<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-2025-876
Date of Submission: 2025-02-16

This report was submitted by a Physician from Kelley, Kim and Soto Medical Center concerning patient ANON-PX-9862. The subject is a 59-year-old female with a significant medical history including seasonal allergies, osteoarthritis. 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 397mg, initiated on 2025-01-20 for Hypothyroidism and discontinued on 2025-02-12; Gabapentin (Anticonvulsant) administered via the Intravenous route at a dosage of 398mg, initiated on 2025-01-20 for Neuropathic pain and discontinued on 2025-02-12.

On approximately 2025-01-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Stevens-Johnson syndrome. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed modern and advised officer. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-876
report_date: '2025-02-16'
patient_details:
  patient_id: ANON-PX-9862
  gender: Female
  relevant_history:
  - seasonal allergies
  - osteoarthritis
  age_at_reaction: 59
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 397mg
  route_of_administration: Topical
  start_date: '2025-01-20'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
  end_date: '2025-02-12'
- drug_name: Gabapentin
  dosage: 398mg
  route_of_administration: Intravenous
  start_date: '2025-01-20'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
  end_date: '2025-02-12'
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2025-01-28'
  severity: Severe
  outcome: Recovered
  intervention_required: true
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-01-28'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed modern and advised officer.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Kelley, Kim and Soto Medical Center
reporter_type: Physician
