<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-2024-383
Date of Submission: 2024-09-18

This report was submitted by a Other Healthcare Professional from James Ltd Medical Center concerning patient ANON-PX-5415. The subject is an adult female with a significant medical history including atrial fibrillation, 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): Metformin (Biguanide) administered via the Intramuscular route at a dosage of 55mg, initiated on 2024-07-25 for Type 2 diabetes and discontinued on 2024-09-16; Sertraline (SSRI) administered via the Oral route at a dosage of 334mg, initiated on 2024-07-25 for Major depressive disorder and discontinued on 2024-09-16.

On approximately 2024-09-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Maculopapular Rash. The Dizziness was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed energy and advised positive. The current patient status regarding this symptom is 'Not Recovered'. 

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: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Letter pick financial message life foot guy. War position letter brother they natural everybody material. Late ready read performance would paper.</data>
report_id: ADR-2024-383
report_date: '2024-09-18'
patient_details:
  patient_id: ANON-PX-5415
  gender: Female
  relevant_history:
  - atrial fibrillation
  - type 2 diabetes
suspected_drugs:
- drug_name: Metformin
  dosage: 55mg
  route_of_administration: Intramuscular
  start_date: '2024-07-25'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2024-09-16'
- drug_name: Sertraline
  dosage: 334mg
  route_of_administration: Oral
  start_date: '2024-07-25'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2024-09-16'
adverse_reactions:
- symptom_name: Dizziness
  onset_date: '2024-09-15'
  severity: Severe
  outcome: Unknown
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2024-09-15'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed energy and advised positive.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 1
reporting_facility: James Ltd Medical Center
reporter_type: Other Healthcare Professional
notes: Letter pick financial message life foot guy. War position letter brother they
  natural everybody material. Late ready read performance would paper.
