<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-2025-444
Date of Submission: 2025-05-23

This report was submitted by a Nurse from Marshall, Noble and Gonzalez Medical Center concerning patient ANON-PX-4363. The subject is a 55-year-old male with a significant medical history including type 2 diabetes, seasonal allergies. 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 Topical route at a dosage of 15mg, initiated on 2025-03-13 for Gastroesophageal reflux disease with the course ongoing; Metformin administered via the Intramuscular route at a dosage of 245mg, initiated on 2025-03-13 for Type 2 diabetes with the course ongoing.

On approximately 2025-04-10, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Dizziness, Nausea. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-444
report_date: '2025-05-23'
patient_details:
  patient_id: ANON-PX-4363
  gender: Male
  relevant_history:
  - type 2 diabetes
  - seasonal allergies
  age_at_reaction: 55
suspected_drugs:
- drug_name: Omeprazole
  dosage: 15mg
  route_of_administration: Topical
  start_date: '2025-03-13'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
- drug_name: Metformin
  dosage: 245mg
  route_of_administration: Intramuscular
  start_date: '2025-03-13'
  indication_for_use: Type 2 diabetes
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2025-04-10'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
- symptom_name: Dizziness
  onset_date: '2025-04-10'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
- symptom_name: Nausea
  onset_date: '2025-04-10'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 7
reporting_facility: Marshall, Noble and Gonzalez Medical Center
reporter_type: Nurse
