<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-2025-503
Date of Submission: 2025-03-25

This report was submitted by a Patient from Harris, Alvarado and Parsons Medical Center concerning patient ANON-PX-9869. The subject is a 38-year-old female with a significant medical history including coronary artery disease, 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): Omeprazole administered via the Intravenous route at a dosage of 377mg, initiated on 2025-01-14 for Gastroesophageal reflux disease and discontinued on 2025-03-12; Sertraline (SSRI) administered via the Intravenous route at a dosage of 234mg, initiated on 2025-01-14 for Major depressive disorder and discontinued on 2025-03-12.

On approximately 2025-03-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Anaphylaxis. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. 

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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Many and including project trial. Nearly arm member student every social. Assume back significant book visit if if already.</data>
report_id: ADR-2025-503
report_date: '2025-03-25'
patient_details:
  patient_id: ANON-PX-9869
  gender: Female
  relevant_history:
  - coronary artery disease
  - seasonal allergies
  age_at_reaction: 38
suspected_drugs:
- drug_name: Omeprazole
  dosage: 377mg
  route_of_administration: Intravenous
  start_date: '2025-01-14'
  indication_for_use: Gastroesophageal reflux disease
  end_date: '2025-03-12'
- drug_name: Sertraline
  dosage: 234mg
  route_of_administration: Intravenous
  start_date: '2025-01-14'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-03-12'
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2025-03-05'
  severity: Mild
  outcome: Recovering
  intervention_required: true
- symptom_name: Anaphylaxis
  onset_date: '2025-03-05'
  severity: Mild
  outcome: Fatal
  intervention_required: true
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 4
reporting_facility: Harris, Alvarado and Parsons Medical Center
reporter_type: Patient
notes: Many and including project trial. Nearly arm member student every social. Assume
  back significant book visit if if already.
