Subject: guillain barre + influenza vaccine (only with abstract)
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Date: Thu, 23 Jul 2009 17:41:05 +0200

guillain barre + influenza vaccine (only with abstract)
66 articles - 23.07.09

1: J Infect Dis. 2009 Aug 1;200(3):321-8.

"Prepandemic" immunization for novel influenza viruses, "swine flu" vaccine, guillain-barre syndrome, and the detection of rare severe adverse events.

Evans D, Cauchemez S, Hayden FG.
The Wellcome Trust and 2MRC Centre for Outbreak Analysis and Modelling, Department of Infectious Diseases Epidemiology, Imperial College London, London, United Kingdom; and 3The Wellcome Trust, London and University of Virginia, Charlottesville, Virginia.
The availability of immunogenic, licensed H5N1 vaccines and the anticipated development of vaccines against "swine" influenza A(H1N1) have stimulated debate about the possible use of these vaccines for protection of those exposed to potential pandemic influenza viruses and for immunization or "priming" of populations in the so-called "prepandemic" (interpandemic) era. However, the safety of such vaccines is a critical issue in policy development for wide-scale application of vaccines in the interpandemic period. For example, wide-scale interpandemic use of H5N1 vaccines could lead to millions of persons receiving vaccines of uncertain efficacy potentially associated with rare severe adverse events and against a virus that may not cause a pandemic. Here, we first review aspects of the 1976 National Influenza Immunization Programme against "swine flu" and its well-documented association with Guillain-Barre syndrome as a case study illustration of a suspected vaccine-associated severe adverse event in a mass interpandemic immunization setting. This case study is especially timely, given the recent spread of a novel influenza A(H1N1) virus in humans in Mexico and beyond. Following this, we examine available safety data from clinical trials of H5N1 vaccines and briefly discuss how vaccine safety could be monitored in a postmarketing surveillance setting.
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=19563262&dopt=ExternalLink
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PMID: 19563262 [PubMed - in process]
2: Drug Saf. 2009;32(4):309-23.

Vaccines and Guillain-Barre syndrome.

Haber P, Sejvar J, Mikaeloff Y, DeStefano F.
Immunization Safety Office, Office of the Chief Science Officer, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA. [email-masked]
Guillain-Barre syndrome (GBS) is the leading cause of acute flaccid paralysis in developed countries and is characterized by various degrees of weakness, sensory abnormalities and autonomic dysfunction. Although the underlying aetiology and pathophysiology of GBS are not completely understood, it is broadly believed that immune stimulation plays a role in its pathogenesis. Thus, since vaccines have an effect on the immune system it is biologically plausible that immunizations may be associated with subsequent GBS. The objective of this article is to review the current body of evidence that either supports or does not support a causal, rather than just temporal, association between various vaccines and GBS, and to provide an evidence-based review of this issue. The scope of the article includes published reports that, regardless of method of case ascertainment, appeared in peer-reviewed literature between 1950 and 2008. Our review indicates that, with rare exceptions, associations between vaccines and GBS have been only temporal. There is little evidence to support a causal association with most vaccines. The evidence for a causal association is strongest for the swine influenza vaccine that was used in 1976-77. Studies of influenza vaccines used in subsequent years, however, have found small or no increased risk of GBS. Older formulations of rabies vaccine cultured in mammalian brain tissues have been found to have an increased risk of GBS, but newer formulations of rabies vaccine, derived from chick embryo cells, do not appear to be associated with GBS at a greater than expected rate. In an earlier review, the Institute of Medicine concluded that the evidence favoured a causal association between oral polio vaccine and tetanus toxoid-containing vaccines and GBS. However, recent evidence from large epidemiological studies and mass immunization campaigns in different countries found no correlation between oral polio vaccine or tetanus toxoid-containing vaccines and GBS. Spontaneous reports to the US Vaccine Adverse Events Reporting System shortly after the introduction of quadrivalent conjugated meningococcal vaccine (MCV4) raised concerns of a possible association with GBS. Comparisons with expected rates of GBS, however, were inconclusive for an increased risk, and lack of controlled epidemiological studies makes it difficult to draw conclusions about a causal association. For other vaccines, available data are based on isolated case reports or very small clusters temporally related to immunizations, and no conclusion about causality can be drawn. There are certain circumstances in which immunizing individuals, particularly those with a prior history of GBS, may require caution. However, the benefit of vaccines in preventing disease and decreasing morbidity and mortality, particularly for influenza, needs to be weighed against the potential risk of GBS.
Publication Types: Research Support, U.S. Gov't, P.H.S. Review
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=19388722&dopt=ExternalLink
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PMID: 19388722 [PubMed - indexed for MEDLINE]
3: Vaccine. 2009 Mar 26;27(15):2114-20. Epub 2009 Feb 6.

Safety of trivalent inactivated influenza vaccines in adults: background for pandemic influenza vaccine safety monitoring.

Vellozzi C, Burwen DR, Dobardzic A, Ball R, Walton K, Haber P.
Immunization Safety Office (ISO), Office of the Chief Science Officer (OCSO), Centers for Disease Control and Prevention, Atlanta, GA, United States. [email-masked]
In preparation for pandemic vaccine safety monitoring, we assessed adverse events reported to the Vaccine Adverse Event Reporting System following receipt of trivalent inactivated influenza vaccines among adults from 1990 through 2005. We calculated reporting rates for nonserious, serious, and neurological adverse events. We reviewed reports of recurrent events and deaths, as well as reports identified through advanced signal detection. The most frequently reported events were local reactions and systemic symptoms. Guillain-Barre syndrome was the most frequently reported serious event (0.70 reports per million vaccinations). Adverse event reporting rates have been reasonably constant over time. No new safety concerns emerged after our review of 15 years of post-licensure surveillance data. These findings provide useful information if pandemic vaccine is rapidly distributed and pre-licensure data are limited.
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=19356614&dopt=ExternalLink
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PMID: 19356614 [PubMed - indexed for MEDLINE]
4: Am J Epidemiol. 2009 Feb 1;169(3):382-8. Epub 2008 Nov 24.

Investigation of the temporal association of Guillain-Barre syndrome with influenza vaccine and influenzalike illness using the United Kingdom General Practice Research Database.

Stowe J, Andrews N, Wise L, Miller E.
Immunisation Department, Health Protection Agency Centre for Infections, London, UK. [email-masked]
In 1976, the national swine influenza vaccination program in the United States was suspended because of an increased risk of Guillain-Barre syndrome. Subsequent studies of seasonal influenza vaccine have given conflicting results. The authors used the self-controlled case series method to investigate the relation of Guillain-Barre syndrome with influenza vaccine and influenzalike illness using cases recorded in the General Practice Research Database from 1990 to 2005 in the United Kingdom. The relative incidence of Guillain-Barre syndrome within 90 days of vaccination was 0.76 (95% confidence interval: 0.41, 1.40). In contrast, the relative incidence of Guillain-Barre syndrome within 90 days of an influenzalike illness was 7.35 (95% confidence interval: 4.36, 12.38), with the greatest relative incidence (16.64, 95% confidence interval: 9.37, 29.54) within 30 days. The relative incidence was similar (0.89, 95% confidence interval: 0.42, 1.89) when the analysis was restricted to a subset of validated cases. The authors found no evidence of an increased risk of Guillain-Barre syndrome after seasonal influenza vaccine. The finding of a greatly increased risk after influenzalike illness is consistent with anecdotal reports of a preceding respiratory illness in Guillain-Barre syndrome and has important implications for the risk/benefit assessment that would be carried out should pandemic vaccines be deployed in the future.
Publication Types: Research Support, Non-U.S. Gov't Validation Studies
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=19033158&dopt=ExternalLink
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PMID: 19033158 [PubMed - indexed for MEDLINE]
5: Arch Soc Esp Oftalmol. 2008 Jul;83(7):433-5.

[Miller Fisher syndrome, internal and external ophthalmoplegia after flu vaccination]

[Article in Spanish]
Blanco-Marchite CI, Buznego-Suarez L, Fagundez-Vargas MA, Mendez-Llatas M, Pozo-Martos P.
Servicio de Oftalmologia, Complejo Hospitalario Universitario de Albacete SESCAM, Albacete, Espana. [email-masked]
CASE REPORT: Miller Fisher Syndrome (MFS) is the most frequent variant of the Guillain-Barre Syndrome. It is characterised by the classic triad of ophthalmoplegia, ataxia and areflexia. We present a case of a patient who developed these clinical findings 5 days after flu vaccination. DISCUSSION: Miller Fisher Syndrome is an unusual condition seen in ophthalmologic clinical practice. Although respiratory and digestive infections have been reported as antecedent infectious agents in MFS, it has not previously been described in relation to the flu vaccine.
Publication Types: Case Reports English Abstract
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=18592444&dopt=ExternalLink
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PMID: 18592444 [PubMed - indexed for MEDLINE]
6: J Infect Dis. 2008 Jul 15;198(2):226-33.

Anti-ganglioside antibody induction by swine (A/NJ/1976/H1N1) and other influenza vaccines: insights into vaccine-associated Guillain-Barre syndrome.

Nachamkin I, Shadomy SV, Moran AP, Cox N, Fitzgerald C, Ung H, Corcoran AT, Iskander JK, Schonberger LB, Chen RT.
Department of Pathology and Laboratory Medicine, University of Pennsylvania School of Medicine, Philadelphia, PA 19104-4283, USA. [email-masked]
BACKGROUND: Receipt of an A/NJ/1976/H1N1 "swine flu" vaccine in 1976, unlike receipt of influenza vaccines used in subsequent years, was strongly associated with the development of the neurologic disorder Guillain-Barre syndrome (GBS). Anti-ganglioside antibodies (e.g., anti-GM(1)) are associated with the development of GBS, and we hypothesized that the swine flu vaccine contained contaminating moieties (such as Campylobacter jejuni antigens that mimic human gangliosides or other vaccine components) that elicited an anti-GM(1) antibody response in susceptible recipients. METHODS: Surviving samples of monovalent and bivalent 1976 vaccine, comprising those from 3 manufacturers and 11 lot numbers, along with several contemporary vaccines were tested for hemagglutinin (HA) activity, the presence of Campylobacter DNA, and the ability to induce anti-Campylobacter and anti-GM(1) antibodies after inoculation into C3H/HeN mice. RESULTS: We found that, although C. jejuni was not detected in 1976 swine flu vaccines, these vaccines induced anti-GM(1) antibodies in mice, as did vaccines from 1991-1992 and 2004-2005. Preliminary studies suggest that the influenza HA induces anti-GM(1) antibodies. CONCLUSIONS: Influenza vaccines contain structures that can induce anti-GM(1) antibodies after inoculation into mice. Further research into influenza vaccine components that elicit anti-ganglioside responses and the role played by these antibodies (if any) in vaccine-associated GBS is warranted.
Publication Types: Research Support, U.S. Gov't, P.H.S.
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=18522505&dopt=ExternalLink
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PMID: 18522505 [PubMed - indexed for MEDLINE]
7: Expert Rev Vaccines. 2008 Feb;7(1):75-82.

Monitoring the safety of annual and pandemic influenza vaccines: lessons from the US experience.

