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Morbidity and Mortality Weekly Report
Surveillance Summaries January 24, 2003 / Vol. 52 / No. SS-1
Centers for Disease Control and PreventionCenters for Disease Control and Prevention
Centers for Disease Control and PreventionCenters for Disease Control and Prevention
Centers for Disease Control and Prevention
SAFER • HEALSAFER • HEAL
SAFER • HEALSAFER • HEAL
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THIER • PEOPLETHIER • PEOPLE
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THIER • PEOPLETM
Surveillance for Safety After Immunization:
Vaccine Adverse Event Reporting System
(VAERS) — United States, 1991–2001
Please note: An erratum has been published for this issue. To view the erratum, please click here.
MMWR
SUGGESTED CITATION
General: Centers for Disease Control and Prevention.
Surveillance Summaries, January 24, 2003.
MMWR 2003:52(No. SS-1).
Specific: [Author(s)]. [Title of particular article]. In:
Surveillance Summaries, January 24, 2003.
MMWR 2003;52(No. SS-1):[inclusive page
numbers].
The MMWR series of publications is published by the
Epidemiology Program Office, Centers for Disease
Control and Prevention (CDC), U.S. Department of
Health and Human Services, Atlanta, GA 30333.
Centers for Disease Control and Prevention
Julie L. Gerberding, M.D., M.P.H.
Director
David W. Fleming, M.D.
Deputy Director for Science and Public Health
Dixie E. Snider, Jr., M.D., M.P.H.
Associate Director for Science
Epidemiology Program Office
Stephen B. Thacker, M.D., M.Sc.
Director
Division of Public Health Surveillance
and Informatics
Daniel M. Sosin, M.D., M.P.H.
Director
Associate Editor, Surveillance Summaries
Office of Scientific and Health Communications
John W. Ward, M.D.
Director
Editor, MMWR Series
Suzanne M. Hewitt, M.P.A.
Managing Editor
Patricia A. McGee
Project Editor
Lynda G. Cupell
Malbea A. Heilman
Beverly J. Holland
Visual Information Specialists
Quang M. Doan
Erica R. Shaver
Information Technology Specialists
CONTENTS
Introduction ......................................................................... 2
Methods .............................................................................. 3
Results ................................................................................. 3
Discussion ........................................................................... 7
Acknowledgments ............................................................... 8
References ........................................................................... 8
Vaccine Codes Used in the Vaccine Adverse Event
Reporting System (VAERS) ............................................... 10
Vol. 52 / SS-1 Surveillance Summaries 1
Surveillance for Safety After Immunization:
Vaccine Adverse Event Reporting System (VAERS) —
United States, 1991–2001
Weigong Zhou, M.D., Ph.D.1, 2
Vitali Pool, M.D.2
John K. Iskander, M.D.2
Roseanne English-Bullard3
Robert Ball, M.D.4
Robert P. Wise, M.D.4
Penina Haber, Ph.D.2
Robert P. Pless, M.D.2
Gina Mootrey, D.O.2
Susan S. Ellenberg , Ph.D.4
M. Miles Braun, M.D.4
Robert T. Chen, M.D.2
1Epidemic Intelligence Service Program
Epidemiology Program Office, CDC
2Epidemiology and Surveillance Division
3Data Management Division
National Immunization Program, CDC
4Center for Biologics Evaluation and Research
Food and Drug Administration
Abstract
Problem/Condition: Vaccines are usually administered to healthy persons who have substantial expectations for the
safety of the vaccines. Adverse events after vaccinations occur but are generally rare. Some adverse events are unlikely to
be detected in prelicensure clinical trials because of their low frequency, the limited numbers of enrolled subjects, and
other study limitations. Therefore, postmarketing monitoring of adverse events after vaccinations is essential. The
cornerstone of monitoring safety is review and analysis of spontaneously reported adverse events.
Reporting Period Covered: This report summarizes the adverse events reported to the Vaccine Adverse Event Reporting
System (VAERS) from January 1, 1991, through December 31, 2001.
Description of Systems: VAERS was established in 1990 under the joint administration of CDC and the Food and
Drug Administration (FDA) to accept reports of suspected adverse events after administration of any vaccine licensed
in the United States. VAERS is a passive surveillance system: reports of events are voluntarily submitted by those who
experience them, their caregivers, or others. Passive surveillance systems (e.g., VAERS) are subject to multiple limita-
tions, including underreporting, reporting of temporal associations or unconfirmed diagnoses, and lack of denomina-
tor data and unbiased comparison groups. Because of these limitations, determining causal associations between vaccines
and adverse events from VAERS reports is usually not possible. Vaccine safety concerns identified through adverse event
monitoring nearly always require confirmation using an epidemiologic or other (e.g., laboratory) study. Reports may be
submitted by anyone suspecting that an adverse event might have been caused by vaccination and are usually submitted
by mail or fax. A web-based electronic reporting system has recently become available. Information from the reports is
entered into the VAERS database, and new reports are analyzed weekly. VAERS data stripped of personal identifiers can
be reviewed by the public by accessing http://www.vaers.org. The objectives of VAERS are to 1) detect new, unusual, or
rare vaccine adverse events; 2) monitor increases in known adverse events; 3) determine patient risk factors for particu-
lar types of adverse events; 4) identify vaccine lots with increased numbers or types of reported adverse events; and 5)
assess the safety of newly licensed vaccines.
Results: During 1991–2001, VAERS received 128,717 reports, whereas >1.9 billion net doses of human vaccines were
distributed. The overall dose-based reporting rate for the 27 frequently reported vaccine types was 11.4 reports per
100,000 net doses distributed. The proportions of reports in the age groups <1 year, 1–6 years, 7–17 years, 18–64 years,
and >65 years were 18.1%, 26.7%, 8.0%, 32.6%, and 4.9%, respectively. In all of the adult age groups, a predominance
among the number of women reporting was observed, but the difference in sex was minimal among children. Overall,
2 MMWR January 24, 2003
the most commonly reported adverse event was fever, which appeared in 25.8% of all reports, followed by injection-site
hypersensitivity (15.8%), rash (unspecified) (11.0%), injection-site edema (10.8%), and vasodilatation (10.8%).
A total of 14.2% of all reports described serious adverse events, which by regulatory definition include death, life-
threatening illness, hospitalization or prolongation of hospitalization, or permanent disability. Examples of the uses of
VAERS data for vaccine safety surveillance are included in this report.
Interpretation: As a national public health surveillance system, VAERS is a key component in ensuring the safety of
vaccines. VAERS data are used by CDC, FDA, and other organizations to monitor and study vaccine safety. CDC and
FDA use VAERS data to respond to public inquiries regarding vaccine safety, and both organizations have published
and presented vaccine safety studies based on VAERS data. VAERS data are also used by the Advisory Committee on
Immunization Practices and the Vaccine and Related Biological Products Advisory Committee to evaluate possible
adverse events after vaccinations and to develop recommendations for precautions and contraindications to vaccina-
tions. Reviews of VAERS reports and the studies based on VAERS reports during 1991–2001 have demonstrated that
vaccines are usually safe and that serious adverse events occur but are rare.
Public Health Actions: Through continued reporting of adverse events after vaccination to VAERS by health-care
providers, public health professionals, and the public and monitoring of reported events by the VAERS working group,
the public health system will continue to be able to detect rare but potentially serious consequences of vaccination. This
knowledge facilitates improvement in the safety of vaccines and the vaccination process.
Introduction
The National Childhood Vaccine Injury Act (NCVIA) (1)
of 1986 required health professionals and vaccine manufac-
turers to report to the U.S. Department of Health and
Human Services specific adverse events that occur after the
administration of routinely recommended vaccines. Postvac-
cination adverse events and the time frames in which they
must occur to qualify as being reportable under NCVIA are
listed in the Reportable Events Table (2). The table is
updated periodically as the vaccination schedule changes, new
vaccines are introduced, and new vaccine-associated adverse
events are identified. Vaccine-associated adverse event reports
were previously collected separately by CDC and the Food
and Drug Administration (FDA). CDC maintained the Moni-
toring System for Adverse Events Following Immunization
(3) for vaccines administered in the public sector; FDA main-
tained the Spontaneous Reporting System (4) to accept
reports from both the public and private sectors, although it
was used primarily by vaccine manufacturers. These systems
were replaced by the Vaccine Adverse Event Reporting Sys-
tem (VAERS) on November 1, 1990 (5). Under the joint
administration of CDC and FDA, VAERS accepts spontane-
ous reports of suspected vaccine adverse events after adminis-
tration of any vaccine licensed in the United States (6–9).
Unlike many surveillance systems that monitor a single
exposure and its associated outcomes, VAERS monitors mul-
tiple exposures (i.e., different vaccines often administered
simultaneously in different combinations) and an increasing
number of potential outcomes. VAERS accepts spontaneous
reports from health professionals, vaccine manufacturers, and
the public. Reports are submitted by mail or fax. In 2002,
electronic reporting to VAERS through the Internet
became available by accessing http://secure.vaers.org/
VaersDataEntryintro.htm. All reports, whether submitted
directly to VAERS by an individual or by state or local public
health authorities or manufacturers, are entered into the
VAERS database.
Federal regulations require that each manufacturer with a
product license from FDA report the following adverse events
to VAERS: all spontaneous reports of adverse experiences
occurring within the United States, whether serious,
nonserious, expected or unexpected, and all serious and
unexpected adverse experiences occurring outside of the
United States or reported in scientific and medical journals as
case reports or as the result of formal clinical trials (10). Data
collected on the VAERS form (11) include information
regarding the patient, the vaccine(s) administered, the reported
adverse event, and the person reporting the event. Federal regu-
lations (10) define serious events as those involving death,
life-threatening illness, hospitalization or prolongation of
hospitalization, or permanent disability. All reports with
adverse events classified as serious are followed up with a
request for additional information (e.g., medical records and
autopsy reports) to provide a complete description of the case.
For all original and follow-up reports, the signs, symptoms,
and diagnoses mentioned in the description of the adverse
event are coded using FDA’s Coding Symbols for Thesaurus
of Adverse Reaction Terms (COSTART) (12). All informa-
tion is stored in a computerized database for subsequent
reference and analyses. All reporters receive written
acknowledgment of receipt of their reports along with a request
for missing information where indicated. In addition, letters
to obtain information regarding the recovery status of per-
Vol. 52 / SS-1 Surveillance Summaries 3
sons with serious adverse events are mailed to the reporters at
60 days and 1 year after vaccination.
All personal identifying information is kept confidential as
required by law. Medical records submitted to VAERS spon-
taneously or as part of follow-up activities are also protected
by confidentiality requirements. VAERS data stripped of per-
sonal identifiers are available at http://www.vaers.org.
The primary objectives of VAERS are to 1) detect new,
unusual, or rare vaccine adverse events; 2) monitor increases
in known adverse events; 3) determine patient risk factors for
particular types of adverse events; 4) identify vaccine lots with
increased numbers or types of reported adverse events; and
5) assess the safety of newly licensed vaccines. Although
VAERS can rarely provide definitive evidence of causal asso-
ciations between vaccines and particular risks, its unique role
as a national spontaneous reporting system enables the early
detection of signals (13) that can then be more rigorously
investigated. In vaccine safety surveillance, sensitivity takes
precedence over specificity. VAERS seeks reports of any clini-
cally important medical event that occurs after vaccination,
even if the reporter cannot be certain that the event was caused
by the vaccine.
The purpose of this report is to provide health-care provid-
ers, public health professionals, vaccine manufacturers, and
members of the public who are interested in vaccine safety
with an overview of the information collected in VAERS
regarding adverse events reported during the previous 11 years.
Specific examples of how the information was used to assess
the safety of the vaccines and how VAERS detected signals
that were later followed up are also included. Characterization
of reporting profiles for different types of adverse events and
vaccines also provides a context within which new and unex-
pected adverse events reported to VAERS can be interpreted.
Methods
The automated data in the VAERS database were used for
analysis. All data were analyzed by using SAS® program ver-
sion 8 (14). Unless otherwise indicated, only reports received
from January 1, 1991, through December 31, 2001, were
included. All known duplicate reports (reports concerning the
same patients but from different reporting sources) were
excluded.
All adverse events in the VAERS database were coded using
COSTART (12). Reports typically involve multiple
COSTART coding terms. Serious adverse events were defined
by the federal regulatory definition for seriousness (10), which
includes information regarding whether the patient died,
experienced life-threatening illness, required hospitalization,
and whether the condition resulted in prolongation of hospi-
talization or in permanent disability.
The numbers of adverse event reports in each of the 50
states were calculated by year. The average reporting rates
(reports per 1 million population) for each state were calcu-
lated by dividing the averages of 11 annual reports of each
state by the averages of 1990 and 2000 state population data
from the Bureau of the Census.
