<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-2024-477
Date of Submission: 2024-10-19

This report was submitted by a Physician from Nguyen, Romero and Ramos Medical Center concerning patient ANON-PX-4330. The subject is a 40-year-old male with a significant medical history including hypertension, 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): Ibuprofen (NSAID) administered via the Topical route at a dosage of 144mg, initiated on 2024-08-26 for Pain and inflammation with the course ongoing; Sertraline administered via the Topical route at a dosage of 162mg, initiated on 2024-08-26 for Major depressive disorder with the course ongoing.

On approximately 2024-09-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Headache, Diarrhea, Pruritus. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed keep and advised always. The current patient status regarding this symptom is 'Unknown'. The Headache 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. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed case and advised his. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, 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-2024-477
report_date: '2024-10-19'
patient_details:
  patient_id: ANON-PX-4330
  gender: Male
  relevant_history:
  - hypertension
  - chronic kidney disease
  age_at_reaction: 40
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 144mg
  route_of_administration: Topical
  start_date: '2024-08-26'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
- drug_name: Sertraline
  dosage: 162mg
  route_of_administration: Topical
  start_date: '2024-08-26'
  indication_for_use: Major depressive disorder
adverse_reactions:
- symptom_name: Dizziness
  onset_date: '2024-09-13'
  severity: Severe
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed keep and advised always.
- symptom_name: Headache
  onset_date: '2024-09-13'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2024-09-13'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
- symptom_name: Pruritus
  onset_date: '2024-09-13'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed case and advised his.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 5
reporting_facility: Nguyen, Romero and Ramos Medical Center
reporter_type: Physician
