<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-2025-771
Date of Submission: 2025-01-02

This report was submitted by a Other Healthcare Professional from Crawford-Cox Medical Center concerning patient ANON-PX-6646. The subject is a 49-year-old female with a significant medical history including atrial fibrillation, chronic kidney disease, osteoarthritis, hypertension. 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): Amoxicillin (Penicillin antibiotic) administered via the Topical route at a dosage of 343mg, initiated on 2024-11-05 for Bacterial infection and discontinued on 2025-01-01.

On approximately 2024-12-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Pruritus, Somnolence. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed simple and advised maybe. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed north and advised simple. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not 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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

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report_id: ADR-2025-771
report_date: '2025-01-02'
patient_details:
  patient_id: ANON-PX-6646
  gender: Female
  relevant_history:
  - atrial fibrillation
  - chronic kidney disease
  - osteoarthritis
  - hypertension
  age_at_reaction: 49
suspected_drugs:
- drug_name: Amoxicillin
  dosage: 343mg
  route_of_administration: Topical
  start_date: '2024-11-05'
  indication_for_use: Bacterial infection
  drug_class: Penicillin antibiotic
  end_date: '2025-01-01'
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2024-12-18'
  severity: Severe
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed simple and advised maybe.
- symptom_name: Pruritus
  onset_date: '2024-12-18'
  severity: Severe
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed north and advised simple.
- symptom_name: Somnolence
  onset_date: '2024-12-18'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 2
reporting_facility: Crawford-Cox Medical Center
reporter_type: Other Healthcare Professional
notes: Really expert health hot address individual economy. Itself lot everyone stock
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