<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-2025-385
Date of Submission: 2025-01-02

This report was submitted by a Other Healthcare Professional from Proctor Ltd Medical Center concerning patient ANON-PX-3266. The subject is a 60-year-old female with a significant medical history including atrial fibrillation, hypertension, coronary artery 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 Topical route at a dosage of 338mg, initiated on 2024-10-08 for Type 2 diabetes and discontinued on 2024-12-20; Omeprazole administered via the Intramuscular route at a dosage of 100mg, initiated on 2024-10-08 for Gastroesophageal reflux disease and discontinued on 2024-12-20.

On approximately 2024-11-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Vomiting, Dizziness, Headache, Diarrhea. The Stevens-Johnson syndrome was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Vomiting was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed low and advised green. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed culture and advised action. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Ask road he drop guess activity. Cultural visit court social media into resource. Specific send eight.</data>
report_id: ADR-2025-385
report_date: '2025-01-02'
patient_details:
  patient_id: ANON-PX-3266
  gender: Female
  relevant_history:
  - atrial fibrillation
  - hypertension
  - coronary artery disease
  age_at_reaction: 60
suspected_drugs:
- drug_name: Metformin
  dosage: 338mg
  route_of_administration: Topical
  start_date: '2024-10-08'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2024-12-20'
- drug_name: Omeprazole
  dosage: 100mg
  route_of_administration: Intramuscular
  start_date: '2024-10-08'
  indication_for_use: Gastroesophageal reflux disease
  end_date: '2024-12-20'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-11-01'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2024-11-01'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Dizziness
  onset_date: '2024-11-01'
  severity: Severe
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed low and advised green.
- symptom_name: Headache
  onset_date: '2024-11-01'
  severity: Severe
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed culture and advised action.
- symptom_name: Diarrhea
  onset_date: '2024-11-01'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 7
reporting_facility: Proctor Ltd Medical Center
reporter_type: Other Healthcare Professional
notes: Ask road he drop guess activity. Cultural visit court social media into resource.
  Specific send eight.
