<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-2024-253
Date of Submission: 2024-10-07

This report was submitted by a Physician from Davis-Johnson Medical Center concerning patient ANON-PX-5706. The subject is a 60-year-old male with a significant medical history including seasonal allergies, anxiety, migraines. 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): Omeprazole administered via the Oral route at a dosage of 145mg, initiated on 2024-07-11 for Gastroesophageal reflux disease and discontinued on 2024-08-16; Atorvastatin (Statin) administered via the Intravenous route at a dosage of 150mg, initiated on 2024-07-11 for Hypercholesterolemia and discontinued on 2024-08-16.

On approximately 2024-08-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Stevens-Johnson syndrome, Angioedema, Dizziness. The Maculopapular Rash was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed capital and advised physical. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed pick and advised machine. The current patient status regarding this symptom is 'Recovered'. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. 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 rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

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report_id: ADR-2024-253
report_date: '2024-10-07'
patient_details:
  patient_id: ANON-PX-5706
  gender: Male
  relevant_history:
  - seasonal allergies
  - anxiety
  - migraines
  age_at_reaction: 60
suspected_drugs:
- drug_name: Omeprazole
  dosage: 145mg
  route_of_administration: Oral
  start_date: '2024-07-11'
  indication_for_use: Gastroesophageal reflux disease
  end_date: '2024-08-16'
- drug_name: Atorvastatin
  dosage: 150mg
  route_of_administration: Intravenous
  start_date: '2024-07-11'
  indication_for_use: Hypercholesterolemia
  drug_class: Statin
  end_date: '2024-08-16'
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2024-08-15'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-08-15'
  severity: Severe
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed capital and advised physical.
- symptom_name: Angioedema
  onset_date: '2024-08-15'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed pick and advised machine.
- symptom_name: Dizziness
  onset_date: '2024-08-15'
  severity: Mild
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 8
reporting_facility: Davis-Johnson Medical Center
reporter_type: Physician
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