<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-2024-214
Date of Submission: 2024-08-22

This report was submitted by a Nurse from Smith PLC Medical Center concerning patient ANON-PX-6807. The subject is a 49-year-old male with a significant medical history including type 2 diabetes, coronary artery disease, hypertension. 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 104mg, initiated on 2024-08-06 for Hypertension and discontinued on 2024-08-20; Amoxicillin (Penicillin antibiotic) administered via the Topical route at a dosage of 341mg, initiated on 2024-08-06 for Bacterial infection and discontinued on 2024-08-20.

On approximately 2024-08-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Angioedema, 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 Angioedema was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed right and advised for. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed sure and advised huge. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. 

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-2024-214
report_date: '2024-08-22'
patient_details:
  patient_id: ANON-PX-6807
  gender: Male
  relevant_history:
  - type 2 diabetes
  - coronary artery disease
  - hypertension
  age_at_reaction: 49
suspected_drugs:
- drug_name: Lisinopril
  dosage: 104mg
  route_of_administration: Topical
  start_date: '2024-08-06'
  indication_for_use: Hypertension
  drug_class: ACE inhibitor
  end_date: '2024-08-20'
- drug_name: Amoxicillin
  dosage: 341mg
  route_of_administration: Topical
  start_date: '2024-08-06'
  indication_for_use: Bacterial infection
  drug_class: Penicillin antibiotic
  end_date: '2024-08-20'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2024-08-12'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2024-08-12'
  severity: Mild
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed right and advised for.
- symptom_name: Maculopapular Rash
  onset_date: '2024-08-12'
  severity: Severe
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed sure and advised huge.
- symptom_name: Vomiting
  onset_date: '2024-08-12'
  severity: Mild
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
reporting_facility: Smith PLC Medical Center
reporter_type: Nurse
