<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-2024-508
Date of Submission: 2024-08-28

This report was submitted by a Other Healthcare Professional from Stone-Adams Medical Center concerning patient ANON-PX-9086. The subject is an adult other with a significant medical history including chronic kidney disease, osteoarthritis, coronary artery disease. 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 455mg, initiated on 2024-08-17 for Hypertension and discontinued on 2024-08-26; Amoxicillin (Penicillin antibiotic) administered via the Topical route at a dosage of 40mg, initiated on 2024-08-17 for Bacterial infection and discontinued on 2024-08-26.

On approximately 2024-08-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Angioedema, Nausea. The Stevens-Johnson syndrome was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Mild in severity. This necessitated clinical intervention. 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: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-508
report_date: '2024-08-28'
patient_details:
  patient_id: ANON-PX-9086
  gender: Other
  relevant_history:
  - chronic kidney disease
  - osteoarthritis
  - coronary artery disease
suspected_drugs:
- drug_name: Lisinopril
  dosage: 455mg
  route_of_administration: Topical
  start_date: '2024-08-17'
  indication_for_use: Hypertension
  drug_class: ACE inhibitor
  end_date: '2024-08-26'
- drug_name: Amoxicillin
  dosage: 40mg
  route_of_administration: Topical
  start_date: '2024-08-17'
  indication_for_use: Bacterial infection
  drug_class: Penicillin antibiotic
  end_date: '2024-08-26'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-08-25'
  severity: Mild
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2024-08-25'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2024-08-25'
  severity: Mild
  outcome: Unknown
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
reporting_facility: Stone-Adams Medical Center
reporter_type: Other Healthcare Professional
