as Severe 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. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed know and advised age. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed just and advised nature. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Trouble share available word keep machine. State develop deep third prevent camera against about.</data>
report_id: ADR-2025-516
report_date: '2025-03-20'
patient_details:
  patient_id: ANON-PX-7542
  gender: Female
  relevant_history:
  - type 2 diabetes
  - osteoarthritis
  - seasonal allergies
  age_at_reaction: 64
suspected_drugs:
- drug_name: Lisinopril
  dosage: 459mg
  route_of_administration: Intramuscular
  start_date: '2025-02-06'
  indication_for_use: Hypertension
  drug_class: ACE inhibitor
  end_date: '2025-02-28'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-02-20'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2025-02-20'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-02-20'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed know and advised age.
- symptom_name: Maculopapular Rash
  onset_date: '2025-02-20'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-02-20'
  severity: Severe
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed just and advised nature.
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 9
reporting_facility: Gonzales PLC Medical Center
reporter_type: Patient
notes: Trouble share available word keep machine. State develop deep third prevent
  camera against about.
