Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 293
6
Influenza Vaccine
INTRODUCTION
Influenza viruses are 80–120 nm enveloped viruses of the family Ortho-
myxoviridae (Treanor, 2010). Divided into three types—A, B, and C—these
viruses can infect a range of hosts from humans only (influenza B) to hu-
mans and swine (influenza C) to multiple host organisms including humans,
swine, equine, avian, and marine mammals (influenza A) (Treanor, 2010).
Influenza viruses are highly changeable viruses. Small antigenic changes,
known as “antigenic drift,” occur regularly, usually as point mutations
in the virus genome or through exchange of small gene segments with
another strain of influenza virus (Han and Marasco, 2011; Treanor, 2010).
Occasionally, influenza viruses undergo an abrupt and dramatic change in
genome. This change, known as “antigenic shift,” results in a new virus that
is so different from previous viruses that no immunity exists in the popula-
tion and can lead to pandemic influenza (Treanor, 2010). Antigenic shift is
usually caused by genetic recombination between two strains of influenza
virus; one from a strain that can infect humans and one that, prior to the
genetic exchange, could not (Han and Marasco, 2011). The impact of these
changes depends on the extent of the change, but because viral epitopes
from the variant strains that result from antigenic shifts and drifts may not
be recognized by the immune system, vaccines must be altered regularly to
combat the infection.
Influenza viruses are named based on the type of influenza, the location
of initial isolation, strain designation number, and the year of isolation (e.g.,
A/Brisbane/59/2007). Influenza A viruses are further divided into subtypes
293
OCR for page 294
294 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY
based on the characteristics of the hemagglutinin (H or HA) and neuramini-
dase (N or NA) surface proteins (Treanor, 2010). This subtyping is the basis
of the H#N# designations of the influenza A viruses. At least 16 distinct
HA and 9 distinct NA surface proteins have been identified (Treanor,
2010). Influenza B viruses are subdivided as Yamagada or Victoria based
on genetic lineage (Xu et al., 2004). Of the three distinct types of influenza
viruses, influenza A viruses are the only viruses proven to cause pandemic
disease and are capable of interspecies transmission, as demonstrated with
the 1997 outbreak of avian (H5N1) influenza from poultry to humans (de
Jong et al., 1997; Subbarao et al., 1998; Yuen et al., 1998).
Influenza viruses have caused epidemics every 1 to 3 years during the
past four centuries, and four major pandemics have occurred including the
great pandemic of 1918 (Treanor, 2010). These pandemics were caused
by influenza A viruses H1N1 (1918 and 2009), H2N2 (1957), and H3N2
(1968) (Treanor, 2010). In any given year, two influenza A strains consid-
ered to be most likely to contribute to widespread (epidemic or pandemic)
illness are included in the trivalent vaccine. Because of its ability to produce
epidemic disease, an influenza B virus strain is also included in all current
vaccines.
In the United States, a nearly annual influenza epidemic usually begins
in late fall and peaks in mid to late winter. Influenza viruses are transmit-
ted by contact with aerosol secretions containing the virus, and this occurs
generally through coughing and sneezing (Belshe et al., 2008; Treanor,
2010). Following an average incubation period of 2 days but ranging from
1 to 4 days, adults and children remain infectious for approximately 5 days
after the onset of the illness (CDC, 2002). Children, who generally have
the highest attack rate and serve as the major source of transmission within
communities (Glezen and Couch, 1978; Monto and Kioumehr, 1975), can
be infectious for longer periods both before and after the onset of illness
(Belshe et al., 2008). Uncomplicated influenza often begins abruptly with
systemic symptoms of fever, chills, headaches, myalgia, malaise, anorexia,
and fatigue. These symptoms persist for the duration of the fever—typically
for 3 days (Treanor, 2010). Respiratory symptoms such as dry cough, sore
throat, and nonproductive cough may also occur and usually persist for
2 weeks or more (Belshe et al., 2008; Treanor, 2010). Fevers tend to be
higher in children and can lead to febrile seizures, while elderly individuals
may experience afebrile disease with lassitude or confusion (Babcock et al.,
2006; Bridges et al., 2008; Neuzil et al., 2003). The risk of complications
from influenza is higher in children and the elderly and those with certain
underlying conditions (Barker, 1986; Bridges et al., 2008; Simonsen et al.,
2000; Thompson et al., 2004). The most common complications include
primary influenza viral pneumonia, secondary bacterial pneumonia, and the
OCR for page 295
295
INFLUENZA VACCINE
exacerbation of chronic pulmonary and cardiopulmonary diseases such as
asthma and congestive heart failure (Bridges et al., 2008).
The influenza viruses were first isolated in the early 1900s by Smith and
his associates (influenza A, 1933), Francis (influenza B, 1939), and Taylor
(influenza C, 1950) (Francis, 1940; Smith et al., 1933; Taylor, 1951). In
1936, Burnet discovered that the virus could be grown in embryonated hen
eggs, and in the 1950s animal cell culture systems were developed (Burnet,
1936; Mogabgab et al., 1954; Treanor, 2010). In 1943, the first commercial
influenza vaccines were approved for use in the United States, and consisted
of inactivated virus grown in chicken eggs (Treanor, 2010). With a few
adaptations, propagation of influenza viruses in chicken eggs remains the
primary means for growing virus for vaccine production and biomedical
research (Treanor, 2010).
Currently, two types of vaccines are available in the United States—the
trivalent, inactivated influenza virus (TIV) vaccine, and the live, attenuated,
cold-adapted influenza virus (LAIV) vaccine (also trivalent). TIV vaccines,
which were first licensed for use in the United States in 1943, are inac-
tivated (killed) virus vaccines that provide immunity against the viruses
without causing any signs or symptoms of the infection (Treanor, 2010).
The LAIV vaccine is a live but attenuated virus vaccine that is capable
of causing mild signs and symptoms of vaccine virus infection (Treanor,
2010). Approved in 2003, LAIV is a live virus vaccine that is cold-adapted
(attenuated) so that it does not replicate in the warmer body temperature
of the lower airways (CDC, 2003; Treanor, 2010). It is capable of causing
mild signs and symptoms of wild-type influenza infection (Treanor, 2010).
TIV is administered through an intramuscular injection, while LAIV is
administered intranasally via an aerosol sprayer. Both vaccines contain
two influenza A and one influenza B subtypes which are recommended by
the World Health Organization (WHO) Global Influenza Programme—for
example A/California/7/2009 (H1N1)-like,1 A/Perth/16/2009 (H3N2)-like,
and B/Brisbane/60-2008-like for the 2010–2011 season (WHO, 2010).
The Advisory Committee on Immunization Practices (ACIP) recom-
mends that all persons 6 months or older receive an annual influenza
virus vaccine (CDC, 2010b). For healthy, nonpregnant persons aged 2 to
49 years either TIV or LAIV vaccine is recommended without preference
(CDC, 2010b). LAIV is not recommended for children under 2 years of
1 A/California/7/2009 (H1N1)-like is derived from the 2009 pandemic influenza A (H1N1)
virus. This strain was included in the trivalent vaccine in 2010. The monovalent vaccine
developed for the pandemic is not covered under the National Vaccine Injury Compensation
Program (VICP); it is covered under the Countermeasures Injury Compensation Program and
is therefore beyond the scope of this report.
OCR for page 296
296 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY
age, pregnant women, adults over 50 years of age, and persons with a
history of hypersensitivity to eggs or LAIV vaccine components (CDC,
2010b). It is also not recommended for persons with asthma and children
between 2 and 4 years of age with a history of asthma or wheezing episodes
in the 12 months prior to vaccination (CDC, 2010b). For these individu-
als and individuals with chronic conditions such as hematologic, hepatic,
metabolic, neurologic or neuromuscular, pulmonary, or renal disorders;
the immunosuppressed; and those between the ages of 6 months and 18
years receiving aspirin or other salicylates; ACIP recommends use of the
age-appropriate TIV vaccine (Table 6-1) (CDC, 2010b).
In the 2008–2009 season, influenza vaccination was received by 29.1
percent of all persons aged 6 months to 18 years (CDC, 2010a). Thirty-
three percent of individuals aged 19 to 49 years, who were considered
high-risk for this age group, were vaccinated in comparison to 19.7 per-
cent of individuals who were not considered high-risk for influenza (CDC,
2010a). The vaccine was administered to 51.5 percent of high-risk adults
aged 50 to 64 years and 34.2 percent of non-high-risk adults in this age
group (CDC, 2010a).
ENCEPHALITIS AND ENCEPHALOPATHY
Epidemiologic Evidence
The committee reviewed four studies to evaluate the risk of encepha-
litis or encephalopathy after the administration of influenza vaccine. One
study (Nakayama and Onoda, 2007) was not considered in the weight of
epidemiologic evidence because it provided data from a passive surveil-
lance system and lacked an unvaccinated comparison population. Three
controlled studies (France et al., 2004; Goodman et al., 2006; Hambidge
et al., 2006) had very serious methodological limitations that precluded
their inclusion in this assessment. The studies by France et al. (2004),
Goodman et al. (2006), and Hambidge et al. (2006) were unable to find
any cases of encephalopathy or encephalitis following influenza vaccination
using a case-crossover or case-control design, so no conclusions could be
drawn from these analyses.
