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Red, swollen arm? Sounds like a good take’
Even normal vaccine reactions look dramatic
If your vaccinated employees have red, swollen arms, swollen lymph glands, and fever, are they having an adverse reaction? Probably not, says William Schaffner, MD, professor and chairman of the Department of Preventive Medicine at the Vanderbilt University School of Medicine in Nashville, TN.
In most cases, even a significant reaction around the smallpox vaccination injection site is completely normal — an example of a good "take," says Schaffner, who monitored reactions during a clinical trial of the vaccine at Vanderbilt.
Careful, daily monitoring of the injection site will be a significant task for employee health professionals, who must determine which reactions require reporting and follow-up. Detailed information, including photos, of normal, robust, and adverse reactions are available in a guidance document from the Centers for Disease Control and Prevention (CDC) in Atlanta. (See editor’s note at the end of this article.)
Schaffner describes the typical response to the vaccine, which usually produces the most significant symptoms about a week after vaccination:
"Smallpox vaccination involves the inoculation of a live vaccinia virus into the skin over the upper arm. What results then is a local skin infection with vaccinia virus, which produces an inflammatory response. The thing you see is this vesicle: a blister that turns into a blister with pus in it. That blister is teeming with vaccinia virus. What you can get is surrounding inflammation: redness, swelling, tenderness, itching. You can get associated swollen lymph glands under the arm. This is well within normal. This simple viral infection can look like there’s a superinfection with staph or strep," he explains.
Some vaccines may develop satellite lesions, a "rosette of bumps" around the injection site. Again, this is a normal reaction, Schaffner says. "The people who’ve been vaccinated will want to talk about that. They’ll need to be provided reassurance," he says. "The people who are following up need to go to the CDC web site and educate themselves about all the variations of normal."
Adverse events, such as eczema vaccinatum, should be reported to local or state public health authorities. For consultation or to request therapy, such as vaccinia immune globulin, for adverse events, EHPs can call CDC’s Clinician Information Line at (877) 554-4625.
In setting up a monitoring program, Schaffner recommends that hospitals:
1. Require all vaccinated employees to receive clearance for work every day until the scab falls off.
No vaccinated employee should report for duty until someone trained in smallpox vaccine reactions has inspected their site, Schaffner advises. "There is a responsibility for any hospital to do this in the most rigorous fashion possible," he says.
In the daily check, EHPs or other trained staff should make sure the injection site is properly covered with gauze and a semipermeable dressing. If the dressing needs changing, which CDC recommends every one to three days, the soiled dressing should be placed in a plastic bag before being disposed of in the trash. The employee also should be advised to keep the site dry.
The Advisory Committee on Immunization Practices determined that health care workers could continue their patient care duties without risk of transmission if the injection site is properly covered and good hand hygiene and other infection control practices are followed.
"If an adverse event occurs involving transmission to a patient, it will take three hours before that’s on CNN," Schaffner warns. "That hospital will be on the news. That kind of event could imperil the National Smallpox Vaccination Program."
However, a good monitoring program could reduce the risk of transmission essentially to zero, he contends. "If you are meticulous and you do this exactly according to protocol, we would look at every person who was vaccinated every day before [he or she] began work; we could offer [the hospital] that assurance," Schaffner says.
2. Caution employees about the dangers of at-home transmission.
The greatest risk of transmission actually involves the closer contact found at home. For example, vaccinated employees need to think of added risks of contact involving soiled towels, clothes, and linens. "It takes prolonged close contact, by and large, to have transmission," he notes.
While bandage changes would take place at the hospital, Schaffner says he had planned to provide one bandage change for emergency use at home. (Vanderbilt University Medical Center decided in January not to participate in the smallpox vaccination program, but conducted screening, education, and planning so the program could be quickly activated if a smallpox case occurred anywhere in the country.)
3. Provide feedback to vaccinated employees.
"If you’re going to vaccinate, then you need to provide counseling and follow-up for the individual," Schaffner says. And you should expect a "bushelful" of questions. "Some interesting circumstances will occur, and you’ve got to be prepared to deal with them," he says.
"You’ll have people coming in and saying, I developed a bump on my thigh, or on my chest. Can that be related to the vaccination?’ Some of those will be disseminated vaccinia," he says. Those cases need to be reported to the state health department, but likely will not cause the vaccinee any problems and will heal on their own, he says.
During the investigational trial, one Vanderbilt employee came to the emergency department with a severe headache, Schaffner recalls. He considered whether this might be a case of vaccine-related encephalitis. "The patient was watched. His headache went away. No lumbar puncture was done." The hospital had no serious adverse reactions associated with the vaccination trial, he says.
4. Make note of employees who do not have a take.
What if a vaccinee has no reaction and no pustule? A small number of people may fail to have a take, Schaffner notes. One potential reason: If alcohol on the skin isn’t allowed to dry before the pricking with the needle, the alcohol may kill the vaccinia. Poor vaccination technique and residual immunity also can cause an "equivocal" reaction.
Vaccination response should be evaluated on day 6, 7, or 8 after vaccination, the time of peak viral replication, the CDC says.1 Evaluating the take too early or too late may be misleading. If the reaction is equivocal, the individual should be revaccinated, CDC says.
"If a patient has never had a successful take, the patient should be informed that he/she is almost certainly not immune," the CDC states.
(Editor’s note: For information on vaccine reactions, see MMWR Dispatch, Smallpox Vaccination and Adverse Reactions, at www.cdc.gov/mmwr/preview/mmwrhtml/di52cha1.htm. For a summary of CDC recommendations on the care of the vaccine site, go to: http://www.bt.cdc.gov/agent/smallpox/vaccination/site-care-pub.asp.)
1. Cono J, Casey CG, Bell DM. Smallpox vaccinational and adverse reactions: Guidance for clinicians. MMWR Dispatch 2003; 52:1-29.