<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-2025-174
Date of Submission: 2025-04-05

This report was submitted by a Nurse from Le Group Medical Center concerning patient ANON-PX-5436. The subject is a 32-year-old male with a significant medical history including type 2 diabetes, 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): Omeprazole administered via the Oral route at a dosage of 139mg, initiated on 2025-01-12 for Gastroesophageal reflux disease and discontinued on 2025-02-17.

On approximately 2025-02-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Nausea, Anaphylaxis, Angioedema. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed herself and advised away. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed television and advised able. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Severe 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 4 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-174
report_date: '2025-04-05'
patient_details:
  patient_id: ANON-PX-5436
  gender: Male
  relevant_history:
  - type 2 diabetes
  - osteoarthritis
  age_at_reaction: 32
suspected_drugs:
- drug_name: Omeprazole
  dosage: 139mg
  route_of_administration: Oral
  start_date: '2025-01-12'
  indication_for_use: Gastroesophageal reflux disease
  end_date: '2025-02-17'
adverse_reactions:
- symptom_name: Headache
  onset_date: '2025-02-02'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed herself and advised away.
- symptom_name: Nausea
  onset_date: '2025-02-02'
  severity: Severe
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed television and advised able.
- symptom_name: Anaphylaxis
  onset_date: '2025-02-02'
  severity: Mild
  outcome: Recovered
  intervention_required: true
- symptom_name: Angioedema
  onset_date: '2025-02-02'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Not applicable
  naranjo_score: 4
reporting_facility: Le Group Medical Center
reporter_type: Nurse
