Table 4. Summary of association of GBS to influenza vaccines in peer-reviewed literature.
Author | Title | Publication year | Type(s) of Influenza vaccine(s) studied | DB used | Method | Conclusion |
Baxter, R. [43] | Recurrent Guillain-Barre Syndrome Following Vaccination | 2012 | TIV | Kaiser Permanente Northern California | review of medical records of GBS confirmed cases | low risk of recurrent GBS |
Lee, S.J. [44] | Neurologic adverse events following influenza A (H1N1) vaccinations in children | 2012 | H1N1 MIV | N/A | single case study of 14 cases Nov.09–Mar.10 | No major Neurologic AEs |
Andrews, N. [45] | Guillain-Barre syndrome and H1N1 (2009) pandemic influenza vaccination using an AS03 adjuvanted vaccine in the United Kingdom: Self-controlled case series | 2011 | H1N1 MIV (2009) | N/A | review of patient records of post-vaccination GBS cases using self-controlled case series method on case identified in hospital episode statistics | no evidence of increased risk of GBS 6 weeks after vaccination |
Cheo, Y.J. [36] | Serious adverse events follwing receipt of trivalent inactivated influenza vaccine in Korea 2003–2010 | 2011 | TIV | Korea National Vaccine Injury Compensation Program (2003–2010) | retrospective review of clinical records, case investigation reports, conference materials and billing records. | GBS was the most-common SAEs reported after TIV immunization |
Dieleman, J. [46] | Guillain-Barre syndrome and adjuvanted pandemic influenza A (H1H1) 2009 vaccine: multinational case-control study in Europe | 2011 | H1N1 MIV (2009) | N/A | GBS and Fisher syndrome case-control study (matched on age, sex, index date, and country) | no increased risk of GBS |
Lee. G.M. [22] | H1N1 and Seasonal Influenza Vaccine Safety in the Vaccine Safety Datalink Project | 2011 | H1N1 MIV, LAMV, TIV, LAIV | Vaccine Safety Datalink | Nov'09–Apr'10 weekly signal detection analysis using self-controlled design /or/ current-vs-historical comparison | No association of GBS and other neurologic outcomes. For MIV - signal of Bell's Palsy. Higher reports of GBS in TIV than LAIV. |
Sejvar, J.J. [47] | Guillain-Barre Syndrome Following Influenza Vaccination: Causal or Coincidental? | 2011 | MIV, TIV | N/A | analysis of past studies | question not answered, causality of GBS with regards to influenza vaccination remained inconclusive |
Verity, C. [48] | Guillain-Barre syndrome and H1N1 influenza vaccine in UK children | 2011 | H1N1 MIV (?) | N/A | Sep'09–Aug'10 follow-up clinical questionairs | no association of GBS to influenza vaccination |
Williams, S. E. [49] | Causality assessment of serious neurologic adverse events following 2009 H1N1 vaccination | 2011 | H1N1 MIV (2009) | VAERS | review of SAE reports in Oct'09–Mar'10 | inconclusive association assessment, investigation of GBS and other SNAEs causality is difficult, VAERS reporting process can be improved |
Burwen, D.R. [37] | Evaluation of Guillain-Barre Syndrome among recipients of influenza vaccine in 2000 and 2001 | 2010 | not specified | Medicare claim data & hospital records | Incidence Rate Ratio | slightly non-significant elevated incidence rate ratio of GBS for all seasons combined |
McNeil, M.M. [50] | A cluster of nonspecific adverse events in a military reserve unit following pandemic influenza A (H1N1) 2009 vaccination-Possible stimulate reporting? | 2010 | H1N1 MIV | VAERS | surey & review of index cases' VAERS reports, hospital records, vaccination status, aiagnostic results and outcome in comparison to VAERS reports of the same screen lot | GBS in the index case not confirmed, possbile stimulated reporting among reporters from the index case's cohort |
Vellozzi, C. [51] | Adverse events following infuenza A (H1N1) 2009 monovalent vaccines reported to the Vaccine Adverse Event Reporting System, United States, October 1, 2009–January 31, 2010 | 2010 | H1N1 MIV | VAERS | empirical Bayesian data mining and reporting proportions with clinical review of reports | death, GBS, and anaphylaxis were rare (<2 per million doses from ∼10,000 VEARS reports) |
Evans, D. [52] | “Prepandemic” Immunization for Novel Influenza Viruses, “Swine Flu” Vaccine, Guillain-Barre Syndrome, and the Detection of Rare Severe Adverse Events | 2009 | clinical trials of H5N1 | N/A | review of past pandemic influenza studies | GBS association with Influenza vaccination remained inconclusive. Possible mechanism of GBS association with influenza vaccine was discussed. |
Vellozzi, C. [38] | Safety of trivalent inactivated influenza vaccines in adults: Background for pandemic influenza vaccine safety monitoring | 2009 | TIV (1990–2005) | VAERS | PRR, review of reports of recurrent events and death | slightly elevated risk of SAEs, GBS - most frequently reported SAE, GBS requires continued monitoring |
Juurlink, D.N. [39] | Guillain-Barre Syndrome after influenza vaccination in adults: a population-based study | 2006 | not specified | N/A | self-matched case-series method and time-series analysis | Influenza vaccination is associated with increased risk of hospitalization due to GBS |
Izurieta, H.S. [53] | Adverse Events Reported Following Live Cold-Adapted, Intranasal Influenza Vaccine | 2005 | LAIV | VAERS (2003–2005) | report rate per 100,000 vaccinees | No unexpected serious risks, no GBS, may rarely cause anaphylaxis |
Kao, C. [54] | Guillain-Barre syndrome coexisting with pericarditis or nephrotic syndrome after influenza vaccination | 2004 | not specified | N/A | 2 individual case studies | pericarditis or onset nephrotic syndrome may coincidoe with GBS development. |
Geier, M.R. [40] | Influenza vaccination and Guillain Barre syndrome | 2003 | not specified 1991–1999 | VAERS | stat. analysis with Corel's Quattro Pro | increased risk of acute GBS and severe GBS in comparison to tetanus-diphtheria control group |
Lasky, T. [41] | The Guillain-Barre Syndrome and the 1992–1993 and 1993–1994 influenza vaccines | 1998 | not specified | VAERS | patient survey and review of hospital discharging records based on VAERS reports | elevated relative risk of GBS 6 weeks after vaccination when combined the two reporting years. No increase in the risk when looking at each year individually. |
Abbreviations: MIV – Monovalent Inactivated Influenza Vaccine, TIV – Trivalent Inactivated Influenza Vaccine, LAIV – Live Attenuated Influenza Vaccine, VAERS – Vaccince Adverse Event Reporting System.