Iskander J, Broder K.
US Public Health Service, Immunization Safety Office, Office of Chief Science Officer, Centers for Disease Control and Prevention, 1600 Clifton Road, MS D-26, Atlanta, GA 30333, USA. [email-masked]
Annual use of influenza vaccines represents the largest vaccine campaign conducted in the USA. Recent expansions in influenza vaccine recommendations suggest a move toward 'universal' vaccination strategies. Although a great deal of safety data has been accumulated, concerns remain regarding rare, serious adverse events following immunization. A proven association between the 1976-1977 swine influenza vaccine and Guillain-Barre syndrome halted that particular national vaccination campaign. Recently, annual influenza vaccines have been associated with novel adverse events, for example, oculorespiratory syndrome in Canada. Any vaccine used against an influenza strain of pandemic potential will have an incompletely described safety profile. Thus, the challenge of influenza vaccine safety is to detect new safety concerns that may arise during seasonal campaigns, while preparing vaccine safety systems for the timely detection of adverse events in the setting of a pandemic.
Publication Types: Review
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=18251695&dopt=ExternalLink
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PMID: 18251695 [PubMed - indexed for MEDLINE]
8: Vaccine. 2007 Jul 20;25(29):5253-5. Epub 2007 May 22.
Comment in: Vaccine. 2007 Nov 23;25(48):8101.

Guillain-Barre syndrome after vaccination in United States a report from the CDC/FDA Vaccine Adverse Event Reporting System.

Souayah N, Nasar A, Suri MF, Qureshi AI.
Epidemiological and Outcomes Research Division, Zeenat Qureshi Stroke Research Center, Department of Medicine, University of Medicine and Dentistry of New Jersey, 90 Bergen Street, DOC 8100, Newark, NJ 07103, United States. [email-masked]
Using the data from Vaccine Adverse Event Reporting System, we present 54 reports of Guillain-Barre Syndrome (GBS) after vaccination that occurred in United States in 2004. In 38 of the patients, GBS occurred within 6 weeks. The highest number (n=31) of GBS was observed in patients receiving influenza vaccine followed by hepatitis vaccine (n=9), 1 patient died and 10 patients were disabled following the event. We conclude that vaccines other than influenza vaccine can be associated with GBS.
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=17560693&dopt=ExternalLink
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PMID: 17560693 [PubMed - indexed for MEDLINE]
9: Arch Intern Med. 2006 Nov 13;166(20):2217-21.

Guillain-Barre syndrome after influenza vaccination in adults: a population-based study.

Juurlink DN, Stukel TA, Kwong J, Kopp A, McGeer A, Upshur RE, Manuel DG, Moineddin R, Wilson K.
Institute of Clinical Evaluative Sciences, Sunnybrook and Women's College Health Sciences Centre, Toronto, Ontario.
BACKGROUND: Whether influenza vaccination is associated with Guillain-Barre syndrome (GBS) remains uncertain. METHODS: We conducted 2 studies using population-based health care data from the province of Ontario, Canada. In the first study, we used the self-matched case-series method to explore the temporal association between probable influenza vaccination (adults vaccinated during October and November) and subsequent hospitalization because of GBS. In the second study, we used time-series analysis to determine whether the institution of a universal influenza immunization program in October 2000 was associated with a subsequent increase in hospital admissions because of GBS at the population level. RESULTS: From April 1, 1992, to March 31, 2004, we identified 1601 incident hospital admissions because of GBS in Ontario. In 269 patients, GBS was diagnosed within 43 weeks of vaccination against influenza. The estimated relative incidence of GBS during the primary risk interval (weeks 2 through 7) compared with the control interval (weeks 20 through 43) was 1.45 (95% confidence interval, 1.05-1.99; P = .02). This association persisted in several sensitivity analyses using risk and control intervals of different durations. However, a separate time-series analysis demonstrated no evidence of seasonality and revealed no statistically significant increase in hospital admissions because of GBS after the introduction of the universal influenza immunization program. CONCLUSION: Influenza vaccination is associated with a small but significantly increased risk for hospitalization because of GBS.
Publication Types: Research Support, Non-U.S. Gov't
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=17101939&dopt=ExternalLink
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PMID: 17101939 [PubMed - indexed for MEDLINE]
10: Liver Transpl. 2006 Oct;12(10):1537-9.

Guillain-Barre syndrome triggered by influenza vaccination in a recipient of liver transplant on FK506.

Moon JS, Souayah N.
Department of Neurology, UMDNJ-New Jersey Medical School, Newark, NJ 07101, USA.
Guillain-Barre syndrome (GBS) has been rarely reported after liver transplantation and generally has good outcome. We report a liver transplant patient on FK506 (tacrolimus) who developed GBS 6 months after liver transplantation. There was no evidence of liver rejection or active infection. Despite treatment with intravenous immunoglobulin, the patient expired. GBS occurred despite downregulation of T cells by FK506, suggesting that humoral dysfunction might be the predominant mechanism of GBS in this report.
Publication Types: Case Reports
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=17004261&dopt=ExternalLink
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PMID: 17004261 [PubMed - indexed for MEDLINE]
11: J Clin Neurosci. 2006 Oct;13(8):866-9. Epub 2006 Sep 7.

Hydrocephalus associated with Guillain-Barre syndrome.

Liu CY, Kao CD, Chen JT, Yeh YS, Wu ZA, Liao KK.
Neurological Institute, Taipei Veterans General Hospital, Peitou District, Taipei, Taiwan.
A 68-year-old man developed progressive four-limb weakness and areflexia 17 days after an influenza vaccination. He was diagnosed with Guillain-Barre syndrome (GBS), and remained ventilator dependent and bed-bound for 3 months, despite plasmapheresis and immunoglobulin infusion. However, cognitive impairment, excessive daytime sleepiness, and motor disability were still present, even when he was no longer ventilator dependent. Brain computerized tomography scan and isotope cisternography was consistent with normal pressure hydrocephalus. His motor control and cognitive function recovered almost completely after insertion of a ventriculoperitoneal shunt. Although hydrocephalus is not frequently associated with GBS, our case report indicates that brain imaging is necessary in GBS patients whose cognitive functions deteriorates after disease onset.
Publication Types: Case Reports Research Support, Non-U.S. Gov't
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=16959489&dopt=ExternalLink
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PMID: 16959489 [PubMed - indexed for MEDLINE]
12: Vaccine. 2007 Jan 5;25(3):570-6. Epub 2006 Aug 4.

Vaccine adverse events reported in post-marketing study of the Kitasato Institute from 1994 to 2004.

Nakayama T, Onoda K.
Laboratory of Viral Infection I, Kitasato Institutes for Life Sciences, Kitasato University, Shirokane 5-9-1, Minato-ku, Tokyo 108-8641, Japan. [email-masked]
General physicians, pediatricians and parents realize that serious adverse events occur with an extremely rare incidence, but have no information on the incidences of vaccine-associated adverse events. A proper understanding of vaccine adverse events would be helpful in promoting an immunization strategy. Causal association can rarely be determined in adverse events through laboratory examinations. We examined the cases reported in the post-marketing surveillance of the Kitasato Institute, categorizing them into two groups: allergic reactions and severe systemic illnesses. Anaphylactic patients with gelatin allergy after immunization with live measles, rubella and mumps monovalent vaccines have been reported since 1993, but the number of reported cases with anaphylaxis dramatically decreased after 1999 when gelatin was removed from all brands of DPT. The incidence of anaphylactic reaction was estimated to be 0.63 per million for Japanese encephalitis virus (JEV) vaccine, 0.95 for DPT and 0.68 for Influenza vaccine, but the causative component has not yet been specified. Among 67.2 million immunization practices, 6 cases with encephalitis or encephalopathy, 7 with acute disseminated encephalomyelitis (ADEM), 10 with Guillain-Barre syndrome and 12 with idiopathic thrombocytopenic purpura (ITP) were reported. The wild-type measles virus genome was detected in a patient with encephalitis and in two of four bone marrow aspirates obtained from ITP after measles vaccination. Enterovirus infection was identified in two patients after mumps vaccination (one each with encephalitis and ADEM), one patient with encephalitis after immunization with JEV vaccine, and one with aseptic meningitis after immunization with influenza vaccine. The total estimated incidence of serious neurological illness after vaccination was 0.1-0.2 per million immunization practices. We found that enterovirus or wild-type measles virus infection was coincidentally associated with vaccination in several cases suspected of being vaccine adverse events.
Publication Types: Research Support, Non-U.S. Gov't
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=16945455&dopt=ExternalLink
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PMID: 16945455 [PubMed - indexed for MEDLINE]
13: Arch Intern Med. 2006 Jun 26;166(12):1301-4.

No association between immunization and Guillain-Barre syndrome in the United Kingdom, 1992 to 2000.

Hughes RA, Charlton J, Latinovic R, Gulliford MC.
Department of Clinical Neuroscience, King's College London School of Medicine, Guy's Campus, London, England. [email-masked]
BACKGROUND: Our goal was to determine whether immunization is associated with the incidence of Guillain-Barre syndrome (GBS). METHODS: We analyzed data for all patients registered with 253 general practices in the United Kingdom General Practice Research Database from 1992 to 2000, with a mean of 1.8 million registered patients. We identified new occurrences of GBS and estimated age- and sex-specific and age-standardized incidence rates. We then determined whether the date of diagnosis was made within 42 days of any immunization and estimated the relative risk of diagnosis following immunization after adjusting for age and sex. RESULTS: There were 228 incident cases of GBS, including 107 women and 121 men. The age-standardized incidence rate per 100 000 person-years was 1.22 (95% confidence interval [CI], 0.98-1.46) in women and 1.45 (95% CI, 1.19-1.72) in men. Age-specific incidence rates per 100 000 person-years were highest in men aged 65 to 74 years (3.86; 95% CI, 2.50-5.70) and women aged 75 to 84 years (2.54; 95% CI, 1.39-4.27). There were 7 cases (3.1%) in which the onset occurred within 42 days of any immunization; 3 of the 7 cases occurred after influenza immunization. There were 221 cases (97.0%) that were not associated with immunization. The adjusted relative risk during the 42 days after immunization was 1.03 (95% CI, 0.48-2.18; P = .94). CONCLUSIONS: There is either minimal or no risk of GBS associated with routine immunization practice in the United Kingdom. Obtaining a precise estimate of any potential risk associated with an individual vaccine would require a study with more GBS cases.
Publication Types: Comparative Study Research Support, Non-U.S. Gov't
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=16801513&dopt=ExternalLink
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PMID: 16801513 [PubMed - indexed for MEDLINE]
14: Emerg Infect Dis. 2006 Jan;12(1):29-33.

Reflections on the 1976 swine flu vaccination program.

Sencer DJ, Millar JD.
Atlanta, Georgia 30329, USA. [email-masked]
In 1976, 2 recruits at Fort Dix, New Jersey, had an influenza like illness. Isolates of virus taken from them included A/New Jersey/76 (Hsw1n1), a strain similar to the virus believed at the time to be the cause of the 1918 pandemic, commonly known as swine flu. Serologic studies at Fort Dix suggested that >200 soldiers had been infected and that person-to-person transmission had occurred. We review the process by which these events led to the public health decision to mass-vaccinate the American public against the virus and the subsequent events that led to the program's cancellation. Observations of policy and implementation success and failures are presented that could help guide decisions regarding avian influenza.
Publication Types: Historical Article
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PMID: 16494713 [PubMed - indexed for MEDLINE]
15: JAMA. 2005 Dec 7;294(21):2720-5.
Erratum in: JAMA. 2005 Dec 28;294(24):3092.
Comment in: JAMA. 2005 Dec 7;294(21):2763-5.

