<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-2024-427
Date of Submission: 2024-08-25

This report was submitted by a Nurse from Adams-Hall Medical Center concerning patient ANON-PX-1716. The subject is a 21-year-old female with a significant medical history including migraines, anxiety. 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 Oral route at a dosage of 37mg, initiated on 2024-07-12 for Neuropathic pain and discontinued on 2024-08-06.

On approximately 2024-07-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Vomiting, Dizziness. The Somnolence was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Severe 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 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-427
report_date: '2024-08-25'
patient_details:
  patient_id: ANON-PX-1716
  gender: Female
  relevant_history:
  - migraines
  - anxiety
  age_at_reaction: 21
suspected_drugs:
- drug_name: Gabapentin
  dosage: 37mg
  route_of_administration: Oral
  start_date: '2024-07-12'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
  end_date: '2024-08-06'
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2024-07-18'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2024-07-18'
  severity: Mild
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Dizziness
  onset_date: '2024-07-18'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 2
reporting_facility: Adams-Hall Medical Center
reporter_type: Nurse
