Guillain-Barre syndrome vaccine-associated

Billions of doses of vaccines were safely administered over the last century to millions of infants, children, and adults [1,4], Vaccine-associated adverse events were nevertheless identified in a minority of patients. Many of the adverse events were directly related to the vaccine others as in the case of MMR have not been substantiated with data but still cause considerable public unease [1], One documented case is that of vaccination with a formalin-inactivated respiratory syncytial virus (RSV) that, when given prophylactically, caused enhanced disease after exposure to the virus and resulted in the death of some children [1,4,5], An increased incidence of Guillain-Barre syndrome appeared to be associated with a swine flu vaccine that was tested in humans in the late 1970s [1,6]. Guillain-Barre syndrome has also been associated with other vaccines including those for polio, measles, and hepatitis B [6]. 

By 1988 it was possible to summarize the adverse effects reported after the distribution of over 1.8 million doses of plasma-derived hepatitis B vaccine (Table 1) (2). From 1982 onwards, the Centers for Disease Control, the Food and Drug Administration, and the manufacturers, Merck Sharp Dohme, had supported a special surveillance system to monitor spontaneous reports of reactions to plasma-derived hepatitis vaccine. During the first 3 years, about 850 000 persons were immunized. In all, 41 reports were received for one of the following neurological adverse events convulsion (n = 5), Bell s palsy (n — 10), Guillain-Barre syndrome (n = 9), lumbar radiculopathy (n — 5), brachial plexus neuropathy (n = 3), optic neuritis (n — 5), and transverse myelitis (n = 4). Half of these events occurred after the first vaccine dose. However, no conclusive causal association could be made between any neurological adverse event and the vaccine (3). 

The number of reports of influenza vaccine-associated Guillain-Barre syndrome to the US Vaccine Adverse Event Reporting System increased from 37 in 1992-93 to 74 in 1993-94, raising concerns about a possible increase in vaccine-associated risk. Detailed data analyses... 

Langmuir AD, Bregman DJ, Kurland LT, Nathanson N, Victor M. An epidemiologic and clinical evaluation of Guillain-Barre syndrome reported in association with the administration of swine influenza vaccines. Am J Epidemiol 1984 119(6) 841-79. 

Safranek TJ, Lawrence DN, Kurland LT, Culver DH, Wiederholt WC, Hayner NS, Osterholm MT, O Brien P, Hughes JM. 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. Am J Epidemiol 1991 133(9) 940-51. 

The available reports on a possible association between polio vaccine and Guillain-Barre syndrome have been reviewed (34). The conclusion of a 1994 US Institnte of... 

The two recombinant hepatitis B vaccine products available in the United States (Recombivax HB, Merck Engerix-B, SmithKline Beecham) have comparable immune responses and safety profiles. The vaccines contain 5 to 40 meg HBsAg protein per milliliter adsorbed onto aluminum. Neither brand of hepatitis B vaccine contains thimerosal. The recent availability of a combined HAV and HBV vaccine allows for a more accelerated schedule for immunization. For a more detailed comparison of the potential vaccination schedules refer to the cited reference. These vaccines are some of the safest available. Side effects of the vaccine are soreness at the injection site, headache, fatigue, irritability, and fever. The number of patients experiencing adverse reactions decreases with each vaccine dose, and adverse reactions are less common in infants and children than in adults. There is no association between Guillain-Barre syndrome and the recombinant vaccine, and the vaccine does not transmit HIV. The hepatitis B vaccine is contraindicated for patients with anaphylaxis to... 

PPV23 safety is well documented. Local reactions occur frequently within the first 48 hours and generally are mild. Lxjcal erythema and induration (30%), local discomfort (40%), and local swelling (3%) are the side effects observed most commonly. Revaccination has been associated with self-limited injection-site reactions more commonly than after the first dose. Rarely, severe systemic reactions can occur, and they consist of weakness, myalgia, headache, photophobia, chills, and fever. Guillain-Barre syndrome has not been reported. In patients with HIV infection, pneumococcal vaccine may cause a transient increase in viral replication, but the importance of this is unknown. 

Pneumococcal polysaccharide vaccine generally is considered safe based on clinical experience since 1977, when the pneumococcal polysaccharide vaccine was licensed in the United States. Mild, local side effects (e.g., pain at the injection site, erythema, and swelling) develop in approximately half of persons who receive pneumococcal vaccine. These reactions usually persist for less than 48 hours. Moderate systemic reactions (e.g., fever and myalgias) and more severe local reactions (e.g., local induration) are rare. Intradermal administration may cause severe local reactions and is inappropriate. Severe systemic adverse effects (e.g., anaphylactic reactions) rarely have been reported after administration of pneumococcal vaccine (34,37). Pneumococcal vaccination has not been causally associated with death or neurological illness (e.g., Guillain-Barre syndrome) among vaccine recipients. 

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