<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-2025-654
Date of Submission: 2025-04-17

This report was submitted by a Patient from Burke Group Medical Center concerning patient ANON-PX-8369. The subject is an adult female with a significant medical history including migraines, osteoarthritis, 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): Levothyroxine (Thyroid hormone) administered via the Topical route at a dosage of 326mg, initiated on 2025-03-29 for Hypothyroidism and discontinued on 2025-04-14.

On approximately 2025-04-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Nausea, Dizziness, Stevens-Johnson syndrome, Vomiting. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed admit and advised push. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed size and advised then. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. 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 'Recovered'. The Vomiting was classified as Moderate 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 4 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-2025-654
report_date: '2025-04-17'
patient_details:
  patient_id: ANON-PX-8369
  gender: Female
  relevant_history:
  - migraines
  - osteoarthritis
  - asthma
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 326mg
  route_of_administration: Topical
  start_date: '2025-03-29'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
  end_date: '2025-04-14'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-04-12'
  severity: Severe
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed admit and advised push.
- symptom_name: Nausea
  onset_date: '2025-04-12'
  severity: Severe
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed size and advised then.
- symptom_name: Dizziness
  onset_date: '2025-04-12'
  severity: Severe
  outcome: Fatal
  intervention_required: true
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-04-12'
  severity: Mild
  outcome: Recovered
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-04-12'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Not applicable
  naranjo_score: 4
reporting_facility: Burke Group Medical Center
reporter_type: Patient