Adverse events reported following live, cold-adapted, intranasal influenza vaccine.

Izurieta HS, Haber P, Wise RP, Iskander J, Pratt D, Mink C, Chang S, Braun MM, Ball R.
Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Md 20852-1448, USA. [email-masked]
CONTEXT: In June 2003, the US Food and Drug Administration licensed a trivalent live, attenuated influenza vaccine (LAIV-T) for intranasal administration to healthy persons 5 to 49 years of age. Although prelicensure testing involved 20 228 vaccinees, clinical trials were not of sufficient size to detect rare adverse events reliably. OBJECTIVE: To identify adverse events reported following LAIV-T administration after licensure. DESIGN, SETTING, AND PARTICIPANTS: All adverse events reported to the US Vaccine Adverse Event Reporting System (VAERS) during the 2003-2004 and the 2004-2005 influenza seasons. MAIN OUTCOME MEASURES: Numbers and proportions of reported adverse events and reporting rates of adverse events per 100,000 vaccinees. RESULTS: Approximately 2,500,000 persons received LAIV-T during the first 2 postlicensure seasons. As of August 16, 2005, VAERS received 460 adverse event reports for vaccinations received from August 2003 through July 2005. No fatalities were reported. There were 7 reports of possible anaphylaxis, 2 reports of Guillain-Barre syndrome, 1 report of Bell palsy, and 8 reports of asthma exacerbation among individuals with a prior asthma history. Events in individuals for whom the vaccine was not indicated accounted for 73 reports (16%). CONCLUSIONS: Reports to VAERS in the first 2 seasons of LAIV-T use did not identify any unexpected serious risks with this vaccine when used according to approved indications. Like many vaccines and other medical products, LAIV-T may rarely cause anaphylaxis. Secondary transmission of the vaccine virus merits further investigation. Reports of asthma exacerbations in vaccinees with prior asthma history highlight the risks of vaccine use inconsistent with approved labeling.
Publication Types: Research Support, U.S. Gov't, P.H.S.
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=16333007&dopt=ExternalLink
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PMID: 16333007 [PubMed - indexed for MEDLINE]
16: Scand J Infect Dis. 2005;37(8):621-623.

A case of influenza vaccination induced Guillain Barre syndrome with normal cerebrospinal fluid protein and improvement on treatment with corticosteroids.

Eckert T, Bartels C, Mawrin C, Feistner H, Welte T.
Department of Pneumology, Medical School of Hannover, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.
We report a case of a 62-y-old male developing an influenza vaccination induced Guillain Barre syndrome (GBS) showing all clinical and neuropathological symptoms of GBS except the characteristic elevation of protein levels in the cerebrospinal fluid. The patient improved under treatment with 100 mg prednisolone. In these cases the administration of corticosteroids might be considered as a treatment option as they might represent a subgroup of GBS with a different immunological response pattern.
Publication Types: Case Reports
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=16138440&dopt=ExternalLink
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PMID: 16138440 [PubMed - indexed for MEDLINE]
17: Neurol Neurochir Pol. 2005 May-Jun;39(3):230-6.

[Guillain-Barre Syndrome and its association with infectious factors.]

[Article in Polish]
Grygorczuk S, Zajkowska J, Kondrusik M, Pancewicz S, Hermanowska-Szpakowicz T.
Klinika Chorob Zakaznych i Neuroinfekcji, Akademia Medyczna w Bialymstoku. [email-masked]
Guillain-Barre Syndrome (GBS) is an acute polyneuropathy often triggered by inflammatory and probably autoimmune mechanisms. Development of GBS is in 2/3 of cases preceded by acute infection, typically with gastrointestinal or respiratory symptoms. Infectious agents related to GBS include cytomegalovirus, Epstein-Barr virus, Campylobacter jejuni, Mycoplasma pneumoniae and Haemophilus influenzae. Molecular mimicry seems to be responsible for GBS development after infection, through the synthesis of autoantibodies against myelin gangliosides. Autoimmune reactions develop only in a small fraction of all exposed individuals, depending on still unresolved factors. Different infections lead to forms of GBS differing in spectrum of autoantibodies and in frequency with which different clinical symptoms appear. This may be of some significance for early prognosis and in future possibly for choosing therapeutic options. An increased risk of GBS may be also related to vaccination, but with presently used vaccines this increase remains below one case of GBS per one million doses.
Publication Types: English Abstract Review
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=15981163&dopt=ExternalLink
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PMID: 15981163 [PubMed - indexed for MEDLINE]
18: Vaccine. 2005 Jun 10;23(30):3876-86. Epub 2005 Apr 7.

Consequence or coincidence? The occurrence, pathogenesis and significance of autoimmune manifestations after viral vaccines.

Schattner A.
Department of Medicine, University of Cambridge, School of Clinical Medicine, Level 5, Addenbrooke's Hospital, Hills Road, Cambridge CB2 2QQ, UK. [email-masked]
BACKGROUND: Viruses and virus-induced lymphokines may have an important role in the pathogenesis of autoimmunity (Schattner A. Clin Immunol Immunopathol; 1994). The occurrence and significance of autoimmune manifestations after the administration of viral vaccines remain controversial. METHODS: Medline search of all relevant publications from 1966 through June 2004 with special emphasis on search of each individual autoimmune manifestation and vaccination, as well as specifically searching each viral vaccine for all potential autoimmune syndromes reported. All relevant publications were retrieved and critically analyzed. RESULTS: The most frequently reported autoimmune manifestations for the various vaccinations, were: hepatitis A virus (HAV)--none; hepatitis B virus (HBV)--rheumatoid arthritis, reactive arthritis, vasculitis, encephalitis, neuropathy, thrombocytopenia; measles, mumps and rubella vaccine (MMR)--acute arthritis or arthralgia, chronic arthritis, thrombocytopenia; influenza--Guillain-Barre syndrome (GBS), vasculitis; polio--GBS; varicella--mainly neurological syndromes. Even these 'frequent' associations relate to a relatively small number of patients. Whenever controlled studies of autoimmunity following viral vaccines were undertaken, no evidence of an association was found. CONCLUSIONS: Very few patients may develop some autoimmune diseases following viral vaccination (in particular - arthropathy, vasculitis, neurological dysfunction and thrombocytopenia). For the overwhelming majority of people, vaccines are safe and no evidence linking viral vaccines with type 1 diabetes, multiple sclerosis (MS) or inflammatory bowel disease can be found.
Publication Types: Meta-Analysis Review
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=15917108&dopt=ExternalLink
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PMID: 15917108 [PubMed - indexed for MEDLINE]
19: J Pak Med Assoc. 2005 Feb;55(2):87-8.

Guillain-Barre syndrome occurring after rabies vaccination.

Siddiqui A, Usmani RI, Anwer S, Afsar S.
Medical Unit IV, Civil Hospital, Karachi.
A variety of events are associated with the onset of Guillain-Barre syndrome, including vaccinations and vaccines. These are the swine influenza vaccine, oral poliovirus vaccine and rabies vaccine. Rabies is a uniformly fatal disease. It is preventable if World Health Organization (WHO) guidelines for post exposure treatment (PET) are followed. These include local treatment of wound, passive immunization with rabies immunoglobulins and administration of a efficacious vaccine. Cell culture vaccines are highly immunogenic with fewer side effects, but are costly. For that reason neurotissue vaccines are still widely used in Pakistan, although they are less immunogenic with higher incidence of neuroparalytic complications. We report a case of Guillain-Barre syndrome secondary to sheep brain anti-rabies vaccine in a young boy, who presented with lower limb weakness with total recovery after treatment.
Publication Types: Case Reports
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=15813639&dopt=ExternalLink
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PMID: 15813639 [PubMed - indexed for MEDLINE]
20: Health Qual Life Outcomes. 2005 Mar 21;3:18.

Values for preventing influenza-related morbidity and vaccine adverse events in children.

Prosser LA, Bridges CB, Uyeki TM, Rego VH, Ray GT, Meltzer MI, Schwartz B, Thompson WW, Fukuda K, Lieu TA.
Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, 133 Brookline Ave,, 6th floor, Boston, MA, USA. [email-masked]
BACKGROUND: Influenza vaccination recently has been recommended for children 6-23 months old, but is not currently recommended for routine use in non-high-risk older children. Information on disease impact, costs, benefits, risks, and community preferences could help guide decisions about which age and risk groups should be vaccinated and strategies for improving coverage. The objective of this study was to measure preferences and willingness-to-pay for changes in health-related quality of life associated with uncomplicated influenza and two rarely-occurring vaccination-related adverse events (anaphylaxis and Guillain-Barre syndrome) in children. METHODS: We conducted telephone interviews with adult members selected at random from a large New England HMO (n = 112). Respondents were given descriptions of four health outcomes: uncomplicated influenza in a hypothetical 1-year-old child of their own, uncomplicated influenza in a hypothetical 14-year-old child of their own, anaphylaxis following vaccination, and Guillain-Barre syndrome. "Uncomplicated influenza" did not require a physician's visit or hospitalization. Preferences (values) for these health outcomes were measured using time-tradeoff and willingness-to-pay questions. Time-tradeoff questions asked the adult to assume they had a child and to consider how much time from the end of their own life they would be willing to surrender to avoid the health outcome in the child. RESULTS: Respondents said they would give a median of zero days of their lives to prevent an episode of uncomplicated influenza in either their (hypothetical) 1-year-old or 14-year-old, 30 days to prevent an episode of vaccination-related anaphylaxis, and 3 years to prevent a vaccination-related case of Guillain-Barre syndrome. Median willingness-to-pay to prevent uncomplicated influenza in a 1-year-old was $175, uncomplicated influenza in a 14-year-old was $100, anaphylaxis $400, and Guillain-Barre syndrome $4000. The median willingness-to-pay for an influenza vaccination for their children with no risk of anaphylaxis or Guillain-Barre syndrome was $50 and $100, respectively. CONCLUSION: Most respondents said they would not be willing to trade any time from their own lives to prevent uncomplicated influenza in a child of their own, and the time traded did not vary by the age of the hypothetical affected child. However, adults did indicate a willingness-to-pay to prevent uncomplicated influenza in children, and that they would give more money to prevent the illness in a 1-year-old than in a 14-year-old. Respondents also indicated a willingness to pay a premium for a vaccine without any risk of severe complications.
Publication Types: Research Support, U.S. Gov't, P.H.S.
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=15780143&dopt=ExternalLink
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PMID: 15780143 [PubMed - indexed for MEDLINE]
21: JAMA. 2004 Nov 24;292(20):2478-81.

Guillain-Barre syndrome following influenza vaccination.

