<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-2025-443
Date of Submission: 2025-07-20

This report was submitted by a Nurse from Anderson and Sons Medical Center concerning patient ANON-PX-9115. The subject is a 52-year-old male with a significant medical history including coronary artery disease, hypertension, seasonal allergies. 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 Oral route at a dosage of 317mg, initiated on 2025-07-08 for Bacterial infection and discontinued on 2025-07-13; Lisinopril (ACE inhibitor) administered via the Oral route at a dosage of 257mg, initiated on 2025-07-08 for Hypertension and discontinued on 2025-07-13.

On approximately 2025-07-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Hepatotoxicity, Angioedema, Pruritus, Anaphylaxis. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed total and advised season. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed when and advised ready. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 was calculated, The assessment concluded the relationship was 'Possible'. 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-2025-443
report_date: '2025-07-20'
patient_details:
  patient_id: ANON-PX-9115
  gender: Male
  relevant_history:
  - coronary artery disease
  - hypertension
  - seasonal allergies
  age_at_reaction: 52
suspected_drugs:
- drug_name: Amoxicillin
  dosage: 317mg
  route_of_administration: Oral
  start_date: '2025-07-08'
  indication_for_use: Bacterial infection
  end_date: '2025-07-13'
- drug_name: Lisinopril
  dosage: 257mg
  route_of_administration: Oral
  start_date: '2025-07-08'
  indication_for_use: Hypertension
  drug_class: ACE inhibitor
  end_date: '2025-07-13'
adverse_reactions:
- symptom_name: Nausea
  onset_date: '2025-07-12'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2025-07-12'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2025-07-12'
  severity: Mild
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed total and advised season.
- symptom_name: Pruritus
  onset_date: '2025-07-12'
  severity: Mild
  outcome: Recovered
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2025-07-12'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed when and advised ready.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 3
reporting_facility: Anderson and Sons Medical Center
reporter_type: Nurse