The vaccine-specific reporting rates for each vaccine type
(number of reports per 100,000 net doses distributed) were
calculated by dividing the number of vaccine-specific reports
by the net doses distributed in the United States, according
to the data provided by the CDC Biologics Surveillance Sys-
tem (personal communication, Lisa Galloway, National
Immunization Program, 2002) (Table 1). These data were pro-
vided by the majority of vaccine manufacturers by type of
antigen and year of distribution. These net distribution fig-
ures are only estimates and serve as approximate denomina-
tors for reporting rates of adverse events in the absence of
data regarding actual number of doses administered. Net dis-
tribution figures represent the total doses distributed by vac-
cine type during the period, less returned doses. The reporting
rates must not be interpreted as incidence rates because
whether the vaccine caused the adverse event was uncertain.
The adverse event might have occurred by chance after vacci-
nation. In addition, substantial and variable underreporting
occurs, and uncertainty exists regarding the actual number of
doses administered.
The numbers of adverse event reports were calculated in
five age groups: <1 year, 1–6 years, 7–17 years, 18–64 years,
and >65 years. The unknown age group was defined as not
being able to determine age because of missing information.
The frequently reported vaccine types or vaccine combina-
tions were defined as vaccine types or vaccine combinations
for which >50 adverse event case reports were received. The
frequently reported adverse events were defined as the
COSTART coding terms of adverse events that were reported
>100 times.
Results
Summary of VAERS Data
General
From January 1, 1991, through December 31, 2001, VAERS
received 128,717 case reports describing adverse events after
immunization. This report includes data regarding the distri-
bution of these reports by year and the population-based
reporting rates in the 50 states (Table 2). The reporting rates
4 MMWR January 24, 2003
varied from 27.7 (Alabama) to 113.2 (Alaska) reports per
million population. The four most populous states in the
United States (California, Florida, Texas, New York) had low
reporting rates of 28.4, 30.3, 32.0, and 35.8, respectively. In
contrast, the states with the highest reporting rates were Alaska
(113.2), Idaho (81.4), and Wyoming (75.2), which are some
of the least populated states.
Data regarding the number of adverse event reports for each
of the 27 frequently reported vaccine types are included in
this report (Table 3). During 1991–2001, >1.9 billion net
doses of human vaccines were distributed (Table 1), resulting
in an overall dose-based reporting rate for the 27 vaccine types
of 11.4 reports per 100,000 net doses distributed. The influ-
enza vaccine (FLU) had the highest distribution (>500 mil-
lion doses) but the lowest overall reporting rate (3.0 reports
per 100,000 net doses distributed). Hepatitis B (HEP) vac-
cine had the second highest distribution (>200 million net
doses) but an overall reporting rate of 11.8 reports per 100,000
net doses distributed. Rhesus rotavirus vaccine-tetravalent
(RRV-TV) had the highest overall reporting rate for a specific
vaccine (156.3 reports per 100,000 net doses distributed).
Two major vaccine substitutions occurred during the 11-year
period: diphtheria and tetanus toxoids and acellular pertussis
(DTaP) replaced diphtheria and tetanus toxoids and pertus-
sis vaccine (DTP), and inactivated poliovirus vaccine (IPV)
replaced oral poliovirus vaccine live trivalent (OPV) for rou-
tine vaccinations. The overall reporting rate has decreased sub-
stantially after vaccination with DTaP (12.5 reports per
100,000 net doses distributed), compared with that for DTP
(26.2). A similar, though limited decrease in average reporting
rate was also observed after vaccination with IPV (13.1), com-
pared with that for OPV (15.1) after transition from OPV to
IPV in 1996.
During the 11-year surveillance period, 44.8% of all
reports involved children aged <7 years (<1 year: 18.1% and
1–6 years: 26.7%) (Table 4). The recommended vaccination
schedules primarily involve these age groups. A total of 32.6%
of all reports were for adults aged 18–64 years, and 4.9%
concerned adults aged >65 years. Among children, the differ-
ence in sex was minimal in all age groups (<1 year, 1–6 years,
and 7–17 years) (Figure 1). In contrast, an excess of reports
for women was noted for all adult age groups (18–64 years
and >65 years) throughout the surveillance period.
Changes in reporting frequencies of different vaccines or
vaccine combinations examined by comparing data from two
surveillance periods are included in this report (Tables 5 and
6). During the earlier period, 1991–1995, >74% of all VAERS
reports mentioned the use of HEP; FLU; measles, mumps,
and rubella (MMR); DTP; or tetanus and diphtheria toxoids
(Td) vaccines and combined use of DTP with Haemophilus b
conjugate virus vaccine (HIBV), OPV, HEP, and MMR
(Table 5). Because of the introduction of multiple new vac-
cines and vaccine combinations and changes in the recom-
mended immunization schedules, the reporting pattern in
VAERS changed during the latter period, 1996–2001. Although
HEP, FLU, Td, and MMR remained among the most fre-
quently reported vaccines, a substantial number of reports
followed the use of varicella (VARCEL), pneumococcal (PPV),
anthrax (ANTH), and Lyme disease vaccines (LYME) as well
as acellular pertussis vaccines administered either alone or in
combination with HEP, HIBV, IPV and/or MMR (Table 6).
Overall, the most commonly reported adverse event was
fever, which appeared in 25.8% of all reports, followed by
injection-site hypersensitivity (15.8%), rash (unspecified)
(11.0%), injection-site edema (10.8%), and vasodilatation
(COSTART coding term for skin redness) (10.8%) (Table 7).
At least one of these primarily nonserious adverse events was
mentioned in 74.2% of all VAERS reports.
VAERS reports were received primarily from vaccine manu-
facturers (36.2%), state and local health departments (27.6%),
and health-care providers (20.0%), with fewer reports filed
directly by patients and parents (4.2%), or others (7.3%)
(Table 8). Data documented a continuous increase in the pro-
portion of reporting by health-care providers during the
11-year period. The percentage of reports from health-care
providers increased from 11.4% in 1991 to 35.3% in 2001.
The improvement in reporting from health-care providers
might reflect the efforts of the VAERS working group to
enhance communication with physicians through yearly
direct mailing, continuing medical education (CME), and
other sources. In addition, publications of analyses of VAERS
data might have increased health-care providers’ recognition
of the potential value of reporting.
Serious Adverse Events
Overall, 14.2% of all reports received in VAERS during
1991–2001 described serious adverse events (10) (Table 9).
During 1991–2001, reports of deaths ranged from 1.4%–
2.3%, and reports of life-threatening illness ranged from
1.4%–2.8% of all adverse event reports. During the previous
3 years when distribution of vaccines reached the highest level,
the annual percentage of reports of death was stable, approxi-
mately 1.5% of all adverse event reports. The reports of life-
threatening illness were also stable throughout the years except
for a peak of 2.8% in 1999, which reflected RRV-TV and
intussusception incident that occurred in that year.
A clinical research team follows up on all deaths reported to
VAERS. The majority of these deaths were ultimately classi-
fied as sudden infant death syndrome (SIDS). Analysis of the
age distribution and seasonality of infant deaths reported to
Vol. 52 / SS-1 Surveillance Summaries 5
VAERS indicated that they matched the age distribution and
seasonality of SIDS; both peaked at aged 2–4 months and
during the winter (15). The decrease in deaths reported to
VAERS since 1992–1993 parallels the overall decrease in SIDS
in the U.S. population since the implementation of the Back
to Sleep campaign (15). Carefully controlled epidemiologic
studies consistently have not found any association between
SIDS and vaccines (16–19). FDA and the Institute of Medi-
cine (IOM) reviewed 206 deaths reported to VAERS during
1990–1991. Only one death was believed to have resulted
from a vaccine. The patient was a woman aged 28 years who
died from Guillain-Barré syndrome after tetanus vaccination
(20). IOM concluded that the majority of deaths reported to
VAERS are temporally but not causally related to vaccination
(20). A similar conclusion was reached regarding neonatal
deaths temporally reported to VAERS in association with hepa-
titis B vaccination (21).
VAERS in Vaccine Safety Surveillance
Intussusception After Rotavirus Vaccine
RRV-TV was licensed in August 1998. The Advisory Com-
mittee on Immunization Practices (ACIP) recommendations
for its use were published in March 1999 (22). From Septem-
ber 1, 1998, through July 7, 1999, VAERS received 15
reports of intussusception among infants who had received
RRV-TV vaccine. CDC reported this finding in July 1999
and recommended that health-care providers postpone use of
RRV-TV at least until November 1999, pending results of a
national case-control study that was being conducted at that
time (23). The manufacturer, in consultation with FDA, vol-
untarily ceased further distribution of the vaccine in mid-
July 1999. On October 22, after a review of scientific data
from multiple sources, ACIP concluded that intussusception
occurred with substantially increased frequency in the first
1–2 weeks after vaccination with RRV-TV, particularly after the
first dose. In 1999, ACIP withdrew its recommendation for vac-
cination of infants in the United States with RRV-TV (24).
From September 1998 through December 1999, VAERS
received 121 reports of intussusception among infants who
received RRV-TV vaccine (Figure 2). The first intussuscep-
tion case was reported in December 1998. During the first
half of 1999, a total of 14 additional cases of intussusception
were reported to VAERS. The majority of cases were reported
during July–August 1999, peaking soon after a MMWR pub-
lication (July 16, 1999) (23). Other studies have documented
similar findings (25–29). All intussusception case-patients
reported to VAERS through December 31, 1999, were vacci-
nated before July 17, 1999 (Figure 3). Before RRV-TV was
licensed and marketed in the United States, VAERS had
received a total of only three reports of intussusception after
other vaccinations (Figure 4).
Influenza Vaccine and Guillain-Barré
Syndrome
Vaccination with swine influenza vaccine is known to
increase the risk for Guillain-Barré syndrome (30–34).
Reports of Guillain-Barré syndrome after any vaccination are
considered serious and followed up by VAERS to obtain
additional information. An increase in reports of Guillain-
Barré syndrome after the receipt of influenza vaccine was noted
in VAERS data by week 29 of the 1993–94 influenza season
(35). The number of reports increased from 23 during 1991–
92 to 40 during 1992–93 and to 80 during 1993–94 (Figure 5).
These findings raised concerns regarding a possible increase
in vaccine-associated risk for Guillain-Barré syndrome. A study
was initiated to investigate the VAERS signal (35). The study
documented that the relative risk of Guillain-Barré syndrome
after influenza vaccination, adjusted for age, sex, and vaccine
season was 1.7 (95% confidence interval = 1.0–2.8). How-
ever, no increase occurred in the risk of vaccine-associated
Guillain-Barré syndrome from 1992–93 to 1993–94. For the
two seasons combined, the adjusted relative risk of 1.7 indi-
cated that slightly >1 additional case of Guillain-Barré syn-
drome occurred per 1 million persons vaccinated against
influenza. This risk is less than the risk from severe influenza,
which can be prevented by the vaccine. In addition, no corre-
lation existed between the number of Guillain-Barré syndrome
reports received in VAERS and influenza vaccine doses
administered (Figure 5). The annual number of Guillain-Barré
syndrome reports has been low and stable during the previ-
ous four influenza seasons when the net doses of influenza
vaccine distributed increased substantially. This finding
reflects data compared with the 1993–94 influenza season in
which VAERS received the highest numbers of Guillain-Barré
syndrome reports in a single influenza season. This example
indicates that VAERS is useful in preliminary evaluation of rare
adverse events when the relation to vaccination is uncertain.
Safety Assessment After Whole Cell
Versus Acellular Pertussis-Containing
Vaccines
Concerns regarding the safety of DTP vaccines led to a
gradual introduction of acellular pertussis-containing vaccines
in the United States. In December 1991, FDA licensed the
first DTaP vaccine for use in the United States (36). Shortly
thereafter, a second DTaP formulation was also licensed (37).
Both DTaP vaccines were licensed for use only as the fourth
and fifth doses of the DTP series recommended for children
6 MMWR January 24, 2003
aged 15 months–7 years. In July 1996, FDA approved the
first DTaP vaccine for infants (38).
VAERS reports from 1991 (when whole cell pertussis vac-
cines were used exclusively) through 2001 (when acellular
pertussis vaccines were used predominantly) documented that
the overall vaccine-specific reporting rates of both serious and
nonserious reports for DTaP had decreased to less than one
half of that for DTP among children aged <7 years (Table 10).
In comparison with all whole cell pertussis-containing vac-
cines (DTP and DTPH), the overall nonserious adverse events
reporting rate for DTaP vaccines was approximately 40% lower
(10.5 versus 16.8 reports per 100,000 net doses distributed).
Although reduction in adverse reporting rates is suggestive of
a safer vaccine, such comparisons must be interpreted cau-
tiously because reporting rates cannot be viewed as incidence
rates. Two studies have documented an improved safety pro-
file of DTaP vaccines based on review of VAERS data from
1991–1993 among children and 1995–1998 among infants
(39,40). The decreasing trends for selected systemic adverse
events (e.g., fever) and neurologic reactions (e.g., seizures)
continued to be observed during 1999–2001 (Figures 6 and 7).
However, an increase in the number of reports concerning
injection-site reactions was detected by the end of this sur-
veillance period (Figure 8). The increase is more prominent
among the recipients of booster doses of DTaP (fourth and
fifth dose). This finding is consistent with the results of a
recent study that documented an increase in the risk of exten-
sive local reactions in recipients of fourth and fifth doses of
the DTaP vaccines (41).
