<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-2025-977
Date of Submission: 2025-01-22

This report was submitted by a Nurse from Smith, Jones and Mcgee Medical Center concerning patient ANON-PX-3661. The subject is a 26-year-old other with a significant medical history including migraines, 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 (Anticonvulsant) administered via the Topical route at a dosage of 240mg, initiated on 2024-11-02 for Neuropathic pain and discontinued on 2025-01-10.

On approximately 2024-12-20, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Diarrhea, Hepatotoxicity, Angioedema, Anaphylaxis. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed however and advised must. The current patient status regarding this symptom is 'Not Recovered'. The Hepatotoxicity was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed rule and advised glass. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

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report_id: ADR-2025-977
report_date: '2025-01-22'
patient_details:
  patient_id: ANON-PX-3661
  gender: Other
  relevant_history:
  - migraines
  - coronary artery disease
  age_at_reaction: 26
suspected_drugs:
- drug_name: Gabapentin
  dosage: 240mg
  route_of_administration: Topical
  start_date: '2024-11-02'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
  end_date: '2025-01-10'
adverse_reactions:
- symptom_name: Dizziness
  onset_date: '2024-12-20'
  severity: Mild
  outcome: Recovering
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2024-12-20'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed however and advised must.
- symptom_name: Hepatotoxicity
  onset_date: '2024-12-20'
  severity: Severe
  outcome: Unknown
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2024-12-20'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed rule and advised glass.
- symptom_name: Anaphylaxis
  onset_date: '2024-12-20'
  severity: Mild
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 5
reporting_facility: Smith, Jones and Mcgee Medical Center
reporter_type: Nurse
notes: Able star clear itself wall teacher professor. Visit challenge mission rich
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