THIS IS FROM THE FLUZONE INSERT-
CONTRAINDICATIONS
INFLUENZA VIRUS IS PROPAGATED IN EGGS FOR THE PREPARATION OF INFLUENZA VIRUS VACCINE. THEREFORE, FLUZONE SHOULD NOT
BE ADMINISTERED TO ANYONE WITH A HISTORY OF HYPERSENSITIVITY (ALLERGY), ESPECIALLY ANAPHYLACTIC REACTIONS, TO EGGS
OR EGG PRODUCTS. IT IS ALSO A CONTRAINDICATION TO ADMINISTER FLUZONE TO INDIVIDUALS KNOWN TO BE SENSITIVE TO
THIMEROSAL. EPINEPHRINE INJECTION (1:1000) MUST BE IMMEDIATELY AVAILABLE SHOULD AN ACUTE ANAPHYLACTIC REACTION
OCCUR DUE TO ANY COMPONENT OF FLUZONE.
Fluzone should not be administered to patients with acute respiratory or other active infections or illnesses.
Immunization should be delayed in a patient with an active neurologic disorder, but should be considered when the disease process has
been stabilized.
WARNINGS
Fluzone should not be administered to individuals who have a prior history of Guillain-Barré syndrome (GBS).
If Fluzone is administered to immunosuppressed persons, the expected antibody response may not be obtained.
As with any vaccine, vaccination with Fluzone may not protect 100% of susceptible individuals.
PRECAUTIONS
GENERAL
Care is to be taken by the health-care provider for the safe and effective use of this vaccine.
EPINEPHRINE INJECTION (1:1000) MUST BE IMMEDIATELY AVAILABLE SHOULD AN ACUTE ANAPHYLACTIC REACTION OCCUR
DUE TO ANY COMPONENT OF THIS VACCINE.
Influenza virus is remarkably capricious in that significant antigenic changes may occur from time to time. It is known definitely that
Influenza Virus Vaccine, as now constituted, is not effective against all possible strains of influenza virus. Protection is limited to those
strains of virus from which the vaccine is prepared or against closely related strains.
During the course of any febrile respiratory illness or other active infection, use of Influenza Virus Vaccine should be delayed.
Since the likelihood of febrile convulsions is greater in children 6 months through 35 months of age, special care should be taken in
weighing relative risks and benefits of vaccination.
Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse reactions. This includes a review of the
patient’s history with respect to possible sensitivity to the vaccine or similar vaccine, to possible sensitivity to dry natural latex rubber,
previous immunization history, current health status (see CONTRAINDICATIONS and WARNINGS sections) and a knowledge of the
current literature concerning the use of the vaccine under consideration.
Special care should be taken to prevent injection into a blood vessel.
A separate, sterile syringe and needle or a sterile disposable unit should be used for each patient to prevent transmission of hepatitis or other
infectious agents from person to person. Needles should not be recapped and should be disposed of according to biohazard waste guidelines.
Caution: The stopper to the vial and the syringe needle cover contain dry natural latex rubber, that may cause allergic reactions.
INFORMATION FOR PATIENT
Patients, parents or guardians should be fully informed by their health-care provider of the benefits and risks of immunization with
Influenza Virus Vaccine.
Patients, parents or guardians should be instructed to report any serious adverse reactions to their health-care provider.
Drug Interaction:
Although influenza vaccination can inhibit the clearance of warfarin, theophylline, phenytoin, and aminopyrine therapy, studies have
failed to show any adverse clinical effects attributable to these drugs in patients receiving influenza vaccine.6-12
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.13
PREGNANCY
REPRODUCTIVE STUDIES – PREGNANCY CATEGORY C
Animal reproduction studies have not been conducted with Influenza Virus Vaccine. It is not known whether Influenza Virus Vaccine can
cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza Virus Vaccine should be given
to a pregnant woman only if clearly needed (see INDICATIONS AND USAGE section).
and yet they advise pregnant women to get the shot!
PEDIATRIC USE
SAFETY AND EFFECTIVENESS OF FLUZONE (SUBVIRION) IN INFANTS BELOW THE AGE OF 6 MONTHS HAVE NOT BEEN ESTABLISHED.