Haber P, DeStefano F, Angulo FJ, Iskander J, Shadomy SV, Weintraub E, Chen RT.
Immunization Safety Branch, Epidemiology and Surveillance Division, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, Ga 30333, USA. [email-masked]
CONTEXT: An unexplained increase in the risk of Guillain-Barre syndrome (GBS) occurred among recipients of the swine influenza vaccine in 1976-1977. Guillain-Barre syndrome remains the most frequent neurological condition reported after influenza vaccination to the Vaccine Adverse Events Reporting System (VAERS) since its inception in 1990. OBJECTIVE: To evaluate trends of reports to VAERS of GBS following influenza vaccination in adults. DESIGN, SETTING, AND PARTICIPANTS: VAERS is the US national spontaneous reporting system for adverse events following vaccination. Reports of GBS in persons 18 years or older following influenza vaccination were evaluated for each influenza season from July 1, 1990, through June 30, 2003. The number of people vaccinated was estimated from the National Health Interview Survey and US census data. Beginning in 1994, active follow-up was conducted to verify GBS diagnosis and obtain other clinical details. MAIN OUTCOME MEASURE: Reporting rates of GBS following influenza vaccination over time. RESULTS: From July 1990 through June 2003, VAERS received 501 reports of GBS following influenza vaccination in adults. The median onset interval (13 days) was longer than that of non-GBS reports of adverse events after influenza vaccine (1 day) (P<.001). The annual reporting rate decreased 4-fold from a high of 0.17 per 100,000 vaccinees in 1993-1994 to 0.04 in 2002-2003 (P<.001). A GBS diagnosis was confirmed in 82% of reports. Preceding illness within 4 weeks of vaccination was identified in 24% of reported cases. CONCLUSIONS: From 1990 to 2003, VAERS reporting rates of GBS after influenza vaccination decreased. The long onset interval and low prevalence of other preexisting illnesses are consistent with a possible causal association between GBS and influenza vaccine. These findings require additional research, which can lead to a fuller understanding of the causes of GBS and its possible relationship with influenza vaccine.
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=15562126&dopt=ExternalLink
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PMID: 15562126 [PubMed - indexed for MEDLINE]
22: Eur J Dermatol. 2004 Mar-Apr;14(2):86-90.

Autoimmune diseases and vaccinations.

Vial T, Descotes J.
Centre Antipoison et Centre Regional de Pharmacovigilance, 162, avenue Lacassagne, 69424 Lyon, France. [email-masked]
The potential association between vaccination and autoimmune diseases has been largely questioned in the past few years, but this assumption has mostly been based on case reports. The available evidence derived from several negative epidemiological studies is reassuring and at least indicates that vaccines are not a major cause of autoimmune diseases. However, there are still uncertainties as to whether a susceptible subpopulation may be at a higher risk of developing an autoimmune disease without causing an overall increase in the disease incidence. Based on selected examples, this review highlights the difficulties in assessing this issue. We suggest that a potential link between vaccines and autoimmune diseases cannot be definitely ruled out and should be carefully explored during the development of new candidate vaccines. Copyright John Libbey Eurotext 2003.
Publication Types: Review
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PMID: 15196997 [PubMed - indexed for MEDLINE]
23: Clin Neurol Neurosurg. 2004 Mar;106(2):136-8.

Guillain-Barre syndrome coexisting with pericarditis or nephrotic syndrome after influenza vaccination.

Kao CD, Chen JT, Lin KP, Shan DE, Wu ZA, Liao KK.
Department of Neurology, National Yang Ming University School of Medicine, Taipei, Taiwan, ROC.
A 68-year-old woman and a 72-year-old man presented with distal weakness of the limbs and numbness following an influenza vaccination within 2 weeks. Moreover, Guillain-Barre syndrome (GBS) was diagnosed in two patients. Pericarditis was diagnosed in the first patient who also had precordial chest pain with referral to trapezius ridge, and nephrotic syndrome, was observed in the second patient who had leg edema and proteinuria. The relationship among GBS, pericarditis and nephrotic syndrome after an influenza vaccination is discussed.
Publication Types: Case Reports Review
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=15003306&dopt=ExternalLink
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PMID: 15003306 [PubMed - indexed for MEDLINE]
24: Nippon Rinsho. 2003 Nov;61(11):1987-91.

[Evidence of indications of influenza vaccine and its efficacy--including Guillain-Barre syndrome as an adverse reaction(?)]

[Article in Japanese]
Watanabe A.
Department of Respiratory Oncology and Molecular Medicine, Institute of Development, Aging and Cancer, Tohoku University.
With respect to the indications of influenza vaccine, the US CDC guidelines are the most rational. All people aged not less than 50 years old, patients with pulmonary diseases, cardiac diseases and metabolic diseases such as diabetes mellitus, residents in old-age homes, high-risk subjects such as pregnant women, medical professionals at the position liable to infect the populations with influenza, employees of institutions, persons in charge of home care, and lodgers with high-risk patients are the subjects recommended for vaccination. There are many evidences of the efficacy of influenza vaccine in the world, and recently, it has been reported that vaccination has significantly reduced hospitalization and death due to not only influenza and pneumonia but also other diseases such as cerebrovascular diseases and cardiac diseases. Since Guillain-Barre syndrome which has been considered an adverse reaction of influenza vaccine was attributable to the swine influenza vaccine (swine type virus vaccine) used in the USA in the season from 1976 to 1977 and no incidence in the syndrome has been reported with subsequent vaccines, this syndrome does not become a reason for avoidance from vaccination in the subjects other than those with a history of the syndrome.
Publication Types: English Abstract Review
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=14619443&dopt=ExternalLink
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PMID: 14619443 [PubMed - indexed for MEDLINE]
25: Clin Immunol. 2003 May;107(2):116-21.
Comment in: Clin Immunol. 2003 Dec;109(3):359; author reply 360-1.

Influenza vaccination and Guillain Barre syndrome small star, filled.

Geier MR, Geier DA, Zahalsky AC.
The Genetic Centers of America, 14 Redgate Court, Silver Spring, MD 20905, USA. [email-masked] <[email-masked]>
Acute and severe Guillain Barre Syndrome (GBS) cases reported following influenza vaccine to the Vaccine Adverse Events Reporting System (VAERS) database from 1991 through 1999 were examined. Endotoxin concentrations were measured using the Limulus amebocyte lysate assay in influenza vaccines. There were a total of 382 cases of GBS reported to the VAERS database following influenza vaccination (male/female ratio, 1.2). The median onset of GBS following influenza vaccine was 12 days (interquartile range, 7 days to 21 days). There was an increased risk of acute GBS (relative risk, 4.3; 95% confidence interval, 3.0 to 6.4) and severe GBS (relative risk, 8.5; 95% confidence interval, 3.7 to 18.9) in comparison to an adult tetanus-diphtheria (Td) vaccine control group. There were maximums in the incidence of GBS following influenza vaccine that occurred approximately every third year (1993, 1996, and 1998) and statistically significant variation in the incidence of GBS among different influenza manufacturers. Influenza vaccines contained from a 125- to a 1250-fold increase in endotoxin concentrations in comparison to an adult Td vaccine control and endotoxin concentrations varied up to 10-fold among different lots and manufacturers of influenza vaccine. The biologic mechanism for GBS following influenza vaccine may involve the synergistic effects of endotoxin and vaccine-induced autoimmunity. There were minimal potential reporting biases in the data reported to the VAERS database in this study. Patients should make an informed consent decision on whether to take this optional vaccine based upon its safety and efficacy and physicians should vigilantly report GBS following influenza vaccination to the VAERS in the United States so that continued evaluation of the safety of influenza vaccine may be undertaken.
Publication Types: Comparative Study
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PMID: 12763480 [PubMed - indexed for MEDLINE]
26: Intern Med. 2003 Feb;42(2):191-4.
Comment in: Intern Med. 2003 Feb;42(2):139.

Neurologic complications associated with influenza vaccination: two adult cases.

Nakamura N, Nokura K, Zettsu T, Koga H, Tachi M, Terada M, Katoh H, Itoh Y, Osawa H, Ozeki T, Yamamoto H.
Department of Neurology, Fujita Health University, School of Medicine, Toyoake, Aichi.
We describe two adult cases of neurologic complications occurring after influenza vaccination. The first case was a 62-year-old man who experienced convulsions 5 days after vaccination, and the second case was a 70-year-old man who exhibited paraplegia 7 days after vaccination. Diagnoses of acute disseminated encephalomyelitis and transverse myelitis with acute motor axonal neuropathy were made, respectively, and steroid pulse therapy and intravenous gamma globulin therapy alleviated the patients' symptoms. Although the efficacy and cost benefit of influenza vaccination have been widely accepted, such neurologic complications might occur in the elderly or even in adults.
Publication Types: Case Reports
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=12636241&dopt=ExternalLink
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PMID: 12636241 [PubMed - indexed for MEDLINE]
27: Curr Opin Neurol. 2002 Jun;15(3):333-8.

Neurological adverse events associated with vaccination.

Piyasirisilp S, Hemachudha T.
Division of Neurology, Department of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand. [email-masked]
Public tolerance to adverse reactions is minimal. Several reporting systems have been established to monitor adverse events following immunization. The present review summarizes data on neurologic complications following vaccination, and provides evidence that indicates whether they were directly associated with the vaccines. These complications include autism (measles vaccine), multiple sclerosis (hepatitis B vaccine), meningoencephalitis (Japanese encephalitis vaccine), Guillain-Barre syndrome and giant cell arteritis (influenza vaccine), and reactions after exposure to animal rabies vaccine. Seizures and hypotonic/hyporesponsive episodes following pertussis vaccination and potential risks associated with varicella vaccination, as well as vaccine-associated paralytic poliomyelitis following oral poliovirus vaccination, are also described. In addition, claims that complications are caused by adjuvants, preservatives and contaminants [i.e. macrophagic myofasciitis (aluminium), neurotoxicity (thimerosal), and new variant Creutzfeldt-Jakob disease (bovine-derived materials)] are discussed.
Publication Types: Review
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=12045734&dopt=ExternalLink
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PMID: 12045734 [PubMed - indexed for MEDLINE]
28: Med Pregl. 2000 Mar-Apr;53(3-4):154-8.

[Influenza--always present among us]

[Article in Croatian]
Turkulov V, Madle-Samardzija N.
Medicinski fakultet, Novi Sad Klinika za infektivne bolesti, Klinicki centar, Novi Sad.
INTRODUCTION: Influenza virus infects about 10 million persons worldwide each year. Two important characteristics of influenza are its epidemic outbreak and high mortality rate, mostly caused by complications. Influenza virus is characterised by a great antigenic variability. Major modifications, called antigenic shifts or type changes, occur approximately three times per century and result in worldwide epidemics--pandemics. Minor modifications, called antigenic drifts or strain changes demand new vaccine compositions each year. HISTORY: Pandemics and epidemics caused by influenza virus, such as the "Spanish Flu", the "Asian Flu", the "Hong Kong Flu" killed many people worldwide. Presently the epidemic, caused by influenza A virus Sydney/97 H3N2 is spreading over USA and most of Europe, including Yugoslavia. EPIDEMIOLOGY AND CLINICAL FEATURES: In humans influenza virus spreads over respiratory secretions, thrown out by coughing and sneezing. Children and older people, as well as immunosuppressed patients are prone to the infection. The onset of illness is sudden, with fever usually over 39 degrees C. Headache and myalgia are prominent. Other signs include fatigue, sore throat, nasal congestion and red eyes. Cough is a very important symptom, which starts as dry and progresses to wet with thick mucous. COMPLICATIONS: Pneumonia is the main cause of death among the high-risk patients. Bronchitis and tracheobronchitis also occur. Croup is a serious complication, often encountered in small children. Cardiac complications, especially myocarditis, are described as influenza complications. Neurological complications include encephalitis, encephalopathy, myelitis, Guillain-Barre syndrome, Reye syndrome, etc. Neurotropism of the influenza virus is under investigation. DIFFERENTIAL DIAGNOSIS AND DIAGNOSIS: Differential diagnosis of influenza includes all diseases which exhibit by increased body temperature, cough, headache, sore throat, myalgia and lethargy. Among serious diseases, pneumonia, sepsis, and meningitis should be considered. Various tests are used when diagnosing influenza: antigen detection, polymerase chain reaction, immunofluorescent tests, etc. THERAPY: Treatment of influenza by antiviral drugs can be prophylactic and therapeutic. Amantadine and rimantadine are older drugs effective in cases caused by virus type A. The newest generation of influenza antiviral agents are neuraminidase inhibitors--zanamivir and oseltamivir, effective against both virus types. The symptomatic therapy is still a basis of influenza treatment. PREVENTION: The main means of influenza prevention is a yearly vaccine. The three-valent vaccine is in common use. It is recommended that high-risk population should be vaccinated. If the composition of the vaccine is well matched with the prevalent virus strain, it is efficient in 50-80% of vaccinees. CONCLUSION: Influenza is the sixth cause of death in the world, the forth among the older population. The next pandemic can occur at anytime. It will be a different virus subtype, never before encountered by humans. Are we ready?
Publication Types: English Abstract Review
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=10965680&dopt=ExternalLink
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PMID: 10965680 [PubMed - indexed for MEDLINE]
29: Pol Merkur Lekarski. 2000 May;8(47):360-1.

