<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-2025-919
Date of Submission: 2025-02-22

This report was submitted by a Other Healthcare Professional from Richard-Brock Medical Center concerning patient ANON-PX-3649. The subject is an adult female with a significant medical history including seasonal allergies, migraines, 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): Gabapentin (Anticonvulsant) administered via the Topical route at a dosage of 377mg, initiated on 2025-01-26 for Neuropathic pain and discontinued on 2025-01-31; Atorvastatin (Statin) administered via the Intravenous route at a dosage of 400mg, initiated on 2025-01-26 for Hypercholesterolemia and discontinued on 2025-01-31.

On approximately 2025-01-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Pruritus, Nausea, Stevens-Johnson syndrome. The Diarrhea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed too and advised either. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 4 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-2025-919
report_date: '2025-02-22'
patient_details:
  patient_id: ANON-PX-3649
  gender: Female
  relevant_history:
  - seasonal allergies
  - migraines
  - osteoarthritis
suspected_drugs:
- drug_name: Gabapentin
  dosage: 377mg
  route_of_administration: Topical
  start_date: '2025-01-26'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
  end_date: '2025-01-31'
- drug_name: Atorvastatin
  dosage: 400mg
  route_of_administration: Intravenous
  start_date: '2025-01-26'
  indication_for_use: Hypercholesterolemia
  drug_class: Statin
  end_date: '2025-01-31'
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2025-01-29'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2025-01-29'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed too and advised either.
- symptom_name: Nausea
  onset_date: '2025-01-29'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-01-29'
  severity: Mild
  outcome: Unknown
  intervention_required: true
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 4
reporting_facility: Richard-Brock Medical Center
reporter_type: Other Healthcare Professional
