<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-2025-894
Date of Submission: 2025-02-01

This report was submitted by a Pharmacist from Skinner and Sons Medical Center concerning patient ANON-PX-3021. The subject is an adult female with a significant medical history including seasonal allergies, anxiety, asthma, 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 Intramuscular route at a dosage of 274mg, initiated on 2024-11-10 for Neuropathic pain and discontinued on 2025-01-30.

On approximately 2024-12-31, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Somnolence, Anaphylaxis, Stevens-Johnson syndrome, Headache. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed area and advised act. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Anaphylaxis was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Debate per use issue person item. Government will grow style behind late. All fill line responsibility.</data>
report_id: ADR-2025-894
report_date: '2025-02-01'
patient_details:
  patient_id: ANON-PX-3021
  gender: Female
  relevant_history:
  - seasonal allergies
  - anxiety
  - asthma
  - chronic kidney disease
suspected_drugs:
- drug_name: Gabapentin
  dosage: 274mg
  route_of_administration: Intramuscular
  start_date: '2024-11-10'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
  end_date: '2025-01-30'
adverse_reactions:
- symptom_name: Pruritus
  onset_date: '2024-12-31'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed area and advised act.
- symptom_name: Somnolence
  onset_date: '2024-12-31'
  severity: Mild
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2024-12-31'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-12-31'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Headache
  onset_date: '2024-12-31'
  severity: Mild
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 7
reporting_facility: Skinner and Sons Medical Center
reporter_type: Pharmacist
notes: Debate per use issue person item. Government will grow style behind late. All
  fill line responsibility.
