<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-2024-792
Date of Submission: 2024-12-10

This report was submitted by a Other Healthcare Professional from Mayer-Davis Medical Center concerning patient ANON-PX-6843. The subject is an adult other with a significant medical history including osteoarthritis, atrial fibrillation, type 2 diabetes, 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 Intramuscular route at a dosage of 424mg, initiated on 2024-10-28 for Gastroesophageal reflux disease and discontinued on 2024-12-05; Sertraline (SSRI) administered via the Oral route at a dosage of 385mg, initiated on 2024-10-28 for Major depressive disorder and discontinued on 2024-12-05.

On approximately 2024-11-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Angioedema. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed plant and advised gas. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 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. 

</data>
report_id: ADR-2024-792
report_date: '2024-12-10'
patient_details:
  patient_id: ANON-PX-6843
  gender: Other
  relevant_history:
  - osteoarthritis
  - atrial fibrillation
  - type 2 diabetes
  - hypertension
suspected_drugs:
- drug_name: Omeprazole
  dosage: 424mg
  route_of_administration: Intramuscular
  start_date: '2024-10-28'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2024-12-05'
- drug_name: Sertraline
  dosage: 385mg
  route_of_administration: Oral
  start_date: '2024-10-28'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2024-12-05'
adverse_reactions:
- symptom_name: Pruritus
  onset_date: '2024-11-11'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2024-11-11'
  severity: Mild
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed plant and advised gas.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 3
reporting_facility: Mayer-Davis Medical Center
reporter_type: Other Healthcare Professional
