<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-2024-409
Date of Submission: 2024-11-04

This report was submitted by a Patient from Walker Ltd Medical Center concerning patient ANON-PX-4477. The subject is a 84-year-old female with a significant medical history including anxiety, 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 Topical route at a dosage of 81mg, initiated on 2024-08-14 for Hypertension and discontinued on 2024-09-28; Sertraline administered via the Oral route at a dosage of 127mg, initiated on 2024-08-14 for Major depressive disorder and discontinued on 2024-09-28.

On approximately 2024-09-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Headache. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. 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. 

</data>
report_id: ADR-2024-409
report_date: '2024-11-04'
patient_details:
  patient_id: ANON-PX-4477
  gender: Female
  relevant_history:
  - anxiety
  - type 2 diabetes
  age_at_reaction: 84
suspected_drugs:
- drug_name: Lisinopril
  dosage: 81mg
  route_of_administration: Topical
  start_date: '2024-08-14'
  indication_for_use: Hypertension
  drug_class: ACE inhibitor
  end_date: '2024-09-28'
- drug_name: Sertraline
  dosage: 127mg
  route_of_administration: Oral
  start_date: '2024-08-14'
  indication_for_use: Major depressive disorder
  end_date: '2024-09-28'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-09-11'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
- symptom_name: Headache
  onset_date: '2024-09-11'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
reporting_facility: Walker Ltd Medical Center
reporter_type: Patient
