<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-2025-814
Date of Submission: 2025-03-16

This report was submitted by a Patient from Oneal LLC Medical Center concerning patient ANON-PX-9413. The subject is a 85-year-old other with a significant medical history including migraines, atrial fibrillation. 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 327mg, initiated on 2025-03-05 for Hypothyroidism and discontinued on 2025-03-12.

On approximately 2025-03-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Maculopapular Rash, Hepatotoxicity, Nausea. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed laugh and advised play. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Nausea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed line and advised third. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Describe any south. Camera determine one artist from body sound.</data>
report_id: ADR-2025-814
report_date: '2025-03-16'
patient_details:
  patient_id: ANON-PX-9413
  gender: Other
  relevant_history:
  - migraines
  - atrial fibrillation
  age_at_reaction: 85
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 327mg
  route_of_administration: Topical
  start_date: '2025-03-05'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
  end_date: '2025-03-12'
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2025-03-09'
  severity: Mild
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed laugh and advised play.
- symptom_name: Maculopapular Rash
  onset_date: '2025-03-09'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2025-03-09'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
- symptom_name: Nausea
  onset_date: '2025-03-09'
  severity: Mild
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed line and advised third.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 5
reporting_facility: Oneal LLC Medical Center
reporter_type: Patient
notes: Describe any south. Camera determine one artist from body sound.
