<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-2025-126
Date of Submission: 2025-07-20

This report was submitted by a Patient from Wright, Sandoval and Austin Medical Center concerning patient ANON-PX-5596. The subject is a 66-year-old other with a significant medical history including coronary artery disease, hypertension, chronic kidney disease, migraines. 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 Intramuscular route at a dosage of 382mg, initiated on 2025-05-15 for Major depressive disorder and discontinued on 2025-07-10.

On approximately 2025-07-10, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Anaphylaxis, Vomiting, Pruritus. The Hepatotoxicity was classified as Moderate 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. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed should and advised city. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 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-2025-126
report_date: '2025-07-20'
patient_details:
  patient_id: ANON-PX-5596
  gender: Other
  relevant_history:
  - coronary artery disease
  - hypertension
  - chronic kidney disease
  - migraines
  age_at_reaction: 66
suspected_drugs:
- drug_name: Sertraline
  dosage: 382mg
  route_of_administration: Intramuscular
  start_date: '2025-05-15'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-07-10'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-07-10'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2025-07-10'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-07-10'
  severity: Severe
  outcome: Unknown
  intervention_required: true
- symptom_name: Pruritus
  onset_date: '2025-07-10'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed should and advised city.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Not applicable
  naranjo_score: 1
reporting_facility: Wright, Sandoval and Austin Medical Center
reporter_type: Patient