Safety Assessment After IPV Versus OPV
Since it was licensed in 1963, OPV has been the vaccine
used for the prevention of poliovirus infection in the United
States. The use of OPV led to the elimination of wild-type
poliovirus in the United States in <20 years. However, the
risk of vaccine-associated paralytic poliomyelitis (VAPP) was
estimated to be approximately 1 case per 2.4 million doses
distributed, with the majority of VAPP cases occurring after
the administration of the first dose (1 case per 750,000 first
doses) (42,43). The reporting sensitivity of VAPP in VAERS
was an estimated 68%–72% (44). In September 1996, to
reduce the occurrence of VAPP, ACIP recommended an
increase in the use of IPV through a sequential schedule of
IPV followed by OPV (42). VAERS has not received any
report of VAPP after OPV/IPV vaccination since 1997, sug-
gesting a positive effect of the sequential schedule of IPV
followed by OPV (Figure 9). This result is consistent with
previously reported data (45). In July 1999, ACIP recom-
mended that IPV be used exclusively in the United States to
maintain disease elimination and to prevent any further cases
of VAPP (46).
Safety Assessment After Varicella
Vaccine
In March 1995, varicella vaccine was licensed in the United
States. In July 1996, varicella vaccine was recommended by
ACIP for all children without contraindications at aged 12–18
months, for all susceptible children by their thirteenth birth-
day, and for susceptible adolescents and adults who are at high
risk for exposure to varicella (47). In February 1999, ACIP
expanded its recommendations for varicella vaccine to pro-
mote an expanded use of the vaccine for susceptible children
and adults (48).
VAERS received 15,180 adverse event reports after varicella
vaccination from March 1995 through December 2001, the
majority (14,421, or 95%) of which described nonserious
events. The highest numbers of reports were received soon
after licensure (Figure 10). As the net distribution of varicella
vaccine increased, the number of adverse event reports
decreased continuously over the years. Of the 15,180 adverse
event reports received, the number of serious adverse events
reported for varicella vaccine was 759 (5%). The proportion
of reports of serious adverse events was stable over the years
(range: 3.7%–6.3%).
A detailed review of VAERS reports received during the
first 3 years after the licensure of varicella vaccine documented
that the majority of reported adverse events for varicella vac-
cine were minor, and serious events were rare (49). A vaccine
etiology for the majority of reported serious events could not
be confirmed; further research is needed to clarify whether
varicella vaccine played a role.
Safety Assessment After Lyme Disease
Vaccine
In December 1998, FDA licensed the first vaccine to pre-
vent Lyme disease. ACIP stated that the vaccine should be
considered for persons who reside in areas where Lyme dis-
ease is endemic and who have frequent or prolonged expo-
sure to tick-infested habitats (50). Review of early reports to
VAERS revealed adverse events that corresponded to Lyme
vaccine safety data from the prelicensure trials, including
injection-site reactions, transient arthralgia and myalgia within
30 days of vaccination, fever, and flu-like symptoms. Hyper-
sensitivity reactions, not observed in the clinical trial, were
also reported to VAERS. Some of the reported hypersensitiv-
ity reactions can be linked to the vaccine on the basis of the
specificity of the symptoms, close temporal proximity to
Vol. 52 / SS-1 Surveillance Summaries 7
vaccination, and the known association of the reactions with
other vaccines. For other reported adverse events, causal rela-
tions with Lyme disease vaccine have not been established.
No clear patterns in age, sex, time to onset, or vaccine dose
have been identified. The onset of symptoms consistent with
Lyme disease (e.g., facial paralysis and arthritis) after Lyme
disease vaccination has also been reported to VAERS. Deter-
mining whether the facial paralysis was part of the expected
background incidence or attributable to the vaccine or to Lyme
disease was not possible. A higher proportion of arthritis-
related events was reported after the second or third dose com-
pared with all events combined. This higher proportion might
be attributable to the increased amount of time available for a
vaccine recipient to report an adverse event: 11 months
between the second and third doses (51). Because of persis-
tent public concerns, a follow-up study was conducted to fur-
ther evaluate reports of arthritis after vaccination for Lyme
disease. In 7 of 14 confirmed arthritis cases, a history of con-
comitant exposure or another medical condition existed,
including Lyme disease, that provided a possible explanation
for arthritis (52). In early 2001, the manufacturer withdrew
the vaccine from the market, citing poor sales.
Discussion
This report provides an overview of reports to VAERS dur-
ing 1991–2001. The VAERS data should be interpreted with
caution, because they describe events that occurred after vac-
cination but they do not necessarily imply that the events
were caused by vaccination. Although the 128,717 adverse
event reports received in VAERS during the previous 11 years
are a substantial number, it is low in comparison with the
>1.9 billion doses of vaccines administered in the United States
during the same period (Table 1). VAERS seeks to capture as
many clinically important medical events after vaccination as
possible, even if the person who reported the event was not
certain that the incident was vaccine-related. Temporal asso-
ciation alone does not mean that the vaccine caused the ill-
ness or symptoms. The illness or symptoms could have been a
coincidence or might have been related to an underlying dis-
ease or condition or might have been related to medicines or
other products taken concurrently.
During 1999–2001, more reports were submitted to VAERS
annually than in the early 1990s. Multiple factors that likely
contributed to this increase include the introduction of new
vaccines in the mid- to late 1990s (rotavirus vaccine, Lyme
disease vaccine, varicella vaccine, and pneumococcal conju-
gate vaccine), the increased use of anthrax vaccine by military
personnel, and the increase in the number of doses of
vaccines administered to both adult and children (Table 1). In
addition, reporters have become increasingly aware of VAERS.
Because of the diverse population VAERS covers and the
number of reports it receives, VAERS is useful for detecting
new, unusual, or rare events and assessing newly licensed vac-
cines. Review of reports during the initial months of licensed
use of a new vaccine cannot only rapidly identify problems
not detected during prelicensure evaluation (e.g., intussucep-
tion and RRV-TV) but also reassure the general public con-
cerning the safety of a new vaccine, as in the safety assessments
of varicella vaccine and hepatitis A (HEPA) vaccine (53).
VAERS has also been useful in screening for unusual increases
in previously reported adverse events (e.g., influenza vaccine
and Guillain-Barré syndrome investigation during the 1992–
93 and 1993–94 influenza seasons).
Investigating changes in reporting rates in VAERS might
lead to positive change in vaccine practices. After the licen-
sure of DTaP for the fourth and fifth doses in the vaccination
schedule of older children, VAERS data were used to com-
pare reporting rates for specific adverse events after DTaP
versus DTP within the first 72 hours after vaccination (39).
This study confirmed a better safety record for DTaP among
older children and was one factor in ACIP’s subsequent rec-
ommendation for the use of DTaP among infants. As was
also critical in the safety assessment of IPV versus OPV,
VAERS provided evidence of improved safety in evaluating
changes in immunization practices recommended by ACIP.
VAERS has also facilitated the lot-specific safety evalua-
tions, which have periodically been of public concern. Lot
sizes vary substantially. Every lot of vaccine must meet strict
criteria for purity, potency, and sterility before it can be
released to the public by the manufacturer. FDA medical
officers review all reports of death and other serious events,
and they also look each week for clusters within the same
vaccine lot. In addition, FDA medical officers evaluate re-
porting rates of adverse events by lot, as needed, looking for
unexpected patterns. During the 11 years, no lot needed to be
recalled on this basis.
VAERS is subject to the limitations inherent in any passive
surveillance system (54). Among those, underreporting (only
a fraction of the total number of potentially reportable events
occurring after vaccination are reported) and differential
reporting (more serious events and events with shorter onset
time after vaccinations are more likely to be reported than
minor events) are most noticeable (44). Overreporting also
occurs because certain reported adverse events might not be
caused by vaccines, and some reported conditions do not meet
standard diagnostic criteria. Many reported events, including
serious ones, might occur coincidentally after vaccination and
are not causally related to vaccination. Other potential
Please note: An erratum has been published for this issue. To view the erratum, please click here.
8 MMWR January 24, 2003
reporting biases include increased reporting in the first few
years after licensure, increased reporting of events occurring
soon after vaccination, and increased reporting after public-
ity about a particular known or alleged type of adverse event.
Individual reports might contain inaccurate or incomplete
information. Because of all of these reasons as well as the
absence of control groups, differentiating causal from coinci-
dental conditions by using VAERS data alone usually is not
possible. Other methodologic limitations of VAERS include
the fact that it does not provide information regarding back-
ground incidence of adverse events in the general population
nor does it provide information concerning the total number
of doses of vaccine or vaccine combinations actually admin-
istered to patients.
Despite its limitations, VAERS contributes to public health
in critical ways. CDC and FDA have published and presented
numerous vaccine safety studies based on the analyses of
VAERS data (55). The high number of reports and the
national coverage increase the possibility of detecting or bet-
ter understanding adverse events that might occur too rarely
to be considered as a signal in prelicensure clinical trials or
even in a postmarketing active surveillance program. The iden-
tification of signals by monitoring VAERS data might ini-
tiate further investigation of potential problems in vaccine
safety or efficacy and subsequent dissemination of safety-
related information to the scientific community and the pub-
lic. VAERS is also used to evaluate the safety of vaccines used
in unique populations (e.g., travelers and the military). Stud-
ies have been published regarding Japanese encephalitis (56),
Lyme (51), meningococcal (57), and yellow fever vaccines
(58,59), among others.
To provide a more rigorous setting in which investigators
can follow up on signals from VAERS or concerns arising
from other sources, the Vaccine Safety Datalink (VSD) Project,
a large-linked database, was established in 1991 (60). VSD
includes information concerning >7 million persons in eight
health maintenance organizations (HMOs) throughout the
United States. The strengths of VSD include the documenta-
tion of immunizations, the absence of underreporting bias of
medical outcomes, and the inclusion in the database of a high
number of vaccinated persons who did not have adverse events.
However, the VSD data are not available for analysis in as
timely a manner as the VAERS data and are not fully repre-
sentative of the U.S. population regarding race, socioeconomic
status, health-care setting, or vaccine lot uses. Nonetheless,
VSD permits the conducting of planned epidemiologic vac-
cine safety studies as well as, in certain situations, urgent
investigations of new hypotheses (28).
In addition to VSD, CDC has established a new collabora-
tive project, the national network of Clinical Immunization
Safety Assessment (CISA) Centers. The centers will develop
and disseminate standardized clinical evaluation protocols to
clinicians. In addition, the CISA centers will provide referral
and consultation services to health-care providers regarding
the evaluation of patients who might have had an adverse
reaction to vaccination, which will include how to manage
the adverse reaction and provide counsel on advisability of
continued vaccination. The CISA centers will undertake
outreach and educational interventions in the area of vacci-
nation safety. The objectives of CISA are to enhance under-
standing of known serious or unusual vaccine reactions,
including the pathophysiology and risk factors for such reac-
tions, as well as to evaluate newly hypothesized syndromes or
events identified from the assessment of VAERS data to clarify
any potential relation between the reported adverse events and
immunization. Certain adverse events are rarely seen in clini-
cal trials, and clinicians see them too rarely to manage them
in a standardized manner. CISA will fill this gap by assisting
clinicians in the management of adverse events after
immunization.
Acknowledgments
The authors acknowledge the contributions of the other members
of the VAERS working group, Scott Campbell, M.P.H., Kathleen
Fullerton, M.P.H., Sharon Holmes, Young Hur, M.D., Elaine Miller,
M.P.H., Susanne Pickering, M.S., and Ali Rashidee, M.D., National
Immunization Program; Dale Burwen, M.D., David Davis; Phil
Perucci, Sean Shadomy, D.V.M., Frederick Varricchio, M.D., P.h.D.,
and Jane Woo, M.D., Food and Drug Administration, Rockville,
MD; and Vito Caserta, M.D. and Geoffrey Evans, M.D., Health
Resources and Services Administration, Rockville, Maryland. We
also acknowledge Stephen Gordon, Pharm.D. and other staff of
Analytical Sciences, Inc., Durham, North Carolina; Xiaojun Wang,
M.D., Emory University Rollins School of Public Health, Atlanta,
Georgia; and John Grabenstein, MD, Department of Defense,
Washington, D.C. In addition, the authors acknowledge Walter
Orenstein, M.D., Susan Chu, Ph.D., Mary McCauley, MTSC,
Benjamin Schwartz, M.D., and Phil Smith, Ph.D., National
Immunization Program for their review of the manuscript; and the
health-care providers, public health professionals, and members of
the public who have reported events of potential concern to VAERS.