[Vaccination against influenza and Guillain-Barre syndrome: are there any relations?]

[Article in Polish]
Wiercinska-Drapalo A, Grzeszczuk A, Wasilewski K, Prokopowicz D.
Kliniki Obserwacyjno-Zakaznej Akademii Medycznej w Bialymstoku.
Influenza, a disease known for centuries, continues to be a major medical problem throughout the world with substantial economical and health impact. The risk of death related to influenza is higher among individuals over 65 years of age and those with chronic diseases. Vaccination against influenza was successfully applied in massive prophylaxis of the disease in different countries for many years. Although there are some well known and monitored adverse reactions to influenza vaccines, the evidence whether influenza vaccination might be causally associated with higher risk of Guillain-Barre syndrome is not clear. In this paper the available literature data concerning this problem were reviewed. Own experiences on influenza vaccination and plasmapheresis treatment of Guillain-Barre syndrome were presented.
Publication Types: English Abstract Review
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PMID: 10944963 [PubMed - indexed for MEDLINE]
30: Eval Rev. 1999 Dec;23(6):619-47.

The swine flu vaccine and Guillain-Barre syndrome. A case study in relative risk and specific causation.

Freedman DA, Stark PB.
University of California, Berkeley, USA.
Epidemiologic methods were developed to prove general causation: identifying exposures that increase the risk of particular diseases. Courts often are more interested in specific causation: On balance of probabilities, was the plaintiff's disease caused by exposure to the agent in question? Some authorities have suggested that a relative risk greater than 2.0 meets the standard of proof for specific causation. Such a definite criterion is appealing, but there are difficulties. Bias and confounding are familiar problems; individual differences must be considered too. The issues are explored in the context of the swine flu vaccine and Guillain-Barre syndrome. THE CONCLUSION: There is a considerable gap between relative risks and proof of specific causation.
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=10662072&dopt=ExternalLink
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PMID: 10662072 [PubMed - indexed for MEDLINE]
31: J Autoimmun. 2000 Feb;14(1):1-10.

Vaccination and autoimmunity-'vaccinosis': a dangerous liaison?

Shoenfeld Y, Aron-Maor A.
Department of Internal Medicine B, Sheba Medical Center, Tel Hashomer, Israel. [email-masked]
The question of a connection between vaccination and autoimmune illness (or phenomena) is surrounded by controversy. A heated debate is going on regarding the causality between vaccines, such as measles and anti-hepatitis B virus (HBV), and multiple sclerosis (MS). Brain antibodies as well as clinical symptoms have been found in patients vaccinated against those diseases. Other autoimmune illnesses have been associated with vaccinations. Tetanus toxoid, influenza vaccines, polio vaccine, and others, have been related to phenomena ranging from autoantibodies production to full-blown illness (such as rheumatoid arthritis (RA)). Conflicting data exists regarding also the connection between autism and vaccination with measles vaccine.So far only one controlled study of an experimental animal model has been published, in which the possible causal relation between vaccines and autoimmune findings has been examined: in healthy puppies immunized with a variety of commonly given vaccines, a variety of autoantibodies have been documented but no frank autoimmune illness was recorded. The findings could also represent a polyclonal activation (adjuvant reaction). The mechanism (or mechanisms) of autoimmune reactions following immunization has not yet been elucidated. One of the possibilities is molecular mimicry; when a structural similarity exists between some viral antigen (or other component of the vaccine) and a self-antigen. This similarity may be the trigger to the autoimmune reaction. Other possible mechanisms are discussed.Even though the data regarding the relation between vaccination and autoimmune disease is conflicting, it seems that some autoimmune phenomena are clearly related to immunization (e.g. Guillain-Barre syndrome).The issue of the risk of vaccination remains a philosophical one, since to date the advantages of this policy have not been refuted, while the risk for autoimmune disease has not been irrevocably proved. We discuss the pros and cons of this issue (although the temporal relationship (i.e. always 2-3 months following immunization) is impressive). Copyright 2000 Academic Press.
Publication Types: Review
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PMID: 10648110 [PubMed - indexed for MEDLINE]
32: N Engl J Med. 1998 Dec 17;339(25):1797-802.
Comment in: N Engl J Med. 1998 Dec 17;339(25):1845-6.

The Guillain-Barre syndrome and the 1992-1993 and 1993-1994 influenza vaccines.

Lasky T, Terracciano GJ, Magder L, Koski CL, Ballesteros M, Nash D, Clark S, Haber P, Stolley PD, Schonberger LB, Chen RT.
Department of Epidemiology and Preventive Medicine, School of Medicine, University of Maryland, Baltimore 21201, USA.
BACKGROUND: The number of reports of influenza-vaccine-associated Guillain-Barre syndrome to the national Vaccine Adverse Event Reporting System increased from 37 in 1992-1993 to 74 in 1993-1994, arousing concern about a possible increase in vaccine-associated risk. METHODS: Patients given a diagnosis of the Guillain-Barre syndrome in the 1992-1993 and 1993-1994 influenza-vaccination seasons were identified in the hospital-discharge data bases of four states. Vaccination histories were obtained by telephone interviews during 1995-1996 and were confirmed by the vaccine providers. Disease with an onset within six weeks after vaccination was defined as vaccine-associated. Vaccine coverage in the population was measured through a random-digit-dialing telephone survey. RESULTS: We interviewed 180 of 273 adults with the Guillain-Barre syndrome; 15 declined to participate, and the remaining 78 could not be contacted. The vaccine providers confirmed influenza vaccination in the six weeks before the onset of Guillain-Barre syndrome for 19 patients. The relative risk of the Guillain-Barre syndrome associated with vaccination, adjusted for age, sex, and vaccine season, was 1.7 (95 percent confidence interval, 1.0 to 2.8; P=0.04). The adjusted relative risks were 2.0 for the 1992-1993 season (95 percent confidence interval, 1.0 to 4.3) and 1.5 for the 1993-1994 season (95 percent confidence interval, 0.8 to 2.9). In 9 of the 19 vaccine-associated cases, the onset was in the second week after vaccination, all between day 9 and day 12. CONCLUSIONS: There was no increase in the risk of vaccine-associated Guillain-Barre syndrome from 1992-1993 to 1993-1994. For the two seasons combined, the adjusted relative risk of 1.7 suggests slightly more than one additional case of Guillain-Barre syndrome per million persons vaccinated against influenza.
Publication Types: Research Support, U.S. Gov't, P.H.S.
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PMID: 9854114 [PubMed - indexed for MEDLINE]
33: MMWR Recomm Rep. 1998 May 1;47(RR-6):1-26.

Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP). Centers for Disease Control and Prevention.

[No authors listed]
These recommendations update information concerning the vaccine and antiviral agents available for controlling influenza during the 1998-99 influenza season (superseding MMWR 1997;46[No. RR-9:1-25]). The principal changes include a) information about the influenza virus strains included in the trivalent vaccine for 1998-99, b) more detailed information about influenza-associated rates of hospitalization, and c) updated information on the possible relationship between Guillain-Barre syndrome and influenza vaccination.
Publication Types: Guideline Practice Guideline
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PMID: 9590726 [PubMed - indexed for MEDLINE]
34: Psychiatry Clin Neurosci. 1997 Aug;51(4):181-4.

Influenza virus and neurological diseases.

Hayase Y, Tobita K.
Department of Virology, Jichi Medical School, Tochigi, Japan.
Influenza viruses rarely cause acute encephalopathy. Post-influenzal encephalitis, which occurs a few weeks after recovery from influenza is thought to be an autoimmune process associated with demyelination and vasculopathy. It has been suggested that Economo lethargic encephalitis followed by postencephalitic Parkinsonism was associated with the influenza A epidemic of 1918 (Spanish flu). The incidence of Reye's syndrome has markedly decreased due to the avoidance of salicylates in the treatment of influenza or varicella. One inactivated flu vaccine is thought to have caused Guillain Barre syndrome due to molecular mimicry between viral protein and myelin, which triggered autoimmune responses. The persistence of influenza virus genes in neural cells as one of the causes of chronic degenerative diseases of the central nervous system by inducing apoptosis of the host cells is yet to be proven.
Publication Types: Review
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PMID: 9316161 [PubMed - indexed for MEDLINE]
35: J Infect Dis. 1997 Aug;176 Suppl 1:S69-72.

Pandemic influenza: confronting a re-emergent threat. The 1976 experience.

Dowdle WR.
The Task Force for Child Survival and Development, Atlanta, Georgia 30307, USA.
The Swine Influenza Immunization Program began in January 1976 with an outbreak of swine influenza among trainees at Ft. Dix, New Jersey. The program ended in December 1976 after an increased incidence of Guillain-Barre syndrome was attributed to the vaccine. The issues and events of 1976 provide valuable lessons for the future. A thorough and objective review of the swine flu program should be a prerequisite for influenza pandemic planning. Strong consideration should be given to creating separate structures for risk assessment and risk management. Risk assessment estimates the probability of a pandemic, the options available for control, and the relative benefits of those options as situations change. Risk management is the political response to that assessment.
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PMID: 9240699 [PubMed - indexed for MEDLINE]
36: Semin Respir Infect. 1992 Mar;7(1):26-37.

Clinical features of influenza.

Nicholson KG.
Department of Microbiology, School of Medicine, University of Leicester, England.
Influenza, an acute, usually self-limited, febrile illness of global importance, appears virtually every year and infects the respiratory tract either sporadically, as a local outbreak, or as a widespread epidemic. The most severe outbreak known, the 1918 to 1919 influenza A pandemic, was responsible for an estimated 20 million deaths globally. In the United States, the influenza pandemics of 1957 and 1968 were associated with an attack rate of up to 50% and an estimated 100,000 deaths. Interpandemic influenza is responsible for considerable morbidity and mortality, which exceed that associated with the introduction of the pandemic strain. Influenza B infections resemble those due to influenza A, but are associated with fewer deaths. Features of influenza include headache, myalgia, malaise, anorexia, sore throat, nonproductive cough, sneezing, and nasal discharge; these symptoms are not pathognomic for influenza, and asymptomatic infection can occur. The pulmonary complications of influenza include pneumonia (viral and bacterial), croup, asthma, and bronchitis. Myocarditis and pericarditis are occasional cardiac complications. In addition to Reye's syndrome, a range of neurologic complications have been noted, including confusion, convulsions, psychosis, neuritis, Guillain-Barre syndrome, coma, transverse myelitis, and encephalomyelitis. Influenza has also been associated with the toxic shock syndrome, myositis, myoglobinuria, and renal failure. In view of its enormous human and economic toll, influenza remains a major target for improved vaccines and vaccine delivery, and antiviral treatment and prophylaxis.
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PMID: 1609165 [PubMed - indexed for MEDLINE]
37: Am J Infect Control. 1991 Aug;19(4):177-84.

