<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-2025-985
Date of Submission: 2025-01-16

This report was submitted by a Nurse from Mays, Holland and Guzman Medical Center concerning patient ANON-PX-5579. The subject is a 46-year-old female with a significant medical history including osteoarthritis, hypertension, asthma, coronary artery disease. 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 (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 301mg, initiated on 2024-12-22 for Gastroesophageal reflux disease and discontinued on 2025-01-14; Ibuprofen administered via the Topical route at a dosage of 149mg, initiated on 2024-12-22 for Pain and inflammation and discontinued on 2025-01-14.

On approximately 2025-01-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Somnolence, Headache, Angioedema. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed reason and advised give. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Headache was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Real cold physical recent. Give adult recognize manage. Hit treatment at. Firm call always whatever play game must artist.</data>
report_id: ADR-2025-985
report_date: '2025-01-16'
patient_details:
  patient_id: ANON-PX-5579
  gender: Female
  relevant_history:
  - osteoarthritis
  - hypertension
  - asthma
  - coronary artery disease
  age_at_reaction: 46
suspected_drugs:
- drug_name: Omeprazole
  dosage: 301mg
  route_of_administration: Subcutaneous
  start_date: '2024-12-22'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2025-01-14'
- drug_name: Ibuprofen
  dosage: 149mg
  route_of_administration: Topical
  start_date: '2024-12-22'
  indication_for_use: Pain and inflammation
  end_date: '2025-01-14'
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2025-01-12'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed reason and advised give.
- symptom_name: Somnolence
  onset_date: '2025-01-12'
  severity: Mild
  outcome: Fatal
  intervention_required: false
- symptom_name: Headache
  onset_date: '2025-01-12'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2025-01-12'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Mays, Holland and Guzman Medical Center
reporter_type: Nurse
notes: Real cold physical recent. Give adult recognize manage. Hit treatment at. Firm
  call always whatever play game must artist.
