<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-2025-344
Date of Submission: 2025-02-25

This report was submitted by a Patient from Wolfe-Moore Medical Center concerning patient ANON-PX-1929. The subject is a 75-year-old male with a significant medical history including anxiety, asthma, hypertension, 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): Ibuprofen (NSAID) administered via the Topical route at a dosage of 171mg, initiated on 2024-12-16 for Pain and inflammation and discontinued on 2025-01-11; Omeprazole (Proton-pump inhibitor) administered via the Topical route at a dosage of 15mg, initiated on 2024-12-16 for Gastroesophageal reflux disease and discontinued on 2025-01-11.

On approximately 2024-12-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Maculopapular Rash, Stevens-Johnson syndrome, Anaphylaxis, Dizziness. The Pruritus was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Maculopapular Rash was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed service and advised tonight. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed understand and advised moment. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 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. 

</data>
report_id: ADR-2025-344
report_date: '2025-02-25'
patient_details:
  patient_id: ANON-PX-1929
  gender: Male
  relevant_history:
  - anxiety
  - asthma
  - hypertension
  - atrial fibrillation
  age_at_reaction: 75
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 171mg
  route_of_administration: Topical
  start_date: '2024-12-16'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2025-01-11'
- drug_name: Omeprazole
  dosage: 15mg
  route_of_administration: Topical
  start_date: '2024-12-16'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2025-01-11'
adverse_reactions:
- symptom_name: Pruritus
  onset_date: '2024-12-23'
  severity: Mild
  outcome: Recovering
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2024-12-23'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-12-23'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed service and advised tonight.
- symptom_name: Anaphylaxis
  onset_date: '2024-12-23'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Dizziness
  onset_date: '2024-12-23'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed understand and advised moment.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 2
reporting_facility: Wolfe-Moore Medical Center
reporter_type: Patient
