<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-2025-547
Date of Submission: 2025-06-29

This report was submitted by a Patient from Mitchell-Gonzalez Medical Center concerning patient ANON-PX-9567. The subject is a 56-year-old other with a significant medical history including coronary artery disease, atrial fibrillation, osteoarthritis, asthma. 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 369mg, initiated on 2025-05-26 for Bacterial infection and discontinued on 2025-06-25; Ibuprofen (NSAID) administered via the Intravenous route at a dosage of 148mg, initiated on 2025-05-26 for Pain and inflammation and discontinued on 2025-06-25.

On approximately 2025-06-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Angioedema, Nausea, Hepatotoxicity. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed rest and advised machine. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed try and advised subject. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-547
report_date: '2025-06-29'
patient_details:
  patient_id: ANON-PX-9567
  gender: Other
  relevant_history:
  - coronary artery disease
  - atrial fibrillation
  - osteoarthritis
  - asthma
  age_at_reaction: 56
suspected_drugs:
- drug_name: Amoxicillin
  dosage: 369mg
  route_of_administration: Intravenous
  start_date: '2025-05-26'
  indication_for_use: Bacterial infection
  drug_class: Penicillin antibiotic
  end_date: '2025-06-25'
- drug_name: Ibuprofen
  dosage: 148mg
  route_of_administration: Intravenous
  start_date: '2025-05-26'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2025-06-25'
adverse_reactions:
- symptom_name: Anaphylaxis
  onset_date: '2025-06-19'
  severity: Severe
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed rest and advised machine.
- symptom_name: Angioedema
  onset_date: '2025-06-19'
  severity: Severe
  outcome: Recovering
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2025-06-19'
  severity: Severe
  outcome: Recovering
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2025-06-19'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed try and advised subject.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 6
reporting_facility: Mitchell-Gonzalez Medical Center
reporter_type: Patient
