<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-2025-202
Date of Submission: 2025-02-21

This report was submitted by a Physician from Fuller-Drake Medical Center concerning patient ANON-PX-4406. The subject is an adult female with a significant medical history including seasonal allergies, asthma, atrial fibrillation. 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 Intravenous route at a dosage of 400mg, initiated on 2024-11-24 for Gastroesophageal reflux disease and discontinued on 2025-01-18; Levothyroxine administered via the Oral route at a dosage of 444mg, initiated on 2024-11-24 for Hypothyroidism and discontinued on 2025-01-18.

On approximately 2025-01-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Angioedema, Diarrhea, Pruritus, Hepatotoxicity. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed mission and advised laugh. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Diarrhea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed feel and advised she. The current patient status regarding this symptom is 'Recovering'. 

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

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report_id: ADR-2025-202
report_date: '2025-02-21'
patient_details:
  patient_id: ANON-PX-4406
  gender: Female
  relevant_history:
  - seasonal allergies
  - asthma
  - atrial fibrillation
suspected_drugs:
- drug_name: Omeprazole
  dosage: 400mg
  route_of_administration: Intravenous
  start_date: '2024-11-24'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2025-01-18'
- drug_name: Levothyroxine
  dosage: 444mg
  route_of_administration: Oral
  start_date: '2024-11-24'
  indication_for_use: Hypothyroidism
  end_date: '2025-01-18'
adverse_reactions:
- symptom_name: Vomiting
  onset_date: '2025-01-15'
  severity: Mild
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed mission and advised laugh.
- symptom_name: Angioedema
  onset_date: '2025-01-15'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2025-01-15'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2025-01-15'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2025-01-15'
  severity: Mild
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed feel and advised she.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Fuller-Drake Medical Center
reporter_type: Physician
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