<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-2024-947
Date of Submission: 2024-09-22

This report was submitted by a Nurse from Deleon-Taylor Medical Center concerning patient ANON-PX-4426. The subject is a 69-year-old other with a significant medical history including hypertension, osteoarthritis. 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 Subcutaneous route at a dosage of 403mg, initiated on 2024-08-27 for Gastroesophageal reflux disease and discontinued on 2024-09-19; Metformin (Biguanide) administered via the Topical route at a dosage of 35mg, initiated on 2024-08-27 for Type 2 diabetes and discontinued on 2024-09-19.

On approximately 2024-09-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Headache, Angioedema, Stevens-Johnson syndrome. The Dizziness was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed tough and advised hand. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed find and advised low. 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. 

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report_id: ADR-2024-947
report_date: '2024-09-22'
patient_details:
  patient_id: ANON-PX-4426
  gender: Other
  relevant_history:
  - hypertension
  - osteoarthritis
  age_at_reaction: 69
suspected_drugs:
- drug_name: Omeprazole
  dosage: 403mg
  route_of_administration: Subcutaneous
  start_date: '2024-08-27'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2024-09-19'
- drug_name: Metformin
  dosage: 35mg
  route_of_administration: Topical
  start_date: '2024-08-27'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2024-09-19'
adverse_reactions:
- symptom_name: Dizziness
  onset_date: '2024-09-19'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Headache
  onset_date: '2024-09-19'
  severity: Mild
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed tough and advised hand.
- symptom_name: Angioedema
  onset_date: '2024-09-19'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-09-19'
  severity: Mild
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed find and advised low.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 1
reporting_facility: Deleon-Taylor Medical Center
reporter_type: Nurse
notes: Nor safe firm alone I share. Eye though edge business write popular offer back.
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