<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-2025-420
Date of Submission: 2025-06-19

This report was submitted by a Other Healthcare Professional from Jones, Leonard and Henry Medical Center concerning patient ANON-PX-4058. The subject is a 48-year-old other with a significant medical history including chronic kidney disease, osteoarthritis, asthma, 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): Amoxicillin administered via the Topical route at a dosage of 321mg, initiated on 2025-05-31 for Bacterial infection with the course ongoing.

On approximately 2025-06-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Stevens-Johnson syndrome, Hepatotoxicity, Nausea, Maculopapular Rash. The Dizziness was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash 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. 

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report_id: ADR-2025-420
report_date: '2025-06-19'
patient_details:
  patient_id: ANON-PX-4058
  gender: Other
  relevant_history:
  - chronic kidney disease
  - osteoarthritis
  - asthma
  - coronary artery disease
  age_at_reaction: 48
suspected_drugs:
- drug_name: Amoxicillin
  dosage: 321mg
  route_of_administration: Topical
  start_date: '2025-05-31'
  indication_for_use: Bacterial infection
adverse_reactions:
- symptom_name: Dizziness
  onset_date: '2025-06-09'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-06-09'
  severity: Severe
  outcome: Recovered
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2025-06-09'
  severity: Mild
  outcome: Unknown
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2025-06-09'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2025-06-09'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 9
reporting_facility: Jones, Leonard and Henry Medical Center
reporter_type: Other Healthcare Professional
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  station.
