<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-2025-640
Date of Submission: 2025-06-30

This report was submitted by a Physician from Jones Inc Medical Center concerning patient ANON-PX-4912. The subject is a 46-year-old female with a significant medical history including coronary artery disease, type 2 diabetes, osteoarthritis, seasonal allergies. 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 Intravenous route at a dosage of 180mg, initiated on 2025-04-20 for Neuropathic pain with the course ongoing; Omeprazole (Proton-pump inhibitor) administered via the Oral route at a dosage of 135mg, initiated on 2025-04-20 for Gastroesophageal reflux disease with the course ongoing.

On approximately 2025-06-10, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Anaphylaxis, Diarrhea, Maculopapular Rash. The Angioedema was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed card and advised conference. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed lay and advised especially. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 4 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Owner and skill yet per design. Just study bill note.</data>
report_id: ADR-2025-640
report_date: '2025-06-30'
patient_details:
  patient_id: ANON-PX-4912
  gender: Female
  relevant_history:
  - coronary artery disease
  - type 2 diabetes
  - osteoarthritis
  - seasonal allergies
  age_at_reaction: 46
suspected_drugs:
- drug_name: Gabapentin
  dosage: 180mg
  route_of_administration: Intravenous
  start_date: '2025-04-20'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
- drug_name: Omeprazole
  dosage: 135mg
  route_of_administration: Oral
  start_date: '2025-04-20'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2025-06-10'
  severity: Mild
  outcome: Recovering
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2025-06-10'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2025-06-10'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed card and advised conference.
- symptom_name: Maculopapular Rash
  onset_date: '2025-06-10'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed lay and advised especially.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 4
reporting_facility: Jones Inc Medical Center
reporter_type: Physician
notes: Owner and skill yet per design. Just study bill note.
