<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-2025-130
Date of Submission: 2025-02-04

This report was submitted by a Pharmacist from Ross PLC Medical Center concerning patient ANON-PX-1531. The subject is a 74-year-old female with a significant medical history including chronic kidney disease, asthma, atrial fibrillation, hypertension. 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): Ibuprofen (NSAID) administered via the Subcutaneous route at a dosage of 431mg, initiated on 2024-11-15 for Pain and inflammation and discontinued on 2024-12-25.

On approximately 2024-11-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Anaphylaxis, Maculopapular Rash, Hepatotoxicity. The Nausea was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Maculopapular Rash was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-130
report_date: '2025-02-04'
patient_details:
  patient_id: ANON-PX-1531
  gender: Female
  relevant_history:
  - chronic kidney disease
  - asthma
  - atrial fibrillation
  - hypertension
  age_at_reaction: 74
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 431mg
  route_of_administration: Subcutaneous
  start_date: '2024-11-15'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2024-12-25'
adverse_reactions:
- symptom_name: Nausea
  onset_date: '2024-11-19'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
- symptom_name: Anaphylaxis
  onset_date: '2024-11-19'
  severity: Severe
  outcome: Recovering
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2024-11-19'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2024-11-19'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 9
reporting_facility: Ross PLC Medical Center
reporter_type: Pharmacist
