<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-2025-695
Date of Submission: 2025-05-06

This report was submitted by a Physician from Ferguson, Marshall and Sullivan Medical Center concerning patient ANON-PX-2823. The subject is a 58-year-old female with a significant medical history including atrial fibrillation, asthma. 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 Subcutaneous route at a dosage of 238mg, initiated on 2025-03-29 for Type 2 diabetes and discontinued on 2025-05-01; Atorvastatin (Statin) administered via the Intravenous route at a dosage of 278mg, initiated on 2025-03-29 for Hypercholesterolemia and discontinued on 2025-05-01.

On approximately 2025-04-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Somnolence, Pruritus, Nausea, Anaphylaxis. The Headache was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed reduce and advised certainly. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed people and advised budget. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 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. 

Reporter's Narrative Summary: Around generation building inside usually. Particular me trial. Matter bar cup professional consumer.</data>
report_id: ADR-2025-695
report_date: '2025-05-06'
patient_details:
  patient_id: ANON-PX-2823
  gender: Female
  relevant_history:
  - atrial fibrillation
  - asthma
  age_at_reaction: 58
suspected_drugs:
- drug_name: Metformin
  dosage: 238mg
  route_of_administration: Subcutaneous
  start_date: '2025-03-29'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2025-05-01'
- drug_name: Atorvastatin
  dosage: 278mg
  route_of_administration: Intravenous
  start_date: '2025-03-29'
  indication_for_use: Hypercholesterolemia
  drug_class: Statin
  end_date: '2025-05-01'
adverse_reactions:
- symptom_name: Headache
  onset_date: '2025-04-11'
  severity: Severe
  outcome: Unknown
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-04-11'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2025-04-11'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed reduce and advised certainly.
- symptom_name: Nausea
  onset_date: '2025-04-11'
  severity: Severe
  outcome: Recovering
  intervention_required: true
- symptom_name: Anaphylaxis
  onset_date: '2025-04-11'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed people and advised budget.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 8
reporting_facility: Ferguson, Marshall and Sullivan Medical Center
reporter_type: Physician
notes: Around generation building inside usually. Particular me trial. Matter bar
  cup professional consumer.
