<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-2025-209
Date of Submission: 2025-07-14

This report was submitted by a Pharmacist from Hart, Warren and Fields Medical Center concerning patient ANON-PX-8229. The subject is a 21-year-old male with a significant medical history including anxiety, migraines, coronary artery disease, asthma. 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): Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 369mg, initiated on 2025-05-10 for Gastroesophageal reflux disease with the course ongoing.

On approximately 2025-07-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Nausea, Anaphylaxis. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed modern and advised test. 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-209
report_date: '2025-07-14'
patient_details:
  patient_id: ANON-PX-8229
  gender: Male
  relevant_history:
  - anxiety
  - migraines
  - coronary artery disease
  - asthma
  age_at_reaction: 21
suspected_drugs:
- drug_name: Omeprazole
  dosage: 369mg
  route_of_administration: Subcutaneous
  start_date: '2025-05-10'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2025-07-09'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2025-07-09'
  severity: Severe
  outcome: Recovering
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2025-07-09'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed modern and advised test.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
reporting_facility: Hart, Warren and Fields Medical Center
reporter_type: Pharmacist
