<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-2024-309
Date of Submission: 2024-12-26

This report was submitted by a Physician from Hopkins PLC Medical Center concerning patient ANON-PX-3418. The subject is a 70-year-old other with a significant medical history including hypertension, migraines, coronary artery 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 Topical route at a dosage of 366mg, initiated on 2024-11-26 for Hypothyroidism and discontinued on 2024-12-20.

On approximately 2024-12-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Nausea, Dizziness, Angioedema, Diarrhea. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed present and advised newspaper. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-309
report_date: '2024-12-26'
patient_details:
  patient_id: ANON-PX-3418
  gender: Other
  relevant_history:
  - hypertension
  - migraines
  - coronary artery disease
  age_at_reaction: 70
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 366mg
  route_of_administration: Topical
  start_date: '2024-11-26'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
  end_date: '2024-12-20'
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2024-12-01'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
- symptom_name: Nausea
  onset_date: '2024-12-01'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Dizziness
  onset_date: '2024-12-01'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed present and advised newspaper.
- symptom_name: Angioedema
  onset_date: '2024-12-01'
  severity: Mild
  outcome: Recovering
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2024-12-01'
  severity: Mild
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 1
reporting_facility: Hopkins PLC Medical Center
reporter_type: Physician
