<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-2024-560
Date of Submission: 2024-09-19

This report was submitted by a Patient from James LLC Medical Center concerning patient ANON-PX-7232. The subject is a 78-year-old other with a significant medical history including chronic kidney disease, type 2 diabetes, 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): Amoxicillin (Penicillin antibiotic) administered via the Oral route at a dosage of 48mg, initiated on 2024-08-13 for Bacterial infection and discontinued on 2024-09-18.

On approximately 2024-08-31, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Diarrhea, Nausea, Stevens-Johnson syndrome, Hepatotoxicity. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed stock and advised scientist. The current patient status regarding this symptom is 'Recovered'. The Diarrhea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed order and advised oil. The current patient status regarding this symptom is 'Recovering'. 

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: Involve direction size involve weight. Society natural pressure. Check top various term.</data>
report_id: ADR-2024-560
report_date: '2024-09-19'
patient_details:
  patient_id: ANON-PX-7232
  gender: Other
  relevant_history:
  - chronic kidney disease
  - type 2 diabetes
  - hypertension
  - coronary artery disease
  age_at_reaction: 78
suspected_drugs:
- drug_name: Amoxicillin
  dosage: 48mg
  route_of_administration: Oral
  start_date: '2024-08-13'
  indication_for_use: Bacterial infection
  drug_class: Penicillin antibiotic
  end_date: '2024-09-18'
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2024-08-31'
  severity: Severe
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed stock and advised scientist.
- symptom_name: Diarrhea
  onset_date: '2024-08-31'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2024-08-31'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-08-31'
  severity: Mild
  outcome: Recovering
  intervention_required: true
- symptom_name: Hepatotoxicity
  onset_date: '2024-08-31'
  severity: Mild
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed order and advised oil.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 7
reporting_facility: James LLC Medical Center
reporter_type: Patient
notes: Involve direction size involve weight. Society natural pressure. Check top
  various term.
