<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-2024-393
Date of Submission: 2024-10-06

This report was submitted by a Nurse from Harris-Taylor Medical Center concerning patient ANON-PX-8320. The subject is a 32-year-old female with a significant medical history including hypertension, type 2 diabetes. 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 Topical route at a dosage of 59mg, initiated on 2024-08-02 for Pain and inflammation and discontinued on 2024-09-17; Amoxicillin (Penicillin antibiotic) administered via the Intravenous route at a dosage of 167mg, initiated on 2024-08-02 for Bacterial infection and discontinued on 2024-09-17.

On approximately 2024-09-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Angioedema. The Dizziness was classified as Life-threatening 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. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. 

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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-393
report_date: '2024-10-06'
patient_details:
  patient_id: ANON-PX-8320
  gender: Female
  relevant_history:
  - hypertension
  - type 2 diabetes
  age_at_reaction: 32
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 59mg
  route_of_administration: Topical
  start_date: '2024-08-02'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2024-09-17'
- drug_name: Amoxicillin
  dosage: 167mg
  route_of_administration: Intravenous
  start_date: '2024-08-02'
  indication_for_use: Bacterial infection
  drug_class: Penicillin antibiotic
  end_date: '2024-09-17'
adverse_reactions:
- symptom_name: Dizziness
  onset_date: '2024-09-17'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2024-09-17'
  severity: Mild
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 9
reporting_facility: Harris-Taylor Medical Center
reporter_type: Nurse