Influenza and hepatitis B vaccine acceptance: a survey of health care workers.

Christian MA.
Infection Control Department, Valley Hospital and Medical Center, Spokane, WA 99216.
To assist in the nonrequired vaccine program evaluation at Valley Hospital and Medical Center in Spokane, Washington, a survey of all employees (n = 379) was conducted, with a 63.3% return rate. The most common reasons for not accepting influenza vaccine were wish to avoid medications whenever possible (47%, 96/203), concern about getting influenza from the vaccine (45%, 89/199), and concern about severe reactions such as Guillain-Barre syndrome (37%, 73/196). The most common reasons for not accepting hepatitis B vaccine were not enough exposure to hepatitis B to get vaccinated (52%, 57/110), wish to avoid medications whenever possible (44%, 51/117), and concern about side effects (43%, 50/117). Twelve percent (22/177) of the respondents who reported potential exposure identified the belief of "not enough exposure" as a reason to refuse hepatitis B vaccine. It was also noted that health care workers who rejected hepatitis B vaccine indicated that fear of "getting AIDS from the vaccine" did not influence them (96%, 108/113).
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PMID: 1833994 [PubMed - indexed for MEDLINE]
38: Am J Epidemiol. 1991 May 1;133(9):952-5.
Comment in: Am J Epidemiol. 1992 Aug 1;136(3):374-6.

Guillain-Barre syndrome and influenza vaccination in the US Army, 1980-1988.

Roscelli JD, Bass JW, Pang L.
Department of Pediatrics, Tripler Army Medical Center, Honolulu, HI 96859-5000.
An increased incidence of Guillain-Barre syndrome (polyradiculoneuritis) occurred in individuals who received the A/New Jersey (swine) influenza vaccine in 1976-1977. A retrospective study encompassing the years 1980-1988 was conducted to determine if the US Army's mass influenza vaccination program has been associated with an increased incidence of Guillain-Barre syndrome in active duty soldiers during the study years. No temporally related increase in Guillain-Barre syndrome was found during the study years.
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PMID: 2028981 [PubMed - indexed for MEDLINE]
39: Am J Epidemiol. 1991 May 1;133(9):940-51.

Reassessment of the association between Guillain-Barre syndrome and receipt of swine influenza vaccine in 1976-1977: results of a two-state study. Expert Neurology Group.

Safranek TJ, Lawrence DN, Kurland LT, Culver DH, Wiederholt WC, Hayner NS, Osterholm MT, O'Brien P, Hughes JM.
Hospital Infections Program, Centers for Disease Control, Atlanta, GA.
Although the original Centers for Disease Control study of the relation between A/New Jersey/8/76 (swine flu) vaccine and Guillain-Barre syndrome (polyradiculoneuritis) demonstrated a statistical association and suggested a causal relation between the two events, controversy has persisted. To reassess this association, the authors obtained medical records of all previously reported adult patients with Guillain-Barre syndrome in Michigan and Minnesota from October 1, 1976 through January 31, 1977. To identify previously unreported hospitalized cases with onset of symptoms during this period, the authors surveyed medical care facilities. A group of expert neurologists formulated diagnostic criteria for Guillain-Barre syndrome and then reviewed the clinical records in a blinded fashion. Of the 98 adult patients from the original Centers for Disease Control study eligible for consideration, three were found to have been misclassified by date of onset and were excluded. Of the remaining 95, the 28 (29%) who did not meet the diagnostic criteria were equally distributed between the vaccinated group (18 of 60, 30%) and the unvaccinated group (10 of 35, 29%). In addition to the 67 remaining cases who met the diagnostic criteria, six previously unreported cases (three of whom had been vaccinated) were found and included in this analysis. The relative risk of developing Guillain-Barre syndrome in the vaccinated population of these two states during the 6 weeks following vaccination was 7.10, comparable to the relative risk of 7.60 found in the original study. These findings suggest that there was an increased risk of developing Guillain-Barre syndrome during the 6 weeks following vaccination in adults. The excess cases of Guillain-Barre syndrome during the first 6 weeks attributed to the vaccine was 8.6 per million vaccinees in Michigan and 9.7 per million vaccinees in Minnesota. No increase in relative risk for Guillain-Barre syndrome was noted beyond 6 weeks after vaccination.
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PMID: 1851395 [PubMed - indexed for MEDLINE]
40: Medicina (Firenze). 1990 Apr-Jun;10(2):169.

[Influenza vaccination and polyradiculoneuritis of the Guillain-Barre type]

[Article in Italian]
Pelosio A, Galassi A, Massini R, Longhi C, Marchetti P, Recine U.
III Divisione Medica, Ospedale S. Spirito, Roma.
The Authors present a Guillain-Barre like case of polyradiculoneuritis occurring two weeks after the 1988-89 influenza vaccination. The existence of similar cases recently reported in the literature and their frequent association with swine influenza vaccination suggest the opportunity of a better epidemiological survey of similar cases.
Publication Types: Case Reports English Abstract
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PMID: 2273957 [PubMed - indexed for MEDLINE]
41: Neurology. 1987 Apr;37(4):685-8.

Risk factors for Guillain-Barre syndrome.

Kaslow RA, Sullivan-Bolyai JZ, Holman RC, Hafkin B, Dicker RC, Schonberger LB.
In 100 cases of Guillain-Barre syndrome (GBS) reported from 10 metropolitan areas to the Centers for Disease Control (CDC) after the 1976-77 influenza vaccination campaign and matched associate or spouse controls, we searched for risk factors for GBS other than A/New Jersey/1976 influenza vaccination and acute respiratory infection. The 47 vaccinated cases recalled influenza vaccination in past years less frequently than did controls (p less than 0.025). Cases and controls did not differ in the number of previous vaccinations or in interval from last vaccination. Cases also gave a history of allergy less frequently than controls. There were no other significant differences.
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PMID: 3561781 [PubMed - indexed for MEDLINE]
42: Arch Neurol. 1985 Nov;42(11):1053-7.

Guillain-Barre syndrome. Clinicoepidemiologic features and effect of influenza vaccine.

Beghi E, Kurland LT, Mulder DW, Wiederholt WC.
A study of the epidemiologic and clinical features of Guillain-Barre syndrome in the population of Olmsted County, Minnesota, over the 46-year period 1935 through 1980 was conducted through the centralized diagnostic index maintained at Mayo Clinic, Rochester, Minn. A total of 48 cases were identified, giving an age- and sex-adjusted incidence of 1.8 per 100,000 person-years. The rate increased over time from 1.2 in the interval 1935 through 1956 to 2.4 in the interval 1970 through 1980. Males were affected more than females (age-adjusted rates of 2.3 and 1.2, respectively). The rate increased with age from 0.8 in those under 18 years old to 3.2 for those 60 years and older. Antecedent infectious diseases were reported in 65% of the cases. Implications with regard to the incidence of Guillain-Barre syndrome associated with the A/New Jersey/76 (swine flu) vaccine are discussed.
Publication Types: Research Support, Non-U.S. Gov't Research Support, U.S. Gov't, P.H.S.
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PMID: 4051833 [PubMed - indexed for MEDLINE]
43: Am J Epidemiol. 1984 Jun;119(6):880-9.

Guillain-Barre syndrome and its relationship to swine influenza vaccination in Michigan, 1976-1977.

Breman JG, Hayner NS.
Active surveillance to detect all patients with Guillain-Barre syndrome who had had onset of illness from July 1, 1976 through April 30, 1977 was undertaken in Michigan after indications that the syndrome might be associated with the National Influenza Immunization Program of 1976-1977. Hospital record room librarians, neurologists, and neurosurgeons reported the greatest number of cases; coded hospital discharge records were the best means of ascertaining case occurrence. This differed from national surveillance, which relied essentially on reports that neurologists and other clinicians sent to state epidemiologists and then to the Centers for Disease Control; hospital discharge lists were not systemically reviewed nationally. A total of 79 of the Michigan cases were in persons who had not received swine influenza vaccine, while 46 cases were in persons who had received it. For unvaccinated adults, the incidence of Guillain-Barre syndrome during the 10-month surveillance period was 0.36 cases per 10(6) person-weeks; for adults with onset within six weeks of vaccination, it was 2.31 cases per 10(6) person-weeks. After six weeks post-vaccination, the rate decreased to 0.17 cases per 10(6) person-weeks. The attributable risk for acquiring Guillain-Barre syndrome within six weeks after receiving swine influenza vaccine was 11.70 cases per 10(6) persons vaccinated.
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=6731430&dopt=ExternalLink
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PMID: 6731430 [PubMed - indexed for MEDLINE]
44: Am J Epidemiol. 1984 Jun;119(6):841-79.

An epidemiologic and clinical evaluation of Guillain-Barre syndrome reported in association with the administration of swine influenza vaccines.

Langmuir AD, Bregman DJ, Kurland LT, Nathanson N, Victor M.
As a result of a court order, computerized summaries of approximately 1,300 cases reported as Guillain-Barre syndrome by state health departments to the Centers for Disease Control during the intensive national surveillance instituted following the swine influenza vaccination program in 1976-1977 became available for further study. Although the data were not uniformly adequate to confirm the diagnosis of Guillain-Barre syndrome, they were sufficient to enable classification according to extent of motor involvement. Vaccinated cases with "extensive" paresis or paralysis occurred in a characteristic epidemiologic pattern closely approximated by a lognormal curve, suggesting a causal relationship between the disease and the vaccine. Cases with "limited" motor involvement showed no such pattern, suggesting that this group included a substantial proportion of cases which were unrelated to the vaccine. The effect attributed to the vaccine lasted for at least six weeks and possibly for eight weeks but not longer. The relative risk of acquiring "extensive" disease over a six-week period following vaccination ranged from 3.96 to 7.75 depending on the particular baseline estimate of expected normal or endemic incidence that was chosen. Correspondingly, the number of cases that could be attributed to the vaccine over the six-week period ranged from 211 to 246, or very slightly higher over an eight-week period if the lowest baseline estimate was used. The total rate of Guillain-Barre syndrome cases attributed to prior use of the vaccine was 4.9 to 5.9 per million vaccinees.
Publication Types: Research Support, U.S. Gov't, Non-P.H.S.
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PMID: 6328974 [PubMed - indexed for MEDLINE]
45: J Neuroimmunol. 1984 Feb;6(1):1-8.

Experimental neuritis induced by a mixture of neural antigens and influenza vaccines. A possible model for Guillain-Barre syndrome.

Hjorth RN, Bonde GM, Piner E, Hartzell RW, Rorke LB, Rubin BA.
We describe the development in rats of a possible model for Guillain-Barre syndrome (GBS): experimental neuritis (EN). The clinical symptoms, histopathology and the presence of antibody to nervous tissue are features that EN has in common with both GBS and experimental allergic neuritis (EAN), another GBS model. However, EN may be a more appropriate model than EAN for studying the role of autoimmune reactions in diseases such as GBS, which are triggered by various viruses or antigens, since EN depends on such agents being administered concomitantly with the syngeneic tissue.
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PMID: 6707195 [PubMed - indexed for MEDLINE]
46: Rev Infect Dis. 1983 Jul-Aug;5(4):723-36.

