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During the civilian smallpox vaccination program, CDC, the Food and
Drug Administration, and state health departments are conducting surveillance
for vaccine-associated adverse events. In the first stage of the program,
active surveillance is being conducted for potentially life-threatening, moderate-to-severe,
and other serious adverse events and for vaccinia transmission to contacts
of vaccinees.1 Nonserious events are reported through passive surveillance
and are expected to be underreported. This report summarizes smallpox vaccine
adverse events reported among civilians vaccinated as of March 7, 2003, and
among contacts of vaccinees, received by CDC from the Vaccine Adverse Event
Reporting System (VAERS) as of March 10.
Potentially life-threatening and moderate-to-severe events are classified
on the basis of evidence in support of the reported diagnoses. For probable
cases, possible alternative etiologies are investigated, and supportive information
is available. Events are classified as suspected if they have clinical features
compatible with the diagnosis but either further investigation is required
or additional investigation of the case did not provide supporting evidence
for the diagnosis and did not identify an alternative diagnosis. CDC and state
and local health departments also receive reports of other events that are
associated temporally with smallpox vaccination. Reported adverse events are
not necessarily associated with vaccination, and some or all of these events
might be coincidental.
During January 24–March 7, smallpox vaccine was administered to
16,919 civilian health-care and public health workers in 50 jurisdictions.
No potentially life-threatening adverse events of a type known previously
to be caused by smallpox vaccination have been reported as of March 10.
During March 4-10, three moderate-to-severe adverse events were reported.
All were cases of inadvertent inoculation and were traced to contact with
military personnel who received smallpox vaccine.
On February 15, a man aged 23 years with no history of smallpox vaccination
wrestled with a military recruit who had recently received smallpox vaccine
and who had no covering in place over his inoculation site. On February 17,
the patient noted a small pimple on his chest. A few days later, he noted
a pustular lesion on his right shoulder. On March 3, the patient was assessed
by local health authorities, who observed a 1.5 cm lesion on the patient's
chest, with a well-defined scab and indurated center. A second 1.0 cm lesion
was noted on the patient's face just below the nose and above his lip. The
patient reported mild malaise but was otherwise well. Right axillary lymphadenopathy
was noted on physical examination. On March 4, a swab specimen obtained from
a pustular lesion tested positive for vaccinia DNA by real-time polymerase
chain reaction (RT-PCR); confirmatory testing at CDC is pending.
On March 4, a woman aged 18 years with no history of smallpox vaccination
reported to a local health department with a 0.5 cm pustular lesion on her
right forearm, surrounded by a nearly 6.0 cm area of erythema. The lesion
had developed during the previous 4 days after close physical contact with
her partner, a military vaccinee who was vaccinated on February 10. The vaccinee
had maintained a small adhesive bandage over the lesion at all times, and
the patient reported no sharing of towels or clothing; however, considerable
oozing through the bandage was reported, which might have contaminated shared
sheets and bedding. On March 6, a swab specimen from the pustular lesion tested
positive for vaccinia DNA by RT-PCR.
On March 5, a woman aged 25 years with no history of smallpox vaccination
was seen in an emergency department with three vesicular lesions on the proximal
lateral aspect of her right arm. The patient was otherwise well. She reported
close physical contact with a military vaccinee during February 14-17, 2003.
Swab specimens were obtained from the vesicular lesions for viral culture
and direct fluorescent antibody testing for vaccinia, herpes zoster, and herpes
simplex virus; results are pending.
Four other serious adverse events were reported during March 4-10. None
of these events was of a type known to be associated causally with vaccination.
On February 16, a woman aged 43 years was hospitalized 4 days after
vaccination with chest pain and dyspnea. Cardiac catheterization revealed
a pre-existing coronary artery anomaly. Angina considered to be related to
this condition was diagnosed, and she was discharged the following day.
On February 26, a woman aged 53 years was hospitalized 8 days after
vaccination with vomiting and diarrhea. Her symptoms improved after treatment
with intravenous fluids and an antibiotic, and she was discharged the following
On February 28, a woman aged 57 years with a history of chronic obstructive
pulmonary disease (COPD) was hospitalized 6 days after vaccination with an
exacerbation of COPD, diarrhea, and dehydration. She was treated with intravenous
fluids and was discharged the following day.
On February 28, a woman aged 45 years with a history of smallpox vaccination
had sharp left shoulder pain and chest pain 2 days after vaccination. Her
symptoms resolved after treatment with a nonsteroidal anti-inflammatory medication.
Approximately 2 weeks before vaccination, she had onset of influenza-like
illness (ILI) with fever, chill, myalgias, malaise, and cough, which were
resolving at the time of vaccination after 1 week away from work. On March
3, she complained again of exertional chest pain and was hospitalized the
following day with dyspnea and exertional chest pain that radiated to her
neck. An echocardiogram on March 5 demonstrated a small pericardial effusion,
left ventricular wall motion abnormality, and a mild decrease in left ventricular
function. Cardiac catheterization found no evidence of coronary artery narrowing.
Viral myocarditis judged to be associated with the antecedent ILI was diagnosed.
On March 6, the patient was discharged after 2 days of hospitalization.
Among the 76 vaccinees with reported other nonserious adverse events
during January 24–March 10, the most common signs and symptoms were
rash (n = 20), fever (n = 18), pruritus (n = 17), and pain (n = 12). All of
these commonly reported events are consistent with mild expected reactions
following receipt of smallpox vaccine. Some vaccinees reported multiple signs
Surveillance for adverse events during the civilian smallpox vaccination
program is ongoing; regular surveillance reports will be published in MMWR.
References: 1 available
Smallpox Vaccine Adverse Events Among Civilians—United States, March 4-10, 2003. JAMA. 2003;289(15):1921–1922. doi:10.1001/jama.289.15.1921
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