<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-2025-556
Date of Submission: 2025-02-01

This report was submitted by a Pharmacist from Baker, Becker and Collins Medical Center concerning patient ANON-PX-9489. The subject is a 42-year-old other with a significant medical history including chronic kidney disease, seasonal allergies, atrial fibrillation, 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 Intramuscular route at a dosage of 338mg, initiated on 2024-12-10 for Neuropathic pain and discontinued on 2025-01-12; Omeprazole administered via the Intravenous route at a dosage of 74mg, initiated on 2024-12-10 for Gastroesophageal reflux disease and discontinued on 2025-01-12.

On approximately 2024-12-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Stevens-Johnson syndrome, Maculopapular Rash, Anaphylaxis, Somnolence. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed reality and advised Mrs. The current patient status regarding this symptom is 'Not Recovered'. The Stevens-Johnson syndrome was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed world and advised organization. The current patient status regarding this symptom is 'Fatal'. The Somnolence 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. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-556
report_date: '2025-02-01'
patient_details:
  patient_id: ANON-PX-9489
  gender: Other
  relevant_history:
  - chronic kidney disease
  - seasonal allergies
  - atrial fibrillation
  - anxiety
  age_at_reaction: 42
suspected_drugs:
- drug_name: Gabapentin
  dosage: 338mg
  route_of_administration: Intramuscular
  start_date: '2024-12-10'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
  end_date: '2025-01-12'
- drug_name: Omeprazole
  dosage: 74mg
  route_of_administration: Intravenous
  start_date: '2024-12-10'
  indication_for_use: Gastroesophageal reflux disease
  end_date: '2025-01-12'
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2024-12-13'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed reality and advised Mrs.
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-12-13'
  severity: Severe
  outcome: Recovering
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2024-12-13'
  severity: Mild
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2024-12-13'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed world and advised organization.
- symptom_name: Somnolence
  onset_date: '2024-12-13'
  severity: Mild
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Baker, Becker and Collins Medical Center
reporter_type: Pharmacist