ADVERSE REACTIONS
When educating patients about potential side effects, clinicians should emphasize that a) inactivated influenza vaccine contains noninfectious
killed viruses and cannot cause influenza; and b) coincidental respiratory disease unrelated to influenza vaccine can occur after vaccination.1
Local Reactions
In placebo-controlled studies among adults, the most frequent side effect of vaccination is soreness at the vaccination site (affecting
10%–64% of patients) that lasts ≤2 days. These local reactions typically are mild and rarely interfere with the person’s ability to
conduct usual daily activities.1
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Systemic Reactions
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).1,14 These reactions begin 6 to 12 hours after vaccination and can persist for
1–2 days. Recent placebo-controlled trials demonstrate that among older persons and healthy young adults, administration of split-virus 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) rarely occur after
influenza vaccination. These reactions probably result from hypersensitivity to certain vaccine components; the majority of reactions
likely are caused by residual egg protein. Although current influenza vaccines contain only a limited quantity of egg protein, this protein
can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Persons who have experienced 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 to egg protein––also might be at increased risk for allergic reactions to influenza vaccine, and consultation with a physician
should be considered. Protocols have been published for safely administering influenza vaccine to persons with egg allergies.1,15
The 1976 swine influenza vaccine was associated with an increased frequency of Guillain-Barré syndrome (GBS).1,16 Among persons
who received the swine influenza vaccine in 1976, the rate of GBS that exceeded the background rate was <10 cases/1,000,000
persons vaccinated. Evidence for a causal relationship of GBS with subsequent vaccines prepared from other influenza viruses is
unclear. Obtaining strong epidemiologic evidence for such a possible limited increase in risk is difficult for such a rare condition as GBS,
which has an annual incidence of 10–20 cases/1,000,000 adults, and stretches the limits of epidemiologic investigation.1
During three of four influenza seasons studied from 1977–1991, the overall relative risk estimates for GBS after influenza vaccination
were slightly elevated but were not statistically significant in any of these studies. However, in a study of the 1992–1993 and
1993–1994 seasons, the overall relative risk for GBS was 1.7 (95% confidence interval = 1.0-2.8; p = 0.04) during the 6 weeks after
vaccination, representing approximately 1 additional case of GBS/1,000,000 persons vaccinated. The combined number of GBS cases
peaked two weeks after vaccination. Thus, investigations to date indicate that there is no substantial increase in GBS associated with
influenza vaccines (other than the swine influenza vaccine in 1976) and that, if influenza vaccine does pose a risk, it is probably slightly
more than 1 additional case/1,000,000 persons vaccinated.1
Even if GBS were a true side effect of vaccination in the years after 1976, the estimated risk for GBS of approximately 1 additional
case/1,000,000 persons vaccinated is substantially less than the risk for severe influenza, which could be prevented by vaccination in
all age groups, especially and chiefly persons aged ≥65 years and those who have medical indications for influenza vaccination. 1
The potential benefits of influenza vaccination in preventing serious illness, hospitalization, and death greatly outweigh the possible
risks for developing vaccine-associated GBS. The average case-fatality ratio for GBS is 6% and increases with age. No evidence
indicates that the case-fatality ratio for GBS differs among vaccinated persons and those not vaccinated. 1
The incidence of GBS among the general population is low, but 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 specifically might increase the risk for recurrence of GBS is not known.1
Neurological disorders temporally associated with influenza vaccination such as encephalopathy, optic neuritis/neuropathy,17,18 partial
facial paralysis, and brachial plexus neuropathy have been reported. However, no cause and effect has been established.19,20 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.14,21,22
Microscopic polyangitis (vasculitis) has been reported temporally associated with influenza vaccination. However, no cause and effect
has been established.23
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) dairy, corn, and egg allergies. The only thing I can find about egg being in vaccines is that there isn't a *significant* amount in the MMR. So that means there is some in it, right? But what I read went on to say to go ahead and give the MMR, even if the kid is allergic to egg. Anyone have any experience with this? The MMR one is coming up soon and I was already wary about it right now so I'm definately at least delaying it but I need someone to build up my backbone to stand up to his doctor.
:
Most DRs will say it's completely safe to give MMR to egg allergic people. The problem is that there is a very select few who will still react. What is your son's reaction to eggs? Is he ana? If he is, I would strongly consider not getting it based on that alone (I would consider doing research and not getting it anyways, but that's not what you asked). The MMR also has beef and gelatin in it, 2 of the more common allergens. Has he been tested for those yet?
), so I don't put much weight on anything he's said.
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