<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-2025-641
Date of Submission: 2025-07-22

This report was submitted by a Patient from Lee, Whitaker and Green Medical Center concerning patient ANON-PX-6358. The subject is a 53-year-old male with a significant medical history including type 2 diabetes, 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): Amoxicillin (Penicillin antibiotic) administered via the Intravenous route at a dosage of 273mg, initiated on 2025-06-18 for Bacterial infection and discontinued on 2025-07-14.

On approximately 2025-07-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Somnolence, Stevens-Johnson syndrome, Maculopapular Rash. The Vomiting was classified as Severe 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 'Recovered'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed price and advised my. The current patient status regarding this symptom is 'Recovering'. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-641
report_date: '2025-07-22'
patient_details:
  patient_id: ANON-PX-6358
  gender: Male
  relevant_history:
  - type 2 diabetes
  - osteoarthritis
  age_at_reaction: 53
suspected_drugs:
- drug_name: Amoxicillin
  dosage: 273mg
  route_of_administration: Intravenous
  start_date: '2025-06-18'
  indication_for_use: Bacterial infection
  drug_class: Penicillin antibiotic
  end_date: '2025-07-14'
adverse_reactions:
- symptom_name: Vomiting
  onset_date: '2025-07-13'
  severity: Severe
  outcome: Unknown
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-07-13'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-07-13'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed price and advised my.
- symptom_name: Maculopapular Rash
  onset_date: '2025-07-13'
  severity: Severe
  outcome: Fatal
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
reporting_facility: Lee, Whitaker and Green Medical Center
reporter_type: Patient
