<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-2025-444
Date of Submission: 2025-04-07

This report was submitted by a Patient from Key-Mack Medical Center concerning patient ANON-PX-7164. The subject is an adult other with a significant medical history including asthma, atrial fibrillation, 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): Sertraline administered via the Intramuscular route at a dosage of 164mg, initiated on 2025-01-24 for Major depressive disorder and discontinued on 2025-03-17.

On approximately 2025-03-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Headache. The Pruritus was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Headache 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 7 was calculated, The assessment concluded the relationship was '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-2025-444
report_date: '2025-04-07'
patient_details:
  patient_id: ANON-PX-7164
  gender: Other
  relevant_history:
  - asthma
  - atrial fibrillation
  - chronic kidney disease
suspected_drugs:
- drug_name: Sertraline
  dosage: 164mg
  route_of_administration: Intramuscular
  start_date: '2025-01-24'
  indication_for_use: Major depressive disorder
  end_date: '2025-03-17'
adverse_reactions:
- symptom_name: Pruritus
  onset_date: '2025-03-11'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
- symptom_name: Headache
  onset_date: '2025-03-11'
  severity: Mild
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 7
reporting_facility: Key-Mack Medical Center
reporter_type: Patient
