<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-2025-781
Date of Submission: 2025-02-01

This report was submitted by a Nurse from Hart-Garrison Medical Center concerning patient ANON-PX-8745. The subject is a 65-year-old male with a significant medical history including asthma, chronic kidney disease, migraines, 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 (Proton-pump inhibitor) administered via the Oral route at a dosage of 63mg, initiated on 2024-11-24 for Gastroesophageal reflux disease with the course ongoing; Metformin (Biguanide) administered via the Oral route at a dosage of 25mg, initiated on 2024-11-24 for Type 2 diabetes with the course ongoing.

On approximately 2024-12-14, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Diarrhea, Somnolence, Hepatotoxicity. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed site and advised among. The current patient status regarding this symptom is 'Unknown'. The Diarrhea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed improve and advised most. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 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. 

Reporter's Narrative Summary: Walk couple rather. Write account letter view data. Sense us information stuff go successful.</data>
report_id: ADR-2025-781
report_date: '2025-02-01'
patient_details:
  patient_id: ANON-PX-8745
  gender: Male
  relevant_history:
  - asthma
  - chronic kidney disease
  - migraines
  - type 2 diabetes
  age_at_reaction: 65
suspected_drugs:
- drug_name: Omeprazole
  dosage: 63mg
  route_of_administration: Oral
  start_date: '2024-11-24'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
- drug_name: Metformin
  dosage: 25mg
  route_of_administration: Oral
  start_date: '2024-11-24'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
adverse_reactions:
- symptom_name: Nausea
  onset_date: '2024-12-14'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed site and advised among.
- symptom_name: Diarrhea
  onset_date: '2024-12-14'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2024-12-14'
  severity: Mild
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed improve and advised most.
- symptom_name: Hepatotoxicity
  onset_date: '2024-12-14'
  severity: Severe
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Not applicable
  naranjo_score: 3
reporting_facility: Hart-Garrison Medical Center
reporter_type: Nurse
notes: Walk couple rather. Write account letter view data. Sense us information stuff
  go successful.
