<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-2025-178
Date of Submission: 2025-04-15

This report was submitted by a Patient from Lopez, Kelly and Thompson Medical Center concerning patient ANON-PX-5239. The subject is a 47-year-old female with a significant medical history including hypertension, 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 Intramuscular route at a dosage of 362mg, initiated on 2025-02-18 for Type 2 diabetes with the course ongoing; Warfarin (Anticoagulant) administered via the Oral route at a dosage of 104mg, initiated on 2025-02-18 for Thromboembolism prevention with the course ongoing.

On approximately 2025-02-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Diarrhea, Nausea, Pruritus. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed start and advised cup. The current patient status regarding this symptom is 'Recovering'. The Nausea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed beyond and advised listen. The current patient status regarding this symptom is 'Recovering'. The Pruritus 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 4 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Oil property call indicate get past benefit. Continue hospital participant. Head race another Mrs.</data>
report_id: ADR-2025-178
report_date: '2025-04-15'
patient_details:
  patient_id: ANON-PX-5239
  gender: Female
  relevant_history:
  - hypertension
  - migraines
  age_at_reaction: 47
suspected_drugs:
- drug_name: Metformin
  dosage: 362mg
  route_of_administration: Intramuscular
  start_date: '2025-02-18'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
- drug_name: Warfarin
  dosage: 104mg
  route_of_administration: Oral
  start_date: '2025-02-18'
  indication_for_use: Thromboembolism prevention
  drug_class: Anticoagulant
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2025-02-28'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: true
- symptom_name: Diarrhea
  onset_date: '2025-02-28'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed start and advised cup.
- symptom_name: Nausea
  onset_date: '2025-02-28'
  severity: Mild
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed beyond and advised listen.
- symptom_name: Pruritus
  onset_date: '2025-02-28'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 4
reporting_facility: Lopez, Kelly and Thompson Medical Center
reporter_type: Patient
notes: Oil property call indicate get past benefit. Continue hospital participant.
  Head race another Mrs.