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Vaccine Codes* Used in the Vaccine
Adverse Event Reporting System
(VAERS)
Vaccine
Code Description
ANTH Anthrax vaccine adsorbed
DT Diphtheria and tetanus toxoids adsorbed
DTAP Diphtheria and tetanus toxoids and acellular
pertussis vaccine adsorbed
DTP Diphtheria and tetanus toxoids and pertussis
vaccine adsorbed
DTPH Diphtheria and tetanus toxoids and pertussis
vaccine adsorbed and Haemophilus b conjugate
vaccine (diphtheria CRM197 protein conjugate)
FLU Influenza virus vaccines
HBHEPB Haemophilus b conjugate vaccine and hepatitis B
vaccine (recombinant)
HEP Hepatitis B vaccines (recombinant)
HEPA Hepatitis A vaccines inactivated
HIBV Haemophilus b conjugate vaccines
IPV Inactivated poliovirus vaccine
JEV Japanese encephalitis virus vaccine inactivated
LYME Lyme disease vaccine (recombinant OspA)
M Measles virus vaccine live
MEN Meningococcal polysaccharide vaccine
MMR Measles, mumps, and rubella virus vaccine live
OPV Oral poliovirus vaccine live trivalent (sabin strains
types 1, 2 and 3)
PNC Pneumococcal 7-valent conjugate vaccine
(diphtheria CRM197 protein)
PPV Pneumococcal vaccines, polyvalent
R Rubella virus vaccine live
RAB Rabies vaccines
RV Rotavirus vaccine live, oral, tetravalent
TD Tetanus and diphtheria toxoids adsorbed for
adult use
TTOX Tetanus toxoid
TYP Typhoid vaccines
VARCEL Varicella virus vaccine live
YF Yellow fever vaccine
*Vaccine codes used in VAERS for vaccine types, which might represent
multiple similar vaccines made by different vaccine manufacturers.
Vol. 52 / SS-1 Surveillance Summaries 11
TABLE 1. CDC biologics surveillance data* — United States, 1991–2001
Total net doses distributed†
Year
types§1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 Total
ANTH¶—**——————481,515 996,638 481,514 25,987 1,985,654
DT 1,384,390 1,377,432 1,800,499 1,079,191 1,338,871 1,090,017 573,267 690,465 443,702 336,987 428,140 10,542,961
DTAP — 1,708,228 3,907,915 4,706,165 4,939,410 6,830,615 14,874,775 16,707,325 19,848,959 17,355,117 17,955,984 108,834,493
DTP 19,341,055 19,502,535 16,667,844 7,754,229 5,246,313 3,632,971 474,127 257,155 466,360 152,556 67,903 73,563,048
DTPH — — 3,210,340 12,013,470 12,650,370 11,291,600 5,656,830 2,573,220 834,564 — — 48,230,394
DTaP-HIB†† ——————528,273 602,880 645,458 690,171 453,534 2,920,316
FLU 32,809,662 40,352,367 42,980,814 60,084,728 36,512,538 38,915,520 40,996,883 48,080,122 60,468,427 65,582,650 61,953,006 528,736,717
HBHEPB ——————882,606 1,850,319 2,935,569 4,754,165 5,230,135 15,652,794
HEP 3,555,775 20,404,964 32,777,217 31,200,758 16,595,241 22,030,609 28,395,242 34,394,128 30,437,611 28,013,544 28,698,635 276,503,724
HEPA ————3,823,000 2,302,925 3,487,445 4,256,114 4,151,283 6,426,621 7,258,381 31,705,769
HIBV 16,862,932 15,076,004 12,848,397 8,145,126 5,272,618 4,438,343 9,573,546 12,531,386 13,698,620 11,383,516 9,431,417 119,261,905
IPV 103,436 275,376 281,257 347,656 448,030 1,275,537 5,228,097 6,048,082 10,420,168 17,712,225 18,119,320 60,259,184
JEV — — 41,695 174,629 162,925 162,093 175,956 101,312 135,918 139,708 104,643 1,198,879
LYME§§ 967,000 428,000 93,000 1,488,000
M 1,138,740 493,290 406,566 279,902 184,294 205,113 135,083 134,909 107,736 83,764 94,403 3,263,800
MEN 58,842 385,035 400,523 624,714 859,183 532,677 710,168 997,430 723,096 1,296,864 1,424,442 8,012,974
MMR 13,662,657 13,399,606 13,388,958 15,281,375 13,614,411 11,091,265 13,188,702 13,822,162 13,896,719 12,682,704 11,552,532 145,581,091
OPV 19,052,840 19,411,620 18,992,060 22,606,350 20,300,000 18,516,650 12,595,000 11,740,830 10,072,300 — — 153,287,650
PNC —————————13,663,100 15,256,865 28,919,965
PPV 2,713,281 2,555,262 3,597,095 4,492,680 4,927,380 7,103,615 6,825,035 7,781,485 7,037,540 7,056,265 4,358,078 58,447,716
R 363,826 321,261 300,610 280,397 294,170 289,131 299,238 288,615 315,635 241,295 259,707 3,253,885
RAB 168,166 191,716 118,272 223,813 247,545 236,819 265,362 227,275 249,558 155,822 200,752 2,285,100
RV ————————453,120 — — 453,120
TD 12,452,950 12,991,037 15,189,664 17,151,343 13,872,190 12,667,682 15,235,446 15,987,245 13,693,807 12,539,325 11,000,458 152,781,147
TTOX 4,016,110 3,407,521 3,208,265 2,893,330 2,632,505 1,678,600 1,436,824 1,599,110 1,902,657 1,367,046 909,777 25,051,745
TYP ——————192,902 564,400 1,144,922 1,368,040 1,099,159 4,369,423
VARCEL ————1,140,449 2,685,538 3,736,938 5,323,008 5,526,977 6,164,324 5,787,866 30,365,100
YF 134,270 668,875 247,255 898,680 725,415 724,695 671,875 718,185 602,227 533,065 502,162 6,426,704
Total 127,818,932 152,522,129 170,365,246 190,238,536 145,786,858 147,702,015 166,139,620 187,758,677 202,176,571 210,608,388 202,266,286 1,903,383,258
* Personal communication, Lisa Galloway, National Immunization Program, 2002.
†Total net doses of vaccine distributed equals the total doses distributed by vaccine type and by year, less the doses returned.
§The Vaccine Adverse Event Reporting System (VAERS) coding terms for vaccine types. See the Vaccine Codes Used in the Vaccine Adverse Event Reporting System (VAERS)
section of this report for a description of each coding term.
¶Data provided by the Department of Defense.
** Data not available.
†† Not a VAERS coding term; represents the combination product of DTaP and HIBV.
§§ Not licensed until December 1998; data provided by the vaccine manufacturer.
Vaccine
12 MMWR January 24, 2003
TABLE 2. Vaccine Adverse Event Reporting System (VAERS) reports and population-based reporting rates in the 50 states —
United States, 1991–2001
1991 1992 1993 1994 1995 1996 1997
State No. % No. % No. % No. % No. % No. % No. %
AK 46 0.5 61 0.6 54 0.5 47 0.5 62 0.6 68 0.6 45 0.4
AL 115 1.1 222 2.1 90 0.9 119 1.1 105 1.0 85 0.8 120 1.0
AR 122 1.2 90 0.8 146 1.4 137 1.3 131 1.3 124 1.1 151 1.3
AZ 105 1.0 105 1.0 112 1.1 116 1.1 136 1.3 155 1.4 149 1.3
CA 661 6.6 804 7.4 827 8.0 849 8.2 892 8.7 908 8.1 864 7.4
CO 186 1.9 197 1.8 158 1.5 182 1.8 181 1.8 245 2.2 193 1.6
CT 87 0.9 102 0.9 145 1.4 127 1.2 126 1.2 124 1.1 136 1.2
DC 36 0.4 23 0.2 36 0.3 39 0.4 24 0.2 39 0.3 36 0.3
DE 27 0.3 28 0.3 28 0.3 36 0.3 24 0.2 21 0.2 29 0.2
FL 311 3.1 403 3.7 379 3.7 392 3.8 421 4.1 436 3.9 459 3.9
GA 489 4.9 330 3.0 293 2.8 305 2.9 320 3.1 320 2.8 324 2.8
HI 35 0.3 67 0.6 33 0.3 54 0.5 37 0.4 60 0.5 40 0.3
IA 220 2.2 136 1.3 118 1.1 95 0.9 104 1.0 105 0.9 134 1.1
ID 78 0.8 95 0.9 102 1.0 123 1.2 70 0.7 106 0.9 86 0.7
IL 382 3.8 346 3.2 372 3.6 403 3.9 375 3.6 419 3.7 388 3.3
IN 169 1.7 144 1.3 212 2.1 154 1.5 180 1.7 155 1.4 173 1.5
KS 128 1.3 129 1.2 107 1.0 110 1.1 119 1.2 115 1.0 111 0.9
KY 115 1.1 143 1.3 75 0.7 89 0.9 59 0.6 89 0.8 91 0.8
LA 161 1.6 128 1.2 117 1.1 130 1.3 127 1.2 126 1.1 112 1.0
MA 160 1.6 246 2.3 315 3.1 298 2.9 276 2.7 329 2.9 414 3.5
MD 272 2.7 243 2.2 211 2.0 204 2.0 236 2.3 276 2.5 256 2.2
ME 32 0.3 72 0.7 106 1.0 72 0.7 62 0.6 61 0.5 79 0.7
MI 354 3.5 391 3.6 445 4.3 389 3.8 372 3.6 456 4.1 459 3.9
MN 186 1.9 216 2.0 226 2.2 191 1.8 205 2.0 243 2.2 269 2.3
MO 220 2.2 212 2.0 218 2.1 255 2.5 204 2.0 257 2.3 224 1.9
MS 94 0.9 112 1.0 95 0.9 112 1.1 85 0.8 90 0.8 89 0.8
MT 32 0.3 48 0.4 49 0.5 48 0.5 36 0.3 41 0.4 48 0.4
NC 273 2.7 314 2.9 264 2.6 260 2.5 308 3.0 338 3.0 272 2.3
ND 19 0.2 36 0.3 37 0.4 38 0.4 54 0.5 47 0.4 44 0.4
NE 59 0.6 65 0.6 62 0.6 53 0.5 79 0.8 79 0.7 103 0.9
NH 117 1.2 93 0.9 70 0.7 82 0.8 77 0.7 91 0.8 74 0.6
NJ 324 3.2 299 2.8 298 2.9 344 3.3 310 3.0 348 3.1 309 2.6
NM 81 0.8 50 0.5 58 0.6 57 0.6 62 0.6 79 0.7 66 0.6
NV 41 0.4 31 0.3 62 0.6 45 0.4 76 0.7 54 0.5 58 0.5
NY 491 4.9 582 5.4 590 5.7 616 5.9 624 6.1 744 6.6 731 6.2
OH 330 3.3 358 3.3 404 3.9 394 3.8 448 4.3 530 4.7 419 3.6
OK 141 1.4 96 0.9 113 1.1 115 1.1 80 0.8 110 1.0 110 0.9
OR 153 1.5 155 1.4 142 1.4 149 1.4 128 1.2 103 0.9 153 1.3
PA 693 6.9 767 7.1 624 6.0 478 4.6 660 6.4 539 4.8 658 5.6
RI 35 0.3 37 0.3 20 0.2 21 0.2 21 0.2 47 0.4 37 0.3
SC 237 2.4 186 1.7 218 2.1 173 1.7 155 1.5 131 1.2 179 1.5
SD 60 0.6 47 0.4 53 0.5 58 0.6 32 0.3 35 0.3 52 0.4
TN 329 3.3 291 2.7 265 2.6 238 2.3 198 1.9 202 1.8 164 1.4
TX 463 4.6 724 6.7 504 4.9 585 5.6 530 5.1 571 5.1 624 5.3
UT 58 0.6 37 0.3 81 0.8 58 0.6 45 0.4 83 0.7 110 0.9
VA 223 2.2 295 2.7 236 2.3 275 2.7 262 2.5 275 2.4 301 2.6
VT 20 0.2 18 0.2 24 0.2 25 0.2 25 0.2 23 0.2 32 0.3
WA 258 2.6 238 2.2 257 2.5 227 2.2 238 2.3 323 2.9 301 2.6
WI 283 2.8 294 2.7 243 2.4 245 2.4 168 1.6 243 2.2 234 2.0
WV 124 1.2 131 1.2 87 0.8 72 0.7 76 0.7 81 0.7 73 0.6
WY 10 <0.1 33 0.3 28 0.3 30 0.3 74 0.7 32 0.3 24 0.2
Other†359 3.6 551 5.1 518 5.0 641 6.2 602 5.8 677 6.0 1,104 9.4
Total 10,004 100.0 10,821 100.0 10,327 100.0 10,355 100.0 10,301 100.0 11,238 100.0 11,711 100.0
* Number of reports per million of population. The population-based reporting rates were calculated by using the 11-year (1991–2001) average number of
reports in each state as numerator and the average of 1990 and 2000 Bureau of the Census data for each state as denominator.
†Data include reports of foreign and unidentifiable origin.
