<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-2024-656
Date of Submission: 2024-12-13

This report was submitted by a Nurse from White-Huffman Medical Center concerning patient ANON-PX-6861. The subject is a 86-year-old female with a significant medical history including osteoarthritis, seasonal allergies, hypertension. 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 Subcutaneous route at a dosage of 372mg, initiated on 2024-11-18 for Hypothyroidism and discontinued on 2024-11-27.

On approximately 2024-11-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Dizziness, Somnolence. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed he and advised hard. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed same and advised let. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-656
report_date: '2024-12-13'
patient_details:
  patient_id: ANON-PX-6861
  gender: Female
  relevant_history:
  - osteoarthritis
  - seasonal allergies
  - hypertension
  age_at_reaction: 86
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 372mg
  route_of_administration: Subcutaneous
  start_date: '2024-11-18'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
  end_date: '2024-11-27'
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2024-11-24'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed he and advised hard.
- symptom_name: Dizziness
  onset_date: '2024-11-24'
  severity: Mild
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2024-11-24'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed same and advised let.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 2
reporting_facility: White-Huffman Medical Center
reporter_type: Nurse
