Table 2.
Definitions of SAEs after YF vaccination
| Refs. | Definition of SAE or anaphylaxis |
|---|---|
| 12 | Code of Federal regulations definition: “any adverse experience, occurring after administration of any vaccine dose that results in any of the following outcomes: death, life-threatening illness, inpatient hospitalization, prolongation of existing hospitalization, persistence of significant disability” (included cases of anaphylaxis/hypersensitivity in the non-serious category). |
| 14 | Systemic AEs: onset within 2 weeks of vaccination. Neurological: new onset seizures, encephalitis, myelitis, altered mental status, focal cranial or peripheral neurological deficits, paresthesia, and vertigo with or without headache. Multisystemic: myalgia, arthralgia, impaired hepatic function, respiratory distress, nausea, vomiting, and impaired renal function with or without fever.* |
| 16 | Reports of death, hospitalization, disability, or life-threatening illness requiring an emergency room or doctor visit. Onset < 2 weeks after vaccination, and duration > 72 hours. Neurologic: Guillain–Barré syndrome, new onset seizures, encephalitis, myelitis, altered mental status, focal cranial or peripheral neurologic deficits, paresthesias, vertigo, and headaches (headaches alone are not sufficient for neurologic diagnosis). Multisystemic: myalgias, arthralgias, rhabdomyolysis, elevated transaminases, respiratory distress, nausea, vomiting, diarrhea, nephropathy, and disseminated intravascular coagulation with or without fever. |
| 17 | Systemic AEs: onset < 2 weeks after vaccination, and duration > 72 hours. Neurologic: Guillain–Barré syndrome, new onset seizures, encephalitis, myelitis, altered mental status, focal cranial or peripheral neurologic deficits, paresthesias, vertigo, and headaches (headaches alone are not sufficient for neurologic diagnosis). Multisystemic: myalgias, arthralgias, elevated transaminases, respiratory distress, nausea, vomiting, diarrhea, nephropathy, and disseminated intravascular coagulation with or without fever.* |
| 15 | If reaction occurred within 4 hours of vaccination and at least one dermatologic symptom (urticaria, flushing, angioedema, pruritis, or rash) and at least one respiratory symptom (dyspnea, bronchospasm, pharyngeal edema, wheezing, throat tightness, or dysphonia).† |