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Hum Vaccin Immunother. 2014;10(1):232-7. doi: 10.4161/hv.26292. Epub 2013 Sep 6.

Guillain-Barre syndrome following quadrivalent human papillomavirus vaccination among vaccine-eligible individuals in the United States.

Author information

  • 1Department of Epidemiology and Cancer Control; St. Jude Children's Research Hospital; Memphis, TN USA.
  • 2Division of Preventive Medicine; Department of Medicine; University of Alabama at Birmingham; Birmingham, AL USA.
  • 3Division of Cancer Epidemiology; Department of Epidemiology; Biostatistics, and Occupational Health; McGill University; Montreal, QC Canada.
  • 4Office of Infectious Disease Epidemiology; Delaware Health and Social Services; Dover, DE USA.

Abstract

Post-marketing surveillance studies provide conflicting evidence about whether Guillain-Barre syndrome occurs more frequently following quadrivalent human papillomavirus (HPV4) vaccination. We aimed to assess whether Guillain-Barre syndrome is reported more frequently following HPV4 vaccination than other vaccinations among females and males aged 9 to 26 y in the United States. We used adverse event reports received by the United States Vaccine Adverse Event Reporting System (VAERS) between January 1, 2010 and December 31, 2012 to estimate overall, age-, and sex-specific proportional reporting ratios (PRRs) and corresponding Χ2 values for reports of Guillain-Barre syndrome between 5 and 42 d following HPV vaccination. Minimum criteria for a signal using this approach are 3 or more cases, PRR≥2, and Χ2≥4. Guillain-Barre syndrome was listed as an adverse event in 45 of 14,822 reports, of which 9 reports followed HPV4 vaccination and 36 reports followed all other vaccines. The overall, age-, and sex-specific PRR estimates were uniformly below 1. In addition, the overall, age-, and sex-specific Χ2 values were uniformly below 3. Our analysis of post-marketing surveillance data does not suggest that Guillain-Barre syndrome is reported more frequently following HPV4 vaccination than other vaccinations among vaccine-eligible females or males in the United States. Our findings may be useful when discussing the risks and benefits of HPV4 vaccination.

KEYWORDS:

Guillain-Barre syndrome; adverse event; human papillomavirus; post-marketing surveillance; safety; vaccine

PMID:
24013368
PMCID:
PMC4181024
DOI:
10.4161/hv.26292
[PubMed - indexed for MEDLINE]
Free PMC Article
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