title: Guillain-Barre syndrome following quadrivalent human papillomavirus vaccination among vaccine-eligible individuals in the United States.
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.
authors.affiliation: Department of Epidemiology and Cancer Control; St. Jude Children's Research Hospital; Memphis, TN USA.
authors.forename: Rohit P
authors.initials: RP
authors.lastname: Ojha
authors.affiliation: Division of Preventive Medicine; Department of Medicine; University of Alabama at Birmingham; Birmingham, AL USA.
authors.forename: Bradford E
authors.initials: BE
authors.lastname: Jackson
authors.affiliation: Division of Cancer Epidemiology; Department of Epidemiology; Biostatistics, and Occupational Health; McGill University; Montreal, QC Canada.
authors.forename: Joseph E
authors.initials: JE
authors.lastname: Tota
authors.affiliation: Office of Infectious Disease Epidemiology; Delaware Health and Social Services; Dover, DE USA.
authors.forename: Tabatha N
authors.initials: TN
authors.lastname: Offutt-Powell
authors.affiliation: Division of Preventive Medicine; Department of Medicine; University of Alabama at Birmingham; Birmingham, AL USA.
authors.forename: Karan P
authors.initials: KP
authors.lastname: Singh
authors.affiliation: Division of Preventive Medicine; Department of Medicine; University of Alabama at Birmingham; Birmingham, AL USA.
authors.forename: Sejong
authors.initials: S
authors.lastname: Bae
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D020275:Guillain-Barre Syndrome / Q000139:chemically induced* / Q000453:epidemiology*; D006801:Humans; D008297:Male; D053918:Papillomavirus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects*; D014481:United States / Q000453:epidemiology; D014611:Vaccination / Q000009:adverse effects*; D055815:Young Adult
chemical_list: D053918:Papillomavirus Vaccines
keywords: Guillain-Barre syndrome; adverse event; human papillomavirus; post-marketing surveillance; safety; vaccine