Summary of clinical trials of inactivated influenza vaccine - 1978.

La Montagne JR, Noble GR, Quinnan GV, Curlin GT, Blackwelder WC, Smith JI, Ennis FA, Bozeman FM.
This report summarizes the clinical trials of the A/USSR/77 (H1N1) influenza vaccines performed in 1978. A total of 2,091 subjects participated in these trials. The results of these clinical trials indicated that two doses of H1N1 viral antigen were necessary to produce serum titers of hemagglutinin-inhibiting (HAI) antibody of greater than 1:40 in 80% or more of the test subjects younger than 25 years of age, who were unlikely to have experienced natural infection during the earlier period of prevalence of H1N1 virus (1947-1957). Only one dose of the A/Texas/77 (H3N2) or B/Hong Kong/72 antigen was necessary to stimulate equivalent titers of HAI antibody in serum. Thus, previous natural exposure to H1N1 viruses primed individuals 26 years of age or older to respond to H1N1 antigens. No major differences in antigenicity were noted between whole-virus and split-virus vaccines. No differences in reaction indexes measuring systemic reactions were noted when vaccine types were compared. Only one vaccine was associated with a reaction index appreciably higher than that of placebo. The relatively uniform antibody responses observed were attributed to the newer methods of vaccine standardization introduced after the clinical trials in 1976. No cases of vaccine-related neurological problems, including Guillain-Barre syndrome, were found during these trials. Vaccines containing 7-21 micrograms of each viral antigen were antigenic and were well tolerated.
Publication Types: Clinical Trial Research Support, Non-U.S. Gov't Research Support, U.S. Gov't, P.H.S.
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PMID: 6353529 [PubMed - indexed for MEDLINE]
47: Neurology. 1983 May;33(5):633-7.

Guillain-Barre syndrome in the United States, 1978-1981: additional observations from the national surveillance system.

Kaplan JE, Schonberger LB, Hurwitz ES, Katona P.
During the period January 1978-March 1981, 2,575 cases of Guillain-Barre syndrome (GBS) were reported by participating neurologists in the national GBS surveillance system. The incidence of GBS was highest in the 50- to 74-year-old age group, but a lesser peak was observed in persons aged 15 to 35. The frequencies of antecedent respiratory (43%) and gastrointestinal (21%) illness exceeded frequencies of such illnesses in the US population (10 and 0.8%, respectively), based on survey data compiled by the National Center for Health Statistics; the differences in these frequencies of illness were similar in all seasons of the year, in males and in females, and in persons less than 6, 6 to 16, 17 to 44, and greater than 44 years of age. Nineteen percent of adult patients for whom information was available (67% of the total) reported receiving an A/New Jersey influenza vaccine in 1976, a lower percentage than would be expected on the basis of a survey conducted in that year. The data suggest that persons who received this vaccine have not been at increased risk and may even have been at decreased risk of acquiring GBS during the period covered by this study.
Publication Types: Comparative Study
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PMID: 6682501 [PubMed - indexed for MEDLINE]
48: Neurology. 1983 Feb;33(2):150-7.

National surveillance for Guillain-Barre syndrome: January 1978-March 1979.

Hurwitz ES, Holman RC, Nelson DB, Schonberger LB.
Between January 1, 1978, and March 31, 1979, 1,034 cases of Guillain-Barre syndrome (GBS) were reported to the Centers for Disease Control by the 1,813 American Academy of Neurology sentinel physicians who participated in the national GBS surveillance program. A direct correlation was observed between increasing age and the age-specific attack (incidence) rates. Based on the cases observed and the total US population, age-adjusted attack rates were statistically higher in males (0.52 per 100,000) than in females (0.40). Rates for whites were 0.44 and those for blacks 0.28 per 100,000; although the difference is statistically significant, uncertainties as to the true denominators by race preclude acceptance of these differences as valid. Sixty-seven percent, or 682 of the patients, reported that they had had an antecedent illness within 8 weeks before onset of GBS, and among them the peak period of onset of GBS was in the second week after the onset of the prior illness. There were also 52 patients (5%) who had undergone surgery and 45 (4.5%) who had received vaccinations, both within the 8 weeks before onset of GBS. However, the high proportions of antecedent illness in these groups (45% of those operated and 53% of those vaccinated) made attribution of GBS to the procedures tenuous. Risk of GBS in patients who reported receiving a swine influenza vaccination in 1976 was no greater than in those who reported that they did not receive this vaccine.
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PMID: 6681655 [PubMed - indexed for MEDLINE]
49: Acta Neurol Scand. 1982 Oct;66(4):413-31.

Neurological complications of swine influenza vaccination.

Poser CM.
The emphasis upon the remarkably large number of cases of Guillain-Barre syndrome which resulted from the 1976 National Swine Influenza immunization program in the U.S.A. has obscured the fact that other neurological complications, involving the central nervous system also occurred. The anatomical distribution of lesions is almost identical with that seen following other types of vaccination: involvement of the brain, cerebellum, optic nerve, cranial nerves and spinal cord occurred with approximately the same frequency. 5 instances of the very rare subacute or chronic, progressive, post-vaccinal encephalopathy are described, a situation which is identical to the subacute and chronic forms of polyradiculoneuropathy. In a number of cases, in particular the myelopathies, a subclinical involvement of peripheral nerves was demonstrated by means of electrodiagnostic studies, illustrating the often overlooked fact that central nervous system involvement will mask peripheral nerve lesions. The etiological significance of the swine influenza vaccination was overlooked and completely erroneous diagnoses were established in a surprisingly large number of the 26 new cases reported here.
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PMID: 6128862 [PubMed - indexed for MEDLINE]
50: JAMA. 1982 Aug 13;248(6):698-700.

Guillain-Barre syndrome in the United States, 1979-1980 and 1980-1981. Lack of an association with influenza vaccination.

Kaplan JE, Katona P, Hurwitz ES, Schonberger LB.
An ongoing surveillance program was intensified during the 1979-1980 and the 1980-1981 influenza seasons to determine whether an increased risk of acquiring Guillain-Barre syndrome (GBS) within eight weeks after influenza vaccination existed for adults in the United States who received influenza vaccine, when compared with adult who had not been vaccinated recently. Five hundred twenty-eight cases of GBS with onset between Sept 1 and March 31, including seven following recent vaccination, were reported by participating neurologists in 1979-1980; 459 cases, including 12 following recent vaccination, were reported in 1980-1981. The relative risk of acquiring GBS following influenza vaccination--0.6 in 1979-1980 and 1.4 in 1980-1981--was not significantly different from 1.0 in either season. These results suggest that there was no increased risk of acquiring GBS associated with the influenza vaccines administered during these seasons and that the causative "trigger agent" in the A/New Jersey (swine) influenza vaccine administered in 1976 has not been present in subsequent influenza vaccine preparations.
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PMID: 7097920 [PubMed - indexed for MEDLINE]
51: Ann Neurol. 1982 Aug;12(2):119-28.

Neurological complications of immunization.

Fenichel GM.
Vaccines prepared from whole, killed organisms (pertussis and possibly influenza) may cause neurological allergic reactions producing encephalopathy. These reactions are characterized by acute, monophasic demyelinative processes and occur with no greater frequency than 1 per 100,000 vaccine recipients; onset is within 4 days of immunization, and recovery is usually complete. No evidence suggests that these vaccines produce an insidious, progressive encephalopathy. Only with the swine influenza program of 1976 has Guillain-Barre syndrome appeared to follow immunization. Vaccines prepared from live-attenuated viruses (measles, mumps, rubella, and trivalent oral poliovirus) can cause symptomatic viral infection of the nervous system, including measles encephalitis, which occurs in 1 of 1,000,000 vaccine recipients; rubella neuritis, in less than 1 of 10,000 recipients; and paralytic poliomyelitis, in 1 of 3,000,000 vaccine recipients or their close contacts. A cause-and-effect relationship between immunization and brachial plexus neuritis, acute transverse myelitis, and cranial neuropathies has been suggested but never proved.
Publication Types: Comparative Study Review
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PMID: 6751212 [PubMed - indexed for MEDLINE]
52: J Neuroimmunol. 1982 Aug;3(1):27-41.

Late onset of Guillain-Barre syndrome.

Poser CM, Behan PO.
The Guillain-Barre syndrome (GBS) usually occurs within one month of the precipitating cause. It is the purpose of this paper to show that typical cases may, however, appear weeks to months later. We have reviewed the collected data on these cases and suggest that they provide evidence which is in favour of a humoral, rather than a cell-mediated, aetiology for GBS.
Publication Types: Case Reports
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PMID: 6124552 [PubMed - indexed for MEDLINE]
53: Arch Neurol. 1982 Jan;39(1):21-4.

Guillain-Barre syndrome in the US Army.

Johnson DE.
Using the US Army's operational reporting system, the medical records of soldiers with Guillain-Barre syndrome were retrieved and compared with reported incidence figures from the 1976 national influenza immunization program. Military personnel sustained an incidence of disease approximatley 50% higher than unvaccinated civilians but less than 25% of the rate attributed to civilian vaccinees.
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PMID: 7055443 [PubMed - indexed for MEDLINE]
54: N Engl J Med. 1981 Jun 25;304(26):1557-61.

Guillain-Barre syndrome and the 1978-1979 influenza vaccine.

Hurwitz ES, Schonberger LB, Nelson DB, Holman RC.
An ongoing surveillance program was intensified to determine whether an increased risk of acquiring vaccine-related Guillain-Barre syndrome (GBS) (similar to that observed after vaccination with the A/New Jersey swine-influenza vaccine in 1976) existed for the approximately 12.5 million adults (greater than or equal to 18 years old) vaccinated in the 1978-1979 influenza campaign. In the contiguous United States (excluding Maryland) 544 cases of GBS with onset between September 1, 1978, and March 31, 1979, were reported, including 12 adults who had been vaccinated within eight weeks before the onset of GBS and 393 who had not. The relative risk of vaccine-associated GBS for adults reported in this surveillance was 1.4 (95% confidence limits, 0.7 to 2.7)--significantly below the risk (6.2) associated with A/New Jersey vaccine for the equivalent eight-week period. In contrast to the A/New Jersey vaccine, the 1978-1979 influenza vaccine was not associated with a statistically significant excess risk of GBS.
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PMID: 7231501 [PubMed - indexed for MEDLINE]
55: Ann Neurol. 1981;9 Suppl:31-8.

Guillain-Barre syndrome: its epidemiology and associations with influenza vaccination.

Schonberger LB, Hurwitz ES, Katona P, Holman RC, Bregman DJ.
The epidemiology of Guillain-Barre syndrome (GBS) and the associations of GBS with influenza vaccination are described based on review of three types of epidemiological data: case-control studies, incidence rate studies of GBS in well-defined populations, and surveillance data from a sentinel neurologist surveillance system of GBS in the United States. These data indicate that the crude annual incidence rate of GBS per 100,000 people ranges from 0.6 to 1.9 in different populations in widely scattered areas of the world. In general, incidence rates are higher with advancing age until about 75 years, higher for men than women, and higher for whites than blacks. No specific HLA antigen has been significantly associated with GBS in general, although HLA AW 30 and AW 31 have been associated with chronic relapsing polyneuritis. Important trigger agents of GBS include nonspecific respiratory and gastrointestinal infections and cytomegalovirus infection. Influenza infection and influenza vaccinations are not generally important trigger agents. A major exception to this is the occurrence of just under 1 excess case of GBS per 100,000 A/New Jersey influenza vaccinations administered in the United States, 1976-1977. A significant excess risk of GBS was not observed after administration of influenza vaccine in 1978-1979 and 1979-1980. The differences between the contents of and immunological reaction to A/New Jersey influenza vaccine and the more recent influenza vaccines deserve further study.
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PMID: 7224614 [PubMed - indexed for MEDLINE]
56: Neurology. 1980 Sep;30(9):929-33.

