Vaccine
Complications
of Vaccination
General
Information on Complications (19:17)
More severe complications are rare but occur more than 10 times more often
among revaccinees and are more frequent among primary vaccines than among revaccinees
and are more frequent among infants than among older children and adults.
Fever is common after administration of the smallpox vaccine. 70% of children
experience 1 or more days of temperature 100 F or higher for 4-14 days after
primary vaccination.15-20% of children experience higher than 102¾ F. After
revaccination, 35% of children experience temperature of 100¾ F or higher and
5% experience temperatures of 102¾ F or higher. Fever is less common among
adults after vaccination or revaccination.
The most common
symptoms experienced by vaccinees in a recent vaccine trial were: (22:V6:69) Fatigue
in 50%, Headache in 40%, Muscle aches and chills or nausea in 20%
and Fever in 10%.
Successful vaccination
produces a lesion at the vaccination site. If the lesion is touched,
virus can be transferred to another part of the body – this
is called autoinoculation.
Death resulting
from smallpox vaccination is rare, with approximately 1 death per
million primary vaccinations and 1 death per 4 million revaccinations. (19:17) Death
is most often the result of postvaccinial encephalitis or progressive
vaccinia.
“ Around
twenty percent of the population can’t be vaccinated. They’re
immune compromised, or they have eczema, or they’re pregnant
women, or they’re very young children. That’s a large
number of people who will have no protection if smallpox comes
back.” (15:158)
Autoinoculation (19:17) (major
complication)
Autoinoculation
or inadvertent inoculation is considered a major complication.
This is the most frequent complication of smallpox vaccination.
It is caused when live vaccinia virus is transferred from the inoculation
site to another part of the body. Lesions of inadvertent inoculation
could occur anywhere on the body, but the most common sites involved
were the face, eyelid, nose, mouth, genitalia and rectum.
When it occurs
at the time of vaccination, it can produce coprimary lesions. When
it occurs at the time when the primary lesion is well developed,
small or attenuated lesions may be produced.
Most
lesions healed without incident, although VIG was useful in some
cases of periocular implanation. (9:9) Inoculation
of the virus in the eye can result in several clinical manifestations
including blepharitis or infection of the eyelid, conjunctivitis,
keratitis or iritis, or a combination of these conditions. (22:V1:44) Periocular
and ocular implantation, otherwise referred to as ocular vaccinial
disease, account for the majority of inadvertent inoculations and
were often noted within 7-10 days of vaccination in first-time
vaccinees. Because ocular vaccinia disease may occur in several
forms, when evaluating a patient with new onset of a red eye or
periocular vesicles, vaccinia infection should be considered. The
patient should be asked about recent vaccinia exposures including
a smallpox vaccination or close contact with a vaccine recipient.
Erythematous
or Urticarial Rashes (minor complication)
This type of
complication is considered a minor complication, as they usually
resolve quickly. A variety of these types of rashes occur approximately
10 days after primary vaccination. (19:17) These
rashes are referred to as erythema multiforme, roseola vaccinia,
toxic erythema, ad postvaccinial uticaria.
These
types of rashes are flat, erythematous, macular or uticarial lesions,
usually with microscopic vasculitis. The pathophysiology of these
rashes not well understood. Urticarial rashes usually don’t
become vesicular, and don’t appear to involove viral multiplication.
The rash resolves spontaneously within 2 to 4 days.
Patients with
erythematous uticarial rashes associated with vaccinia are generally
not severely ill and are usually afebrile despite extensive skin
involvement (except upon the rare occasions when Stevens-Johnson
syndrome, or bullous erythema multiforme develops.)
