<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-2025-461
Date of Submission: 2025-01-16

This report was submitted by a Physician from Garcia-Woods Medical Center concerning patient ANON-PX-9386. The subject is a 33-year-old other with a significant medical history including chronic kidney disease, hypertension, coronary artery disease, 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): Gabapentin (Anticonvulsant) administered via the Topical route at a dosage of 397mg, initiated on 2024-11-02 for Neuropathic pain and discontinued on 2024-12-12; Levothyroxine (Thyroid hormone) administered via the Intramuscular route at a dosage of 41mg, initiated on 2024-11-02 for Hypothyroidism and discontinued on 2024-12-12.

On approximately 2024-12-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Diarrhea, Somnolence. The Headache was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Diarrhea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed explain and advised area. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Purpose meet necessary worker serve. Between one budget country development office. Debate edge represent too situation make suffer.</data>
report_id: ADR-2025-461
report_date: '2025-01-16'
patient_details:
  patient_id: ANON-PX-9386
  gender: Other
  relevant_history:
  - chronic kidney disease
  - hypertension
  - coronary artery disease
  - atrial fibrillation
  age_at_reaction: 33
suspected_drugs:
- drug_name: Gabapentin
  dosage: 397mg
  route_of_administration: Topical
  start_date: '2024-11-02'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
  end_date: '2024-12-12'
- drug_name: Levothyroxine
  dosage: 41mg
  route_of_administration: Intramuscular
  start_date: '2024-11-02'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
  end_date: '2024-12-12'
adverse_reactions:
- symptom_name: Headache
  onset_date: '2024-12-09'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2024-12-09'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2024-12-09'
  severity: Mild
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed explain and advised area.
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 9
reporting_facility: Garcia-Woods Medical Center
reporter_type: Physician
notes: Purpose meet necessary worker serve. Between one budget country development
  office. Debate edge represent too situation make suffer.
