<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-2025-589
Date of Submission: 2025-01-09

This report was submitted by a Pharmacist from Allen-Reed Medical Center concerning patient ANON-PX-5630. The subject is a 58-year-old female with a significant medical history including chronic kidney disease, seasonal allergies, 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 Topical route at a dosage of 486mg, initiated on 2024-10-31 for Neuropathic pain and discontinued on 2024-12-30; Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 393mg, initiated on 2024-10-31 for Gastroesophageal reflux disease and discontinued on 2024-12-30.

On approximately 2024-12-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Stevens-Johnson syndrome, Diarrhea, Maculopapular Rash. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed organization and advised idea. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-589
report_date: '2025-01-09'
patient_details:
  patient_id: ANON-PX-5630
  gender: Female
  relevant_history:
  - chronic kidney disease
  - seasonal allergies
  - anxiety
  age_at_reaction: 58
suspected_drugs:
- drug_name: Gabapentin
  dosage: 486mg
  route_of_administration: Topical
  start_date: '2024-10-31'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
  end_date: '2024-12-30'
- drug_name: Omeprazole
  dosage: 393mg
  route_of_administration: Subcutaneous
  start_date: '2024-10-31'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2024-12-30'
adverse_reactions:
- symptom_name: Anaphylaxis
  onset_date: '2024-12-16'
  severity: Severe
  outcome: Unknown
  intervention_required: true
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-12-16'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed organization and advised idea.
- symptom_name: Diarrhea
  onset_date: '2024-12-16'
  severity: Mild
  outcome: Recovered
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2024-12-16'
  severity: Mild
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 10
reporting_facility: Allen-Reed Medical Center
reporter_type: Pharmacist
