<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-2024-396
Date of Submission: 2024-11-25

This report was submitted by a Patient from Rodriguez Inc Medical Center concerning patient ANON-PX-4543. The subject is an adult female with a significant medical history including hypertension, migraines. 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 431mg, initiated on 2024-09-06 for Hypothyroidism and discontinued on 2024-11-10.

On approximately 2024-11-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Somnolence, Pruritus, Maculopapular Rash. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed what and advised firm. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Pruritus was classified as Moderate 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 information and advised information. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. 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-2024-396
report_date: '2024-11-25'
patient_details:
  patient_id: ANON-PX-4543
  gender: Female
  relevant_history:
  - hypertension
  - migraines
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 431mg
  route_of_administration: Topical
  start_date: '2024-09-06'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
  end_date: '2024-11-10'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2024-11-01'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed what and advised firm.
- symptom_name: Somnolence
  onset_date: '2024-11-01'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2024-11-01'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2024-11-01'
  severity: Severe
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed information and advised information.
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 10
reporting_facility: Rodriguez Inc Medical Center
reporter_type: Patient
