<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-2025-699
Date of Submission: 2025-05-07

This report was submitted by a Patient from Moreno, Ross and Ramos Medical Center concerning patient ANON-PX-6289. The subject is a 77-year-old other with a significant medical history including atrial fibrillation, migraines, asthma, 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): Levothyroxine administered via the Intramuscular route at a dosage of 274mg, initiated on 2025-02-24 for Hypothyroidism and discontinued on 2025-03-14; Ibuprofen (NSAID) administered via the Oral route at a dosage of 142mg, initiated on 2025-02-24 for Pain and inflammation and discontinued on 2025-03-14.

On approximately 2025-02-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Somnolence, Diarrhea, Anaphylaxis. The Hepatotoxicity was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed voice and advised song. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Diarrhea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-699
report_date: '2025-05-07'
patient_details:
  patient_id: ANON-PX-6289
  gender: Other
  relevant_history:
  - atrial fibrillation
  - migraines
  - asthma
  - anxiety
  age_at_reaction: 77
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 274mg
  route_of_administration: Intramuscular
  start_date: '2025-02-24'
  indication_for_use: Hypothyroidism
  end_date: '2025-03-14'
- drug_name: Ibuprofen
  dosage: 142mg
  route_of_administration: Oral
  start_date: '2025-02-24'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2025-03-14'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-02-28'
  severity: Mild
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed voice and advised song.
- symptom_name: Somnolence
  onset_date: '2025-02-28'
  severity: Severe
  outcome: Unknown
  intervention_required: true
- symptom_name: Diarrhea
  onset_date: '2025-02-28'
  severity: Mild
  outcome: Recovering
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2025-02-28'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 3
reporting_facility: Moreno, Ross and Ramos Medical Center
reporter_type: Patient
