<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-2025-305
Date of Submission: 2025-02-13

This report was submitted by a Pharmacist from Henry, Williams and Scott Medical Center concerning patient ANON-PX-7965. The subject is a 71-year-old other with a significant medical history including type 2 diabetes, atrial fibrillation, seasonal allergies, osteoarthritis. 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 473mg, initiated on 2024-11-18 for Pain and inflammation with the course ongoing.

On approximately 2024-11-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Dizziness, Maculopapular Rash, Nausea. The Anaphylaxis was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Dizziness was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Maculopapular Rash was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed pressure and advised beyond. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed Mr and advised first. The current patient status regarding this symptom is 'Unknown'. 

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. 

</data>
report_id: ADR-2025-305
report_date: '2025-02-13'
patient_details:
  patient_id: ANON-PX-7965
  gender: Other
  relevant_history:
  - type 2 diabetes
  - atrial fibrillation
  - seasonal allergies
  - osteoarthritis
  age_at_reaction: 71
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 473mg
  route_of_administration: Topical
  start_date: '2024-11-18'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
adverse_reactions:
- symptom_name: Anaphylaxis
  onset_date: '2024-11-24'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
- symptom_name: Dizziness
  onset_date: '2024-11-24'
  severity: Severe
  outcome: Recovering
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2024-11-24'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed pressure and advised beyond.
- symptom_name: Nausea
  onset_date: '2024-11-24'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed Mr and advised first.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
reporting_facility: Henry, Williams and Scott Medical Center
reporter_type: Pharmacist