Weight of Epidemiologic Evidence
The epidemiologic evidence is insufficient or absent to assess
an association between influenza vaccine and encephalitis or
encephalopathy.
OCR for page 297
TABLE 6-1 Influenza Vaccines Licensed and Available in the United States
Mercury
Content Number
(mcg Hg/ of
Vaccine Trade Name Manufacturer Presentation 0.5 mL dose) Age Group Doses Route
TIVa Fluzone Sanofi Pasteur, Inc. 0.25 mL prefilled syringe 0.0 6–35 months 1 or 2b Intramuscularc
0.5 mL prefilled syringe 0.0 36 months– 1 or 2b Intramuscularc
8 years
0.5 mL single-dose vial 0.0 1 or 2b Intramuscularc
≥ 36 months
5.0 mL multidose vial 25.0 1 or 2b Intramuscularc
≥ 6 months
TIV Fluzone Sanofi Pasteur, Inc. 0.1 mL prefilled 0.0 18–64 years 1 Intradermal
Intradermal microinjection system
TIV Fluzone High-Dosed Sanofi Pasteur, Inc. 0.5 mL prefilled syringe 0.0 1 Intramuscularc
≥ 65 years
TIV Fluvirin Novartis Vaccines and 5.0 mL multidose vial 25.0 1 or 2b Intramuscularc
≥ 4 years
Diagnostics Limited
0.5 mL prefilled syringe 0.0 1 or 2b Intramuscularc
≥ 4 years
TIV Fluarix GlaxoSmithKline 0.5 mL prefilled syringe 0.0 1 or 2b Intramuscularc
≥ 3 years
TIV FluLaval ID Biomedical 5.0 mL multidose vial 25.0 1 Intramuscularc
≥ 18 years
Corporation of Quebec
TIV Afluria CSL Limited 0.5 mL prefilled syringe 0.0 1 or 2b Intramuscularc
≥ 5 years
5.0 mL multidose vial 24.5 1 or 2b Intramuscularc
≥ 5 years
297
continued
OCR for page 298
TABLE 6-1 Continued
298
Mercury
Content Number
(mcg Hg/ of
Vaccine Trade Name Manufacturer Presentation 0.5 mL dose) Age Group Doses Route
TIV Agriflu Novartis Vaccines and 0.5 mL prefilled syringe 0.0 1 Intramuscularc
≥ 18 years
Diagnostics, Inc.
LAIVe FluMistf MedImmune, LLC 0.2 mL sprayer, divided dose 0.0 2–49 years 1 or 2b Intranasal
a Trivalent inactivated vaccine.
b Children less than 9 years of age not previously vaccinated with an influenza vaccine or vaccinated for the first time in the last season with only
one dose should receive two doses, spaced more than 4 weeks apart. Children less than 9 years of age given two doses in the previous season and
individuals greater than 9 years of age should receive only one dose of the vaccine.
c For adults and older children, the recommended site of vaccination is the deltoid muscle. If applicable, the preferred site for infants and young
children is the anterolateral aspect of the thigh.
d Trivalent inactivated vaccine high dose. A 0.5-mL dose contains 60 mcg each of A/California/7/2009 (H1N1)-like, A/Perth/16/2009 (H3N2)-like,
and B/Brisbane/60/2008-like antigens.
e Live attenuated influenza vaccine.
f FluMist is shipped refrigerated and should be stored in the refrigerator between 36°F and 46°F (2°C to 8°C) after arrival in the vaccination clinic.
The dose is 0.2 mL divided equally between each nostril.
SOURCES: CSL Limited, 2011; GlaxoSmithKline, 2011a,b; MedImmune, LLC, 2011; Novartis Vaccines and Diagnostics, Inc., 2010, 2011; Sanofi
Pasteur, 2011.
OCR for page 299
299
INFLUENZA VACCINE
Mechanistic Evidence Regarding Encephalitis
The committee identified 11 publications reporting meningoencephali-
tis or encephalitis after administration of an influenza vaccine. Ten publi-
cations did not provide evidence beyond temporality (Blanco et al., 1999;
Buchner et al., 1988; Chhor et al., 2008; Drouet et al., 2002; Ehrengut and
Allerdist, 1977; Gross et al., 1978; Rosenberg, 1970; Saito and Yanagisawa,
1989; Turkoglu and Tuzun, 2009; Utumi et al., 2010). One publication at-
tributed the development of encephalitis after vaccination to a concomitant
infection with herpes simplex virus (Utumi et al., 2010). These publications
did not contribute to the weight of mechanistic evidence.
Described below is one publication reporting clinical, diagnostic, or ex-
perimental evidence that contributed to the weight of mechanistic evidence.
Froissart et al. (1978) described a 29-year-old woman presenting with
vomiting, fever, and a stiff neck leading to a diagnosis of meningoencepha-
litis 2 days after administration of an influenza vaccine. The previous year
the patient presented with similar symptoms 2 days after receiving an
influenza vaccine.
Weight of Mechanistic Evidence
While rare, infection with influenza has been associated with encephali-
tis (Treanor, 2010). The committee considers the effects of natural infection
one type of mechanistic evidence.
The publication, described above, did not present evidence sufficient
for the committee to conclude the vaccine may be a contributing cause of
encephalitis after administration of an influenza vaccine. The symptoms
described in the publications referenced above are consistent with those
leading to a diagnosis of encephalitis, but the only evidence that could be
attributed to the vaccine was recurrence of symptoms upon vaccine rechal-
lenge. Viral infection and viral reactivation may contribute to the symptoms
of encephalitis; however, the publications did not provide evidence linking
these mechanisms to influenza vaccine.
The committee assesses the mechanistic evidence regarding an as-
sociation between influenza vaccine and encephalitis as weak based
on knowledge about the natural infection and one case.
Causality Conclusion
Conclusion 6.1: The evidence is inadequate to accept or reject a
causal relationship between influenza vaccine and encephalitis.
OCR for page 300
300 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY
Mechanistic Evidence Regarding Encephalopathy
The committee identified five publications reporting encephalopathy
after administration of an influenza vaccine. Three publications did not pro-
vide evidence beyond temporality and therefore did not contribute to the
weight of mechanistic evidence (Ehrengut and Allerdist, 1977; Morimoto
et al., 1985; Woods and Ellison, 1964).
Described below are two publications reporting clinical, diagnostic,
or experimental evidence that contributed to the weight of mechanistic
evidence.
Boutros and Keck (1993) described a 75-year-old woman presenting
with confusion 12 days after receiving an influenza vaccine. Physical ex-
amination showed anorexia, insomnia, hallucinations, and delirium. High
signal lesions in the white matter were revealed upon magnetic resonance
imaging. The symptoms resolved upon treatment with thiothixene. One
year prior to the current episode the patient developed similar symptoms
21 days after receiving an influenza vaccine.
Warren (1956) described a 19-year-old man presenting with profuse
rhinorrhea, wheezing, feverishness, soreness behind the eyes, shaking chills,
and aching of the arms, back, and head hours after receiving an influenza
vaccine. Two hours later the patient was weak, dizzy, unable to sit upright,
and began to black out. Physical examination revealed the patient to be
semicomatose and delirious. One year prior to the current episode the pa-
tient had presented with severe malaise 2 days after receiving an influenza
vaccine.
Weight of Mechanistic Evidence
The publications described above did not present evidence sufficient
for the committee to conclude the vaccine may be a contributing cause of
encephalopathy after administration of an influenza vaccine. The symptoms
described in the publications referenced above are consistent with those
leading to a diagnosis of encephalopathy, but the only evidence that could
be attributed to the vaccine was recurrence of symptoms upon vaccine
rechallenge. Viral infection and viral reactivation may contribute to the
symptoms of encephalopathy; however, the publications did not provide
evidence linking these mechanisms to influenza vaccine.
The committee assesses the mechanistic evidence regarding an as-
sociation between influenza vaccine and encephalopathy as weak
based on two cases.
OCR for page 301
301
INFLUENZA VACCINE
Causality Conclusion
Conclusion 6.2: The evidence is inadequate to accept or reject a
causal relationship between influenza vaccine and encephalopathy.
SEIZURES
Epidemiologic Evidence
The committee reviewed eight studies to evaluate the risk of seizures
after the administration of influenza vaccine. Four studies (D’Heilly et al.,
2006; Izurieta et al., 2005; McMahon et al., 2005; Rosenberg et al., 2009)
were not considered in the weight of epidemiologic evidence because they
provided data from passive surveillance systems and lacked unvaccinated
comparison populations.
The four remaining controlled studies (France et al., 2004; Goodman
et al., 2006; Greene et al., 2010; Hambidge et al., 2006) were included in
the weight of epidemiologic evidence and are described below.
