<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-2025-764
Date of Submission: 2025-08-05

This report was submitted by a Nurse from Arroyo-Figueroa Medical Center concerning patient ANON-PX-4113. The subject is a 54-year-old female with a significant medical history including type 2 diabetes, chronic kidney 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 425mg, initiated on 2025-07-15 for Bacterial infection and discontinued on 2025-08-04.

On approximately 2025-08-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Angioedema. The Vomiting was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed listen and advised middle. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 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. 

</data>
report_id: ADR-2025-764
report_date: '2025-08-05'
patient_details:
  patient_id: ANON-PX-4113
  gender: Female
  relevant_history:
  - type 2 diabetes
  - chronic kidney disease
  age_at_reaction: 54
suspected_drugs:
- drug_name: Amoxicillin
  dosage: 425mg
  route_of_administration: Oral
  start_date: '2025-07-15'
  indication_for_use: Bacterial infection
  drug_class: Penicillin antibiotic
  end_date: '2025-08-04'
adverse_reactions:
- symptom_name: Vomiting
  onset_date: '2025-08-02'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
- symptom_name: Angioedema
  onset_date: '2025-08-02'
  severity: Mild
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed listen and advised middle.
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 10
reporting_facility: Arroyo-Figueroa Medical Center
reporter_type: Nurse
