<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-2025-598
Date of Submission: 2025-02-03

This report was submitted by a Pharmacist from Sherman and Sons Medical Center concerning patient ANON-PX-4626. The subject is an adult male with a significant medical history including osteoarthritis, 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): Omeprazole administered via the Oral route at a dosage of 387mg, initiated on 2024-12-08 for Gastroesophageal reflux disease and discontinued on 2025-01-27; Metformin administered via the Oral route at a dosage of 69mg, initiated on 2024-12-08 for Type 2 diabetes and discontinued on 2025-01-27.

On approximately 2025-01-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Angioedema, Stevens-Johnson syndrome, Somnolence. The Vomiting was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. 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: Send include tough minute somebody attorney. Road some more past affect head street.</data>
report_id: ADR-2025-598
report_date: '2025-02-03'
patient_details:
  patient_id: ANON-PX-4626
  gender: Male
  relevant_history:
  - osteoarthritis
  - chronic kidney disease
suspected_drugs:
- drug_name: Omeprazole
  dosage: 387mg
  route_of_administration: Oral
  start_date: '2024-12-08'
  indication_for_use: Gastroesophageal reflux disease
  end_date: '2025-01-27'
- drug_name: Metformin
  dosage: 69mg
  route_of_administration: Oral
  start_date: '2024-12-08'
  indication_for_use: Type 2 diabetes
  end_date: '2025-01-27'
adverse_reactions:
- symptom_name: Vomiting
  onset_date: '2025-01-02'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
- symptom_name: Angioedema
  onset_date: '2025-01-02'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-01-02'
  severity: Severe
  outcome: Recovering
  intervention_required: true
- symptom_name: Somnolence
  onset_date: '2025-01-02'
  severity: Mild
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
reporting_facility: Sherman and Sons Medical Center
reporter_type: Pharmacist
notes: Send include tough minute somebody attorney. Road some more past affect head
  street.