France et al. (2004) conducted a case-crossover study in 251,600 chil-
dren (younger than 18 years of age) enrolled in five health maintenance
organizations (HMOs) participating in the Vaccine Safety Datalink (VSD).
The study investigated the occurrence of adverse events (reported as out-
patient, inpatient, and emergency department visits) within 14 days of TIV
administration from January 1993 through December 1999. Two control
periods were defined as 15 to 28 days before vaccination (control period 1)
and 15 to 28 days after vaccination (control period 2). The inclusion
criteria required participants to be enrolled in the HMO 28 days before
and 28 days after receiving TIV, and have a record of an adverse event in
either the risk period or one of the two control periods. Study participants
were excluded from the analysis if they experienced an event during both
the risk period and one of the control periods, which limited the analysis
to discordant pairs. Multiple vaccinations in an individual were treated as
independent in the analysis and the pre- and postvaccination control peri-
ods in the same individual were analyzed independently, which would tend
to increase the number of associations found to be significant by chance
alone (type I error). Seizures were observed in 81 children, but no signifi-
cant associations were reported for outpatient, inpatient, and emergency
department visits for seizures during the 14-day risk period when compared
to the prevaccination control period or postvaccination control period. Ad-
ditional analyses with liberalized significance criterion (.05 < p ≤ .20) were
used to identify potentially overlooked associations, but seizures remained
nonsignificant.
Hambidge et al. (2006) conducted case-crossover analysis to examine
OCR for page 302
302 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY
the risk of seizures after influenza vaccination in 45,356 children (6 to 23
months of age) enrolled in eight medical care organizations (MCOs) partici-
pating in the VSD. The study investigated the occurrence of adverse events
(reported as outpatient, inpatient, and emergency department visits) within
14 days (primary analysis) of TIV administration from 1991 through 2003.
Two control periods were defined as 15 to 28 days before vaccination (con-
trol period 1) and 15 to 28 days after vaccination (control period 2). Only
discordant pairs were analyzed, and participants that experienced an event
during both the risk period and one of the control periods were excluded.
Half of the study population overlapped the patients observed in the study
by France et al. (2004), but separate analyses for the unique subgroups
presented in this paper (1991–1992 and 2000–2003) were not performed.
A total of 24 seizures were observed in the 14-day risk window; 22 were
found to be febrile seizures, and 17 were reported during the same period
that has been associated with febrile seizures following measles, mumps,
and rubella (MMR) immunization (7–14 days postvaccination). Children
who received MMR vaccine on the same day as TIV were excluded from
the analysis (nine cases and one control). The matched odds ratio for sei-
zures within 14 days of TIV administration was 1.36 (95% CI, 0.63–2.97).
The authors concluded that after excluding children who received MMR
vaccine on the same day, TIV administration was not associated with an
increased risk in febrile seizures. They also noted that no signal of seizures
within 3 days of TIV administration was observed.
Goodman et al. (2006) conducted a nested case-control study in
children (6 to 23 months of age) enrolled in the HealthPartners Medical
Group (HPMG) during the 2002–2003 and 2003–2004 influenza seasons.
Vaccination histories were obtained from the HPMG vaccine registry and
the investigators coded whether the TIV injection was a first or second
dose during the given influenza season. Seizure diagnoses were verified
by reviewing the medical charts. The risk window was defined as 0–42
days following vaccination, but the investigators also analyzed 0–3-day,
4–14-day, and 14–42-day windows. The cohort included 13,383 children,
of whom 3,697 received TIV during the study period. Cases were matched
to three controls (children who did not have the outcome of interest) on
date of birth and gender; the index date for the controls was the date
the event was observed in the matched case. The authors did not report
how many cases and controls were included in the seizure analysis or list
characteristics of these two groups. The hazard ratio for seizures within
42 days of a first dose of TIV was 1.17 (95% CI, 0.36–3.86), and within
42 days of a second dose of TIV the hazard ratio was 1.026 (95% CI,
0.19–5.56). Shorter time windows did not have the power to assess the
hazard ratio for seizures following TIV and were not listed in the study.
OCR for page 303
303
INFLUENZA VACCINE
The authors concluded that TIV administration is not associated with an
increased rate of seizures.
Greene et al. (2010) conducted a retrospective cohort study in children
(6 months to 17 years of age) and adults (≥ 18 years of age) enrolled in
eight MCOs participating in the VSD. The study investigated the occur-
rence of adverse events (reported as inpatient and emergency department
visits) after receipt of influenza vaccine from September through April of
the 2005–2006, 2006–2007, and 2007–2008 influenza seasons. The risk
period for the seizures analysis (0 to 7 days after vaccination) of the given
season was compared to the control period (8 to 15 days after vaccination)
of the same season. The number of vaccine doses administered to children
during the 2005–2006 season was 317,108; during the 2006–2007 season
was 415,446; and during the 2007–2008 season was 462,998. The relative
risk of seizures in children within 7 days of influenza vaccination was 1.35,
0.80, and 0.98 for the 2005–2006, 2006–2007, and 2007–2008 influenza
seasons, respectively. The number of vaccine doses administered to adults
during the 2005–2006 season was 1,429,974; during the 2006–2007 season
it was 1,598,880; and during the 2007–2008 season it was 1,742,858. The
relative risk of seizures in adults within 7 days of influenza vaccination
was 0.99, 0.96, and 1.09 for the 2005–2006, 2006–2007, and 2007–2008
influenza seasons, respectively. None of the associations reached the criti-
cal value of the log-likelihood ratio, and none of the relative risks achieved
statistical significance. This paper also included an analysis comparing rate
ratios in the current year with the cumulative ratios in prior comparison
years. All of these comparisons also found no increase in seizures in the
risk period.
Weight of Epidemiologic Evidence
Analyses from four studies (one retrospective cohort, one case-control,
and two case-crossover designs) were included in the epidemiologic evi-
dence. France et al. (2004) did not find a statistically significant association
between seizures and TIV, even with liberalized significance criterion (.05 <
p ≤ .20). The study by Hambidge et al. (2006) observed a null association in
seizures within 14 days of TIV administration when children who received
MMR simultaneously with TIV were removed from the case-crossover
analysis. The case-control study by Goodman et al. (2006) found no asso-
ciation between seizures and TIV, but the precision was low. Greene et al.
(2010) did not find a statistically significant association among the analyses
for children and adults; however, the control period was within the risk
period of the other papers. Although power was limited in all the studies,
they were generally well done and results were consistent, supporting the
OCR for page 410
410 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY
Guillevin, L., and Y. Levy. 1983. Hypersensitivity reaction following vaccination against in-
fluenza [in French]. Presse Medicale 12(26):1668-1669.
Haber, P., F. DeStefano, F. J. Angulo, J. Iskander, S. V. Shadomy, E. Weintraub, and R. T. Chen.
2004. Guillain-Barré syndrome following influenza vaccination. Journal of the American
Medical Association 292(20):2478-2481.
Hajiabdolbaghi, M., S. Jafari, A. R. Esteghamati, M. N. Dadras, M. M. Gouya, S. Jam, H. E.
Koochak, P. Kheirandish, S. Shahriari, and B. M. Badie. 2009. Adverse events of trivalent
influenza vaccine among health care workers in Iran. Iranian Journal of Public Health
38(2):51-57.
Hambidge, S. J., J. M. Glanz, E. K. France, D. McClure, S. Xu, K. Yamasaki, L. Jackson, J. P.
Mullooly, K. M. Zangwill, S. M. Marcy, S. B. Black, E. M. Lewis, H. R. Shinefield, E.
Belongia, J. Nordin, R. T. Chen, D. K. Shay, R. L. Davis, and F. DeStefano. 2006. Safety
of trivalent inactivated influenza vaccine in children 6 to 23 months old. Journal of the
American Medical Association 296(16):1990-1997.
Han, T., and W. A. Marasco. 2011. Structural basis of influenza virus neutralization. Annals
of the New York Academy of Sciences 1217:178-190.
Hanania, N. A., M. Sockrider, M. Castro, J. T. Holbrook, J. Tonascia, R. Wise, and R. L.
Atmar. 2004. Immune response to influenza vaccination in children and adults with
asthma: Effect of corticosteroid therapy. Journal of Allergy and Clinical Immunology
113(4):717-724.
Hansen, O. 2005. A case of acute brachial neuropathy following influenza vaccination [in
Danish]. Ugeskrift for Laeger 167(11):1297-1298.
Harrison, B. J., W. Thomson, L. Pepper, W. E. R. Ollier, K. Chakravarty, E. M. Barrett, A. J.
Silman, and D. P. M. Symmons. 1997. Patients who develop inflammatory polyarthritis
(IP) after immunization are clinically indistinguishable from other patients with IP. British
Journal of Rheumatology 36(3):366-369.
Hernan, M. A., S. S. Jick, M. J. Olek, and H. Jick. 2004. Recombinant hepatitis B vaccine and
the risk of multiple sclerosis: A prospective study. Neurology 63(5):838-842.
