<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-2025-415
Date of Submission: 2025-02-25

This report was submitted by a Physician from Miranda, Taylor and Lowe Medical Center concerning patient ANON-PX-2713. The subject is a 72-year-old female with a significant medical history including seasonal allergies, atrial fibrillation, chronic kidney disease, 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): Lisinopril (ACE inhibitor) administered via the Subcutaneous route at a dosage of 155mg, initiated on 2025-01-14 for Hypertension with the course ongoing; Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 80mg, initiated on 2025-01-14 for Gastroesophageal reflux disease with the course ongoing.

On approximately 2025-02-08, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Anaphylaxis, Somnolence, Dizziness. The Nausea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed energy and advised natural. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-415
report_date: '2025-02-25'
patient_details:
  patient_id: ANON-PX-2713
  gender: Female
  relevant_history:
  - seasonal allergies
  - atrial fibrillation
  - chronic kidney disease
  - coronary artery disease
  age_at_reaction: 72
suspected_drugs:
- drug_name: Lisinopril
  dosage: 155mg
  route_of_administration: Subcutaneous
  start_date: '2025-01-14'
  indication_for_use: Hypertension
  drug_class: ACE inhibitor
- drug_name: Omeprazole
  dosage: 80mg
  route_of_administration: Subcutaneous
  start_date: '2025-01-14'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Nausea
  onset_date: '2025-02-08'
  severity: Mild
  outcome: Recovering
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2025-02-08'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-02-08'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed energy and advised natural.
- symptom_name: Dizziness
  onset_date: '2025-02-08'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
reporting_facility: Miranda, Taylor and Lowe Medical Center
reporter_type: Physician
