<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-2025-488
Date of Submission: 2025-04-01

This report was submitted by a Patient from Hardin-White Medical Center concerning patient ANON-PX-8508. The subject is a 37-year-old other with a significant medical history including hypertension, 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): Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 21mg, initiated on 2025-03-05 for Gastroesophageal reflux disease with the course ongoing; Sertraline (SSRI) administered via the Topical route at a dosage of 374mg, initiated on 2025-03-05 for Major depressive disorder with the course ongoing.

On approximately 2025-03-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Headache, Angioedema, Maculopapular Rash. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed PM and advised character. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash 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. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: These allow couple continue collection station Mr. Road animal front keep.</data>
report_id: ADR-2025-488
report_date: '2025-04-01'
patient_details:
  patient_id: ANON-PX-8508
  gender: Other
  relevant_history:
  - hypertension
  - chronic kidney disease
  age_at_reaction: 37
suspected_drugs:
- drug_name: Omeprazole
  dosage: 21mg
  route_of_administration: Subcutaneous
  start_date: '2025-03-05'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
- drug_name: Sertraline
  dosage: 374mg
  route_of_administration: Topical
  start_date: '2025-03-05'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2025-03-13'
  severity: Mild
  outcome: Recovered
  intervention_required: true
- symptom_name: Headache
  onset_date: '2025-03-13'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed PM and advised character.
- symptom_name: Angioedema
  onset_date: '2025-03-13'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2025-03-13'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Not applicable
  naranjo_score: 2
reporting_facility: Hardin-White Medical Center
reporter_type: Patient
notes: These allow couple continue collection station Mr. Road animal front keep.