Herron, A., G. Dettleff, B. Hixon, L. Brandwin, D. Ortbals, R. Hornick, and B. Hahn. 1979.
Influenza vaccination in patients with rheumatic diseases. Safety and efficacy. Journal of
the American Medical Association 242(1):53-56.
Hirtz, D. G., K. B. Nelson, and J. H. Ellenberg. 1983. Seizures following childhood immuniza-
tions. Journal of Pediatrics 102(1):14-18.
Holgate, S. T. 2008. Pathogenesis of asthma. Clinical and Experimental Allergy 38(6):872-897.
Holvast, A., A. De Haan, S. Van Assen, C. A. Stegeman, M. G. Huitema, A. Huckriede,
C. A. Benne, J. Westra, A. Palache, J. Wilschut, C. G. M. Kallenberg, and M. Bijl. 2010.
Cell-mediated immune responses to influenza vaccination in Wegener’s granulomatosis.
Annals of the Rheumatic Diseases 69(5):924-927.
Holvast, A., C. A. Stegeman, C. A. Benne, A. Huckriede, J. C. Wilschut, A. M. Palache,
C. G. M. Kallenberg, and M. Bijl. 2009a. Wegener’s granulomatosis patients show an
adequate antibody response to influenza vaccination. Annals of the Rheumatic Diseases
68(6):873-878.
Holvast, A., S. van Assen, A. de Haan, A. Huckriede, C. A. Benne, J. Westra, A. Palache, J.
Wilschut, C. G. M. Kallenberg, and M. Bijl. 2009b. Effect of a second, booster, influenza
vaccination on antibody responses in quiescent systemic lupus erythematosus: An open,
prospective, controlled study. Rheumatology 48(10):1294-1299.
Houston, T. P. 1983. Small-vessel vasculitis following simultaneous influenza and pneumo-
coccal vaccination. New York State Journal of Medicine 83(11-12):1182-1183.
Hu, S. C., C. L. Ke, G. S. Chen, and S. T. Cheng. 2009. Parallel correlation of immuno-
fluorescence studies with clinical course in a patient with influenza vaccine-induced lym-
phocytic vasculitis. Journal of the European Academy of Dermatology and Venereology
23(4):463-465.
OCR for page 411
411
INFLUENZA VACCINE
Hughes, R. A., J. Charlton, R. Latinovic, and M. C. Gulliford. 2006. No association between
immunization and Guillain-Barré syndrome in the United Kingdom, 1992 to 2000. Ar-
chives of Internal Medicine 166(12):1301-1304.
Hull, T. P., and J. H. Bates. 1997. Optic neuritis after influenza vaccination. American Journal
of Ophthalmology 124(5):703-704.
Hurwitz, E. S., L. B. Schonberger, D. B. Nelson, and R. C. Holman. 1981. Guillain-Barré
syndrome and the 1978-1979 influenza vaccine. New England Journal of Medicine
304(26):1557-1561.
Huynh, W., D. J. Cordato, E. Kehdi, L. T. Masters, and C. Dedousis. 2008. Post-vaccination
encephalomyelitis: Literature review and illustrative case. Journal of Clinical Neurosci-
ence 15(12):1315-1322.
Hyla-Klekot, L., G. Kucharska, and W. Cieslak. 2005. Necrotizing glomerulonephritis in
decursu vasculitis after vaccination against influenza [in Polish]. Polski Merkuriusz
Lekarski 19(109):75-77.
Ichikawa, N., S. Takase, and K. Kogure. 1983. Recurrent aseptic meningitis after influenza
vaccination in a case with systemic lupus erythematosus [in Japanese]. Clinical Neurol-
ogy 23(7):570-576.
Innes, A., E. Beresford, and J. Bedford. 2000. Influenza vaccination in asthma: A primary care
experience. British Journal of General Practice 50(450):27-30.
Institute of Medicine. 2004. Immunization safety review: Influenza vaccines and neurological
complications. Washington, DC: The National Academies Press.
Iyngkaran, P., V. Limaye, C. Hill, D. Henderson, K. D. Pile, and M. Rischmueller. 2003.
Rheumatoid vasculitis following influenza vaccination. Rheumatology 42(7):907-909.
Iyoda, K., N. Mitsuda, K. Ogawa, and T. Okazaki. 2004. The head MRI by fluid attenuated
inversion recovery (FLAIR) was useful for diagnosis in the patient with post influenza
vaccinal acute disseminated encephalomyelitis (ADEM) [in Japanese]. No to Hattatsu
36(5):401-406.
Izurieta, H. S., P. Haber, R. P. Wise, J. Iskander, D. Pratt, C. Mink, S. Chang, M. M. Braun,
and R. Ball. 2005. Adverse events reported following live, cold-adapted, intranasal influ-
enza vaccine. Journal of the American Medical Association 294(21):2720-2725.
Jackson, D. J., and S. L. Johnston. 2010. The role of viruses in acute exacerbations of asthma.
Journal of Allergy and Clinical Immunology 125(6):1178-1187; quiz 1188-1189.
James, J. M., R. S. Zeiger, M. R. Lester, M. B. Fasano, J. E. Gern, L. E. Mansfield, H. J.
Schwartz, H. A. Sampson, H. H. Windom, S. B. Machtinger, and S. Lensing. 1998. Safe
administration of influenza vaccine to patients with egg allergy. Journal of Pediatrics
133(5):624-628.
Johnson, D. E. 1982. Guillain-Barré syndrome in the U.S. Army. Archives of Neurology
39(1):21-24.
Jover-Saenz, A., E. M. Fernandez, S. Garrido-Calvo, and J. M. Porcel-Perez. 2008. Postvaccine
temporal arteritis [in Spanish]. Medicina Clinica 130(16):638-639.
Juurlink, D. N., T. A. Stukel, J. Kwong, A. Kopp, A. McGeer, R. E. Upshur, D. G. Manuel, R.
Moineddin, and K. Wilson. 2006. Guillain-Barré syndrome after influenza vaccination
in adults: A population-based study. Archives of Internal Medicine 166(20):2217-2221.
Kao, C. D., J. T. Chen, K. P. Lin, D. E. Shan, Z. A. Wu, and K. K. Liao. 2004. Guillain-Barré
syndrome coexisting with pericarditis or nephrotic syndrome after influenza vaccination.
Clinical Neurology and Neurosurgery 106(2):136-138.
Kaplan, J. E., P. Katona, E. S. Hurwitz, and L. B. Schonberger. 1982. Guillain-Barré syndrome
in the United States, 1979-1980 and 1980-1981—lack of an association with influenza
vaccination. Journal of the American Medical Association 248(6):698-700.
Kasper, H. U., V. Dries, U. Drebber, D. Stippel, K. Reinhold, and H. P. Dienes. 2004. Florid
ischemic cholangitis due to leucocytoclastic vasculitis. Journal of Gastroenterology 39(2):
188-191.
OCR for page 412
412 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY
Kato, T., A. Kiire, H. Yamagata, H. Yamanaka, and N. Kamatani. 2006. Hypersensitivity reac-
tion against influenza vaccine in a patient with rheumatoid arthritis after the initiation
of etanercept injections. Modern Rheumatology 16(5):327-329.
Kava, T., and L. A. Laitinen. 1985. Effects of killed and live attenuated influenza vaccine on
symptoms and specific airway conductance in asthmatics and healthy subjects. Allergy:
European Journal of Allergy and Clinical Immunology 40(1):42-47.
Kava, T., A. Lindqvist, J. Karjalainen, and L. A. Laitinen. 1987. Unchanged bronchial reac-
tivity after killed influenza virus vaccine in adult asthmatics. Respiration 51(2):98-104.
Kavadas, F., A. Bitnun, D. MacGregor, H. Heurter, and E. Lee Ford Jones. 2008. Acute neuro-
logical events associated with influenza vaccination: Are the WHO criteria for assessing
causality adequate? Scandinavian Journal of Infectious Diseases 40(6-7):565-570.
Kelkar, P. 2006. Chronic inflammatory demyelinating polyneuropathy (CIDP) with rapid pro-
gression after influenza vaccination: A report of three cases. Journal of Clinical Neuro-
muscular Disease 8(1):20-25.
Kelsall, J. T., A. Chalmers, C. H. Sherlock, V. A. Tron, and A. C. Kelsall. 1997. Microscopic
polyangiitis after influenza vaccination. Journal of Rheumatology 24(6):1198-1202.
Kennedy, M. J., J. M. Carpenter, R. A. Lozano, and R. G. Castile. 2002. Impaired recovery of
hypothalamic-pituitary-adrenal axis function and hypoglycemic seizures after high-dose
inhaled corticosteroid therapy in a toddler. Annals of Allergy, Asthma, and Immunology
88(5):523-526.
Kepes, J. J. 1993. Large focal tumor-like demyelinating lesions of the brain-intermediate entity
betweeen multiple-sclerosis and acute disseminated encephalomyelitis—a study of 31
patients. Annals of Neurology 33(1):18-27.
