<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-2024-649
Date of Submission: 2024-10-15

This report was submitted by a Other Healthcare Professional from Murray-Edwards Medical Center concerning patient ANON-PX-2570. The subject is a 45-year-old other with a significant medical history including chronic kidney disease, atrial fibrillation, migraines. 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): Metformin (Biguanide) administered via the Oral route at a dosage of 134mg, initiated on 2024-08-12 for Type 2 diabetes and discontinued on 2024-10-11; Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 437mg, initiated on 2024-08-12 for Gastroesophageal reflux disease and discontinued on 2024-10-11.

On approximately 2024-09-26, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Diarrhea. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed cup and advised letter. The current patient status regarding this symptom is 'Fatal'. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed again and advised visit. The current patient status regarding this symptom is 'Unknown'. 

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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-649
report_date: '2024-10-15'
patient_details:
  patient_id: ANON-PX-2570
  gender: Other
  relevant_history:
  - chronic kidney disease
  - atrial fibrillation
  - migraines
  age_at_reaction: 45
suspected_drugs:
- drug_name: Metformin
  dosage: 134mg
  route_of_administration: Oral
  start_date: '2024-08-12'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2024-10-11'
- drug_name: Omeprazole
  dosage: 437mg
  route_of_administration: Subcutaneous
  start_date: '2024-08-12'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2024-10-11'
adverse_reactions:
- symptom_name: Vomiting
  onset_date: '2024-09-26'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed cup and advised letter.
- symptom_name: Diarrhea
  onset_date: '2024-09-26'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed again and advised visit.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Not applicable
  naranjo_score: 1
reporting_facility: Murray-Edwards Medical Center
reporter_type: Other Healthcare Professional
