<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-2024-287
Date of Submission: 2024-12-07

This report was submitted by a Patient from Wright Inc Medical Center concerning patient ANON-PX-3200. The subject is a 48-year-old female with a significant medical history including type 2 diabetes, anxiety, chronic kidney disease, asthma. 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): Omeprazole (Proton-pump inhibitor) administered via the Intramuscular route at a dosage of 410mg, initiated on 2024-10-20 for Gastroesophageal reflux disease and discontinued on 2024-11-24; Gabapentin (Anticonvulsant) administered via the Intravenous route at a dosage of 190mg, initiated on 2024-10-20 for Neuropathic pain and discontinued on 2024-11-24.

On approximately 2024-11-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Stevens-Johnson syndrome, Hepatotoxicity, Headache, Somnolence. The Dizziness was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Hepatotoxicity was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed popular and advised front. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed religious and advised magazine. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 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. 

</data>
report_id: ADR-2024-287
report_date: '2024-12-07'
patient_details:
  patient_id: ANON-PX-3200
  gender: Female
  relevant_history:
  - type 2 diabetes
  - anxiety
  - chronic kidney disease
  - asthma
  age_at_reaction: 48
suspected_drugs:
- drug_name: Omeprazole
  dosage: 410mg
  route_of_administration: Intramuscular
  start_date: '2024-10-20'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2024-11-24'
- drug_name: Gabapentin
  dosage: 190mg
  route_of_administration: Intravenous
  start_date: '2024-10-20'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
  end_date: '2024-11-24'
adverse_reactions:
- symptom_name: Dizziness
  onset_date: '2024-11-05'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-11-05'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2024-11-05'
  severity: Mild
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed popular and advised front.
- symptom_name: Headache
  onset_date: '2024-11-05'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2024-11-05'
  severity: Severe
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed religious and advised magazine.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 6
reporting_facility: Wright Inc Medical Center
reporter_type: Patient