Kmiecik, T., S. Arnoux, A. Kobryn, and P. Gorski. 2007. Influenza vaccination in adults
with asthma: Safety of an inactivated trivalent influenza vaccine. Journal of Asthma
44(10):817-822.
Kokia, E. S., B. G. Silverman, M. Green, H. Kedem, M. Guindy, and J. Shemer. 2007. Deaths
following influenza vaccination—background mortality or causal connection? Vaccine
25(51):8557-8561.
Kramarz, P., F. DeStefano, P. M. Gargiullo, R. L. Davis, R. T. Chen, J. P. Mullooly, S. B. Black,
H. R. Shinefield, K. Bohlke, J. I. Ward, and M. S. Marcy. 2000. Does influenza vaccina-
tion exacerbate asthma? Analysis of a large cohort of children with asthma. Archives of
Family Medicine 9(7):617-623.
Kuitwaard, K., M. E. Bos-Eyssen, P. H. Blomkwist-Markens, and P. A. Van Doorn. 2009.
Recurrences, vaccinations and long-term symptoms in GBS and CIDP. Journal of the
Peripheral Nervous System 14(4):310-315.
Larner, A. J., and S. F. Farmer. 2000. Myelopathy following influenza vaccination in inflam-
matory CNS disorder treated with chronic immunosuppression. European Journal of
Neurology 7(6):731-733.
Lasky, T., G. J. Terracciano, L. Magder, C. L. Koski, M. Ballesteros, D. Nash, S. Clark, P.
Haber, P. D. Stolley, L. B. Schonberger, and R. T. Chen. 1998. The Guillain-Barré syn-
drome and the 1992-1993 and 1993-1994 influenza vaccines. New England Journal of
Medicine 339(25):1797-1802.
Lasley, M. V. 2007. Anaphylaxis after booster influenza vaccine due to gelatin allergy. Pediatric
Asthma, Allergy and Immunology 20(3):201-205.
Lauer, K., and W. Firnhaber. 1990. The possible risk of vaccinations for the first manifestation
of multiple sclerosis [in German]. Aktuelle Neurologie 17(2):42-46.
Liozon, E., R. Ittig, N. Vogt, J. P. Michel, and G. Gold. 2000. Polymyalgia rheumatica follow-
ing influenza vaccination. Journal of the American Geriatrics Society 48(11):1533-1534.
Liu, C. Y., C. D. Kao, J. T. Chen, Y. S. Yeh, Z. A. Wu, and K. K. Liao. 2006. Hydrocephalus as-
sociated with Guillain-Barré syndrome. Journal of Clinical Neuroscience 13(8):866-869.
OCR for page 413
413
INFLUENZA VACCINE
Lohse, A., F. Michel, B. Auge, E. Toussirot, and D. Wendling. 1999. Vascular purpura and
cryoglobulinemia after influenza vaccination: Case-report and literature review. Revue
du Rhumatisme (English Edition) 66(6):359-360.
Mader, R., A. Narendran, J. Lewtas, V. Bykerk, R. C. J. Goodman, J. R. Dickson, and E. C.
Keystone. 1993. Systemic vasculitis following influenza vaccination—report of 3 cases
and literature review. Journal of Rheumatology 20(8):1429-1431.
Malleson, P. N., J. L. Tekano, D. W. Scheifele, and J. M. Weber. 1993. Influenza immuniza-
tion in children with chronic arthritis: A prospective study. Journal of Rheumatology
20(10):1769-1773.
Marine, W. M., and C. Stuart-Harris. 1976. Reactions and serologic responses in young
children and infants after administration of inactivated monovalent influenza A vaccine.
Journal of Pediatrics 88(1):26-30.
McMahon, A. W., J. Iskander, P. Haber, S. J. Chang, E. J. Woo, M. M. Braun, and R. Ball.
2005. Adverse events after inactivated influenza vaccination among children less than
2 years of age: Analysis of reports from the Vaccine Adverse Event Reporting System,
1990-2003. Pediatrics 115(2):453-460.
MedImmune, LLC. 2011. Flumist [package insert]. Gaithersburg, MD: MedImmune, LLC.
Migueres, J., F. Sallerin, R. Zayani, and R. Escamilla. 1987. Influenza vaccination and asthma
[in French]. Allergie et Immunologie 19(1):18-21.
Miller, A. E., L. A. Morgante, L. Y. Buchwald, S. M. Nutile, P. K. Coyle, L. B. Krupp, C. A.
Doscher, F. D. Lublin, R. L. Knobler, F. Trantas, L. Kelley, C. R. Smith, N. La Rocca,
and S. Lopez. 1997. A multicenter, randomized, double-blind, placebo-controlled trial of
influenza immunization in multiple sclerosis. Neurology 48(2):312-314.
Mogabgab, W. J., I. J. Green, and O. C. Dierkhising. 1954. Primary isolation and propagation
of influenza virus in cultures of human embryonic renal tissue. Science 120(3112):320-321.
Mokhtarian, F. 1997. Influenza virus vaccination of patients with multiple sclerosis. Multiple
Sclerosis 3(4):243-247.
Molina, M., G. Ortega, J. Galvez, and L. Munoz. 1990. Leukocytoclastic vasculitis secondary
to flu vaccination [in Spanish]. Medicina Clinica 95(2):78.
Monsalvo, A. C., J. P. Batalle, M. F. Lopez, J. C. Krause, J. Klemenc, J. Z. Hernandez,
B. Maskin, J. Bugna, C. Rubinstein, L. Aguilar, L. Dalurzo, R. Libster, V. Savy, E.
Baumeister, G. Cabral, J. Font, L. Solari, K. P. Weller, J. Johnson, M. Echavarria, K. M.
Edwards, J. D. Chappell, J. E. Crowe, Jr., J. V. Williams, G. A. Melendi, and F. P. Polack.
2011. Severe pandemic 2009 H1N1 influenza disease due to pathogenic immune com-
plexes. Nature Medicine 17(2):195-199.
Monto, A. S., and F. Kioumehr. 1975. Tecumseh study of respiratory illness. 9. Occurrence of
influenza in community, 1966-1971. American Journal of Epidemiology 102(6):553-563.
Moon, J. S., and N. Souayah. 2006. Guillain-Barré syndrome triggered by influenza vaccina-
tion in a recipient of liver transplant on FK506. Liver Transplantation 12(10):1537-1539.
Moriabadi, N. F., S. Niewiesk, N. Kruse, S. Jung, B. Weissbrich, V. ter Meulen, K. V. Toyka,
and P. Rieckmann. 2001. Influenza vaccination in MS: Absence of T-cell response against
white matter proteins. Neurology 56(7):938-943.
Morimoto, T., H. Oguni, Y. Awaya, T. Hayakawa, and Y. Fukuyama. 1985. A case of a rapidly
progressive central nervous system disorder manifesting as a pallidal posture and ocular
motor apraxia. Brain and Development 7(4):449-453.
Mormile, R., V. D’Alterio, G. Treccagnoli, and P. Sorrentino. 2004. Henoch-Schonlein pur-
pura with antiphospholipid antibodies after influenza vaccination: How fearful is it in
children? Vaccine 23(5):567-568.
Muhammad, R. D., P. Haber, K. R. Broder, Z. Leroy, R. Ball, M. M. Braun, R. L. Davis, and
A. W. McMahon. 2011. Adverse events following trivalent inactivated influenza vac-
cination in children: Analysis of the vaccine adverse event reporting system. Pediatric
Infectious Disease Journal 30(1):e1-e8.
OCR for page 414
414 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY
Murphy, K. R., and R. C. Strunk. 1985. Safe administration of influenza vaccine in asthmatic
children hypersensitive to egg proteins. Journal of Pediatrics 106(6):931-933.
Mutsch, M., W. Zhou, P. Rhodes, M. Bopp, R. T. Chen, T. Linder, C. Spyr, and R. Steffen.
2004. Use of the inactivated intranasal influenza vaccine and the risk of Bell’s palsy in
Switzerland. New England Journal of Medicine 350(9):896-903.
Nachamkin, I., S. V. Shadomy, A. P. Moran, N. Cox, C. Fitzgerald, H. Ung, A. T. Corcoran,
J. K. Iskander, L. B. Schonberger, and R. T. Chen. 2008. Anti-ganglioside antibody in-
duction by swine (a/NJ/1976/H1N1) and other influenza vaccines: Insights into vaccine-
associated Guillain-Barré syndrome. Journal of Infectious Diseases 198(2):226-233.
Nagano, T., M. Mizuguchi, E. Kurihara, Y. Mizuno, K. Tamagawa, and K. Komiya. 1988.
A case of acute disseminated encephalomyelitis with convulsion, gait disturbance, facial
palsy and multifocal CT lesions [in Japanese]. No to Hattatsu 20(4):325-329.
