Risk of Guillain-Barré Syndrome following quadrivalent human papillomavirus vaccine in the Vaccine Safety Datalink

Gee, Julianne; Sukumaran, Lakshmi; Weintraub, Eric

doi:10.1016/j.vaccine.2017.09.009

i

Risk of Guillain-Barré Syndrome following quadrivalent human papillomavirus vaccine in the Vaccine Safety Datalink

Supporting Files

10 13 2017
By Gee, Julianne ; Sukumaran, Lakshmi ; Weintraub, Eric

File Language:

English

Details

Alternative Title:

Vaccine
Personal Author:

Gee, Julianne ; Sukumaran, Lakshmi ; Weintraub, Eric
Corporate Authors:

Vaccine Safety Datalink Team
Description:

Objective:

Describe the Vaccine Safety Datalink’s (VSD) Guillain Barré Syndrome (GBS) surveillance following quadrivalent HPV vaccine (4vHPV) from 2006 through 2015.

Methods:

Among 4vHPV vaccinated persons aged 9–26, ICD-9 coded GBS was identified in VSD’s electronic data. Medical records were reviewed and adjudicated to confirm GBS. We calculated incidence rates of confirmed GBS within 1–42 days following 4vHPV with a one-sided 95% confidence interval.

Results:

Following 2,773,185 4vHPV doses, we confirmed 1 case of GBS in a male and no cases among females. The incidence rate of medical record confirmed GBS within 42 days following 4vHPV vaccine was 0.36 cases per million 4vHPV doses administered (1-sided 95% CI 1.71), which was less than the background rate.

Conclusion:

We found no evidence of an increased risk of GBS following 4vHPV. With an upper 95% confidence limit, we estimate that, if an increased risk exists, we would expect at most 1.08 additional cases of GBS per million people vaccinated with 4vHPV.
Subjects:

Adolescent Adult Child Female Guillain-Barre Syndrome Humans Incidence Male Papillomavirus Vaccines Risk Assessment Young Adult
Keywords:

Guillain Barré Syndrome Human Papillomavirus Vaccine Vaccine Safety
Source:

Vaccine. 35(43):5756-5758
Pubmed ID:

28935469
Pubmed Central ID:

PMC6719547
Document Type:

Journal Article
Funding:

CC999999/Intramural CDC HHSUnited States/
Volume:

35
Issue:

43
Collection(s):

CDC Public Access
Main Document Checksum:

urn:sha256:9f828626a6d0fa8d7f30a06fcc718dab0100b8146e7c718e6328aa7a9bd51ea4
Download URL:

https://stacks.cdc.gov/view/cdc/81119/cdc_81119_DS1.pdf
File Type:

[PDF - 53.02 KB ]

nihms-1048346.nxml

Download xml

File Language:

English

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