<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-2025-511
Date of Submission: 2025-03-09

This report was submitted by a Nurse from Donovan and Sons Medical Center concerning patient ANON-PX-8844. The subject is a 79-year-old female with a significant medical history including hypertension, anxiety, chronic kidney disease. 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): Warfarin (Anticoagulant) administered via the Intravenous route at a dosage of 329mg, initiated on 2025-01-26 for Thromboembolism prevention with the course ongoing; Sertraline (SSRI) administered via the Topical route at a dosage of 114mg, initiated on 2025-01-26 for Major depressive disorder with the course ongoing.

On approximately 2025-02-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Pruritus, Headache, Vomiting. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed citizen and advised organization. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed simply and advised garden. The current patient status regarding this symptom is 'Unknown'. The Vomiting 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. 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. 

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report_id: ADR-2025-511
report_date: '2025-03-09'
patient_details:
  patient_id: ANON-PX-8844
  gender: Female
  relevant_history:
  - hypertension
  - anxiety
  - chronic kidney disease
  age_at_reaction: 79
suspected_drugs:
- drug_name: Warfarin
  dosage: 329mg
  route_of_administration: Intravenous
  start_date: '2025-01-26'
  indication_for_use: Thromboembolism prevention
  drug_class: Anticoagulant
- drug_name: Sertraline
  dosage: 114mg
  route_of_administration: Topical
  start_date: '2025-01-26'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2025-02-25'
  severity: Mild
  outcome: Recovered
  intervention_required: true
- symptom_name: Pruritus
  onset_date: '2025-02-25'
  severity: Mild
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed citizen and advised organization.
- symptom_name: Headache
  onset_date: '2025-02-25'
  severity: Severe
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed simply and advised garden.
- symptom_name: Vomiting
  onset_date: '2025-02-25'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
reporting_facility: Donovan and Sons Medical Center
reporter_type: Nurse
notes: Especially white brother pretty same vote. Another might side true nearly create
  several. Guy model recently same may hundred local a.
