<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-2024-655
Date of Submission: 2024-10-27

This report was submitted by a Nurse from Nichols, Cannon and Davila Medical Center concerning patient ANON-PX-2957. The subject is an adult male with a significant medical history including seasonal allergies, anxiety, migraines, 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): Sertraline (SSRI) administered via the Oral route at a dosage of 499mg, initiated on 2024-08-22 for Major depressive disorder and discontinued on 2024-10-02.

On approximately 2024-09-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Maculopapular Rash, Hepatotoxicity, Vomiting, Somnolence. The Headache was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed look and advised late. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed around and advised today. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Between too hotel face throughout social. Resource mean middle against.</data>
report_id: ADR-2024-655
report_date: '2024-10-27'
patient_details:
  patient_id: ANON-PX-2957
  gender: Male
  relevant_history:
  - seasonal allergies
  - anxiety
  - migraines
  - osteoarthritis
suspected_drugs:
- drug_name: Sertraline
  dosage: 499mg
  route_of_administration: Oral
  start_date: '2024-08-22'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2024-10-02'
adverse_reactions:
- symptom_name: Headache
  onset_date: '2024-09-24'
  severity: Severe
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed look and advised late.
- symptom_name: Maculopapular Rash
  onset_date: '2024-09-24'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed around and advised today.
- symptom_name: Hepatotoxicity
  onset_date: '2024-09-24'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
- symptom_name: Vomiting
  onset_date: '2024-09-24'
  severity: Severe
  outcome: Recovering
  intervention_required: true
- symptom_name: Somnolence
  onset_date: '2024-09-24'
  severity: Mild
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 8
reporting_facility: Nichols, Cannon and Davila Medical Center
reporter_type: Nurse
notes: Between too hotel face throughout social. Resource mean middle against.
