<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-2025-123
Date of Submission: 2025-02-19

This report was submitted by a Physician from Herrera-Pena Medical Center concerning patient ANON-PX-6219. The subject is an adult female with a significant medical history including atrial fibrillation, anxiety, coronary artery disease, migraines. 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): Atorvastatin administered via the Oral route at a dosage of 403mg, initiated on 2024-11-27 for Hypercholesterolemia with the course ongoing; Gabapentin (Anticonvulsant) administered via the Intravenous route at a dosage of 84mg, initiated on 2024-11-27 for Neuropathic pain with the course ongoing.

On approximately 2025-01-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Nausea, Anaphylaxis, Dizziness, Headache. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed become and advised sense. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Severe 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. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-123
report_date: '2025-02-19'
patient_details:
  patient_id: ANON-PX-6219
  gender: Female
  relevant_history:
  - atrial fibrillation
  - anxiety
  - coronary artery disease
  - migraines
suspected_drugs:
- drug_name: Atorvastatin
  dosage: 403mg
  route_of_administration: Oral
  start_date: '2024-11-27'
  indication_for_use: Hypercholesterolemia
- drug_name: Gabapentin
  dosage: 84mg
  route_of_administration: Intravenous
  start_date: '2024-11-27'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2025-01-02'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed become and advised sense.
- symptom_name: Nausea
  onset_date: '2025-01-02'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2025-01-02'
  severity: Severe
  outcome: Fatal
  intervention_required: true
- symptom_name: Dizziness
  onset_date: '2025-01-02'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Headache
  onset_date: '2025-01-02'
  severity: Severe
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
reporting_facility: Herrera-Pena Medical Center
reporter_type: Physician
