A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Fluzone Side Effects, and Drug Interactions - Influenza Virus Vaccine
Fluzone Side Effects, and Drug Interactions - Influenza Virus Vaccine
SIDE EFFECTS
Because influenza
vaccine contains only
noninfectious viruses, it cannot cause
influenza. Respiratory disease
after vaccination
represents coincidental illness
unrelated to influenza
vaccination. The most frequent side effect
of vaccination is
soreness at the vaccination
site that lasts up to 2
days. These local reactions
generally are mild and rarely interfere with the ability
to conduct usual daily activities. 1
Two types of systemic
reactions have occurred:
- Fever, malaise,
myalgia, and other
systemic symptoms
can occur following vaccination and most often affect
persons who have had no
exposure to the influenza
virus antigens in the
vaccine (e. g., young
children). These reactions begin 6 to 12 hours after vaccination
and can persist for 1 or 2 days. Recent placebo-controlled trials
suggest that in elderly persons and healthy
young adults, split-virus influenza
vaccine is not associated
with higher rates of systemic
symptoms (e. g., fever,
malaise, myalgia,
and headache) when compared with placebo
injections. 1
- Immediate – presumably allergic
– reactions (e. g., hives,
angioedema, allergic asthma,
and systemic anaphylaxis)
occur rarely after influenza vaccination. These reactions probably
result from hypersensitivity
to some vaccine component; the majority of reactions are most
likely related to residual egg
protein. Although current
influenza vaccines
contain only a small quantity
of egg protein,
this protein can induce
immediate hypersensitivity
reactions among persons who have severe egg
allergy. Persons who have developed hives, have had swelling
of the lips or tongue, or have experienced acute respiratory distress
or collapse after
eating eggs should consult a physician for appropriate
evaluation to help
determine if vaccine
should be administered. Persons who have documented immunoglobulin
E( IgE) mediated hypersensitivity to eggs – including those who
have had occupational
asthma or other allergic
responses due to exposure
to egg protein
– also might be at increased risk for reactions from influenza
vaccine, and similar
consultation
should be considered. 1,10,11,12,13,14,15,16,17
The protocol for influenza
vaccination developed
by Murphy and Strunk may be considered for patients who have egg
allergies and medical
conditions that place them at increased risk
for influenza- associated complications. 1,19
Although the 1976 swine influenza
vaccine was associated
with an increased frequency of Guillain-Barré syndrome
(GBS), evidence for
a causal relationship of GBS
with subsequent vaccines prepared from other virus strains is less
clear. 1,20,21,22 However, obtaining
strong evidence for
a possible small increase in risk
is difficult for a rare condition
such as GBS, which has
an annual background incidence of only 10 to 20 cases per
million adults. During three of four influenza seasons studied from
1977 through 1991, the point
estimates of the overall relative risks of GBS
after influenza vaccination
were slightly elevated; but were not statistically significant
in any of these studies. However, a recent study of the 1992-93
and 1993-94 seasons, investigators found an elevation
in the overall relative risk
for GBS of 1.83 (95% Confidence
Interval =1.12 to 3.00) during the 6 weeks following vaccination,
representing an excess of an estimated 1 to 2 cases of GBS
per million persons vaccinated;
the combined number of
GBS cases peaked 2 weeks
after vaccination. The increase in the relative risks and the increased
number of cases in the
second week after vaccination
may be the result of vaccination
but also could be the result of other factors (e. g., confounding
or diagnostic bias) rather than a true vaccine- related risk. 1
Among persons who received the swine influenza
vaccine in 1976, the
rate of GBS that exceeded
the background rate was
slightly less than 10 cases per
million persons vaccinated. Even if GBS
were a true side effect
in subsequent years, the estimated risk
for GBS of 1 to 2 cases
per million persons vaccinated
is substantially less than that for severe influenza, which could
be prevented by vaccination
in all age groups, especially
persons greater than or equal to 65 years of age
and those who have medical
indications for influenza
vaccination. During different epidemics occurring from 1972 through
1981, estimated rates of influenza- associated hospitalization have
ranged from approximately 200 to 300 hospitalizations per
million population for previously healthy
persons 5 to 44 years of age
and from 2,000 to greater than 10,000 hospitalizations per
million population
for persons greater than or equal to 65 years of age. During epidemics
from 1972-73 through 1994-95, estimated rates of influenza-associated
deaths have ranged from approximately 300 to greater than 1,500
per million persons greater
than or equal to 65 years of age, who account for more than 90%
of all influenzaassociated deaths. The potential
benefits of influenza vaccination clearly outweigh the possible
risks for vaccine-associated GBS. 1
The average case-fatality
ratio for GBS
is 6% and increases with age. However, no
evidence indicates
that the case-fatality ratio
for GBS differs among vaccinated
persons and those not vaccinated.1
Whereas the incidence
of GBS in the general population
is very low, persons with a history
of GBS have a substantially
greater likelihood of subsequently developing GBS
than persons without such
a history. Thus, the likelihood of coincidently developing GBS
after influenza vaccination
is expected to be greater among persons with a history
of GBS than among persons
with no history
of this syndrome. Whether influenza
vaccination might be causally associated with this risk
for recurrence is
not known. 1
Neurological disorders temporally associated with influenza
vaccination such as encephalopathy,
optic neuritis,
partial facial paralysis,
and brachial plexus neuropathy
have been reported. However, no
cause and effect
has been established. 23,24 Almost
all persons affected were adults, and the described clinical
reactions began as soon as a few hours and as late as 2 weeks after
vaccination. Full recovery was almost always reported. 25,26,27
Reporting of Adverse Events
Reporting by patients, parents or guardians of all adverse events
occurring after vaccine
administration
should be encouraged. Adverse events following immunization with
vaccine should be reported
by the health-care provider to the US Department of Health and Human
Services (DHHS) Vaccine Adverse Event Reporting System (VAERS).
Reporting forms and information about reporting requirements or
completion of the form
can be obtained from VAERS through a toll- free number
1-800-822-7967. 28
The health-care provider
also should report these
events to the Director of Medical Affairs, Connaught Laboratories,
Inc., a Pasteur Mérieux Connaught Company, Route 611, PO
Box 187, Swiftwater, PA 18370
or call 1-800-822-2463.
DRUG INTERACTIONS
Although influenza
vaccination can
inhibit the clearance
of warfarin, theophylline, phenytoin, aminopyrine, and carbamazepine
therapy, studies have
failed to show any adverse
clinical effects attributable
to these drugs in patients receiving influenza
vaccine. 10,11,12,13,14,15,16,17
If Fluzone is administered to immunosuppressed persons or persons
receiving immunosuppressive therapy,
the expected antibody
response may not be
obtained. This includes patients with asymptomatic
HIV infection,
AIDS or AIDS-Related Complex,
severe combined immunodeficiency, hypogammaglobulinemia, or aggammaglobulinemia;
altered immune states
due to diseases such as
leukemia, lymphoma,
or generalized malignancy; or an immune
system compromised by
treatment with corticosteroids,
alkylating drugs, antimetabolites or radiation. 18
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