Nakajima, H., S. Ohtsuka, T. Nishina, M. Sugino, F. Kimura, T. Hanafusa, T. Ikemoto, and
A. Shimizu. 2003. Multiple sclerosis after allergen-specific immunotherapy and influenza
vaccination. European Neurology 50(4):248-249.
Nakamura, N., K. Nokura, T. Zettsu, H. Koga, M. Tachi, M. Terada, H. Katoh, Y. Itoh, H.
Osawa, T. Ozeki, and H. Yamamoto. 2003. Neurologic complications associated with
influenza vaccination: Two adult cases. Internal Medicine 42(2):191-194.
Nakashima, K., H. Shoji, and T. Toyomasu. 1982. Two cases of acute polyradiculoneuritis
associated with influenza A virus infection and vaccination [in Japanese]. Clinical Neu-
rology 22(3):223-228.
Nakayama, T., and K. Onoda. 2007. Vaccine adverse events reported in post-marketing study
of the Kitasato Institute from 1994 to 2004. Vaccine 25(3):570-576.
Neuzil, K. M., T. Z. O’Connor, G. J. Gorse, and K. L. Nichol. 2003. Recognizing influenza in
older patients with chronic obstructive pulmonary disease who have received influenza
vaccine. Clinical Infectious Diseases 36(2):169-174.
Nicholson, K. G., J. S. Nguyen-Van-Tam, A. H. Ahmed, M. J. Wiselka, J. Leese, J. Ayres, J. H.
Campbell, P. Ebden, N. M. Eiser, B. J. Hutchcroft, J. C. G. Pearson, R. F. Willey, R. J.
Wolstenholme, and M. A. Woodhead. 1998. Randomised placebo-controlled crossover
trial on effect of inactivated influenza vaccine on pulmonary function in asthma. Lancet
351(9099):326-331.
Novartis Vaccines and Diagnostics, Inc. 2010. Agriflu [package insert]. Cambridge, MA:
Novartis Vaccines and Diagnostics, Inc.
Novartis Vaccines and Diagnostics, Inc. 2011. Fluvirin [package insert]. Cambridge, MA:
Novartis Vaccines and Diagnostics, Inc.
Older, S. A., D. F. Battafarano, R. J. Enzenauer, and A. M. Krieg. 1999. Can immunization
precipitate connective tissue disease? Report of five cases of systemic lupus erythemato-
sus and review of the literature. Seminars in Arthritis and Rheumatism 29(3):131-139.
Ouellette, J. J., and C. E. Reed. 1965. Increased response of asthmatic subjects to methacholine
after influenza vaccine. Journal of Allergy 36(6):558-563.
Patel, U., J. R. Bradley, and D. V. Hamilton. 1988. Henoch-Schonlein purpura after influenza
vaccination. British Medical Journal 296(6639):1800.
Payne, D. C., C. E. Rose, J. Kerrison, A. Aranas, S. Duderstadt, and M. M. McNeil. 2006.
Anthrax vaccination and risk of optic neuritis in the United States military, 1998-2003.
Archives of Neurology 63(6):871-875.
Pedroza, A., J. G. Huerta, M. de la Luz Garcia, A. Rojas, I. Lopez-Martinez, M. Penagos, C.
Franco-Paredes, C. Deroche, and C. Mascarenas. 2009. The safety and immunogenicity
of influenza vaccine in children with asthma in Mexico. International Journal of Infec-
tious Diseases 13(4):469-475.
Pelosio, A., A. Galassi, R. Massini, C. Longhi, P. Marchetti, and U. Recine. 1990. Influenza
vaccination and Guillain-Barré syndrome [in Italian]. Medicina—Rivista della Enciclo-
pedia Medica Italiana 10(2):169.
OCR for page 415
415
INFLUENZA VACCINE
Peng, M. M., and H. Jick. 2004. A population-based study of the incidence, cause, and severity
of anaphylaxis in the United Kingdom. Archives of Internal Medicine 164(3):317-319.
Perez, C., E. Loza, and T. Tinture. 2000. Giant cell arteritis after influenza vaccination. Ar-
chives of Internal Medicine 160(17):2677.
Philippin, O., M. Dobbie, and P. Reusser. 2002. Bell’s palsy: Idiopathic or infectious? [in
French]. Revue Medicale de la Suisse Romande 122(2):81-83.
Piedra, P. A., M. J. Gaglani, M. Riggs, G. Herschler, C. Fewlass, M. Watts, C. Kozinetz,
C. Hessel, and W. P. Glezen. 2005. Live attenuated influenza vaccine, trivalent, is safe
in healthy children 18 months to 4 years, 5 to 9 years, and 10 to 18 years of age in a
community-based, nonrandomized, open-label trial. Pediatrics 116(3):e397-e407.
Pou, M. A., C. Diaz-Torne, S. Vidal, C. Corchero, J. Narvaez, J. M. Nolla, and C. Diaz-Lopez.
2008. Development of autoimmune diseases after vaccination. Journal of Clinical Rheu-
matology 14(4):243-244.
Pritchard, J., R. Mukherjee, and R. A. C. Hughes. 2002. Risk of relapse of Guillain-Barré
syndrome or chronic inflammatory demyelinating polyradiculoneuropathy following im-
munisation. Journal of Neurology, Neurosurgery, and Psychiatry 73(3):348-349.
Rabin, J. 1973. Hazard of influenza vaccine in neurologic patients. Journal of the American
Medical Association 225(1):63-64.
Ramagopalan, S. V., W. Valdar, D. A. Dyment, G. C. Deluca, I. M. Yee, G. Giovannoni, G. C.
Ebers, and A. D. Sadovnick. 2009. Association of infectious mononucleosis with multiple
sclerosis. Neuroepidemiology 32(4):257-262.
Ravaglia, S., M. Ceroni, A. Moglia, A. Todeschini, and E. Marchioni. 2004. Post-infectious
and post-vaccinal acute disseminated encephalomyelitis occurring in the same patients.
Journal of Neurology 251(9):1147-1150.
Ray, C. L., and I. J. Dreizin. 1996. Bilateral optic neuropathy associated with influenza vac-
cination. Journal of Neuro-Ophthalmology 16(3):182-184.
Redding, G., R. E. Walker, C. Hessel, F. S. Virant, G. H. Ayars, G. Bensch, J. Cordova, S. J.
Holmes, and P. M. Mendelman. 2002. Safety and tolerability of cold-adapted influenza
virus vaccine in children and adolescents with asthma. Pediatric Infectious Disease
Journal 21(1):44-48.
Reizis, Z., J. Frank, and E. Sikuler. 1987. Allergic vasculitis and bronchial asthma following
influenza vaccination [in Hebrew]. Harefuah 112(2):70-71.
Ritter, O., A. Bonz, J. Strotmann, and H. Langenfeld. 2003. Myocardial infarction after influ-
enza vaccination [in German]. Zeitschrift fur Kardiologie 92(11):962-965.
Roscelli, J. D., J. W. Bass, and L. Pang. 1991. Guillain-Barré syndrome and influenza vaccina-
tion in the U.S. Army, 1980-1988. American Journal of Epidemiology 133(9):952-955.
Rosenberg, G. A. 1970. Meningoencephalitis following an influenza vaccination. New England
Journal of Medicine 283(22):1209.
Rosenberg, M., R. Sparks, A. McMahon, J. Iskander, J. D. Campbell, and K. M. Edwards.
2009. Serious adverse events rarely reported after trivalent inactivated influenza vaccine
(TIV) in children 6-23 months of age. Vaccine 27(32):4278-4283.
Saito, H., M. Endo, S. Takase, and K. Itahara. 1980. Acute disseminated encephalomyelitis
after influenza vaccination. Archives of Neurology 37(9):564-566.
Saito, H., and T. Yanagisawa. 1989. Acute cerebellar ataxia after influenza vaccination with
recurrence and marked cerebellar atrophy. Tohoku Journal of Experimental Medicine
158(1):95-103.
Salemi, S., A. Picchianti-Diamanti, V. Germano, I. Donatelli, A. Di Martino, M. Facchini, R.
Nisini, R. Biselli, C. Ferlito, E. Podesta, A. Cappella, F. Milanetti, F. Rossi, R. Amodeo,
F. Tabacco, R. Di Rosa, B. Lagana, and R. D’Amelio. 2010. Influenza vaccine administra-
tion in rheumatoid arthritis patients under treatment with TNF alpha blockers: Safety
and immunogenicity. Clinical Immunology 134(2):113-120.
OCR for page 416
416 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY
Salvetti, M., A. Pisani, S. Bastianello, E. Millefiorini, C. Buttinelli, and C. Pozzilli. 1995.
Clinical and MRI assessment of disease activity in patients with multiple sclerosis after
influenza vaccination. Journal of Neurology 242(3):143-146.
Sanofi Pasteur. 2011. Fluzone/Fluzone High-Dose/Fluzone Intradermal [package insert].
Swiftwater, PA: Sanofi Pasteur.
Scheifele, D. W., B. Duval, M. L. Russell, R. Warrington, G. DeSerres, D. M. Skowronski, M.