Vol. 52 / SS-1 Surveillance Summaries 13
TABLE 2 (
Continued
). Vaccine Adverse Event Reporting System (VAERS) reports and population-based reporting rates in the 50
states — United States, 1991–2001
1998 1999 2000 2001 All Average
State No. % No. % No. % No. % No. % rate*
AK 90 0.8 58 0.4 95 0.6 107 0.7 733 0.6 113.2
AL 81 0.7 112 0.9 136 0.9 109 0.7 1,294 1.0 27.7
AR 103 0.9 105 0.8 133 0.9 87 0.6 1,329 1.0 48.1
AZ 141 1.3 194 1.5 190 1.3 176 1.2 1,579 1.2 32.6
CA 696 6.4 1,105 8.4 1,234 8.1 1,099 7.4 9,939 7.7 28.4
CO 201 1.8 238 1.8 214 1.4 206 1.4 2,201 1.7 52.7
CT 130 1.2 175 1.3 230 1.5 141 1.0 1,523 1.2 41.4
DC 30 0.3 40 0.3 43 0.3 54 0.4 400 0.3 61.7
DE 26 0.2 136 1.0 122 0.8 53 0.4 530 0.4 66.5
FL 475 4.4 523 4.0 511 3.4 510 3.5 4,820 3.7 30.3
GA 281 2.6 401 3.0 461 3.0 427 2.9 3,951 3.1 49.0
HI 38 0.3 70 0.5 60 0.4 62 0.4 556 0.4 43.6
IA 111 1.0 130 1.0 140 0.9 112 0.8 1,405 1.1 44.8
ID 87 0.8 85 0.6 85 0.6 113 0.8 1,030 0.8 81.4
IL 329 3.0 449 3.4 508 3.4 457 3.1 4,428 3.4 33.8
IN 176 1.6 232 1.8 282 1.9 263 1.8 2,140 1.7 33.5
KS 104 1.0 127 1.0 144 1.0 139 0.9 1,333 1.0 46.9
KY 96 0.9 144 1.1 171 1.1 198 1.3 1,270 1.0 29.9
LA 96 0.9 119 0.9 125 0.8 114 0.8 1,355 1.1 28.4
MA 302 2.8 427 3.2 367 2.4 379 2.6 3,513 2.7 51.7
MD 200 1.8 314 2.4 300 2.0 258 1.7 2,770 2.2 50.0
ME 50 0.5 92 0.7 78 0.5 118 0.8 822 0.6 59.7
MI 391 3.6 497 3.8 545 3.6 519 3.5 4,818 3.7 45.5
MN 216 2.0 279 2.1 256 1.7 252 1.7 2,539 2.0 49.7
MO 238 2.2 239 1.8 300 2.0 221 1.5 2,588 2.0 43.9
MS 79 0.7 96 0.7 110 0.7 96 0.7 1,058 0.8 35.5
MT 73 0.7 53 0.4 78 0.5 54 0.4 560 0.4 59.8
NC 280 2.6 313 2.4 324 2.1 316 2.1 3,262 2.5 40.4
ND 36 0.3 57 0.4 56 0.4 41 0.3 465 0.4 66.0
NE 86 0.8 91 0.7 84 0.6 82 0.6 843 0.7 46.6
NH 62 0.6 94 0.7 92 0.6 110 0.7 962 0.7 74.6
NJ 287 2.6 400 3.0 559 3.7 400 2.7 3,878 3.0 43.7
NM 60 0.6 76 0.6 95 0.6 95 0.6 779 0.6 42.5
NV 47 0.4 58 0.4 70 0.5 77 0.5 619 0.5 35.2
NY 554 5.1 771 5.9 887 5.9 679 4.6 7,269 5.6 35.8
OH 392 3.6 499 3.8 540 3.6 496 3.4 4,810 3.7 39.4
OK 123 1.1 129 1.0 145 1.0 116 0.8 1,278 1.0 35.2
OR 131 1.2 178 1.4 197 1.3 178 1.2 1,667 1.3 48.4
PA 538 4.9 722 5.5 869 5.7 667 4.5 7,215 5.6 54.3
RI 78 0.7 52 0.4 53 0.3 58 0.4 459 0.4 40.7
SC 161 1.5 228 1.7 243 1.6 177 1.2 2,088 1.6 50.6
SD 20 0.2 50 0.4 28 0.2 45 0.3 480 0.4 60.2
TN 139 1.3 194 1.5 173 1.1 196 1.3 2,389 1.9 41.1
TX 463 4.2 692 5.3 738 4.9 775 5.3 6,669 5.2 32.0
UT 74 0.7 116 0.9 121 0.8 120 0.8 903 0.7 41.5
VA 257 2.4 305 2.3 344 2.3 353 2.4 3,126 2.4 42.8
VA 257 2.4 305 2.3 344 2.3 353 2.4 3,126 2.4 42.8
VT 24 0.2 22 0.2 46 0.3 44 0.3 303 0.2 47.0
WA 270 2.5 317 2.4 367 2.4 299 2.0 3,095 2.4 52.3
WI 223 2.0 283 2.2 302 2.0 301 2.0 2,819 2.2 50.0
WV 73 0.7 71 0.5 86 0.6 81 0.5 955 0.7 48.2
WY 40 0.4 38 0.3 64 0.4 19 0.1 392 0.3 75.2
Other†1,640 15.0 961 7.3 1,752 11.6 2,703 18.3 11,508 8.9
Total 10,898 100.0 13,157 100.0 15,153 100.0 14,752 100.0 128,717 100.0 44.1
* Number of reports per million of population. The population-based reporting rates were calculated by using the 11-year (1991–2001) average number of
reports in each state as numerator and the average of 1990 and 2000 Bureau of the Census data for each state as denominator.
†Data include reports of foreign and unidentifiable origin.
14 MMWR January 24, 2003
TABLE 3. Vaccine Adverse Event Reporting System (VAERS) reports and dose-based reporting rates for frequently reported
vaccine types* — United States, 1991–2001
Year report received
Vaccine 1991 1992 1993 1994 1995 1996
type†No. (%)§No. (%) No. (%) No. (%) No. (%) No. (%)
ANTH —** 0 — 0 4 (<.1) — 0 — 0 — 0
DT 118 (1.2) 178 (1.6) 179 (1.7) 183 (1.8) 166 (1.6) 150 (1.3)
DTAP†† — 0 67 (0.6) 183 (1.8) 324 (3.1) 394 (3.8) 531 (4.7)
DTP 4,255 (42.6) 4,003 (37.0) 3,312 (32.1) 2,826 (27.3) 2,033 (19.8) 1,192 (10.6)
DTPH — 0 — 0 176 (1.7) 952 (9.2) 1,422 (13.8) 1,783 (15.9)
FLU 537 (5.4) 875 (8.1) 1,159 (11.2) 1,549 (15.0) 1,228 (12.0) 1,403 (12.5)
HBHEPB — 0 — 0 — 0 — 0 — 0 — 0
HEP 2,548 (25.5) 3,534 (32.7) 3,762 (36.5) 3,345 (32.4) 2,979 (29.0) 2,930 (26.2)
HEPA — 0 — 0 — 0 — 0 95 (0.9) 278 (2.5)
HIBV§§ 2,814 (28.2) 3,190 (29.5) 2,746 (26.6) 2,323 (22.5) 1,849 (18.0) 1,158 (10.3)
IPV 30 (0.3) 54 (0.5) 72 (0.7) 64 (0.6) 71 (0.7) 98 (0.9)
JEV — 0 — 0 13 (0.1) 25 (0.2) 26 (0.3) 18 (0.2)
LYME — 0 — 0 — 0 — 0 — 0 — 0
M 51 (0.5) 98 (0.9) 47 (0.5) 35 (0.3) 22 (0.2) 21 (0.2)
MEN 4 (<.1) 11 (0.1) 30 (0.3) 25 (0.2) 20 (0.2) 16 (0.1)
MMR 2,093 (20.9) 2,067 (19.1) 1,743 (16.9) 1,965 (19.0) 1,998 (19.4) 1,951 (17.4)
OPV 3,222 (32.2) 3,302 (30.5) 2,939 (28.5) 3,356 (32.5) 3,056 (29.7) 2,620 (23.4)
PNC —0 —0 —0 —0 —0 —0
PPV 207 (2.1) 221 (2.0) 237 (2.3) 342 (3.3) 553 (5.4) 465 (4.2)
R 85 (0.9) 76 (0.7) 61 (0.6) 42 (0.4) 59 (0.6) 56 (0.5)
RAB 48 (0.5) 89 (0.8) 204 (2.0) 177 (1.7) 161 (1.6) 130 (1.2)
RV —0 —0 —0 —0 —0 —0
TD 479 (4.8) 501 (4.6) 715 (6.9) 730 (7.1) 1,011 (9.8) 1,083 (9.7)
TTOX 64 (0.6) 73 (0.7) 82 (0.8) 93 (0.9) 145 (1.4) 141 (1.3)
TYP 99 (1.0) 129 (1.2) 99 (1.0) 176 (1.7) 116 (1.1) 162 (1.4)
VARCEL — 0 — 0 — 0 — 0 649 (6.3) 1,904 (17.0)
YF 13 (0.1) 27 (0.2) 69 (0.7) 43 (0.4) 40 (0.4) 62 (0.6)
Other¶¶ 53 (0.5) 58 (0.5) 35 (0.3) 37 (0.4) 62 (0.6) 50 (0.4)
Total*** 10,004 ††† 10,821 ††† 10,327 ††† 10,355 ††† 10,301 ††† 11,238 †††
* The frequently reported vaccine types were defined as the vaccine types for which a total of >100 reports were received during 1991–2001.
†VAERS coding terms for vaccine types. See the Vaccine Codes Used in This Report section for a description of each coding term. Each vaccine type might
represent similar vaccines from multiple vaccine manufacturers. Vaccines were either reported alone or in combination with other vaccines.
§Percentages represent the proportion of reports concerning the vaccine type among the total number of reports in each year.
¶Number of reports per 100,000 net vaccine doses distributed. The dose-based reporting rates were calculated using the 11-year (1991–2001) total
number of reports as numerators and the 11-year total number of net doses of vaccines distributed (Table 1) as denominators.
** Not available.
†† The dose-based reporting rate for DTAP was calculated using the sum of the total numbers of net distributed doses of DTAP and DTaP-HIB (Table 1) as
denominator.
§§ The dose-based reporting rate for HIBV was calculated using the sum of the total numbers of net distributed doses of HIBV and DTaP-HIB (Table 1) as
denominator.
¶¶ Data from vaccine types not listed in Table 3.
*** Total number of reports received in VAERS, by year, not the total of each column. The total percentages are not applicable because each report might
include multiple vaccine types or vaccine combinations.
††† Not applicable.
Vol. 52 / SS-1 Surveillance Summaries 15
TABLE 3 (
Continued
). Vaccine Adverse Event Reporting System (VAERS) reports and dose-based reporting rates for frequently
reported vaccine types* — United States, 1991–2001
Year report received
Vaccine 1997 1998 1999 2000 2001 1991–2001
type No. (%) No. (%) No. (%) No. (%) No. (%) No. Rate¶
ANTH — 0 62 (0.6) 629 (4.8) 1,004 (6.7) 123 (0.8) 1,822 91.8
DT 173 (1.5) 82 (0.8) 79 (0.6) 135 (0.9) 131 (0.9) 1,574 14.9
DTAP†† 1,175 (10.0) 1,772 (16.3) 2,515 (19.2) 2,996 (19.9) 4,059 (27.5) 14,016 12.5
DTP 675 (5.8) 312 (2.9) 293 (2.2) 203 (1.3) 187 (1.3) 19,291 26.2
DTPH 1,124 (9.6) 278 (2.6) 124 (0.9) 75 (0.5) 34 (0.2) 5,968 12.4
FLU 1,770 (15.1) 1,900 (17.5) 1,786 (13.6) 1,771 (11.8) 1,674 (11.3) 15,652 3.1
HBHEPB 31 (0.3) 128 (1.2) 300 (2.3) 621 (4.1) 940 (6.4) 2,020 12.9
HEP 2,966 (25.4) 2,802 (25.8) 2,755 (21.1) 2,604 (17.3) 2,334 (15.8) 32,559 11.8
HEPA 309 (2.6) 306 (2.8) 399 (3.0) 594 (3.9) 753 (5.1) 2,734 8.6
HIBV§§ 1,178 (10.1) 1,378 (12.7) 1,842 (14.1) 1,783 (11.8) 1,884 (12.8) 22,145 18.1
IPV 365 (3.1) 642 (5.9) 1,169 (8.9) 2,220 (14.7) 3,135 (21.3) 7,920 13.1
JEV 30 (0.3) 33 (0.3) 25 (0.2) 31 (0.2) 28 (0.2) 229 19.1
LYME — 0 — 0 386 (2.9) 781 (5.2) 367 (2.5) 1,534 103.1
M 26 (0.2) 33 (0.3) 28 (0.2) 11 (<0.1) 15 (0.1) 387 12.0
MEN 35 (0.3) 96 (0.9) 64 (0.5) 171 (1.1) 158 (1.1) 630 7.9
MMR 1,994 (17.0) 1,923 (17.7) 2,189 (16.7) 2,549 (16.9) 3,315 (22.5) 23,787 16.3
OPV 1,803 (15.4) 1,153 (10.6) 1,168 (8.9) 348 (2.3) 174 (1.2) 23,141 15.1
PNC — 0 — 0 — 0 817 (5.4) 2,871 (19.5) 3,688 12.8
PPV 590 (5.0) 809 (7.4) 958 (7.3) 958 (6.4) 1,058 (7.2) 6,398 10.9
R 46 (0.4) 47 (0.4) 24 (0.2) 74 (0.5) 41 (0.3) 611 18.8
RAB 198 (1.7) 112 (1.0) 126 (1.0) 190 (1.3) 126 (0.9) 1,561 68.3
RV — 0 24 (0.2) 540 (4.1) 117 (0.8) 27 (0.2) 708 156.3
TD 1,001 (8.6) 1,079 (9.9) 1,160 (8.9) 1,207 (8.0) 726 (4.9) 9,692 6.3
TTOX 123 (1.1) 126 (1.2) 134 (1.0) 130 (0.9) 119 (0.8) 1,230 4.9
TYP 141 (1.2) 136 (1.3) 157 (1.2) 220 (1.5) 217 (1.5) 1,652 37.8
VARCEL 2,424 (20.7) 1,929 (17.7) 2,708 (20.7) 2,870 (19.1) 2,696 (18.3) 15,180 50.0
YF 42 (0.4) 53 (0.5) 69 (0.5) 93 (0.6) 104 (0.7) 615 9.6
Other¶¶ 33 (0.3) 34 (0.3) 53 (0.4) 137 (0.9) 438 (3.0) — —
Total*** 11,711 ††† 10,898 ††† 13,157 ††† 15,153 ††† 14,752 ††† 128,717 †††
* The frequently reported vaccine types were defined as the vaccine types for which a total of >100 reports were received during 1991–2001.
