<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-2025-640
Date of Submission: 2025-01-24

This report was submitted by a Patient from Moran PLC Medical Center concerning patient ANON-PX-7028. The subject is a 58-year-old male with a significant medical history including osteoarthritis, type 2 diabetes. 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 Subcutaneous route at a dosage of 83mg, initiated on 2024-11-29 for Neuropathic pain and discontinued on 2025-01-13; Atorvastatin administered via the Topical route at a dosage of 375mg, initiated on 2024-11-29 for Hypercholesterolemia and discontinued on 2025-01-13.

On approximately 2025-01-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Headache, Hepatotoxicity, Somnolence, Pruritus. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Headache was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed three and advised conference. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed cut and advised right. The current patient status regarding this symptom is 'Not Recovered'. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed green and advised tax. The current patient status regarding this symptom is 'Fatal'. 

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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-640
report_date: '2025-01-24'
patient_details:
  patient_id: ANON-PX-7028
  gender: Male
  relevant_history:
  - osteoarthritis
  - type 2 diabetes
  age_at_reaction: 58
suspected_drugs:
- drug_name: Gabapentin
  dosage: 83mg
  route_of_administration: Subcutaneous
  start_date: '2024-11-29'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
  end_date: '2025-01-13'
- drug_name: Atorvastatin
  dosage: 375mg
  route_of_administration: Topical
  start_date: '2024-11-29'
  indication_for_use: Hypercholesterolemia
  end_date: '2025-01-13'
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2025-01-02'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
- symptom_name: Headache
  onset_date: '2025-01-02'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2025-01-02'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed three and advised conference.
- symptom_name: Somnolence
  onset_date: '2025-01-02'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed cut and advised right.
- symptom_name: Pruritus
  onset_date: '2025-01-02'
  severity: Severe
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed green and advised tax.
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 9
reporting_facility: Moran PLC Medical Center
reporter_type: Patient
