<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-2025-521
Date of Submission: 2025-04-12

This report was submitted by a Patient from Hayes, Miller and Jackson Medical Center concerning patient ANON-PX-2819. The subject is an adult female with a significant medical history including chronic kidney disease, hypertension, osteoarthritis. 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 administered via the Topical route at a dosage of 69mg, initiated on 2025-03-09 for Gastroesophageal reflux disease with the course ongoing; Gabapentin (Anticonvulsant) administered via the Subcutaneous route at a dosage of 171mg, initiated on 2025-03-09 for Neuropathic pain with the course ongoing.

On approximately 2025-03-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Pruritus, Maculopapular Rash, Anaphylaxis, Dizziness. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Severe 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 documented action was: Prescribed position and advised heavy. The current patient status regarding this symptom is 'Recovered'. The Dizziness was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. 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-2025-521
report_date: '2025-04-12'
patient_details:
  patient_id: ANON-PX-2819
  gender: Female
  relevant_history:
  - chronic kidney disease
  - hypertension
  - osteoarthritis
suspected_drugs:
- drug_name: Omeprazole
  dosage: 69mg
  route_of_administration: Topical
  start_date: '2025-03-09'
  indication_for_use: Gastroesophageal reflux disease
- drug_name: Gabapentin
  dosage: 171mg
  route_of_administration: Subcutaneous
  start_date: '2025-03-09'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2025-03-15'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
- symptom_name: Pruritus
  onset_date: '2025-03-15'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2025-03-15'
  severity: Severe
  outcome: Recovering
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2025-03-15'
  severity: Severe
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed position and advised heavy.
- symptom_name: Dizziness
  onset_date: '2025-03-15'
  severity: Severe
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 2
reporting_facility: Hayes, Miller and Jackson Medical Center
reporter_type: Patient
