<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-2025-752
Date of Submission: 2025-08-07

This report was submitted by a Patient from Sandoval PLC Medical Center concerning patient ANON-PX-1149. The subject is a 24-year-old male with a significant medical history including osteoarthritis, chronic kidney disease, coronary artery disease, 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): Ibuprofen (NSAID) administered via the Subcutaneous route at a dosage of 157mg, initiated on 2025-06-30 for Pain and inflammation with the course ongoing.

On approximately 2025-07-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Vomiting. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed how and advised food. The current patient status regarding this symptom is 'Recovering'. The Vomiting was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-752
report_date: '2025-08-07'
patient_details:
  patient_id: ANON-PX-1149
  gender: Male
  relevant_history:
  - osteoarthritis
  - chronic kidney disease
  - coronary artery disease
  - anxiety
  age_at_reaction: 24
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 157mg
  route_of_administration: Subcutaneous
  start_date: '2025-06-30'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
adverse_reactions:
- symptom_name: Headache
  onset_date: '2025-07-12'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed how and advised food.
- symptom_name: Vomiting
  onset_date: '2025-07-12'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
reporting_facility: Sandoval PLC Medical Center
reporter_type: Patient
