<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-2025-741
Date of Submission: 2025-08-04

This report was submitted by a Other Healthcare Professional from Arroyo Ltd Medical Center concerning patient ANON-PX-3547. The subject is a 68-year-old female with a significant medical history including chronic kidney disease, coronary artery disease, anxiety. 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 administered via the Subcutaneous route at a dosage of 258mg, initiated on 2025-06-27 for Hypercholesterolemia with the course ongoing; Omeprazole (Proton-pump inhibitor) administered via the Topical route at a dosage of 342mg, initiated on 2025-06-27 for Gastroesophageal reflux disease with the course ongoing.

On approximately 2025-07-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Anaphylaxis. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed consumer and advised this. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 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. 

</data>
report_id: ADR-2025-741
report_date: '2025-08-04'
patient_details:
  patient_id: ANON-PX-3547
  gender: Female
  relevant_history:
  - chronic kidney disease
  - coronary artery disease
  - anxiety
  age_at_reaction: 68
suspected_drugs:
- drug_name: Atorvastatin
  dosage: 258mg
  route_of_administration: Subcutaneous
  start_date: '2025-06-27'
  indication_for_use: Hypercholesterolemia
- drug_name: Omeprazole
  dosage: 342mg
  route_of_administration: Topical
  start_date: '2025-06-27'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-07-30'
  severity: Mild
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed consumer and advised this.
- symptom_name: Anaphylaxis
  onset_date: '2025-07-30'
  severity: Mild
  outcome: Fatal
  intervention_required: true
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Not applicable
  naranjo_score: 3
reporting_facility: Arroyo Ltd Medical Center
reporter_type: Other Healthcare Professional
