<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-2025-406
Date of Submission: 2025-06-16

This report was submitted by a Pharmacist from Taylor-Clark Medical Center concerning patient ANON-PX-8449. The subject is a 20-year-old male with a significant medical history including migraines, asthma, 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 Intramuscular route at a dosage of 31mg, initiated on 2025-05-03 for Pain and inflammation and discontinued on 2025-05-28; Omeprazole administered via the Subcutaneous route at a dosage of 494mg, initiated on 2025-05-03 for Gastroesophageal reflux disease and discontinued on 2025-05-28.

On approximately 2025-05-14, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Anaphylaxis, Dizziness, Somnolence, Vomiting. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed herself and advised bring. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed page and advised bring. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Vomiting was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. 

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-2025-406
report_date: '2025-06-16'
patient_details:
  patient_id: ANON-PX-8449
  gender: Male
  relevant_history:
  - migraines
  - asthma
  - chronic kidney disease
  age_at_reaction: 20
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 31mg
  route_of_administration: Intramuscular
  start_date: '2025-05-03'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2025-05-28'
- drug_name: Omeprazole
  dosage: 494mg
  route_of_administration: Subcutaneous
  start_date: '2025-05-03'
  indication_for_use: Gastroesophageal reflux disease
  end_date: '2025-05-28'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-05-14'
  severity: Severe
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed herself and advised bring.
- symptom_name: Anaphylaxis
  onset_date: '2025-05-14'
  severity: Mild
  outcome: Fatal
  intervention_required: false
- symptom_name: Dizziness
  onset_date: '2025-05-14'
  severity: Severe
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed page and advised bring.
- symptom_name: Somnolence
  onset_date: '2025-05-14'
  severity: Severe
  outcome: Unknown
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-05-14'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Taylor-Clark Medical Center
reporter_type: Pharmacist
