<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-2025-283
Date of Submission: 2025-01-22

This report was submitted by a Nurse from Mcguire-Gonzalez Medical Center concerning patient ANON-PX-2756. The subject is an adult female with a significant medical history including seasonal allergies, anxiety, coronary artery disease, asthma. 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): Sertraline administered via the Topical route at a dosage of 409mg, initiated on 2024-12-23 for Major depressive disorder and discontinued on 2025-01-20; Gabapentin (Anticonvulsant) administered via the Oral route at a dosage of 478mg, initiated on 2024-12-23 for Neuropathic pain and discontinued on 2025-01-20.

On approximately 2025-01-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Diarrhea. The Hepatotoxicity was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Diarrhea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was '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-2025-283
report_date: '2025-01-22'
patient_details:
  patient_id: ANON-PX-2756
  gender: Female
  relevant_history:
  - seasonal allergies
  - anxiety
  - coronary artery disease
  - asthma
suspected_drugs:
- drug_name: Sertraline
  dosage: 409mg
  route_of_administration: Topical
  start_date: '2024-12-23'
  indication_for_use: Major depressive disorder
  end_date: '2025-01-20'
- drug_name: Gabapentin
  dosage: 478mg
  route_of_administration: Oral
  start_date: '2024-12-23'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
  end_date: '2025-01-20'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-01-19'
  severity: Mild
  outcome: Recovered
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2025-01-19'
  severity: Mild
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 5
reporting_facility: Mcguire-Gonzalez Medical Center
reporter_type: Nurse