Generalized
Vaccinia (major complication)
Generalized
vesicular skin lesions occurring in the absence of eczema or other
preexisting skin diseases characterize generalized vaccinia, a
major complication. (22:V6:84) It is believed
to be the result of a vaccinia viremia with implantations in the
skin in a person with underlying illnesses. (19:17)
A secondary
eruption almost always following primary vaccination, generalized
vaccinia resulted from blood-borne dissemination of virus. (9:9) Lesions
emerged between 6 and 9 days after vaccination andwere either few
in number or generalized. (9:9) It consists
of vesicles or pustules appearing on normal skin at a distance
from the vaccination site. (19:17)
This complication
was usually self-limited. Fever and systemic signs vary widely,
but are generally mild. (22:V6:84) Most rashes
labeled as generalized vaccinia produces only minor illness with
little residual damage. (19:17) In severe
cases, VIG was indicated. (9:9)
The differential
diagnosis for this vaccine complication includes other non-specific
immune rashes that can also occur following vaccination, eczema
vaccinatum, metastatic lesions of early progressive vaccinia, or
non-vaccinia related conditions, such as disseminated herpes or
severe varicella. (22:V6:86)
Eczema
Vaccinatum (major complication)
Eczema vaccinatum
is the generalized spread of vaccinia on the skin of patients with
eczema, atopic dermatitis or a those with a history of these conditions
even when the condition is not active. (22:V1:47) It
is considered a major complication. Some of the most severe cases
of eczema vaccinatum have occurred in people with eczema or atopic
dermatitis who were contacts to recently vaccinated individuals.
It
occurs once per 25,000 primary vaccinations. (19:17) Is
generally mild and self-limited, but can be severe. (19:17) Extensive
skin involvement may result from inoculation of vaccinia virus
in skin sites with compromised dermal integrity due to eczema or
other skin conditions or may be the result of hematogenous spread
following initial infection with the virus. Eczema vacciniatum
could involve either blood dissemination of vaccinia virus or by
direct skin inoculation of vaccinia on affected skin. Lesions of
eczema vaccinatum can result in skin discoloration or scarring
following resolution. (22:V6:88)
The rash of
eczema vaccinatum can occur anywhere on the body but has a predilection
for areas effected by atopic dermatitis or eczema. (22:V6:88) The
rash can be quite extensive and even become confluent with popular,
vesicular, or pustular lesions. Patients with significant skin
involvement can become severely ill. (22:V6:88)
A less severe
form of eczema vaccinatum can also occur in people with other skin
disorders, like psoriasis or burns, that are currently active and
effecting the integrity of the skin. (22:V1:45)
Vaccinia immune
globulin was found therapeutic in treating this complication. (9:9)

Progressive
Vaccinia (major complication)
Progressive
vaccinia, also known as Vaccinia Necrosum or Vaccinia Gangrenosa,
is a potential major complication of smallpox vaccination. A severe
potentially fatal illness characterized by progressive necrosis
in the area of vaccination, often with metastatic lesions. (19:17)
It occurs almost
exclusively among persons with cellular immunodeficiency, but can
occur in persons with humoral immunodeficiency. (19:17) Cases
of progressive vaccinia occurred both among primary vaccines and
revaccinees. (9:9) It occurs approximately
once per 600,000 primary vaccinations. (19:17) It
may be more common now, with HIV and post transplant immunosuppression
widely present.
People with
progressive vaccinia usually present with a non-healing, expanding
vaccination site. The site often ulcerates and central necrosis,
or necrosis of the surrounding skin can occur. There is generally
little or no inflammation at the site initially, because of the
poor local immune response to the infection that is induced by
vaccination. This lack of adequate local immune response presumably
allows the virus to spread locally and systemically. Medical conditions
or medications that suppress the immune system would put a person
at risk for this complication. It is currently unknown exactly
what level of immune suppression would put a person at risk for
this complication. (22:V1:46)

VIG, vaccine
immunoglobulin, is the suggested treatment for this complication.
