<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-2024-343
Date of Submission: 2024-12-20

This report was submitted by a Nurse from Sullivan-Reese Medical Center concerning patient ANON-PX-2492. The subject is a 47-year-old male with a significant medical history including atrial fibrillation, hypertension, anxiety. 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): Metformin (Biguanide) administered via the Topical route at a dosage of 303mg, initiated on 2024-11-22 for Type 2 diabetes with the course ongoing; Ibuprofen (NSAID) administered via the Oral route at a dosage of 39mg, initiated on 2024-11-22 for Pain and inflammation with the course ongoing.

On approximately 2024-12-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Anaphylaxis, Maculopapular Rash. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 4 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-343
report_date: '2024-12-20'
patient_details:
  patient_id: ANON-PX-2492
  gender: Male
  relevant_history:
  - atrial fibrillation
  - hypertension
  - anxiety
  age_at_reaction: 47
suspected_drugs:
- drug_name: Metformin
  dosage: 303mg
  route_of_administration: Topical
  start_date: '2024-11-22'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
- drug_name: Ibuprofen
  dosage: 39mg
  route_of_administration: Oral
  start_date: '2024-11-22'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
adverse_reactions:
- symptom_name: Nausea
  onset_date: '2024-12-05'
  severity: Severe
  outcome: Recovered
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2024-12-05'
  severity: Severe
  outcome: Unknown
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2024-12-05'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 4
reporting_facility: Sullivan-Reese Medical Center
reporter_type: Nurse