†VAERS coding terms for vaccine types. See the Vaccine Codes Used in This Report section for a description of each coding term. Each vaccine type might
represent similar vaccines from multiple vaccine manufacturers. Vaccines were either reported alone or in combination with other vaccines.
§Percentages represent the proportion of reports concerning the vaccine type among the total number of reports in each year.
¶Number of reports per 100,000 net vaccine doses distributed. The dose-based reporting rates were calculated using the 11-year (1991–2001) total
number of reports as numerators and the 11-year total number of net doses of vaccines distributed (Table 1) as denominators.
** Not available.
†† The dose-based reporting rate for DTAP was calculated using the sum of the total numbers of net distributed doses of DTAP and DTaP-HIB (Table 1) as
denominator.
§§ The dose-based reporting rate for HIBV was calculated using the sum of the total numbers of net distributed doses of HIBV and DTaP-HIB (Table 1) as
denominator.
¶¶ Data from vaccine types not listed in Table 3.
*** Total number of reports received in VAERS, by year, not the total of each column. The total percentages are not applicable because each report might
include multiple vaccine types or vaccine combinations.
††† Not applicable.
TABLE 4. Vaccine Adverse Event Reports System reports, by age groups — United States, 1991–2001
Age groups (yrs)
<1 1–67–17 18–64 >65 Unknown* Year total
Year No. (%) No. (%) No. (%) No. (%) No. (%) No. (%) No. (%)
1991 2,543 (25.4) 2,531 (25.3) 394 (3.9) 2,936 (29.3) 281 (2.8) 1,319 (13.2) 10,004 (100.0)
1992 2,426 (22.4) 2,378 (22.0) 458 (4.2) 3,744 (34.6) 416 (3.8) 1,399 (12.9) 10,821 (100.0)
1993 2,296 (22.2) 2,154 (20.9) 537 (5.2) 3,838 (37.2) 410 (4.0) 1,092 (10.6) 10,327 (100.0)
1994 2,616 (25.3) 2,208 (21.3) 547 (5.3) 3,411 (32.9) 472 (4.6) 1,101 (10.6) 10,355 (100.0)
1995 2,439 (23.7) 2,484 (24.1) 700 (6.8) 3,204 (31.1) 503 (4.9) 971 (9.4) 10,301 (100.0)
1996 2,159 (19.2) 2,832 (25.2) 943 (8.4) 3,629 (32.3) 511 (4.5) 1,164 (10.4) 11,238 (100.0)
1997 1,732 (14.8) 3,294 (28.1) 1,240 (10.6) 3,734 (31.9) 698 (6.0) 1,013 (8.6) 11,711 (100.0)
1998 1,356 (12.4) 2,891 (26.5) 1,317 (12.1) 3,670 (33.7) 706 (6.5) 958 (8.8) 10,898 (100.0)
1999 1,743 (13.2) 3,557 (27.0) 1,496 (11.4) 4,563 (34.7) 710 (5.4) 1,088 (8.3) 13,157 (100.0)
2000 1,725 (11.4) 4,466 (29.5) 1,443 (9.5) 5,384 (35.5) 818 (5.4) 1,317 (8.7) 15,153 (100.0)
2001 2,260 (15.3) 5,620 (38.1) 1,170 (7.9) 3,913 (26.5) 774 (5.2) 1,015 (6.9) 14,752 (100.0)
Total 23,295 (18.1) 34,415 (26.7) 10,245 (8.0) 42,026 (32.6) 6,299 (4.9) 12,437 (9.7) 128,717 (100.0)
*Age unknown because of missing information regarding date of birth and age.
16 MMWR January 24, 2003
TABLE 5. Vaccine Adverse Event Reporting System (VAERS)
reports of frequently reported vaccines or vaccine
combinations* — United States, 1991–1995
Vaccines or
vaccine combinations No. (%†) Total %
HEP 12,519 (24.2) 24.2
DTP HIBV OPV 5,344 (10.3) 34.5
FLU 4,696 (9.1) 43.5
MMR 3,386 (6.5) 50.1
TD 2,510 (4.8) 54.9
DTP OPV 2,300 (4.4) 59.4
DTP 1,595 (3.1) 62.4
DTP HIBV 1,564 (3.0) 65.5
DTP HEP HIBV OPV 1,543 (3.0) 68.4
DTP MMR OPV 1,523 (2.9) 71.4
DTP HIBV MMR OPV 1,429 (2.8) 74.1
PPV 974 (1.9) 76.0
HIBV MMR 880 (1.7) 77.7
DTPH OPV 877 (1.7) 79.4
DTPH HEP OPV 784 (1.5) 80.9
HIBV 722 (1.4) 82.3
RAB 646 (1.2) 83.6
VARCEL 574 (1.1) 84.7
FLU PPV 455 (0.9) 85.5
TYP 408 (0.8) 86.3
DT 397 (0.8) 87.1
MMR TD 395 (0.8) 87.9
TTOX 384 (0.7) 88.6
DTPH 375 (0.7) 89.3
R 306 (0.6) 89.9
DTAP MMR OPV 265 (0.5) 90.4
DTAP OPV 227 (0.4) 90.9
DTP HIBV MMR 218 (0.4) 91.3
DTP HEP HIBV 215 (0.4) 91.7
M 197 (0.4) 92.1
DTP MMR 178 (0.3) 92.4
DTPH MMR OPV 156 (0.3) 92.7
DTAP HIBV MMR OPV 152 (0.3) 93.0
DTPH MMR 141 (0.3) 93.3
HEP MMR 128 (0.2) 93.5
HIBV MMR OPV 120 (0.2) 93.8
DTAP 117 (0.2) 94.0
MMR OPV TD 101 (0.2) 94.2
DTP HEP OPV 100 (0.2) 94.4
DTPH HEP 92 (0.2) 94.6
DTP HEP HIBV MMR OPV 89 (0.2) 94.7
HIBV OPV 89 (0.2) 94.9
MMR OPV 80 (0.2) 95.1
HEP TD 72 (0.1) 95.2
DT OPV 68 (0.1) 95.3
DT MMR OPV 67 (0.1) 95.5
DT MMR 66 (0.1) 95.6
FLU TD 63 (0.1) 95.7
MR 63 (0.1) 95.8
OPV 63 (0.1) 96.0
HEPA 61 (0.1) 96.1
YF 58 (0.1) 96.2
HEP HIBV OPV 57 (0.1) 96.3
DTP HIBV IPV 52 (0.1) 96.4
OPV TD 52 (0.1) 96.5
TD YF 50 (<0.1) 96.6
Other§1,765 (3.4) 100.0
* The frequently reported vaccines or vaccine combinations were defined
as the vaccines or vaccine combinations for which >50 reports were
received during1991–1995.
†Percentage represents the proportion of reports that include the vaccine
or vaccine combinations among the total number of reports (51,808)
during 1991–1995.
§Data from other vaccines or vaccine combinations not listed in Table 5.
Vol. 52 / SS-1 Surveillance Summaries 17
TABLE 6. Vaccine Adverse Event Reporting System reports
of frequently reported vaccines or vaccine combinations* —
United States, 1996–2001
Vaccines or
vaccine combinations No. (%†) Total %
VARCEL 9,820 (12.8) 12.8
HEP 9,022 (11.7) 24.5
FLU 8,125 (10.6) 35.1
TD 4,053 (5.3) 40.3
MMR 3,644 (4.7) 45.1
PPV 2,857 (3.7) 48.8
ANTH 1,635 (2.1) 50.9
FLU PPV 1,513 (2.0) 52.9
LYME 1,505 (2.0) 54.8
DTAP 1,242 (1.6) 56.5
HEPA 1,141 (1.5) 57.9
MMR VARCEL 1,117 (1.5) 59.4
DTAP HIBV IPV 1,109 (1.4) 60.8
PNC 1,014 (1.3) 62.1
DTPH HEP OPV 972 (1.3) 63.4
DTPH OPV 901 (1.2) 64.6
DTAP MMR OPV 851 (1.1) 65.7
DTAP IPV MMR 840 (1.1) 66.8
RAB 753 (1.0) 67.8
DTAP HIBV 711 (0.9) 68.7
DTAP HEP HIBV IPV 622 (0.8) 69.5
DTAP HBHEPB IPV 583 (0.8) 70.3
TTOX 547 (0.7) 71.0
HEP TD 520 (0.7) 71.6
HEP MMR 495 (0.6) 72.3
DTP HIBV OPV 460 (0.6) 72.9
DTPH 440 (0.6) 73.5
DTP HEP HIBV OPV 438 (0.6) 74.0
DTAP HBHEPB IPV PNC 437 (0.6) 74.6
DTAP PV 424 (0.6) 75.1
MMR TD 404 (0.5) 75.7
HIBV MMR 399 (0.5) 76.2
TYP 388 (0.5) 76.7
DTAP HIBV IPV PNC 374 (0.5) 77.2
HIBV 361 (0.5) 77.6
DTAP HIBV OPV 332 (0.4) 78.1
DTAP HIBV MMR 314 (0.4) 78.5
DTAP OPV 314 (0.4) 78.9
DTPH MMR 312 (0.4) 79.3
HEP VARCEL 280 (0.4) 79.7
R 265 (0.3) 80.0
DT 258 (0.3) 80.3
DTP 255 (0.3) 80.7
HEP HEPA 244 (0.3) 81.0
DTAP MMR 234 (0.3) 81.3
DTP HIBV 232 (0.3) 81.6
MEN 211 (0.3) 81.9
HIBV MMR VARCEL 203 (0.3) 82.1
DTAP HEP HIBV 194 (0.3) 82.4
HEP MMR TD 185 (0.2) 82.6
RV 180 (0.2) 82.9
DTAP HIBV MMR OPV 179 (0.2) 83.1
DTAP HIBV IPV RV 176 (0.2) 83.3
DTAP HIBV MMR VARCEL 176 (0.2) 83.6
DTAP HEP HIBV OPV 174 (0.2) 83.8
DTP MMR OPV 173 (0.2) 84.0
DTP OPV 167 (0.2) 84.2
DTAP HEP MMR OPV 163 (0.2) 84.4
DTAP VARCEL 162 (0.2) 84.6
DTAP HIBV PNC 158 (0.2) 84.9
DTPH MMR OPV 158 (0.2) 85.1
MMR PNC VARCEL 146 (0.2) 85.2
FLU TD 144 (0.2) 85.4
TABLE 6 (
Continued
). Vaccine Adverse Event Reporting
System reports of frequently reported vaccines or vaccine
combinations* — United States, 1996–2001
Vaccines or
vaccine combinations No. (%†) Total %
DTAP HIBV IPV MMR 142 (0.2) 85.6
DTAP HEP 140 (0.2) 85.8
DTP HIBV MMR 138 (0.2) 86.0
DTAP IPV MMR VARCEL 137 (0.2) 86.2
DTAP PNC 135 (0.2) 86.3
DTAP MMR OPV VARCEL 131 (0.2) 86.5
HEPA TYP 129 (0.2) 86.7
PPV TD 116 (0.2) 86.8
YF 112 (0.1) 87.0
DTPH HEP 110 (0.1) 87.1
DTAP IPV PNC 109 (0.1) 87.3
DTP HIBV IPV 108 (0.1) 87.4
M 108 (0.1) 87.5
MMR OPV VARCEL 108 (0.1) 87.7
DTAP HBHEPB 107 (0.1) 87.8
IPV MMR VARCEL 106 (0.1) 88.0
DTAP HIBV IPV MMR VARCEL 104 (0.1) 88.1
IPV 104 (0.1) 88.2
DTAP HEP OPV 99 (0.1) 88.3
DTAP HIBV MMR OPV VARCEL 99 (0.1) 88.5
DTPH HEP IPV 99 (0.1) 88.6
DTPH IPV 98 (0.1) 88.7
DTAP HEP HIBV IPV PNC 97 (0.1) 88.9
HBHEPB 93 (0.1) 89.0
JEV 88 (0.1) 89.1
HEP PNC 86 (0.1) 89.2
DTAP HEPA IPV MMR 85 (0.1) 89.3
DTAP OPV VARCEL 85 (0.1) 89.4
DTAP HEP HIBV IPV RV 80 (0.1) 89.5
MMR OPV 78 (0.1) 89.6
UNK 78 (0.1) 89.7
DTPH MMR VARCEL 77 (0.1) 89.8
HEP MMR VARCEL 77 (0.1) 89.9
PNC VARCEL 76 (<0.1) 90.0
FLU PPV TD 74 (<0.1) 90.1
HEPA TD 74 (<0.1) 90.2
DTPH HEP MMR OPV 73 (<0.1) 90.3
DTAP HIBV VARCEL 71 (<0.1) 90.4
DTP HIBV MMR OPV 68 (<0.1) 90.5
OPV 68 (<0.1) 90.6
DTAP HBHEPB PNC 66 (<0.1) 90.7
DTP MMR 66 (<0.1) 90.8
DT HEP 64 (<0.1) 90.8
DTAP HBHEPB IPV RV 64 (<0.1) 90.9
DTAP HEP HIBV PNC 64 (<0.1) 91.0
DTAP MMR VARCEL 64 (<0.1) 91.1
IPV MMR 64 (<0.1) 91.2
DTAP HBHEPB IPV MMR 61 (<0.1) 91.3
DTAP HEP IPV 59 (<0.1) 91.3
HIBV VARCEL 59 (<0.1) 91.4
DTP HEP HIBV IPV 58 (<0.1) 91.5
DTP HEP OPV 56 (<0.1) 91.6
MMR PNC 55 (<0.1) 91.6
FLU HEP 54 (<0.1) 91.7
HEPA PNC 52 (<0.1) 91.8
DTAP HEP IPV MMR 50 (<0.1) 91.8
Other§6,280 (8.2) 100.0
* Frequently reported vaccines or vaccine combinations were defined as
the vaccines or vaccine combinations for which >50 reports were received
during1996–2001.
