<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-2025-878
Date of Submission: 2025-06-08

This report was submitted by a Nurse from Anderson, Rivas and Holmes Medical Center concerning patient ANON-PX-5423. The subject is an adult male with a significant medical history including seasonal allergies, chronic kidney disease, 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): Levothyroxine administered via the Topical route at a dosage of 159mg, initiated on 2025-05-22 for Hypothyroidism and discontinued on 2025-06-06.

On approximately 2025-06-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Headache, Stevens-Johnson syndrome, Vomiting, Hepatotoxicity. The Maculopapular Rash was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed media and advised summer. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed size and advised only. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-878
report_date: '2025-06-08'
patient_details:
  patient_id: ANON-PX-5423
  gender: Male
  relevant_history:
  - seasonal allergies
  - chronic kidney disease
  - type 2 diabetes
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 159mg
  route_of_administration: Topical
  start_date: '2025-05-22'
  indication_for_use: Hypothyroidism
  end_date: '2025-06-06'
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2025-06-05'
  severity: Mild
  outcome: Recovered
  intervention_required: true
- symptom_name: Headache
  onset_date: '2025-06-05'
  severity: Severe
  outcome: Recovering
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-06-05'
  severity: Mild
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed media and advised summer.
- symptom_name: Vomiting
  onset_date: '2025-06-05'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2025-06-05'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed size and advised only.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 6
reporting_facility: Anderson, Rivas and Holmes Medical Center
reporter_type: Nurse
