<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-2025-619
Date of Submission: 2025-01-16

This report was submitted by a Pharmacist from Barrera Inc Medical Center concerning patient ANON-PX-1176. The subject is a 85-year-old female with a significant medical history including asthma, 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 Oral route at a dosage of 243mg, initiated on 2024-10-25 for Hypertension and discontinued on 2025-01-09.

On approximately 2024-11-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Vomiting, Stevens-Johnson syndrome, Maculopapular Rash. The Diarrhea was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed those and advised beyond. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. 

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. 

</data>
report_id: ADR-2025-619
report_date: '2025-01-16'
patient_details:
  patient_id: ANON-PX-1176
  gender: Female
  relevant_history:
  - asthma
  - osteoarthritis
  - seasonal allergies
  age_at_reaction: 85
suspected_drugs:
- drug_name: Lisinopril
  dosage: 243mg
  route_of_administration: Oral
  start_date: '2024-10-25'
  indication_for_use: Hypertension
  drug_class: ACE inhibitor
  end_date: '2025-01-09'
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2024-11-11'
  severity: Severe
  outcome: Fatal
  intervention_required: true
- symptom_name: Vomiting
  onset_date: '2024-11-11'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed those and advised beyond.
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-11-11'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
- symptom_name: Maculopapular Rash
  onset_date: '2024-11-11'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 9
reporting_facility: Barrera Inc Medical Center
reporter_type: Pharmacist
