VACCINE

“... 2,207 cases were considered probably or possibly related to vaccination.
These represent the largest ASIA cohort ever reported ...”
Immunology Research • February 2015
The epidemiological profile of ASIA syndrome
after HPV vaccination: an evaluation based on the
Vaccine Adverse Event Reporting Systems
Author information
Pellegrino P1, Perrone V, Pozzi M,
Carnovale C, Perrotta C, Clementi E, Radice S.
Unit of Clinical Pharmacology
Department of Biomedical and Clinical Sciences
University Hospital “Luigi Sacco”, University of Milan
Via GB Grassi 74, 20157, Milan, Italy
Abstract
The term “ASIA-Autoimmune/inflammatory Syndrome Induced by Adjuvants” describes an umbrella of clinical
conditions sharing similar signs or symptoms, including post-vaccination phenomena. No information is available
on the epidemiology of the ASIA syndrome, especially following HPV vaccination. We carried out an analysis of
the VAERS database to retrieve all cases of suspected ASIA syndrome according to the Shoenfeld and Agmon-
Levin’s guideline for the diagnosis. After causality assessment and case validation, 2,207 cases were considered
probably or possibly related to vaccination. These represent the largest ASIA cohort ever reported and allowed us
to estimate epidemiological and clinical characteristic of this syndrome. The commonest clinical manifestation
observed were pyrexia (58%), myalgia (27%) and arthralgia or arthritis (19%), and the estimated reporting rate
was of 3.6 cases per 100,000 doses of HPV vaccine distributed (95% CI 3.4-3.7). This study presents the first systematic
estimation of ASIA incidence and expands the knowledge on this pathology. Further analyses are needed
to identify genetic and non-genetic risk factors for ASIA syndrome.
http://www.ncbi.nlm.nih.gov/pubmed/25381482