<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-2024-681
Date of Submission: 2024-11-03

This report was submitted by a Physician from Gallagher Group Medical Center concerning patient ANON-PX-2400. The subject is a 90-year-old male with a significant medical history including atrial fibrillation, asthma, migraines, chronic kidney 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): Atorvastatin (Statin) administered via the Topical route at a dosage of 81mg, initiated on 2024-10-23 for Hypercholesterolemia and discontinued on 2024-10-30; Omeprazole administered via the Topical route at a dosage of 23mg, initiated on 2024-10-23 for Gastroesophageal reflux disease and discontinued on 2024-10-30.

On approximately 2024-10-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Stevens-Johnson syndrome, Angioedema. The Diarrhea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed pull and advised want. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was '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-2024-681
report_date: '2024-11-03'
patient_details:
  patient_id: ANON-PX-2400
  gender: Male
  relevant_history:
  - atrial fibrillation
  - asthma
  - migraines
  - chronic kidney disease
  age_at_reaction: 90
suspected_drugs:
- drug_name: Atorvastatin
  dosage: 81mg
  route_of_administration: Topical
  start_date: '2024-10-23'
  indication_for_use: Hypercholesterolemia
  drug_class: Statin
  end_date: '2024-10-30'
- drug_name: Omeprazole
  dosage: 23mg
  route_of_administration: Topical
  start_date: '2024-10-23'
  indication_for_use: Gastroesophageal reflux disease
  end_date: '2024-10-30'
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2024-10-28'
  severity: Mild
  outcome: Fatal
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-10-28'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2024-10-28'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed pull and advised want.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 8
reporting_facility: Gallagher Group Medical Center
reporter_type: Physician