Dionne, J. Kellner, D. Davies, and J. MacDonald. 2003. Ocular and respiratory symp-
toms attributable to inactivated split influenza vaccine: Evidence from a controlled trial
involving adults. Clinical Infectious Diseases 36(7):850-857.
Selvaraj, N., M. Moonis, and P. Ravin. 1998. Hemiparesis following influenza vaccination.
Postgraduate Medical Journal 74(876):633-635.
Sener, M., G. Gursel, and H. Turktas. 1999. Effects of inactivated influenza virus vaccination
on bronchial reactivity symptom scores and peak expiratory flow variability in patients
with asthma. Journal of Asthma 36(2):165-169.
Shuster, J. 2006. Vasculitis after flu shot; pulmonary toxicity associated with amiodarone
may be difficult to assess; capecitabine-induced severe hypertriglyceridemia; infliximab-
induced lupus erythematosus tumidus; ifosfamide-induced nonconvulsive status epilep-
ticus; seizure activity due to an antiseizure drug—especially when used off-label; two
interesting reviews concerning adverse events. Hospital Pharmacy 41(4):316-320.
Simonsen, L., K. Fukuda, L. B. Schonberger, and N. J. Cox. 2000. The impact of influenza
epidemics on hospitalizations. Journal of Infectious Diseases 181(3):831-837.
Skowronski, D. M., G. Bjornson, E. Husain, D. L. Metzger, and D. W. Scheifele. 2005.
Oculorespiratory syndrome after influenza immunization in children. Pediatric Infectious
Disease Journal 24(1):63-69.
Skowronski, D. M., G. De Serres, D. Scheifele, M. L. Russell, R. Warrington, H. D. Davies,
M. Dionne, B. Duval, J. Kellner, and J. MacDonald. 2003a. Randomized, double-blind,
placebo-controlled trial to assess the rate of recurrence of oculorespiratory syndrome
following influenza vaccination among persons previously affected. Clinical Infectious
Diseases 37(8):1059-1066.
Skowronski, D. M., K. Jacobsen, J. Daigneault, V. P. Remple, L. Gagnon, P. Daly, G. Arsenault,
M. Landry, K. Pielak, B. Duval, T. Tam, and G. De Serres. 2006. Solicited adverse events
after influenza immunization among infants, toddlers, and their household contacts.
Pediatrics 117(6):1963-1971.
Skowronski, D. M., H. Lu, R. Warrington, R. G. Hegele, G. De Serres, K. HayGlass, D. Stark,
R. White, J. Macnabb, Y. Li, H. E. Manson, and R. C. Brunham. 2003b. Does antigen-
specific cytokine response correlate with the experience of oculorespiratory syndrome
after influenza vaccine? Journal of Infectious Diseases 187(3):495-499.
Skowronski, D. M., B. Strauss, G. De Serres, D. MacDonald, S. A. Marion, M. Naus, D. M.
Patrick, and P. Kendall. 2003c. Oculo-respiratory syndrome: A new influenza vaccine-
associated adverse event? Clinical Infectious Diseases 36(6):705-713.
Skowronski, D. M., B. Strauss, P. Kendall, B. Duval, and G. De Serres. 2002. Low risk of
recurrence of oculorespiratory syndrome following influenza revaccination. Canadian
Medical Association Journal 167(8):853-858.
Smeeth, L., S. L. Thomas, A. J. Hall, R. Hubbard, P. Farrington, and P. Vallance. 2004. Risk
of myocardial infarction and stroke after acute infection or vaccination. New England
Journal of Medicine 351(25):2611-2618.
Smith, W., C. H. Andrewes, and P. P. Laidlaw. 1933. A virus obtained from influenza patients.
Lancet 2:66-68.
Souayah, N., A. Nasar, M. F. K. Suri, and A. I. Qureshi. 2007. Guillain-Barré syndrome after
vaccination in United States a report from the CDC/FDA Vaccine Adverse Event Report-
ing System. Vaccine 25(29):5253-5255.
OCR for page 417
417
INFLUENZA VACCINE
Souayah, N., A. Nasar, M. F. K. Suri, and A. I. Qureshi. 2009. Guillain-Barré syndrome after
vaccination in United States: Data from the Centers for Disease Control and Prevention/
Food and Drug Administration Vaccine Adverse Event Reporting System (1990-2005).
Journal of Clinical Neuromuscular Disease 11(1):1-6.
Spaetgens, B., P. van Paassen, and J. W. C. Tervaert. 2009. Influenza vaccination in ANCA-
associated vasculitis. Nephrology Dialysis Transplantation 24(10):3258; author reply
3259.
Stassen, P. M., J. S. F. Sanders, C. G. M. Kallenberg, and C. A. Stegeman. 2008. Influenza
vaccination does not result in an increase in relapses in patients with ANCA-associated
vasculitis. Nephrology Dialysis Transplantation 23(2):654-658.
Stenius-Aarniala, B., J. K. Huttunen, and R. Pyhala. 1986. Lack of clinical exacerbations
in adults with chronic asthma after immunization with killed influenza virus. Chest
89(6):786-789.
Stojanovich, L. 2006. Influenza vaccination of patients with systemic lupus erythemato-
sus (SLE) and rheumatoid arthritis (RA). Clinical and Developmental Immunology
13(2-4):373-375.
Storms, W. W., E. C. Dick, and W. W. Busse. 1976. Intranasal immunization with attenu-
ated live influenza vaccine in asthma. Journal of Allergy and Clinical Immunology
58(2):284-290.
Stowe, J., N. Andrews, L. Wise, and E. Miller. 2006. Bell’s palsy and parenteral inactivated
influenza vaccine. Human Vaccines 2(3):110-112.
Stowe, J., N. Andrews, L. Wise, and E. Miller. 2009. Investigation of the temporal association
of Guillain-Barré syndrome with influenza vaccine and influenza-like illness using the
United Kingdom general practice research database. American Journal of Epidemiology
169(3):382-388.
Subbarao, K., A. Klimov, J. Katz, H. Regnery, W. Lim, H. Hall, M. Perdue, D. Swayne, C.
Bender, J. Huang, M. Hemphill, T. Rowe, M. Shaw, X. Xu, K. Fukuda, and N. Cox.
1998. Characterization of an avian influenza (H5N1) virus isolated from a child with a
fetal respiratory illness. Science 279(5349):393-396.
Sugimoto, N., S. Tanaka, K. Yamaguchi, H. Kimura, and M. Kondo. 1968. A case of transverse
myelitis following influenza vaccination [in Japanese]. Clinical Neurology 8(5):244-248.
Takahashi, Y., K. Matsuda, Y. Kubota, J. Shimomura, E. Yamasaki, T. Kudo, K. Fukushima,
H. Osaka, N. Akasaka, A. Imamura, S. Yamada, N. Kondo, and T. Fujiwara. 2006.
Vaccination and infection as causative factors in Japanese patients with Rasmussen syn-
drome: Molecular mimicry and HLA class I. Clinical and Developmental Immunology
13(2-4):381-387.
Tam, C. C., S. J. O’Brien, I. Petersen, A. Islam, A. Hayward, and L. C. Rodrigues. 2007.
Guillain-Barré syndrome and preceding infection with Campylobacter, influenza and
Epstein-Barr virus in the general practice research database. PLoS ONE 2(4):e344.
Tan, F. U., C. Akarsu, R. Gullu, and T. Kansu. 2010. Bilateral optic neuritis after influenza
vaccination. Neuro-Ophthalmology 34(2):115-117.
Tata, L. J., J. West, T. Harrison, P. Farrington, C. Smith, and R. Hubbard. 2003. Does influ-
enza vaccination increase consultations, corticosteroid prescriptions, or exacerbations in
subjects with asthma or chronic obstructive pulmonary disease? Thorax 58(10):835-839.
Tavadia, S., A. Drummond, C. D. Evans, and N. J. Wainwright. 2003. Leucocytoclastic vas-
culitis and influenza vaccination. Clinical and Experimental Dermatology 28(2):154-156.
Taylor, R. M. 1951. A further note on 1233 influenza C virus. Archiv fur Die Gesamte
Virusforschung 4(4):485-500.
Thaler, A. 2008. Miller Fisher syndrome in a 66-year-old female after flu and pneumovax vac-
cinations. Journal of the American Medical Directors Association 9(4):283-284.
OCR for page 418
418 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY
Thompson, W. W., D. K. Shay, E. Weintraub, I. Brammer, C. B. Bridges, N. J. Cox, and K.
Fukuda. 2004. Influenza-associated hospitalizations in the United States. Journal of the
American Medical Association 292(11):1333-1340.
Thurairajan, G., M. W. Hope-Ross, R. D. Situnayake, and P. I. Murray. 1997. Polyarthropa-
thy, orbital myositis and posterior scleritis: An unusual adverse reaction to influenza
vaccine. British Journal of Rheumatology 36(1):120-123.
