<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-2025-838
Date of Submission: 2025-03-14

This report was submitted by a Physician from King, Cross and Gutierrez Medical Center concerning patient ANON-PX-7250. The subject is an adult female with a significant medical history including asthma, type 2 diabetes, 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): Omeprazole administered via the Subcutaneous route at a dosage of 241mg, initiated on 2025-02-06 for Gastroesophageal reflux disease and discontinued on 2025-03-05; Atorvastatin administered via the Oral route at a dosage of 281mg, initiated on 2025-02-06 for Hypercholesterolemia and discontinued on 2025-03-05.

On approximately 2025-03-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Dizziness, Stevens-Johnson syndrome, Angioedema, Maculopapular Rash. The Somnolence was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed dream and advised specific. 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 'Unknown'. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed customer and advised strategy. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed week and advised role. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Mean be into leg partner almost.</data>
report_id: ADR-2025-838
report_date: '2025-03-14'
patient_details:
  patient_id: ANON-PX-7250
  gender: Female
  relevant_history:
  - asthma
  - type 2 diabetes
  - hypertension
suspected_drugs:
- drug_name: Omeprazole
  dosage: 241mg
  route_of_administration: Subcutaneous
  start_date: '2025-02-06'
  indication_for_use: Gastroesophageal reflux disease
  end_date: '2025-03-05'
- drug_name: Atorvastatin
  dosage: 281mg
  route_of_administration: Oral
  start_date: '2025-02-06'
  indication_for_use: Hypercholesterolemia
  end_date: '2025-03-05'
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2025-03-01'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Dizziness
  onset_date: '2025-03-01'
  severity: Severe
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed dream and advised specific.
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-03-01'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2025-03-01'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed customer and advised strategy.
- symptom_name: Maculopapular Rash
  onset_date: '2025-03-01'
  severity: Severe
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed week and advised role.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 1
reporting_facility: King, Cross and Gutierrez Medical Center
reporter_type: Physician
notes: Mean be into leg partner almost.
