<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-2025-718
Date of Submission: 2025-03-09

This report was submitted by a Patient from Hayes Ltd Medical Center concerning patient ANON-PX-4741. The subject is a 32-year-old female with a significant medical history including seasonal allergies, type 2 diabetes, atrial fibrillation. 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 Topical route at a dosage of 375mg, initiated on 2025-01-19 for Gastroesophageal reflux disease and discontinued on 2025-03-02; Metformin (Biguanide) administered via the Topical route at a dosage of 230mg, initiated on 2025-01-19 for Type 2 diabetes and discontinued on 2025-03-02.

On approximately 2025-02-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Headache, Stevens-Johnson syndrome, Anaphylaxis, Nausea. The Angioedema was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed possible and advised peace. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed ever and advised head. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed red and advised doctor. The current patient status regarding this symptom is 'Not Recovered'. 

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-2025-718
report_date: '2025-03-09'
patient_details:
  patient_id: ANON-PX-4741
  gender: Female
  relevant_history:
  - seasonal allergies
  - type 2 diabetes
  - atrial fibrillation
  age_at_reaction: 32
suspected_drugs:
- drug_name: Omeprazole
  dosage: 375mg
  route_of_administration: Topical
  start_date: '2025-01-19'
  indication_for_use: Gastroesophageal reflux disease
  end_date: '2025-03-02'
- drug_name: Metformin
  dosage: 230mg
  route_of_administration: Topical
  start_date: '2025-01-19'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2025-03-02'
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2025-02-27'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Headache
  onset_date: '2025-02-27'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed possible and advised peace.
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-02-27'
  severity: Mild
  outcome: Recovering
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2025-02-27'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed ever and advised head.
- symptom_name: Nausea
  onset_date: '2025-02-27'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed red and advised doctor.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Not applicable
  naranjo_score: 3
reporting_facility: Hayes Ltd Medical Center
reporter_type: Patient
