<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-2024-284
Date of Submission: 2024-12-03

This report was submitted by a Pharmacist from Nelson-Rios Medical Center concerning patient ANON-PX-5393. The subject is a 60-year-old male with a significant medical history including asthma, 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): Metformin administered via the Topical route at a dosage of 432mg, initiated on 2024-11-25 for Type 2 diabetes and discontinued on 2024-12-01.

On approximately 2024-11-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Somnolence, Anaphylaxis. The Stevens-Johnson syndrome was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Anaphylaxis was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. 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: Onto pattern indicate car several as. Play land wall their whether. Identify reduce ago spend issue. Concern forget letter.</data>
report_id: ADR-2024-284
report_date: '2024-12-03'
patient_details:
  patient_id: ANON-PX-5393
  gender: Male
  relevant_history:
  - asthma
  - osteoarthritis
  age_at_reaction: 60
suspected_drugs:
- drug_name: Metformin
  dosage: 432mg
  route_of_administration: Topical
  start_date: '2024-11-25'
  indication_for_use: Type 2 diabetes
  end_date: '2024-12-01'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-11-30'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2024-11-30'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2024-11-30'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 8
reporting_facility: Nelson-Rios Medical Center
reporter_type: Pharmacist
notes: Onto pattern indicate car several as. Play land wall their whether. Identify
  reduce ago spend issue. Concern forget letter.
