<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-2025-296
Date of Submission: 2025-07-11

This report was submitted by a Patient from Jenkins Inc Medical Center concerning patient ANON-PX-1911. The subject is an adult other with a significant medical history including migraines, atrial fibrillation, seasonal allergies, anxiety. 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 administered via the Intravenous route at a dosage of 483mg, initiated on 2025-06-27 for Type 2 diabetes and discontinued on 2025-07-09.

On approximately 2025-07-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Headache, Pruritus, Somnolence, Vomiting. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed action and advised evening. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed administration and advised about. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed police and advised reveal. The current patient status regarding this symptom is 'Recovered'. 

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. 

Reporter's Narrative Summary: Discussion former learn them one major tax now. Rule provide bag recent pick.</data>
report_id: ADR-2025-296
report_date: '2025-07-11'
patient_details:
  patient_id: ANON-PX-1911
  gender: Other
  relevant_history:
  - migraines
  - atrial fibrillation
  - seasonal allergies
  - anxiety
suspected_drugs:
- drug_name: Metformin
  dosage: 483mg
  route_of_administration: Intravenous
  start_date: '2025-06-27'
  indication_for_use: Type 2 diabetes
  end_date: '2025-07-09'
adverse_reactions:
- symptom_name: Nausea
  onset_date: '2025-07-05'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed action and advised evening.
- symptom_name: Headache
  onset_date: '2025-07-05'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
- symptom_name: Pruritus
  onset_date: '2025-07-05'
  severity: Severe
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed administration and advised about.
- symptom_name: Somnolence
  onset_date: '2025-07-05'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-07-05'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed police and advised reveal.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
reporting_facility: Jenkins Inc Medical Center
reporter_type: Patient
notes: Discussion former learn them one major tax now. Rule provide bag recent pick.
