<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-2024-385
Date of Submission: 2024-09-08

This report was submitted by a Nurse from Bishop and Sons Medical Center concerning patient ANON-PX-2663. The subject is a 37-year-old female with a significant medical history including asthma, type 2 diabetes. 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): Ibuprofen (NSAID) administered via the Topical route at a dosage of 330mg, initiated on 2024-06-25 for Pain and inflammation and discontinued on 2024-09-02; Warfarin (Anticoagulant) administered via the Intravenous route at a dosage of 374mg, initiated on 2024-06-25 for Thromboembolism prevention and discontinued on 2024-09-02.

On approximately 2024-09-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Vomiting, Somnolence, Dizziness, Anaphylaxis. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed speak and advised join. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. 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 dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Tend course customer level. Night north record. Here public rock size size market trade.</data>
report_id: ADR-2024-385
report_date: '2024-09-08'
patient_details:
  patient_id: ANON-PX-2663
  gender: Female
  relevant_history:
  - asthma
  - type 2 diabetes
  age_at_reaction: 37
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 330mg
  route_of_administration: Topical
  start_date: '2024-06-25'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2024-09-02'
- drug_name: Warfarin
  dosage: 374mg
  route_of_administration: Intravenous
  start_date: '2024-06-25'
  indication_for_use: Thromboembolism prevention
  drug_class: Anticoagulant
  end_date: '2024-09-02'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2024-09-01'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2024-09-01'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2024-09-01'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
- symptom_name: Dizziness
  onset_date: '2024-09-01'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed speak and advised join.
- symptom_name: Anaphylaxis
  onset_date: '2024-09-01'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
reporting_facility: Bishop and Sons Medical Center
reporter_type: Nurse
notes: Tend course customer level. Night north record. Here public rock size size
  market trade.
