<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-2025-456
Date of Submission: 2025-03-26

This report was submitted by a Other Healthcare Professional from Jones-Ramos Medical Center concerning patient ANON-PX-5257. The subject is a 70-year-old male with a significant medical history including hypertension, coronary artery disease, 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): Metformin (Biguanide) administered via the Subcutaneous route at a dosage of 50mg, initiated on 2025-03-05 for Type 2 diabetes and discontinued on 2025-03-24.

On approximately 2025-03-21, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Nausea, Stevens-Johnson syndrome, Somnolence, Anaphylaxis. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed hundred and advised concern. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed much and advised thing. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed like and advised really. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed determine and advised appear. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 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-2025-456
report_date: '2025-03-26'
patient_details:
  patient_id: ANON-PX-5257
  gender: Male
  relevant_history:
  - hypertension
  - coronary artery disease
  - chronic kidney disease
  age_at_reaction: 70
suspected_drugs:
- drug_name: Metformin
  dosage: 50mg
  route_of_administration: Subcutaneous
  start_date: '2025-03-05'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2025-03-24'
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2025-03-21'
  severity: Severe
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed hundred and advised concern.
- symptom_name: Nausea
  onset_date: '2025-03-21'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed much and advised thing.
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-03-21'
  severity: Severe
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed like and advised really.
- symptom_name: Somnolence
  onset_date: '2025-03-21'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed determine and advised appear.
- symptom_name: Anaphylaxis
  onset_date: '2025-03-21'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 9
reporting_facility: Jones-Ramos Medical Center
reporter_type: Other Healthcare Professional
