Guillain-Barre Syndrome, influenza vaccination, and antecedent respiratory and gastrointestinal infections: a case-centered analysis in the Vaccine Safety Datalink, 2009-2011.

Greene, Sharon K.; Rett, Melisa D.; Vellozzi, Claudia; Li, Lingling; Kulldorff, Martin; Marcy, S. Michael; Daley, Matthew F.; Belongia, Edward A.; Baxter, Roger; Fireman, Bruce H.; Jackson, Michael L.; Omer, Saad B.; Nordin, James D.; Jin, Robert; Weintraub, Eric S.; Vijayadeva, Vinutha; Lee, Grace M.

doi:10.1371/journal.pone.0067185

Cited by 59Peripheral Neuropathies and DisordersInfluenza Virus Research StudiesPharmacovigilance and Adverse Drug Reactions

Guillain-Barre Syndrome, influenza vaccination, and antecedent respiratory and gastrointestinal infections: a case-centered analysis in the Vaccine Safety Datalink, 2009-2011.

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Greene, Sharon K., Rett, Melisa D., Vellozzi, Claudia, Li, Lingling, Kulldorff, Martin, Marcy, S. Michael, Daley, Matthew F., Belongia, Edward A. +9 more·2013·PLoS ONE

DOI 10.1371/journal.pone.0067185PMC PMC3694016

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Abstract

BACKGROUND: Guillain-Barré Syndrome (GBS) can be triggered by gastrointestinal or respiratory infections, including influenza. During the 2009 influenza A (H1N1) pandemic in the United States, monovalent inactivated influenza vaccine (MIV) availability coincided with high rates of wildtype influenza infections. Several prior studies suggested an elevated GBS risk following MIV, but adjustment for antecedent infection was limited. METHODS: We identified patients enrolled in health plans participating in the Vaccine Safety Datalink and diagnosed with GBS from July 2009 through June 2011. Medical records of GBS cases with 2009-10 MIV, 2010-11 trivalent inactivated influenza vaccine (TIV), and/or a medically-attended respiratory or gastrointestinal infection in the 1 through 141 days prior to GBS diagnosis were reviewed and classified according to Brighton Collaboration criteria for diagnostic certainty. Using a case-centered design, logistic regression models adjusted for patient-level time-varying sources of confounding, including seasonal vaccinations and infections in GBS cases and population-level controls. RESULTS: Eighteen confirmed GBS cases received vaccination in the 6 weeks preceding onset, among 1.27 million 2009-10 MIV recipients and 2.80 million 2010-11 TIV recipients. Forty-four confirmed GBS cases had infection in the 6 weeks preceding onset, among 3.77 million patients diagnosed with medically-attended infection. The observed-versus-expected odds that 2009-10 MIV/2010-11 TIV was received in the 6 weeks preceding GBS onset was odds ratio = 1.54, 95% confidence interval (CI), 0.59-3.99; risk difference = 0.93 per million doses, 95% CI, -0.71-5.16. The association between GBS and medically-attended infection was: odds ratio = 7.73, 95% CI, 3.60-16.61; risk difference = 11.62 per million infected patients, 95% CI, 4.49-26.94. These findings were consistent in sensitivity analyses using alternative infection definitions and risk intervals for prior vaccination shorter than 6 weeks. CONCLUSIONS: After adjusting for antecedent infections, we found no evidence for an elevated GBS risk following 2009-10 MIV/2010-11 TIV influenza vaccines. However, the association between GBS and antecedent infection was strongly elevated.

