<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-2024-266
Date of Submission: 2024-10-02

This report was submitted by a Other Healthcare Professional from Jackson, Harrison and Thomas Medical Center concerning patient ANON-PX-9140. The subject is a 53-year-old male with a significant medical history including seasonal allergies, 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): Omeprazole (Proton-pump inhibitor) administered via the Intravenous route at a dosage of 79mg, initiated on 2024-08-11 for Gastroesophageal reflux disease and discontinued on 2024-09-28; Sertraline (SSRI) administered via the Intravenous route at a dosage of 498mg, initiated on 2024-08-11 for Major depressive disorder and discontinued on 2024-09-28.

On approximately 2024-09-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Angioedema, Maculopapular Rash, Vomiting. The Anaphylaxis was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Angioedema was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Vomiting was classified as Mild 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 4 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. 

</data>
report_id: ADR-2024-266
report_date: '2024-10-02'
patient_details:
  patient_id: ANON-PX-9140
  gender: Male
  relevant_history:
  - seasonal allergies
  - coronary artery disease
  - osteoarthritis
  age_at_reaction: 53
suspected_drugs:
- drug_name: Omeprazole
  dosage: 79mg
  route_of_administration: Intravenous
  start_date: '2024-08-11'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2024-09-28'
- drug_name: Sertraline
  dosage: 498mg
  route_of_administration: Intravenous
  start_date: '2024-08-11'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2024-09-28'
adverse_reactions:
- symptom_name: Anaphylaxis
  onset_date: '2024-09-25'
  severity: Mild
  outcome: Fatal
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2024-09-25'
  severity: Mild
  outcome: Unknown
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2024-09-25'
  severity: Mild
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2024-09-25'
  severity: Mild
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Not applicable
  naranjo_score: 4
reporting_facility: Jackson, Harrison and Thomas Medical Center
reporter_type: Other Healthcare Professional
