<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-2025-477
Date of Submission: 2025-05-02

This report was submitted by a Other Healthcare Professional from Jensen Inc Medical Center concerning patient ANON-PX-7599. The subject is a 39-year-old female with a significant medical history including migraines, anxiety. 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): Amoxicillin administered via the Subcutaneous route at a dosage of 261mg, initiated on 2025-02-20 for Bacterial infection and discontinued on 2025-04-06; Atorvastatin administered via the Intramuscular route at a dosage of 462mg, initiated on 2025-02-20 for Hypercholesterolemia and discontinued on 2025-04-06.

On approximately 2025-03-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Somnolence. The Headache was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed modern and advised throw. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Life-threatening 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 3 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-477
report_date: '2025-05-02'
patient_details:
  patient_id: ANON-PX-7599
  gender: Female
  relevant_history:
  - migraines
  - anxiety
  age_at_reaction: 39
suspected_drugs:
- drug_name: Amoxicillin
  dosage: 261mg
  route_of_administration: Subcutaneous
  start_date: '2025-02-20'
  indication_for_use: Bacterial infection
  end_date: '2025-04-06'
- drug_name: Atorvastatin
  dosage: 462mg
  route_of_administration: Intramuscular
  start_date: '2025-02-20'
  indication_for_use: Hypercholesterolemia
  end_date: '2025-04-06'
adverse_reactions:
- symptom_name: Headache
  onset_date: '2025-03-05'
  severity: Severe
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed modern and advised throw.
- symptom_name: Somnolence
  onset_date: '2025-03-05'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 3
reporting_facility: Jensen Inc Medical Center
reporter_type: Other Healthcare Professional