†Percentage represents the proportion of reports that include the vaccine
or vaccine combinations among the total number of reports (76,909)
during1996–2001.
§Data from other vaccines or vaccine combinations not listed in Table 6.
18 MMWR January 24, 2003
TABLE 7. Frequently reported adverse events* in the Vaccine Adverse Event Reporting System (VAERS) — United States,
1991–2001
Adverse event No. (%) Adverse event No. (%) Adverse event No. (%)
Fever 33,172 (25.8) Abdominal pain 2,254 (1.8) Faci al paralysis 580 (0.5)
Injection-site hypersensitivity 20,359 (15.8) Cellulitis 2,148 (1.7) Confusion 579 (0.4)
Rash 14,112 (11.0) Lab test abnormal 2,056 (1.6) Paralysis 574 (0.4)
Injection-site edema 13,960 (10.8) Myasthenia 1,812 (1.4) Injection-site inflammation 572 (0.4)
Vasodilatation 13,929 (10.8) Cyanosis 1,804 (1.4) Hypoxia 566 (0.4)
Injection-site pain 10,382 (8.1) Chest pain 1,752 (1.4) Joint disorder 562 (0.4)
Infection 9,741 (7.6) Reaction unevaluable 1,704 (1.3) Respiratory disorder 556 (0.4)
Agitation 9,443 (7.3) Apnea 1,618 (1.3) Ataxia 555 (0.4)
Pruritus 8,908 (6.9) Exacerbation of underlying condition 1,606 (1.2) Eye disorder 543 (0.4)
Pain 8,755 (6.8) Otitis media 1,538 (1.2) Hyperventilation 539 (0.4)
Myalgia 8,233 (6.4) Insomnia 1,526 (1.2) Autism 530 (0.4)
Urticaria 7,793 (6.1) Twitching 1,511 (1.2) Sedimentation rate increased 530 (0.4)
Possible vaccine failure 7,625 (5.9) Febrile seizure 1,490 (1.2) Accidental injury 530 (0.4)
Headache 7,068 (5.5) Asthma 1,373 (1.1) Petechiae 510 (0.4)
Injection-site mass 6,987 (5.4) Ecchymosis 1,347 (1.0) Amblyopia 507 (0.4)
Vomiting 6,633 (5.2) Neck pain 1,323 (1.0) Mental retardation 498 (0.4)
Asthenia 6,431 (5.0) Positive rechallenge 1,292 (1.0) Erythema multiforme 483 (0.4)
Convulsion 5,639 (4.4) Back pain 1,277 (1.0) Anemia 482 (0.4)
Maculopapular rash 5,489 (4.3) Tachycardia 1,269 (1.0) Encephalitis 480 (0.4)
Arthralgia 5,364 (4.2) Eyes gaze upward 1,249 (1.0) SGOT increased†477 (0.4)
Nausea 5,260 (4.1) Neuropathy 1,154 (0.9) SGPT increased§459 (0.4)
Vesiculobullous rash 5,237 (4.1) Skin nodule 1,134 (0.9) Thinking abnormality 457 (0.4)
Screaming syndrome 5,020 (3.9) Arthrosis 1,129 (0.9) Dyspepsia 454 (0.4)
Dizziness 4,274 (3.3) Hypertension 1,038 (0.8) Anaphylactoid reaction 452 (0.4)
Peripheral edema 4,165 (3.2) Hypotension 1,021 (0.8) Gastrointestinal disorder 449 (0.3)
Malaise 4,159 (3.2) Leukocytosis 1,021 (0.8) Previous reaction 442 (0.3)
Somnolence 4,093 (3.2) Abnormal gait 998 (0.8) Serum sickness 428 (0.3)
Paresthesia 4,075 (3.2) Arthritis 972 (0.8) Injection-site abscess 426 (0.3)
Crying abnormal 4,017 (3.1) Skin discoloration 909 (0.7) Abnormal electroencephalogram 420 (0.3)
Diarrhea 3,854 (3.0) Herpes zoster 892 (0.7) Leukopenia 417 (0.3)
Dyspnea 3,692 (2.9) Laryngismus 881 (0.7) Sepsis 416 (0.3)
Pharyngitis 3,623 (2.8) Pneumonia 879 (0.7) Weight loss 415 (0.3)
Hypokinesia 3,536 (2.7) Conjunctivitis 860 (0.7) Vertigo 412 (0.3)
Edema 3,504 (2.7) Speech disorder 848 (0.7) Heart arrest 410 (0.3)
Chills 3,403 (2.6) Neck rigidity 829 (0.6) Bronchitis 407 (0.3)
Stupor 3,272 (2.5) Guillain-Barré syndrome 820 (0.6) Grand malconvulsion 402 (0.3)
Anorexia 3,219 (2.5) Nausea and vomiting 812 (0.6) Anxiety 391 (0.3)
Pallor 3,094 (2.4) Sudden infant death 808 (0.6) Hepatitis 387 (0.3)
Face edema 2,869 (2.2) Chills and fever 722 (0.6) Skin disorder 364 (0.3)
Rhinitis 2,733 (2.1) Liver function tests abnormal 717 (0.6) Ear disorder 362 (0.3)
Cough increased 2,657 (2.1) Personality disorder 678 (0.5) Bradycardia 359 (0.3)
Lymphadenopathy 2,635 (2.0) Thrombocytopenia 640 (0.5) Infect viral 358 (0.3)
Hypotonia 2,619 (2.0) Lung disorder 614 (0.5) Vasculitis 353 (0.3)
Tremor 2,615 (2.0) Abnormal vision 609 (0.5) Hemorrhage 338 (0.3)
Hypertonia 2,545 (2.0) Dehydration 603 (0.5) Increased salivation 336 (0.3)
Flu syndrome 2,532 (2.0) Dysphagia 603 0.5) Lacrimation disorder 334 (0.3)
Injection-site reaction 2,496 (1.9) Cerebrospinal fluid abnormal 600 (0.5) Hypoventilation 321 (0.2)
Syncope 2,437 (1.9) Meningitis 592 (0.5) Abscess 318 (0.2)
Sweating 2,301 (1.8) Skin ulcer 584 (0.5) Jaundice 317 (0.2)
Allergic reaction 2,281 (1.8) Nervousness 583 (0.5) Eye pain 316 (0.2)
* Frequently reported adverse events were defined as the adverse events that were mentioned in >100 VAERS reports during1991–2001. Each report might include multiple
adverse events. The percentages represent the proportion of each frequently reported adverse event among the total number of VAERS reports (128,717) during 1991–2001.
†SGOT — Serum glutamic oxaloacetic transaminase.
§SGPT — Serum glutamic pyruvic transaminase.
Vol. 52 / SS-1 Surveillance Summaries 19
TABLE 7 (
Continued
). Frequently reported adverse events* in the Vaccine Adverse Event
Reporting System (VAERS) — United States, 1991–2001
Adverse event No. (%) Adverse event No. (%)
Palpitations 313 (0.2) Gastrointestinal hemorrhage 183 (0.1)
Tongue edema 310 (0.2) Reflexes decreased 178 (0.1)
Ear pain 302 (0.2) Opisthotonos 173 (0.1)
Sinusitis 298 (0.2) Dry mouth 171 (0.1)
Angioedema 296 (0.2) Optic neuritis 171 (0.1)
Rheumatoid arthritis 295 (0.2) Thrombocythemia 171 (0.1)
Immune system disorder 292 (0.2) Lactic dehydrogenase increased 167 (0.1)
Antinuclear antibody present 288 (0.2) Arrhythmia 164 (0.1)
Deafness 287 (0.2) Epistaxis 163 (0.1)
Myelitis 280 (0.2) Lupus syndrome 163 (0.1)
Hypothermia 275 (0.2) Photophobia 163 (0.1)
Hyperglycemia 268 (0.2) Eczema 159 (0.1)
Tinnitus 268 (0.2) Hallucinations 157 (0.1)
Migraine 267 (0.2) Hematuria 156 (0.1)
Thrombocytopenic purpura 267 (0.2) Tongue disorder 156 (0.1)
Multiple sclerosis 264 (0.2) Neuralgia 155 (0.1)
Amnesia 262 (0.2) Lung edema 152 (0.1)
Incoordination 261 (0.2) Circumoral paresthesia 152 (0.1)
Alopecia 260 (0.2) Diplopia 150 (0.1)
Voice alteration 259 (0.2) Thirst 148 (0.1)
Abortion 257 (0.2) Bone disorder 145 (0.1)
Shock 253 (0.2) Intussusception 143 (0.1)
Purpura 251 (0.2) Fetal disorder 142 (0.1)
Bacterial infection 250 (0.2) Muscle atrophy 140 (0.1)
Skin striae 247 (0.2) Mydriasis 139 (0.1)
Mouth ulceration 246 (0.2) Emotional liability 138 (0.1)
Constipation 242 (0.2) Blindness 137 (0.1)
Acute brain syndrome 240 (0.2) Tendon disorder 137 (0.1)
Hypesthesia 238 (0.2) Hostility 136 (0.1)
Urinary incontinence 237 (0.2) Photosensitivity reaction 131 (0.1)
Movement disorder 237 (0.2) Visual field defect 131 (0.1)
Coma 230 (0.2) Apathy 129 (0.1)
Hyperkinesia 227 (0.2) Hemiplegia 129 (0.1)
Staladenitis 226 (0.2) Lymphocytosis 129 (0.1)
Cardiovascular disorder 225 (0.2) Pustular rash 128 (<0.1)
Encephalopathy 224 (0.2) Creatine phosphokinase increased 127 (<0.1)
Urine abnormality 223 (0.2) Stomatitis 121 (<0.1)
Bilirubinemia 221 (0.2) Injection-site hemorrhage 119 (<0.1)
Gastroenteritis 218 (0.2) Intracranial hypertension 118 (<0.1)
Peripheral vascular disorder 215 (0.2) Gamma glutamyl transpeptidase increased 117 (<0.1)
Urinary tract infection 213 (0.2) Abnormal stools 111 (<0.1)
Exfokiative dermatitis 212 (0.2) Hypochromic anemia 109 (<0.1)
Myopathy 199 (0.2) Bone pain 109 (<0.1)
Alkaline phosphatase increased 199 (0.2) Cerebrovascular accident 106 (<0.1)
Depression 196 (0.2) Hepatomegaly 106 (<0.1)
Diabetes mellitus 196 (0.2) Myositis 103 (<0.1)
Neuritis 195 (0.2) Parotid gland enlargement 103 (<0.1)
Taste perversion 191 (0.1) Flatulence 102 (<0.1)
Laryngitis 190 (0.1) Liver damage 102 (<0.1)
Generalized spasm 186 (0.1)
* Frequently reported adverse events were defined as the adverse events that were mentioned in >100 VAERS reports
during1991–2001. Each report might include multiple adverse events. The percentages represent the proportion of each
frequently reported adverse event among the total number of VAERS reports (128,717) during 1991–2001.
