<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-2025-814
Date of Submission: 2025-03-09

This report was submitted by a Patient from Mitchell PLC Medical Center concerning patient ANON-PX-3811. The subject is a 64-year-old female with a significant medical history including atrial fibrillation, seasonal allergies, chronic kidney disease. 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 Intravenous route at a dosage of 458mg, initiated on 2025-02-09 for Neuropathic pain and discontinued on 2025-03-01; Amoxicillin (Penicillin antibiotic) administered via the Intramuscular route at a dosage of 339mg, initiated on 2025-02-09 for Bacterial infection and discontinued on 2025-03-01.

On approximately 2025-02-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Somnolence, Maculopapular Rash. The Stevens-Johnson syndrome was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-814
report_date: '2025-03-09'
patient_details:
  patient_id: ANON-PX-3811
  gender: Female
  relevant_history:
  - atrial fibrillation
  - seasonal allergies
  - chronic kidney disease
  age_at_reaction: 64
suspected_drugs:
- drug_name: Gabapentin
  dosage: 458mg
  route_of_administration: Intravenous
  start_date: '2025-02-09'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
  end_date: '2025-03-01'
- drug_name: Amoxicillin
  dosage: 339mg
  route_of_administration: Intramuscular
  start_date: '2025-02-09'
  indication_for_use: Bacterial infection
  drug_class: Penicillin antibiotic
  end_date: '2025-03-01'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-02-12'
  severity: Mild
  outcome: Unknown
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-02-12'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2025-02-12'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 6
reporting_facility: Mitchell PLC Medical Center
reporter_type: Patient
