<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-2025-482
Date of Submission: 2025-06-01

This report was submitted by a Pharmacist from Colon and Sons Medical Center concerning patient ANON-PX-9077. The subject is a 76-year-old other with a significant medical history including coronary artery disease, osteoarthritis. 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 Oral route at a dosage of 78mg, initiated on 2025-04-09 for Pain and inflammation with the course ongoing.

On approximately 2025-05-10, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Vomiting, Anaphylaxis, Dizziness. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed happy and advised major. The current patient status regarding this symptom is 'Recovered'. The Vomiting 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 Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Dizziness was classified as Severe 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. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-482
report_date: '2025-06-01'
patient_details:
  patient_id: ANON-PX-9077
  gender: Other
  relevant_history:
  - coronary artery disease
  - osteoarthritis
  age_at_reaction: 76
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 78mg
  route_of_administration: Oral
  start_date: '2025-04-09'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2025-05-10'
  severity: Mild
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed happy and advised major.
- symptom_name: Vomiting
  onset_date: '2025-05-10'
  severity: Severe
  outcome: Recovered
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2025-05-10'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
- symptom_name: Dizziness
  onset_date: '2025-05-10'
  severity: Severe
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 9
reporting_facility: Colon and Sons Medical Center
reporter_type: Pharmacist
