<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-2024-284
Date of Submission: 2024-10-27

This report was submitted by a Nurse from Gates-Clark Medical Center concerning patient ANON-PX-7526. The subject is an adult female with a significant medical history including asthma, osteoarthritis, coronary artery 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 administered via the Topical route at a dosage of 165mg, initiated on 2024-09-17 for Neuropathic pain with the course ongoing.

On approximately 2024-10-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Anaphylaxis, Dizziness, Angioedema, Somnolence. The Headache was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Dizziness was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed even and advised coach. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 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-2024-284
report_date: '2024-10-27'
patient_details:
  patient_id: ANON-PX-7526
  gender: Female
  relevant_history:
  - asthma
  - osteoarthritis
  - coronary artery disease
suspected_drugs:
- drug_name: Gabapentin
  dosage: 165mg
  route_of_administration: Topical
  start_date: '2024-09-17'
  indication_for_use: Neuropathic pain
adverse_reactions:
- symptom_name: Headache
  onset_date: '2024-10-16'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2024-10-16'
  severity: Mild
  outcome: Unknown
  intervention_required: false
- symptom_name: Dizziness
  onset_date: '2024-10-16'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
- symptom_name: Angioedema
  onset_date: '2024-10-16'
  severity: Mild
  outcome: Fatal
  intervention_required: true
- symptom_name: Somnolence
  onset_date: '2024-10-16'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed even and advised coach.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 1
reporting_facility: Gates-Clark Medical Center
reporter_type: Nurse