Treanor, J. J. 2010. Influenza viruses, including avian influenza and swine influenza. In
Mandell, Douglas, and Bennett’s principles and practice of infectious diseases. 7th ed.
2 vols. Vol. 2, edited by G. L. Mandell, J. E. Bennett, and R. Dolin. Philadelphia, PA:
Churchill Livingstone Elsevier. Pp. 2265-2288.
Turkoglu, R., and E. Tuzun. 2009. Brainstem encephalitis following influenza vaccination:
Favorable response to steroid treatment. Vaccine 27(52):7253-7256.
Uji, M., H. Matsushita, and S. Iwata. 2005. Microscopic polyangiitis after influenza vaccina-
tion. Internal Medicine 44(8):892-896.
Ulm, S., M. Hummel, M. Emig, M. Barreto-Miranda, W. Back, A. Reiter, R. Hehlmann, and
A. Willer. 2006. Leukocytoclastic vasculitis and acute renal failure after influenza vacci-
nation in an elderly patient with myelodysplastic syndrome. Onkologie 29(10):470-472.
Utumi, Y., E. Iseki, N. Murayama, Y. Ichimiya, and H. Arai. 2010. Limbic encephalitis caused
by herpes simplex virus infection after vaccination against the influenza virus [in Japa-
nese]. Brain and Nerve 62(6):615-619.
Vaglio, A., I. Casazza, C. Grasselli, D. Corradi, R. A. Sinico, and C. Buzio. 2009. Churg-
Strauss syndrome. Kidney International 76(9):1006-1011.
Vainer-Mossel, E. D., Y. A. Mekori, and A. Mor. 2009. Ischemic stroke in a patient with lupus
following influenza vaccination: A questionable association. Israel Medical Association
Journal 11(3):186-187.
Van Assen, S., A. Holvast, C. A. Benne, M. D. Posthumus, M. A. Van Leeuwen, A. E. Voskuyl,
M. Blom, A. P. Risselada, A. De Haan, J. Westra, C. G. M. Kallenberg, and M. Bijl.
2010. Humoral responses after influenza vaccination are severely reduced in patients
with rheumatoid arthritis treated with rituximab. Arthritis and Rheumatism 62(1):75-81.
Vellozzi, C., D. R. Burwen, A. Dobardzic, R. Ball, K. Walton, and P. Haber. 2009. Safety of
trivalent inactivated influenza vaccines in adults: Background for pandemic influenza
vaccine safety monitoring. Vaccine 27(15):2114-2120.
Verschuren, F., and D. Blockmans. 1998. Case history: Cutaneous vasculitis and influenza
vaccination [in French]. Louvain Medical 117(4):149-152.
Vial, T., V. Laine, M. Delcombel, C. Goubier, M. C. Galland, M. Mallaret, and J. Descotes.
1990. Vasculitis after anti-influenza vaccination. Report of 5 cases [in French]. Therapie
45(6):509-512.
Vilain, S., M. P. Waterschoot, and N. Mavroudakis. 2000. Encephalomyelitis and bilateral op-
tic perineuritis after influenza vaccination. Bulletin de la Societe Belge d Ophtalmologie
(277):71-73.
Wada, Y., C. Yanagihara, Y. Nishimura, and N. Oka. 2008. Hepatitis B virus-related vasculitis
manifesting as severe peripheral neuropathy following influenza vaccination. Clinical
Neurology and Neurosurgery 110(7):750-752.
Walker, S. L., K. J. Swindells, and R. J. G. Chalmers. 2004. Leucocytoclastic vasculitis and
influenza immunization. Clinical and Experimental Dermatology 29(1):95-96.
Wallin, L., W. Quintilio, F. Locatelli, A. Cassel, M. B. Silva, and T. L. Skare. 2009. Safety
and efficiency of influenza vaccination in systemic lupus erythematosus patients. Acta
Reumatologica Portuguesa 34(3):498-502.
Warren, W. R. 1956. Encephalopathy due to influenza vaccine. Archives of Internal Medicine
97(6):803-805.
OCR for page 419
419
INFLUENZA VACCINE
Watanabe, T., and H. Onda. 2001. Henoch-Schonlein purpura with antiphospholipid antibodies
following an influenza vaccination. Pediatric Nephrology 16(5):458-459.
Wattiaux, M. J., L. Moulonguet-Doleris, J. Cabane, J. Lebas, and J. C. Imbert. 1988.
Rheumatoid purpura following influenza vaccination [in French]. Presse Medicale
17(13):649-650.
Wells, C. E. C. 1971. A neurological note on vaccination against influenza. British Medical
Journal 3(5777):755-756.
Wharton, C. F., and R. Pietroni. 1974. Letter: Polyarteritis after influenza vaccination. British
Medical Journal 2(5914):331-332.
WHO (World Health Organization). 2010. Recommended composition of influenza virus
vaccines for use in the 2011-2012 northern hemisphere influenza season. http://www.
who.int/csr/disease/influenza/recommendations_2011_12north/en/index.html (accessed
April 9, 2011).
Wiesik-Szewczyk, E., M. Romanowska, P. Mielnik, H. Chwalinska-Sadowska, L. B. Brydak,
M. Olesinska, and J. Zabek. 2010. Anti-influenza vaccination in systemic lupus erythe-
matosus patients: An analysis of specific humoral response and vaccination safety. Clini-
cal Rheumatology 29(6):605-613.
Williams, G. W., A. D. Steinberg, J. L. Reinertsen, L. W. Klassen, J. L. Decker, and R. Dolin.
1978. Influenza immunization in systemic lupus eruthematosus. A double-blind trial.
Annals of Internal Medicine 88(6):729-734.
Willison, H. J. 2005. The immunobiology of Guillain-Barré syndromes. Journal of the Periph-
eral Nervous System 10(2):94-112.
Woods, C. A., and G. W. Ellison. 1964. Encephalopathy following influenza immunization.
Journal of Pediatrics 65:745-748.
Wright, P. F., S. H. Sell, J. Thompson, and D. T. Karzon. 1976. Clinical reactions and serologic
response following inactivated monovalent influenza type B vaccine in young children
and infants. Journal of Pediatrics 88(1):31-35.
Wu, Z., H. Wu, and Q. Wang. 1999. A case-control study on Guillain-Barré syndrome in
children of north China [in Chinese]. Zhonghua Yufang Yixue Zazhi 33(5):279-281.
Xu, X. Y., S. E. Lindstrom, M. W. Shaw, C. B. Smith, H. E. Hall, B. A. Mungall, K. Subbarao,
N. J. Cox, and A. Klimov. 2004. Reassortment and evolution of current human influenza
A and B viruses. Virus Research 103(1-2):55-60.
Yahr, M. D., and J. Lobo-Antunes. 1972. Relapsing encephalomyelitis following use of influ-
enza vaccine. Archives of Neurology 27(2):182-183.
Yanai-Berar, N., O. Ben-Itzhak, J. Green, and F. Nakhoul. 2002. Influenza vaccination induced
leukocytoclastic vasculitis and pauci-immune crescentic glomerulonephritis. Clinical
Nephrology 58(3):220-223.
Yiu, E. M., and A. J. Kornberg. 2010. Acute disseminated encephalomyelitis: Determinants
and manifestations. In Inflammatory diseases of the central nervous system, edited by T.
Kilpatrick, R. M. Ransohoff, and S. Wesselingh. New York, NY: Cambridge University
Press.
Yoo, W. H. 2010. Adult onset Still’s disease following influenza vaccination. Joint Bone Spine
77(4):373-374.
Yuen, K. Y., P. K. S. Chan, M. Peiris, D. N. C. Tsang, T. L. Que, K. F. Shortridge, P. T. Cheung,
W. K. To, R. Sung, and A. F. B. Cheng. 1998. Clinical features and rapid viral diagnosis
of huma disease associated with avian influenza h5n1 virus. The Lancet 351:467-471.
Zhang, J., G. Li, X. Liu, Z. Wang, W. Liu, and X. Ye. 2009. Influenza A virus M1 blocks
the classical complement pathway through interacting with C1qA. Journal of General
Virology 90(Pt 11):2751-2758.
Zheng, W., and S. C. Dreskin. 2007. Thimerosal in influenza vaccine: An immediate hypersen -
sitivity reaction. Annals of Allergy, Asthma and Immunology 99(6):574-575.
OCR for page 420
420 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY
Zhou, W., V. Pool, F. DeStefano, J. K. Iskander, P. Haber, R. T. Chen, S. Campbell, R. English-
Bullard, S. Holmes, A. Khromova, E. Miller, S. Pickering, M. Russell, S. Shadomy, R.
Ball, M. M. Braun, D. Burwen, D. Davis, S. S. Ellenberg, P. Perucci, F. Varricchio, R. P.
Wise, and J. Woo. 2004. A potential signal of Bell’s palsy after parenteral inactivated
influenza vaccines: Reports to the Vaccine Adverse Event Reporting System (VAERS)—
United States, 1991-2001. Pharmacoepidemiology and Drug Safety 13(8):505-510.
