<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-2025-315
Date of Submission: 2025-05-03

This report was submitted by a Patient from Sandoval, Jones and Ward Medical Center concerning patient ANON-PX-8747. The subject is a 49-year-old other with a significant medical history including anxiety, 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): Omeprazole administered via the Topical route at a dosage of 236mg, initiated on 2025-02-10 for Gastroesophageal reflux disease and discontinued on 2025-04-26; Ibuprofen administered via the Intravenous route at a dosage of 244mg, initiated on 2025-02-10 for Pain and inflammation and discontinued on 2025-04-26.

On approximately 2025-04-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Angioedema, Dizziness, Headache, Maculopapular Rash. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed who and advised early. The current patient status regarding this symptom is 'Fatal'. The Angioedema was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed give and advised quality. The current patient status regarding this symptom is 'Fatal'. The Headache was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed feeling and advised various. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. 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-2025-315
report_date: '2025-05-03'
patient_details:
  patient_id: ANON-PX-8747
  gender: Other
  relevant_history:
  - anxiety
  - type 2 diabetes
  age_at_reaction: 49
suspected_drugs:
- drug_name: Omeprazole
  dosage: 236mg
  route_of_administration: Topical
  start_date: '2025-02-10'
  indication_for_use: Gastroesophageal reflux disease
  end_date: '2025-04-26'
- drug_name: Ibuprofen
  dosage: 244mg
  route_of_administration: Intravenous
  start_date: '2025-02-10'
  indication_for_use: Pain and inflammation
  end_date: '2025-04-26'
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2025-04-17'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed who and advised early.
- symptom_name: Angioedema
  onset_date: '2025-04-17'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Dizziness
  onset_date: '2025-04-17'
  severity: Mild
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed give and advised quality.
- symptom_name: Headache
  onset_date: '2025-04-17'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed feeling and advised various.
- symptom_name: Maculopapular Rash
  onset_date: '2025-04-17'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 1
reporting_facility: Sandoval, Jones and Ward Medical Center
reporter_type: Patient
