<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-2024-331
Date of Submission: 2024-09-07

This report was submitted by a Physician from Butler PLC Medical Center concerning patient ANON-PX-5863. The subject is an adult male with a significant medical history including chronic kidney disease, 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): Lisinopril (ACE inhibitor) administered via the Oral route at a dosage of 293mg, initiated on 2024-07-14 for Hypertension and discontinued on 2024-09-06; Ibuprofen administered via the Intramuscular route at a dosage of 469mg, initiated on 2024-07-14 for Pain and inflammation and discontinued on 2024-09-06.

On approximately 2024-09-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Somnolence, Nausea, Vomiting, Angioedema. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed show and advised child. The current patient status regarding this symptom is 'Recovered'. The Nausea was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. 

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-2024-331
report_date: '2024-09-07'
patient_details:
  patient_id: ANON-PX-5863
  gender: Male
  relevant_history:
  - chronic kidney disease
  - osteoarthritis
suspected_drugs:
- drug_name: Lisinopril
  dosage: 293mg
  route_of_administration: Oral
  start_date: '2024-07-14'
  indication_for_use: Hypertension
  drug_class: ACE inhibitor
  end_date: '2024-09-06'
- drug_name: Ibuprofen
  dosage: 469mg
  route_of_administration: Intramuscular
  start_date: '2024-07-14'
  indication_for_use: Pain and inflammation
  end_date: '2024-09-06'
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2024-09-02'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: true
- symptom_name: Somnolence
  onset_date: '2024-09-02'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed show and advised child.
- symptom_name: Nausea
  onset_date: '2024-09-02'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
- symptom_name: Vomiting
  onset_date: '2024-09-02'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
- symptom_name: Angioedema
  onset_date: '2024-09-02'
  severity: Mild
  outcome: Unknown
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
reporting_facility: Butler PLC Medical Center
reporter_type: Physician
