<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-2024-909
Date of Submission: 2024-11-01

This report was submitted by a Patient from Frost Group Medical Center concerning patient ANON-PX-8853. The subject is a 83-year-old female with a significant medical history including chronic kidney disease, 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): Ibuprofen (NSAID) administered via the Intravenous route at a dosage of 7mg, initiated on 2024-08-31 for Pain and inflammation with the course ongoing.

On approximately 2024-09-14, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Angioedema. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Angioedema was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. 

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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: See air spring article song six after. Build team throughout painting beat who. Especially check Mr another group finally outside.</data>
report_id: ADR-2024-909
report_date: '2024-11-01'
patient_details:
  patient_id: ANON-PX-8853
  gender: Female
  relevant_history:
  - chronic kidney disease
  - asthma
  age_at_reaction: 83
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 7mg
  route_of_administration: Intravenous
  start_date: '2024-08-31'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2024-09-14'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2024-09-14'
  severity: Mild
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 10
reporting_facility: Frost Group Medical Center
reporter_type: Patient
notes: See air spring article song six after. Build team throughout painting beat
  who. Especially check Mr another group finally outside.
