<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-2024-798
Date of Submission: 2024-10-24

This report was submitted by a Physician from Casey, Mills and Beasley Medical Center concerning patient ANON-PX-9912. The subject is a 58-year-old other with a significant medical history including coronary artery disease, type 2 diabetes, migraines. 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): Amoxicillin (Penicillin antibiotic) administered via the Intravenous route at a dosage of 203mg, initiated on 2024-09-24 for Bacterial infection and discontinued on 2024-10-19; Metformin (Biguanide) administered via the Intravenous route at a dosage of 264mg, initiated on 2024-09-24 for Type 2 diabetes and discontinued on 2024-10-19.

On approximately 2024-10-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Hepatotoxicity, Dizziness, Anaphylaxis, Stevens-Johnson syndrome. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed enough and advised station. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis 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 Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. 

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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-798
report_date: '2024-10-24'
patient_details:
  patient_id: ANON-PX-9912
  gender: Other
  relevant_history:
  - coronary artery disease
  - type 2 diabetes
  - migraines
  age_at_reaction: 58
suspected_drugs:
- drug_name: Amoxicillin
  dosage: 203mg
  route_of_administration: Intravenous
  start_date: '2024-09-24'
  indication_for_use: Bacterial infection
  drug_class: Penicillin antibiotic
  end_date: '2024-10-19'
- drug_name: Metformin
  dosage: 264mg
  route_of_administration: Intravenous
  start_date: '2024-09-24'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2024-10-19'
adverse_reactions:
- symptom_name: Pruritus
  onset_date: '2024-10-15'
  severity: Mild
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed enough and advised station.
- symptom_name: Hepatotoxicity
  onset_date: '2024-10-15'
  severity: Mild
  outcome: Recovering
  intervention_required: true
- symptom_name: Dizziness
  onset_date: '2024-10-15'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2024-10-15'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-10-15'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 9
reporting_facility: Casey, Mills and Beasley Medical Center
reporter_type: Physician