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In a later analysis including the 2010-2011 season and adjusted for antecedent respiratory infection, there was no increased risk of Guillain-Barré syndrome following 1.27 million 2009-10 MIV or 2.8 million 2010-11 TIV doses.
“However, in a later analysis that included the 2010–2011 season and adjusted for antecedent respiratory infection there was no increased risk following 1.27 million 2009-10 MIV or 2.8 million 2010-11 TIV doses (Greene et al., 2013).”
From Vaccine Safety: Myths and Misinformation (2020) · cites this paper as Greene et al., 2013
The Results report 1,267,745 MIV and 2,798,788 TIV first doses, and the study adjusted for antecedent infection. The Discussion reports no statistically significant association for the vaccines combined, but its confidence interval allows an increased risk; the categorical statement that there was no increased risk overstates that finding. Page numbers are not available in our copy. (LLM, conf=0.86)
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Authors: Greene, S. K., Rett, M. D., Vellozzi, C., Li, L., Kulldorff, M., Marcy, S. M., Daley, M. F., Belongia, E. A., Baxter, R., Fireman, B. H., Jackson, M. L., Omer, S. B., Nordin, J. D., Jin, R., Weintraub, E. S., Vijayadeva, V., & Lee, G. M.
Affiliations: Harvard University (US)
Centers for Disease Control and Prevention (US)
Kaiser Permanente (US)
Marshfield Clinic Research Foundation (US)
Kaiser Permanente Washington Health Research Institute (US)
HealthPartners (US)
Boston Children's Hospital (US)
Corresponding author: Greene, Sharon K.
ORCID: Greene, Sharon K.
Li, Lingling
Kulldorff, Martin
Daley, Matthew F.
Belongia, Edward A.
Fireman, Bruce H.
Jackson, Michael L.
Omer, Saad B.
Nordin, James D.
Weintraub, Eric S.
Lee, Grace M.
Venue: PLoS ONE
Publisher: Public Library of Science (PLoS)
Published: 2013-06-26
Volume: 8
Issue: 6
Pages: e67185
ISSN: 1932-6203 (ISSN-L)
DOI: 10.1371/journal.pone.0067185
PMC: PMC3694016
OpenAlex: W2120221905
Cited by: 59
References: 53
Citations by year: 2025: 2 · 2024: 2 · 2023: 6 · 2022: 4 · 2021: 6 · 2020: 4 · 2019: 8 · 2018: 2 · 2017: 3 · 2016: 3 · 2015: 7 · 2014: 7 · 2013: 3
FWCI: 4.23
Type: journal article
Language: en
Open access: gold
doi.org
Licence: public-domain
creativecommons.org/publicdomain/zero/1.0/ (unspecified)
Locations: PLoS ONE (publishedVersion, public-domain)
Europe PMC (PubMed Central) (publishedVersion, public-domain)
PubMed Central (publishedVersion, public-domain)
PubMed (publishedVersion)
Digital Access to Scholarship at Harvard (DASH) (Harvard University) (submittedVersion, cc-by)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Figshare (submittedVersion, cc-by)
Funders: National Foundation for Infectious Diseases
Sanofi
Brigham and Women's Hospital
Kaiser Permanente
Emory University
Centers for Disease Control and Prevention (200-2002-00732)
School of Medicine, Emory University
Sanofi Pasteur
Topics: Health Sciences › Medicine › Neurology › Peripheral Neuropathies and Disorders
Health Sciences › Medicine › Epidemiology › Influenza Virus Research Studies
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Keywords: Guillain-Barré syndrome, influenza vaccination, inactivated influenza vaccine, 2009 H1N1 pandemic, trivalent inactivated influenza vaccine, antecedent infection, respiratory infections, gastrointestinal infections, vaccine safety, post-marketing surveillance, temporal association, 2010/11 influenza season
MeSH terms: Adult, Antigens, Viral, Female, Gastrointestinal Diseases, Humans, Influenza Vaccines, Male, Middle Aged, Respiratory Tract Infections, Safety, Vaccination, Vaccines, Inactivated, Guillain-Barre Syndrome, Influenza A Virus, H1N1 Subtype

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Guillain-Barre Syndrome, influenza vaccination, and antecedent respiratory and gastrointestinal infections: a case-centered analysis in the Vaccine Safety Datalink, 2009-2011.

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