<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-2025-568
Date of Submission: 2025-01-15

This report was submitted by a Other Healthcare Professional from Levy Group Medical Center concerning patient ANON-PX-2859. The subject is an adult other with a significant medical history including asthma, anxiety, 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 (Proton-pump inhibitor) administered via the Topical route at a dosage of 131mg, initiated on 2024-11-13 for Gastroesophageal reflux disease and discontinued on 2024-12-21; Metformin (Biguanide) administered via the Intramuscular route at a dosage of 302mg, initiated on 2024-11-13 for Type 2 diabetes and discontinued on 2024-12-21.

On approximately 2024-11-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Stevens-Johnson syndrome. 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 Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. 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-2025-568
report_date: '2025-01-15'
patient_details:
  patient_id: ANON-PX-2859
  gender: Other
  relevant_history:
  - asthma
  - anxiety
  - hypertension
suspected_drugs:
- drug_name: Omeprazole
  dosage: 131mg
  route_of_administration: Topical
  start_date: '2024-11-13'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2024-12-21'
- drug_name: Metformin
  dosage: 302mg
  route_of_administration: Intramuscular
  start_date: '2024-11-13'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2024-12-21'
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2024-11-27'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-11-27'
  severity: Mild
  outcome: Recovering
  intervention_required: true
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 10
reporting_facility: Levy Group Medical Center
reporter_type: Other Healthcare Professional
