<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-2024-446
Date of Submission: 2024-08-25

This report was submitted by a Nurse from Haas Inc Medical Center concerning patient ANON-PX-8347. The subject is a 83-year-old other with a significant medical history including 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): Sertraline (SSRI) administered via the Subcutaneous route at a dosage of 272mg, initiated on 2024-06-02 for Major depressive disorder with the course ongoing.

On approximately 2024-08-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Somnolence, Nausea, Angioedema. The Vomiting was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed body and advised magazine. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly 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-2024-446
report_date: '2024-08-25'
patient_details:
  patient_id: ANON-PX-8347
  gender: Other
  relevant_history:
  - migraines
  - coronary artery disease
  - asthma
  age_at_reaction: 83
suspected_drugs:
- drug_name: Sertraline
  dosage: 272mg
  route_of_administration: Subcutaneous
  start_date: '2024-06-02'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
adverse_reactions:
- symptom_name: Vomiting
  onset_date: '2024-08-05'
  severity: Severe
  outcome: Unknown
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2024-08-05'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2024-08-05'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2024-08-05'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed body and advised magazine.
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 10
reporting_facility: Haas Inc Medical Center
reporter_type: Nurse
