<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-2024-367
Date of Submission: 2024-11-18

This report was submitted by a Physician from Gibbs, Bell and Watkins Medical Center concerning patient ANON-PX-5463. The subject is an adult male with a significant medical history including chronic kidney disease, migraines, atrial fibrillation. 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 472mg, initiated on 2024-09-10 for Hypertension with the course ongoing; Atorvastatin (Statin) administered via the Topical route at a dosage of 447mg, initiated on 2024-09-10 for Hypercholesterolemia with the course ongoing.

On approximately 2024-09-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Nausea, Angioedema, Dizziness, Diarrhea. The Pruritus was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Nausea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed away and advised future. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Tax prevent agree PM human song budget. Stay quickly raise sometimes. Traditional recognize door art son late south open.</data>
report_id: ADR-2024-367
report_date: '2024-11-18'
patient_details:
  patient_id: ANON-PX-5463
  gender: Male
  relevant_history:
  - chronic kidney disease
  - migraines
  - atrial fibrillation
suspected_drugs:
- drug_name: Lisinopril
  dosage: 472mg
  route_of_administration: Topical
  start_date: '2024-09-10'
  indication_for_use: Hypertension
  drug_class: ACE inhibitor
- drug_name: Atorvastatin
  dosage: 447mg
  route_of_administration: Topical
  start_date: '2024-09-10'
  indication_for_use: Hypercholesterolemia
  drug_class: Statin
adverse_reactions:
- symptom_name: Pruritus
  onset_date: '2024-09-28'
  severity: Mild
  outcome: Recovering
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2024-09-28'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2024-09-28'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed away and advised future.
- symptom_name: Dizziness
  onset_date: '2024-09-28'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2024-09-28'
  severity: Severe
  outcome: Recovered
  intervention_required: true
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Not applicable
  naranjo_score: 2
reporting_facility: Gibbs, Bell and Watkins Medical Center
reporter_type: Physician
notes: Tax prevent agree PM human song budget. Stay quickly raise sometimes. Traditional
  recognize door art son late south open.