It was almost always fatal before the introduction of VIG and antiviral
agents. The vaccinial lesion failed to heal and progressed to involve
adjacent skin with necrosis of tissue, spreading to other parts
of the skin, to bones, and to viscera. (9:9)
Postvaccinial
Encephalitis (major complication)
Postvaccinial
encephalitis is a major unavoidable complication, which occurs
once in about 80,000 primary vaccinations. (19:17) [1
case per 300,000 vaccinations] (9:9)
It has only
observed in primary vaccines. (9:9) Approximately,
15-25% of affected vaccines with this complication die. (19:17) Of
those who experience this complication, 25% develop permanent neurological
sequelae. (19:17) It was frequently seen
in vaccinated infants less than 1 year old or in older adolescents
or adults receiving their first vaccination. (22:V6:91) Most
cases are believed to result from autoimmune or allergic reactions,
similar to other postviral CNSsyndromes rather than direct viral
invasion of the nervous system. (19:17)
The pathophysiology
of this complication is not well understood, but it is thought
to be a result of a post vaccination immune response, similar to
other post-infectious encephalitides. It has not been causally
linked to the presence of vaccinia virus in the CNS. (22:V1:45) Between
8 and 15 days after vaccination, encephalitic symptoms developed – fever,
headache, vomiting, drowsiness, and sometimes, spastic paralysis,
meningitic signs, coma, and convulsions. It also can present with
any variety of CNS signs, such as ataxia, confusion, paralysis,
seizures, or coma. (19:17) Cerebrospinal
fluid usually showed a pleocytosis.
Recovery was
either complete or associated with residual paralysis and other
central nervous system symptoms and, sometimes, death. (9:9) One
case in a soldier with acquired immunodeficiency syndrome was successfully
treated with VIG and ribavirin. These treatment strategies were
off-label and would be considered experimental. (9:9)
Lymphangitis (minor
complication)
Lymphangitis,
or inflammation of the lymphatic vessels is a minor complication.
This is usually due to a normal robust reaction at the site that
peaks around days 8-10, but can be seen in secondary bacterial
cellulitis. It can also be confused with allergic reactions to
the dressing tape. (22:V1:38)
Robust
Primary Reaction (minor complication)
Some individuals
can have a robust primary reaction (minor complication) that presents
with a large amount of erythema, swelling, pain, and warmth at
the vaccine site. The redness and swelling can sometimes be greater
than 3 inches or may even involve the entire upper arm. This large
reaction is usually seen on days 8-10, corresponding to the same
time when the peak vaccine inflammatory reaction usually occurs.
In recent studies, this robust reaction, or take, occurred in 5%-15%
of vaccine recipients. Both people getting vaccinated for the first
time and people getting revaccinated after a long period since
their last vaccination can have these robust takes. These robust
reactions are expected variants of the evolution of the vaccination
site and generally improve on their own within 24-72 hours. (22:V1:39)
However, sometimes
these large vaccination reactions have been reported as adverse
events and misinterpreted as a “bacterial cellulitis,” prompting
antibiotic treatment. (22:V1:39)
Satellite
Lesions (minor complication)
Satellite lesions
can occur next to the primary lesion. These usually heal at the
same rate as the primary vaccination site. They are considered
a minor complication. (22:V1:40)
Tape
Allergy (minor complication)
Local reactions
due to a tape allergy (minor complication) can occur. This can
usually be distinguished from lymphangitis by observing that the
reaction only occurs in the distribution of the tape. Usually,
individuals with reactions to tape have no other systemic symptoms. (22:V1:41)
Secondary
Bacterial Infection (minor complication)
Secondary bacterial
infections are categorized as a minor complication. Individuals
suspected of having bacterial cellulitis at the site should be
evaluated with gram stain and culture of the lesion, and blood
cultures if systemic symptoms like high fever and malaise are present. (22:V6:76) An
elevated peripheral white blood cell count may also be more indicative
of a bacterial infection than a robust vaccine take. (22:V6:76)
The most common
organisms causing secondary infections are Staphylococcus aureus
and Group A streptococci. Some anaerobic or mixed infections can
be seen, and may occur if occlusive dressings are used for prolonged
periods that prevent aeration of the site and promote an anaerobic
environment. (22:V6:76)
Fetal
Vaccinia (minor complication)
Fetal vaccinia
is a very rare complication that can occur following primary vaccination
of a pregnant woman in the second or third trimester, from hematogenous
spread of the virus to the amniotic fluid, or directly to the fetus. (22:V1:49) It
is categorized as a minor complication.
Only about fifty
cases of this complication have been reported in the literature. (22:V1:49) Studies
are contradictory as to whether spontaneous abortions were increased
in pregnant women vaccinated during the first trimester. (22:V1:49) There
is no known reliable intrauterine diagnostic test to detect the
presence of the vaccinia virus. (22:V1:49)
VIG may benefit
live born infant. (22:V6:92)
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