In the cohort, cases and noncases did not show significant differences in terms of sex, in the use of nonsteroidal anti-inflammatory drugs or oral or depo contraceptives, in medication allergies, in the incidence of fever or lymphadenopathy after vaccination, or in the dilution of vaccine received.
Conclusions Folliculitis is a common and benign eruption observed in vaccinia-naive adult volunteers following smallpox vaccination. This eruption may be seen in volunteers receiving the vaccine in the newly instituted vaccination programs and may be met with heightened anxiety, potentially being confused with generalized vaccinia. This description of folliculitis using clinical, virologic, and histopathological findings should allay these concerns and provide additional insight into this eruption.
Adverse dermatologic reactions after smallpox vaccine administration, including eczema vaccinatum and progressive vaccinia, were well described when smallpox vaccination was routine practice. Other less severe dermatologic reactions to smallpox vaccine also were reported, including generalized vaccinia 2 and erythema multiforme.
During a clinical trial investigating the efficacy and safety of vaccinia immunization in healthy, vaccinia-naive adult volunteers, ie, those not previously vaccinated we observed a papulovesicular eruption following vaccination in several volunteers that mirrored generalized vaccinia on initial inspection.
While cases were initially identified as generalized rashes, with a heightened awareness to this eruption, cases of focal variants were noted as the trial progressed. To further define the focal eruption to and contrast it with generalized vaccinia, we reviewed the cases in our cohort and outlined the clinical, virologic, and histopathological characteristics of this eruption.
After providing written informed consent, healthy, vaccinia-naive adult participants aged 18 years to 32 years were enrolled in a multicenter, double-blind, randomized controlled trial that was investigating the safety and efficacy of 3 dilutions of smallpox vaccine Aventis Pasteur Smallpox Vaccine, Swiftwater, Pa. Exclusion criteria for eligibility to participate in this clinical trial and to receive smallpox vaccine are noted in the Box.
Approval for the trial was granted by the Vanderbilt University institutional review board. Randomization was performed using an Internet-based program with fixed blocks of 6 assignments per block.
Vaccine dilutions were performed by the study pharmacist, and vaccine doses were delivered to the study clinic in vials labeled with a dilution group number G1, G2, or G3. Both volunteers and study personnel were blinded during the course of the study to the specific vaccine dilution associated with each group number. The frozen vaccine was reconstituted with diluent-containing glycerin, phenol, and sterile water.
The vaccine was administered to the deltoid region via scarification by 15 punctures with a bifurcated needle, and the site was covered with occlusive dressings, as described previously. Volunteers were counseled on routine self-assessment for new dermatologic lesions. Baseline dermatologic examinations were performed at initial screening, but subsequent examinations occurred only after volunteer report of a cutaneous eruption.
Bandages were changed until the site was deemed well-scabbed by study investigators, usually several weeks after vaccination. Specimens from eruptions were cultured for vaccinia virus using methods described previously. After thawing, 0. Uninfected BSC cells were used as controls. The presence of the distinctive cytopathic effect of vaccinia 6 were assessed every 48 to 72 hours for 10 days.
Specimens considered positive for vaccinia were those that developed cytopathic effect, while those without cytopathic effect at 10 days were considered negative for vaccinia. Polymerase chain reaction for vaccinia virus was not available for confirmation of culture data. Cases were prospectively defined as volunteers who developed a focal or generalized papulovesicular rash distant from the vaccination site during the month following vaccination.
Noncases did not develop these findings. Variables potentially related to a focal or generalized papulovesicular rash were collected retrospectively for both cases and noncases via chart review and included concurrent medications oral or depo contraceptives, nonsteroidal anti-inflammatory medications , medication allergies, the presence of fever or lymphadenopathy after vaccination surrogate markers of systemic and local immune response , and vaccine dilution group number.
Continuous variables were compared between cases and noncases using the Fisher exact test; age was compared using the Student t test with unequal variances. At the Vanderbilt site, volunteers underwent smallpox vaccination. The mean age of the cohort was All participants completed follow-up. Four participants 2. The eruption was observed on several body sites, including the face, torso, and extremities. The lesions began as follicular erythematous papules that progressed into pustules, which eventually resolved without scarring.
Concurrent lesions were at different stages of development. All 4 participants were afebrile at the time of the eruption. In an additional 11 participants 7. These eruptions occurred on various body sites away from the primary vaccination site, including the face, neck, back, and extremities.
Ten of these cases were afebrile throughout the postvaccination course. One individual developed fever on day 6 postvaccination, 2 days before rash onset. It usually occurs on the genitals or face, including the eyes, where it can damage sight. You can prevent this by washing your hands with soap and water after touching the vaccine site and by following the instructions for caring for the vaccine site. A toxic or allergic rash that can take various forms.
Life-Threatening Reactions Rarely, people have had very bad reactions to the vaccine. These reactions require immediate medical attention: Serious rash caused by widespread infection of the skin known as eczema vaccinatum.
This happened in people with pre-existing skin conditions such as eczema or atopic dermatitis. Many people who got this complication were not vaccinated, but got infected with the virus from the vaccine site of their family member or friend who received vaccination.
To help reduce the risk for your loved ones, be sure to follow the instructions for caring for the vaccine site. Buildup of inflamed tissue around the vaccination site that may at first look like a bullseye and will grow into a large, non-healing sore known as progressive vaccinia.
This usually happened to people with a deficient immune system. Inflammation of the brain known as postvaccinal encephalitis. These are normal features of the healing process. Side effects of the hepatitis B vaccine can include nausea, vomiting, and diarrhea. There may also be no side effects at all. Learn more about the…. The shingles vaccine is effective, but it can cause side effects. Learn about the possible mild, serious, and long term side effects here.
Also, learn…. Chickenpox usually affects children, but it can also occur in adults. In this article, we look at the specific symptoms and treatments of chickenpox…. The tetanus shot protects people from the tetanus infection. It is an important vaccination to have. Most people will not have side effects, but….
For decades, doctors and scientists have advocated for the use of vaccinations to promote public health. Vaccines are safe and effective, but there is…. Everything you need to know about smallpox vaccine scars. Medically reviewed by Elaine K. The dermis is right under the epidermis that is visible to the world. In this case, the vaccination does not penetrate into the subcutaneous tissue. Upon reaching the dermal layer, the virus starts to multiply, causing a pimple to develop, which later turns into a vesicle, which looks like a fluid-filled blister.
Eventually, this area will scab over. This signals the completion of a successful vaccination, but unfortunately, the vaccination leaves a mark for some people. In most cases, the scar is small, round, and lower than the skin bump around it. Some people have complained of itchy and tight skin around the spot.
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