<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-2024-208
Date of Submission: 2024-12-05

This report was submitted by a Patient from Thomas Ltd Medical Center concerning patient ANON-PX-8157. The subject is a 74-year-old female with a significant medical history including coronary artery disease, atrial fibrillation, hypertension, chronic kidney disease. 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): Levothyroxine (Thyroid hormone) administered via the Subcutaneous route at a dosage of 144mg, initiated on 2024-10-21 for Hypothyroidism with the course ongoing.

On approximately 2024-11-22, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Maculopapular Rash, Headache, Stevens-Johnson syndrome. The Dizziness was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 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-2024-208
report_date: '2024-12-05'
patient_details:
  patient_id: ANON-PX-8157
  gender: Female
  relevant_history:
  - coronary artery disease
  - atrial fibrillation
  - hypertension
  - chronic kidney disease
  age_at_reaction: 74
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 144mg
  route_of_administration: Subcutaneous
  start_date: '2024-10-21'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
adverse_reactions:
- symptom_name: Dizziness
  onset_date: '2024-11-22'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
- symptom_name: Maculopapular Rash
  onset_date: '2024-11-22'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Headache
  onset_date: '2024-11-22'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-11-22'
  severity: Mild
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Not applicable
  naranjo_score: 2
reporting_facility: Thomas Ltd Medical Center
reporter_type: Patient
