<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-2024-259
Date of Submission: 2024-11-13

This report was submitted by a Pharmacist from Perry and Sons Medical Center concerning patient ANON-PX-8503. The subject is a 35-year-old female with a significant medical history including chronic kidney disease, hypertension. 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 Topical route at a dosage of 386mg, initiated on 2024-10-13 for Gastroesophageal reflux disease and discontinued on 2024-11-06; Ibuprofen (NSAID) administered via the Subcutaneous route at a dosage of 408mg, initiated on 2024-10-13 for Pain and inflammation and discontinued on 2024-11-06.

On approximately 2024-11-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Somnolence, Diarrhea. The Dizziness was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed brother and advised brother. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Moderate 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 5 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. 

Reporter's Narrative Summary: Lot system contain final response mention customer. Life decision spend check voice. Shake source fly skill course.</data>
report_id: ADR-2024-259
report_date: '2024-11-13'
patient_details:
  patient_id: ANON-PX-8503
  gender: Female
  relevant_history:
  - chronic kidney disease
  - hypertension
  age_at_reaction: 35
suspected_drugs:
- drug_name: Omeprazole
  dosage: 386mg
  route_of_administration: Topical
  start_date: '2024-10-13'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2024-11-06'
- drug_name: Ibuprofen
  dosage: 408mg
  route_of_administration: Subcutaneous
  start_date: '2024-10-13'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2024-11-06'
adverse_reactions:
- symptom_name: Dizziness
  onset_date: '2024-11-06'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2024-11-06'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed brother and advised brother.
- symptom_name: Diarrhea
  onset_date: '2024-11-06'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 5
reporting_facility: Perry and Sons Medical Center
reporter_type: Pharmacist
notes: Lot system contain final response mention customer. Life decision spend check
  voice. Shake source fly skill course.
