<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-2025-188
Date of Submission: 2025-06-15

This report was submitted by a Other Healthcare Professional from Mcguire Inc Medical Center concerning patient ANON-PX-5262. The subject is an adult female with a significant medical history including osteoarthritis, atrial fibrillation, 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): Metformin (Biguanide) administered via the Topical route at a dosage of 338mg, initiated on 2025-04-26 for Type 2 diabetes with the course ongoing; Amoxicillin administered via the Subcutaneous route at a dosage of 490mg, initiated on 2025-04-26 for Bacterial infection with the course ongoing.

On approximately 2025-05-10, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Dizziness, Stevens-Johnson syndrome, Angioedema. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed language and advised send. The current patient status regarding this symptom is 'Unknown'. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed audience and advised eye. The current patient status regarding this symptom is 'Not 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Far project name matter despite hit begin. Movement system radio pretty morning.</data>
report_id: ADR-2025-188
report_date: '2025-06-15'
patient_details:
  patient_id: ANON-PX-5262
  gender: Female
  relevant_history:
  - osteoarthritis
  - atrial fibrillation
  - hypertension
suspected_drugs:
- drug_name: Metformin
  dosage: 338mg
  route_of_administration: Topical
  start_date: '2025-04-26'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
- drug_name: Amoxicillin
  dosage: 490mg
  route_of_administration: Subcutaneous
  start_date: '2025-04-26'
  indication_for_use: Bacterial infection
adverse_reactions:
- symptom_name: Pruritus
  onset_date: '2025-05-10'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed language and advised send.
- symptom_name: Dizziness
  onset_date: '2025-05-10'
  severity: Mild
  outcome: Recovered
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-05-10'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
- symptom_name: Angioedema
  onset_date: '2025-05-10'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed audience and advised eye.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 1
reporting_facility: Mcguire Inc Medical Center
reporter_type: Other Healthcare Professional
notes: Far project name matter despite hit begin. Movement system radio pretty morning.
