Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2013 Oct 16;8(10):e77766.
doi: 10.1371/journal.pone.0077766. eCollection 2013.

Acute disseminated encephalomyelitis onset: evaluation based on vaccine adverse events reporting systems

Paolo Pellegrino  1 , Carla Carnovale, Valentina Perrone, Marco Pozzi, Stefania Antoniazzi, Emilio Clementi, Sonia Radice
Affiliations

Acute disseminated encephalomyelitis onset: evaluation based on vaccine adverse events reporting systems

Paolo Pellegrino et al. PLoS One. .

Erratum in

  • PLoS One. 2013;8(12). doi:10.1371/annotation/1d544202-04f5-4848-83f1-696c2de4221e

Abstract

Objective: To evaluate epidemiological features of post vaccine acute disseminated encephalomyelitis (ADEM) by considering data from different pharmacovigilance surveillance systems.

Methods: The Vaccine Adverse Event Reporting System (VAERS) database and the EudraVigilance post-authorisation module (EVPM) were searched to identify post vaccine ADEM cases. Epidemiological features including sex and related vaccines were analysed.

Results: We retrieved 205 and 236 ADEM cases from the EVPM and VAERS databases, respectively, of which 404 were considered for epidemiological analysis following verification and causality assessment. Half of the patients had less than 18 years and with a slight male predominance. The time interval from vaccination to ADEM onset was 2-30 days in 61% of the cases. Vaccine against seasonal flu and human papilloma virus vaccine were those most frequently associated with ADEM, accounting for almost 30% of the total cases. Mean number of reports per year between 2005 and 2012 in VAERS database was 40±21.7, decreasing after 2010 mainly because of a reduction of reports associated with human papilloma virus and Diphtheria, Pertussis, Tetanus, Polio and Haemophilus Influentiae type B vaccines.

Conclusions: This study has a high epidemiological power as it is based on information on adverse events having occurred in over one billion people. It suffers from lack of rigorous case verification due to the weakness intrinsic to the surveillance databases used. At variance with previous reports on a prevalence of ADEM in childhood we demonstrate that it may occur at any age when post vaccination. This study also shows that the diminishing trend in post vaccine ADEM reporting related to Diphtheria, Pertussis, Tetanus, Polio and Haemophilus Influentiae type B and human papilloma virus vaccine groups is most likely not [corrected] due to a decline in vaccine coverage indicative of a reduced attention to this adverse drug reaction.

PubMed Disclaimer

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Figure 1
Figure 1. Most commonly related vaccine in the VAERS and EVPM databases.
The histograms show the relative distribution of the ten commonest vaccine related to ADEM cases in the VAERS and EVPM databases. HPV (2&4): human papilloma virus vaccine, bivalent and quadrivalent; FLU: seasonal flu vaccine; FLU H1N1: H1N1 vaccine; MMR: measles, mumps, and rubella vaccine; PCV: pneumococcal conjugate vaccine; MNQ meningococcal vaccine; DTAP: Diphtheria, Pertussis, Tetanus; HEP B: Hepatises B vaccine; HEP A+B: Hepatitis A and B vaccine; HEXA: hexavalent vaccines; VARCEL: varicella vaccine; IPV: inactivated poliovirus vaccine; TDAP: vaccine against tetanus, diphtheria, and pertussis in adolescents.
Figure 2
Figure 2. ADEM cases from the VAERS database.
The graph shows the number of cases (black line) and the frequency of specific vaccine groups per years. DTaP+IPV+HiB: Vaccine against Diphtheria, Pertussis, Tetanus, Polio and Haemophilus Influentiae type B; FLU: seasonal flu vaccine; FLU H1N1: H1N1 vaccine; HPV (2&4): human papilloma virus vaccine, bivalent and quadrivalent.
Figure 3
Figure 3. Most frequently reported vaccines in the VAERS database divided by age groups.
The histogram shows the relative distribution of the three most common vaccine related to ADEM cases in the VAERS database by considering different age groups. MMR: measles, mumps, and rubella vaccine; PCV: pneumococcal conjugate vaccine; DTAP: Diphtheria, Pertussis, Tetanus vaccine; HPV (2&4): human papilloma virus vaccine, bivalent and quadrivalent; MNQ meningococcal vaccine; TDAP: vaccine against tetanus, diphtheria, and pertussis in adolescents; FLU: seasonal flu vaccine; TYP: Typhoid Vaccine.
Figure 4
Figure 4. Most frequently reported vaccines in the EVPM database divided by age groups.
The histogram shows the relative distribution of the three commonest vaccines related to ADEM cases in the EVPM database by considering different age groups. MMR: measles, mumps, and rubella vaccine; PCV: pneumococcal conjugate vaccine; DTAP: Vaccine against Diphtheria, Pertussis, Tetanus; HPV (2&4): human papilloma virus vaccine, bivalent and quadrivalent; MNQ meningococcal vaccine; HEXA: hexavalent vaccines; FLU: seasonal flu vaccine; FLU H1N1: H1N1 vaccine.
See this image and copyright information in PMC

References

    1. Tenembaum S, Chitnis T, Ness J, Hahn JS, International Pediatric MS Study Group; (2007) Acute disseminated encephalomyelitis. Neurology. 68: S23-S36. doi:10.1212/01.wnl.0000259404.51352.7f. PubMed: 17438235. - DOI - PubMed
    1. Huynh W, Cordato DJ, Kehdi E, Masters LT, Dedousis C (2008) Post-vaccination encephalomyelitis: literature review and illustrative case. J Clin Neurosci 15: 1315-1322. doi:10.1016/j.jocn.2008.05.002. PubMed: 18976924. - DOI - PMC - PubMed
    1. Shoamanesh A, Traboulsee A (2011) Acute disseminated encephalomyelitis following influenza vaccination. Vaccine. 29: 8182-8185. doi:10.1016/j.vaccine.2011.08.103. PubMed: 21925561. - DOI - PubMed
    1. Loughlin AM, Marchant CD, Adams W, Barnett E, Baxter R et al. (2012) Causality assessment of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS). Vaccine. 30: 7253-7259. doi:10.1016/j.vaccine.2012.09.074. PubMed: 23063829. - DOI - PubMed
    1. McNeil MM, Li R, Pickering S, Real TM, Smith PJ et al. (2013) Who is unlikely to report adverse events after vaccinations to the Vaccine Adverse Event Reporting System (VAERS)? Vaccine 31: 2673-2679. doi:10.1016/j.vaccine.2013.04.009. PubMed: 23597717. - DOI - PubMed

Publication types

LinkOut - more resources