<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-2024-394
Date of Submission: 2024-10-02

This report was submitted by a Patient from Johnson and Sons Medical Center concerning patient ANON-PX-9905. The subject is a 28-year-old male with a significant medical history including asthma, coronary artery 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 administered via the Intramuscular route at a dosage of 462mg, initiated on 2024-07-10 for Pain and inflammation and discontinued on 2024-08-28.

On approximately 2024-08-08, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Somnolence, Dizziness, Anaphylaxis, Nausea. The Stevens-Johnson syndrome was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed impact and advised add. The current patient status regarding this symptom is 'Recovering'. The Nausea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed chair and advised trip. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-394
report_date: '2024-10-02'
patient_details:
  patient_id: ANON-PX-9905
  gender: Male
  relevant_history:
  - asthma
  - coronary artery disease
  age_at_reaction: 28
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 462mg
  route_of_administration: Intramuscular
  start_date: '2024-07-10'
  indication_for_use: Pain and inflammation
  end_date: '2024-08-28'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-08-08'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2024-08-08'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Dizziness
  onset_date: '2024-08-08'
  severity: Mild
  outcome: Fatal
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2024-08-08'
  severity: Severe
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed impact and advised add.
- symptom_name: Nausea
  onset_date: '2024-08-08'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed chair and advised trip.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Johnson and Sons Medical Center
reporter_type: Patient