Fatal Guillain-Barre syndrome after the national influenza immunization program.

Keenlyside RA, Schonberger LB, Bregman DJ, Bolyai JZ.
Fifty-eight fatal cases of Guillain-Barre syndrome (GBS) were reported during the 1976 to 1977 National Influenza Program: Thirty-two (58%) of these patients had received the A/New Jersey influenza vaccine. The mean interval from vaccination to onset was 3.9 weeks, and the incidence of preceding illness in vaccinated or unvaccinated patients was similar. Fifty-eight percent had at least one chronic disease before onset. The clinical features were similar in vaccinated and unvaccinated patients. Most deaths followed medical complications of respiratory paralysis: Fifteen had pneumonia, 29 (83%) died suddenly, 15 had sudden arrhythmias or hypotension, and 7 had myocardial infarction or pulmonary embolus.
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PMID: 6252515 [PubMed - indexed for MEDLINE]
57: JAMA. 1980 Jun 27;243(24):2490-4.

Guillain-Barre syndrome in recipients of A/New Jersey influenza vaccine.

Marks JS, Halpin TJ.
In late 1976, when 32% of the eligible population of Ohio received the A/New Jersey influenza (swine flu) vaccine, systematic contact of neurologists was used to evaluate the possible association of Guillain-Barre syndrome (GBS) with receipt of the vaccine. The overall rate of GBS was significantly higher among vaccine recipients (13.3/10(6)) than in nonrecipients (2.6/10(6)). Peak time of onset was two to three weeks after receiving the vaccine, and cases among vaccinees were less likely to have a history of antecedent infection than were cases in unvaccinated persons. Even when the effect of one highly associated vaccine lot was removed, an elevated risk of GBS remained in vaccinees regardless of manufacturer or vaccine type (bivalent or monovalent). Systematic surveillance is needed for rare serious reactions from all vaccines.
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PMID: 6247520 [PubMed - indexed for MEDLINE]
58: J Am Geriatr Soc. 1980 Jun;28(6):241-50.

Influenza: epidemiology, etiology, immunization and management.

Seneca H.
Influenza, an acute contagious respiratory infection caused by orthomyxoviruses A, B, and C, occurs in local outbreaks, epidemics and pandemics. Differences in the morphology and antigen patterns for these viruses account for the differences in virulence and immunity. Influenza A is virulent, B is mild, and C is nonvirulent. Swine influenza virus may spread from swine to man (recycling of human A virus), causing epidemics and pandemics. The 1976-77 influenza vaccination program involved swine virus, and was associated with 321 cases of Guillain-Barre syndrome and a mortality of 5 percent. Subsequent yearly programs with other types of vaccine are described. Dosages vary according to the age of the vaccinee. Those who need vaccination include persons over 65 years of age, patients with heart/lung, liver/lung or metabolic diseases, severe anemia, or a compromised antigenic system. Side effects include local reaction, fever, an allergic reaction (due to egg protein), and the Guillain-Barre syndrome (only with swine virus vaccine). In general, influenza vaccine is safe and confers 60-85 percent protection. Since immunity lasts only about a year, annual vaccination with recently isolated virus vaccine is recommended. Amantadine seems effective therapeutically and prophylactically for clinical influenza A infection.
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PMID: 6246153 [PubMed - indexed for MEDLINE]
59: Am J Epidemiol. 1980 Mar;111(3):270-8.

Illness after influenza vaccination reported through a nationwide surveillance system, 1976-1977.

Retailliau HF, Curtis AC, Storr G, Caesar G, Eddins DL, Hattwick MA.
In 1976, the Center for Disease Control coordinated nationwide surveillance for illnesses after influenza vaccination as part of an effort to vaccinate the nation against influenza A/New Jersey/76. For the 48,161,019 persons vaccinated in 1976, a total of 4733 reports of illness were received which included reports of 223 deaths. When Guillain-Barre syndrome was reported in vaccine recipients, an investigation was begun to examine this possible association. Other than the Guillain-Barre syndrome and rare cases of anaphylaxis, no serious illnesses were causally associated with influenza vaccination by this type of surveillance. Widespread underreporting of illness and death in the passive phase of this surveillance system, however, impaired the ability to draw conclusions about reactions to vaccine from the reports of illness received.
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PMID: 7361749 [PubMed - indexed for MEDLINE]
60: Am J Epidemiol. 1979 Aug;110(2):105-23.

Guillain-Barre syndrome following vaccination in the National Influenza Immunization Program, United States, 1976--1977.

Schonberger LB, Bregman DJ, Sullivan-Bolyai JZ, Keenlyside RA, Ziegler DW, Retailliau HF, Eddins DL, Bryan JA.
Because of an increase in the number of reports of Guillian-Barre syndrome (GBS) following A/New Jersey influenza vaccination, the National Influenza Immunization Program was suspended December 16, 1976 and nationwide surveillance for GBS was begun. This surveillance uncovered a total of 1098 patients with onset of GBS from October 1, 1976, to January 31, 1977, from all 50 states, District of Columbia, and Puerto Rico. A total of 532 patients had recently received an A/New Jersey influenza vaccination prior to their onset of GBS (vaccinated cases), and 15 patients received a vaccination after their onset of GBS. Five hundred forty-three patients had not been recently vaccinated with A/New Jersey influenza vaccine and the vaccination status for 8 was unknown. Epidemiologic evidence indicated that many cases of GBS were related to vaccination. When compared to the unvaccinated population, the vaccinated population had a significantly elevated attack rate in every adult age group. The estimated attributable risk of vaccine-related GBS in the adult population was just under one case per 100,000 vaccinations. The period of increased risk was concentrated primarily within the 5-week period after vaccination, although it lasted for approximately 9 or 10 weeks.
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PMID: 463869 [PubMed - indexed for MEDLINE]
61: Am J Clin Pathol. 1978 Jul;70(1 Suppl):146-52.

Review of existing vaccines for influenza.

Meyer HM Jr, Hopps HE, Parkman PD, Ennis FA.
The problems of producing and distributing influenza vaccines are described as well as effectiveness and adverse reactions. It appears that Guillain-Barre (GBS) is likely to be encountered with the use of any of the inactivated influenza vaccines.
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PMID: 685887 [PubMed - indexed for MEDLINE]
62: Neurology. 1978 Jul;28(7):725-6.

Recurrent Guillain-Barre syndrome following influenza vaccine.

Seyal M, Ziegler DK, Couch JR.
Two patients recovered from an attack of Guillain-Barre syndrome and then had a second attack of this disease, with a shorter latent period, following monovalent influenza vaccination. These cases suggest that an attack of Guillain-Barre syndrome may result in greater risk of future episodes of the syndrome in conjunction with exposure to influenza or other vaccinations.
Publication Types: Case Reports
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=566873&dopt=ExternalLink
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PMID: 566873 [PubMed - indexed for MEDLINE]
63: Can Med Assoc J. 1978 Jun 24;118(12):1528-30.

Surveillance of the swine influenza vaccination program at the Royal Military College, Kingston.

Rohrer JW, Hamilton GG.
In a prospective study symptoms appearing in a previously healthy population within 6 weeks after inoculation with monovalent swine influenza vaccine (A/New Jersey/76) were tabulated. Of the 703 persons (ranging in age from 17 to 55 years) participating in the follow-up 54% reported experiencing symptoms, usually within 24 hours of vaccination; the symptoms were usually minor and none of the participants displayed evidence of Guillain-Barre syndrome.
Publication Types: Case Reports
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=657050&dopt=ExternalLink
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PMID: 657050 [PubMed - indexed for MEDLINE]
64: Arch Neurol. 1978 Mar;35(3):166-70.

Recurrent disseminated vasculomyelinopathy.

Poser CM, Roman G, Emery ES 3rd.
The monosymptomatic (recurrent infantile hemiplegia) and the polysymptomatic forms of disseminated vasculomyelinopathy that follow various infections and antigenic challenge to the nervous system were seen in two cases. These cases emphasize the importance of vasculopathy as the initial and obligatory component of the postinfectious and postimmunization neurologic syndromes as well as the clinical and pathological variability of the secondary effects on the nervous system. Recurrent infantile hemiplegia occurred in the first patient. In the second patient, after two episodes of postinfectious myelinoclastic encephalopathy, concurrent acute hemorrhagic leukoencephalopathy and an acute Guillain-Barre syndrome following swine flu vaccination developed.
Publication Types: Case Reports
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=629662&dopt=ExternalLink
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PMID: 629662 [PubMed - indexed for MEDLINE]
65: Adv Neurol. 1978;19:249-60.

Epidemiology of Guillain-Barre syndrome.

Schoenberg BS.
The only measures of morbidity for Guillain-Barre syndrome in well-defined populations in the continental United States come from Olmsted County, Minnesota, and San Joaquin County, California. The estimated incidence rates are between 1 and 2 cases per 100,000 population per year. Despite the hazards of generalizing from such small samples, these are the only estimates available. Large case series have suggested that the syndrome is more common in males, that it may occur at any age, and that it is frequently associated with some antecedent infection. Only two case-control comparisons have been carried out which reveal an association between Guillain-Barre syndrome and an infection 1 month prior to onset of neurological symptoms. A recent survey of four states in the United States revealed that the risk of Guillain-Barre syndrome among individuals receiving immunization against influenza A/New Jersey is 7.3 times the risk among the nonvaccinated. Aside from these investigations and one study linking Guillian-Barre syndrome and high antibody titers to cytomegalovirus, adequate epidemiologic studies to test suggested etiologic hypotheses have not yet been carried out. The rarity of the condition and the variations in its clinical presentation and course pose certain problems for epidemiologic investigations. Strategies for overcoming these difficulties are discussed.
Publication Types: Review
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=369322&dopt=ExternalLink
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PMID: 369322 [PubMed - indexed for MEDLINE]
66: MMW Munch Med Wochenschr. 1977 May 20;119(20):705-10.

[Neurological complications after influenza vaccination (author's transl)]

[Article in German]
Ehrengut W, Allerdist H.
The clinical aspects and differential diagnosis of 11 neural complications following influenza vaccination (Guillain-Barre syndrome, serogenetic polyneuritis, encephalomyelitis) are discussed. Etiopathogenetically a hypersensitivity to components in the serum must be taken into consideration, as a case with anaphylactoid reaction shows. The incubation period of the remaining cases (beginning only after the 4th day post vaccination) is on the other hand consistent with the assumption of a pathomechanism rather like that of serum sickness. The number of influenza vaccinations previously administered in the individual case bears no relation to the neurological disturbances described. Vaccines of different manufacture can, in the same way, provoke these rare inoculation complications (frequency: 1 case per 0.7-1.3 mio vaccinations). The indication for influenza vaccinations is not limited by these occurrences.
Publication Types: Case Reports English Abstract
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PMID: 406554 [PubMed - indexed for MEDLINE]

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