†SGOT — Serum glutamic oxaloacetic transaminase.
§SGPT — Serum glutamic pyruvic transaminase.
20 MMWR January 24, 2003
TABLE 8. Vaccine Adverse Event Reporting System (VAERS) reports, by reporting source — United States, 1991–2001
Year report received
1991 1992 1993 1994 1995 1996
Reporting source No. (%) No. (%) No. (%) No. (%) No. (%) No. (%)
Manufacturer 3,947 (39.5) 4,207 (38.9) 3,661 (35.5) 3,290 (31.8) 3,212 (31.2) 4,261 (37.9)
Patient/Parent 101 (1.0) 134 (1.2) 176 (1.7) 265 (2.6) 372 (3.6) 449 (4.0)
Provider 1,138 (11.4) 1,385 (12.8) 1,328 (12.9) 1,558 (15.0) 1,842 (17.9) 2,059 (18.3)
State health coordinator 3,992 (39.9) 3,974 (36.7) 3,984 (38.6) 4,019 (38.8) 3,566 (34.6) 2,998 (26.7)
Other* 486 (4.9) 665 (6.1) 726 (7.0) 697 (6.7) 765 (7.4) 822 (7.3)
Unknown†340 (3.4) 456 (4.2) 452 (4.4) 526 (5.1) 544 (5.3) 649 (5.8)
Total 10,004 (100.0) 10,821 (100.0) 10,327 (100.0) 10,355 (100.0) 10,301 (100.0) 11,238 (100.0)
TABLE 8 (
Continued
). Vaccine Adverse Event Reporting System (VAERS) reports, by reporting source — United States, 1991–2001
Year report received
1997 1998 1999 2000 2001 Total
Reporting source No. (%) No. (%) No. (%) No. (%) No. (%) No. (%)
Manufacturer 4,662 (39.8) 3,861 (35.4) 4,670 (35.5) 5,846 (38.6) 4,946 (33.5) 46,563 (36.2)
Patient/Parent 422 (3.6) 482 (4.4) 966 (7.3) 1,087 (7.2) 902 (6.1) 5,356 (4.2)
Provider 1,945 (16.6) 1,968 (18.1) 2,870 (21.8) 4,454 (29.4) 5,207 (35.3) 25,754 (20.0)
State health coordinator 3,244 (27.7) 2,927 (26.9) 2,531 (19.2) 2,178 (14.4) 2,115 (14.3) 35,528 (27.6)
Other* 832 (7.1) 960 (8.8) 1,378 (10.5) 1,102 (7.3) 997 (6.8) 9,430 (7.3)
Unknown†606 (5.2) 700 (6.4) 742 (5.6) 486 (3.2) 585 (4.0) 6,086 (4.7)
Total 11,711 (100.0) 10,898 (100.0) 13,157 (100.0) 15,153 (100.0) 14,752 (100.0) 128,717 (100.0)
* Reported by persons other than manufacturers, patients/parents, providers, or state health coordinators.
†Unknown reporting source because of missing information.
TABLE 9. Nonserious and serious* Vaccine Adverse Event Report System (VAERS)† reports — United States, 1991–2001
Year report received
1991 1992 1993 1994 1995 1996
Category No. (%) No. (%) No. (%) No. (%) No. (%) No. (%)
Nonserious total 8,703 (87.0) 9,380 (86.7) 8,875 (85.9) 8,810 (85.1) 8,835 (85.8) 9,783 (87.1)
Serious
Patient died 167 (1.7) 228 (2.1) 235 (2.3) 236 (2.3) 159 (1.5) 152 (1.4)
Life-threatening illness 142 (1.4) 223 (2.1) 182 (1.8) 220 (2.1) 223 (2.2) 217 (1.9)
Required hospitalization 1,019 (10.2) 1,079 (10.0) 1,091 (10.6) 1,152 (11.1) 1,145 (11.1) 1,100 (9.8)
Resulted in prolongation
of hospitalization 45 (0.4) 37 (0.3) 62 (0.6) 76 (0.7) 62 (0.6) 122 (1.1)
Resulted in permanent
disability 172 (1.7) 151 (1.4) 182 (1.8) 243 (2.3) 189 (1.8) 227 (2.0)
Total 1,301 (13.0) 1,441 (13.3) 1,452 (14.1) 1,545 (14.9) 1,466 (14.2) 1,455 (12.9)
TOTAL§10,004 (100.0) 10,821 (100.0) 10,327 (100.0) 10,355 (100.0) 10,301 (100.0) 11,238 (100.0)
TABLE 9 (
Continued
). Nonserious and serious* Vaccine Adverse Event Report System (VAERS)† reports — United States, 1991–2001
Year report received
1997 1998 1999 2000 2001 Total
Category No. (%) No. (%) No. (%) No. (%) No. (%) No. (%)
Nonserious total 10,123 (86.4) 9,225 (84.6) 11,120 (84.5) 13,147 (86.8) 12,420 (84.2) 110,421 (85.8)
Serious
Patient died 176 (1.5) 172 (1.6) 180 (1.4) 213 (1.4) 224 (1.5)
Life-threatening illness 212 (1.8) 246 (2.3) 369 (2.8) 279 (1.8) 306 (2.1)
Required hospitalization 1,205 (10.3) 1,209 (11.1) 1,424 (10.8) 1,373 (9.1) 1,527 (10.4)
Resulted in prolongation
of hospitalization 163 (1.4) 415 (3.8) 322 (2.4) 62 (0.4) 91 (0.6)
Resulted in permanent
disability 258 (2.2) 313 (2.9) 420 (3.2) 428 (2.8) 594 (4.0)
Total 1,588 (13.6) 1,673 (15.4) 2,037 (15.5) 2,006 (13.2) 2,332 (15.8) 18,296 (14.2)
TOTAL§11,711 (100.0) 10,898 (100.0) 13,157 (100.0) 15,153 (100.0) 14,752 (100.0) 128,717 (100.0)
* According to the regulatory definition, serious adverse events involve hospitalization or prolongation of hospitalization, death, or reported life-threatening
illness or permanent disability. Food and Drug Administration 21 CFR Part 600.80. Postmarketing reporting of adverse experiences. Federal Register
1997;62:52252–3.
†Serious categories are not mutually exclusive. One VAERS report may involve >1 serious category. The percentages for each serious category represent
the proportion of the number of reports involved in that category among the total number of reports in each year.
§Total numbers of reports received in VAERS, by year (not the total of each column), which equal to the sum of the nonserious totals and the serious totals.
Vol. 52 / SS-1 Surveillance Summaries 21
TABLE 10. Vaccine Adverse Event Report System (VAERS) reports on DTaP,*
DTP,† and DTPH§ for children aged <7 years — United States, 1991–2001
Report Nonserious Serious¶
year DTAP DTP DTPH Total DTAP DTP DTPH Total
1991 —** 3,579 — 3,579 — 662 — 662
1992 59 3,325 — 3,384 6 651 — 657
1993 160 2,717 135 3,012 20 570 41 631
1994 288 2,275 736 3,299 34 524 209 767
1995 349 1,650 1,173 3,172 42 355 247 644
1996 476 955 1,524 2,955 51 220 250 521
1997 973 496 918 2,387 194 157 203 554
1998 1,468 184 238 1,890 285 113 38 436
1999 2,003 177 86 2,266 490 107 35 632
2000 2,484 97 33 2,614 476 92 40 608
2001 3,432 94 17 3,543 576 80 15 671
Total 11,692 15,549 4,860 32,101 2,174 3,531 1,078 6,783
Rate†† 10.5 21.1 10.1 13.7 1.9 4.8 2.2 2.9
* Diphtheria and tetanus toxoids and acellular pertussis vaccine.
†Diphtheria and tetanus toxoids and pertussis vaccine.
§Diphtheria and tetanus toxoids and pertussis vaccine and
Haemophilus
b conjugate vaccine.
¶According to the regulatory definition, serious adverse events involve hospitalization or pro-
longation of hospitalization, death, or reported life-threatening illness or permanent disabil-
ity. Food and Drug Administration. 21 CFR Part 600.80. Postmarketing reporting of adverse
experiences. Federal Register 1997;62:52252–3.
** Not availabl e.
†† Number of reports per 100,000 net doses distributed. Calculated by using the total numbers
of reports as numerators and the total net doses of the vaccines distributed (Table 1) as
denominators.
22 MMWR January 24, 2003
FIGURE 1. Vaccine Adverse Event Reporting System (VAERS)
reports, by age and sex — United States, 1991–2001
* Age not included because of missing information.
†Sex not included because of missing information.
Percentage of all reports
0
10
20
30
40
50
60
70
80
<1 1–6
–
7–17
–
18–64
–
>65 Unknown
†
Age group (yrs)
Male
Female
Unknown*
FIGURE 3. Number of intussusception reports after the rhesus
rotavirus vaccine-tetravalent (RRV-TV) by vaccination date —
United States, September 1998–December 1999
0
10
20
30
40
Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec
Date of vaccination (mo)
Number of reports
FIGURE 2. Number of intussusception reports after the rhesus
rotavirus vaccine-tetravalent (RRV-TV) — United States,
September 1998–December 1999
* CDC. Intussusception among recipients of rotavirus vaccine—United
States, 1998–1999. MMWR 1999;48:577–81.
0
10
20
30
40
50
60
Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Date of reports (mo)
MMWR*
Number of reports
FIGURE 4. Number of intussusception reports after any
vaccines, by vaccination date — United States, January 1991–
December 1999
0
10
20
30
40
1991 1992 1993 1994 1995 1996 1997 1998 1999
Date of vaccination (mo)
Number of reports
Vol. 52 / SS-1 Surveillance Summaries 23
FIGURE 7. Reports of febrile seizure and other convulsive
disorders after DTaP,* DTP,† or DTPH§ vaccination — United
States, 1991–2001
* Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed.
†Diphtheria and tetanus toxoids and pertussis vaccine adsorbed.
§Diphtheria and tetanus toxoids and pertussis vaccine adsorbed and
Haemophilus
b conjugate vaccine (diphtheria CRM197 protein conjugate).
Percentage of all reports
0
10
20
30
40
50
60
70
80
<1 1–6
–7–17–18–64–>65 Unknown†
Age group (yrs)
Male
Female
Unknown*
FIGURE 8. Reports of injection-site edema after fourth and
fifth doses of DTaP,* DTP,† or DTPH§ vaccination — United
States, 1991–2001
* Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed.
†Diphtheria and tetanus toxoids and pertussis vaccine adsorbed.
§Diphtheria and tetanus toxoids and pertussis vaccine adsorbed and
Haemophilus
b conjugate vaccine (diphtheria CRM197 protein conjugate).
0
100
200
300
400
500
600
1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001
Date of vaccination (yr)
DTaP
DTP
DTPH
Number of reports
FIGURE 5. Reports of Guillain-Barré syndrome after influenza
vaccination, by influenza seasons — United States, 1991–2001
* Net doses distributed equals total doses distributed during the period,
less returned doses.
Percentage of all reports
0
10
20
30
40
50
60
70
80
<1 1–6
–
7–17
–
18–64
–
>65 Unknown†
Age group (yrs)
Male
Female
Unknown*
FIGURE 6. Reports of fever after DTaP,* DTP,† or DTPH§
vaccination — United States, 1991–2001
* Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed.
†Diphtheria and tetanus toxoids and pertussis vaccine adsorbed.
§Diphtheria and tetanus toxoids and pertussis vaccine adsorbed and
Haemophilus
b conjugate vaccine (diphtheria CRM197 protein conjugate).
0
500
1,000
1,500
2,000
2,500
1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001
Date of vaccination (yr)
DTaP
DTP
DTPH
Number of reports
Please note: An erratum has been published for this issue. To view the erratum, please click here.
24 MMWR January 24, 2003
FIGURE 9. Reports of vaccine-associated paralytic
poliomyelitis (VAPP) after OPV* vaccination — United States,
1991–2001†
* Oral poliovirus vaccine live trivalent.
†No VAPP case after inactivated poliovirus vaccine during 1991–2001
was reported to the Vaccine Adverse Event Reporting System.
0
1
2
3
4
5
6
7
8
1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001
Date of vaccination (yr)
Number of reports
FIGURE 10. Reports of adverse events after varicella
vaccination — United States, 1991–2001
* Net doses distributed equals total doses distributed during the period,
less returned doses.
†According to the regulatory definition, serious adverse events involve
hospitalization or prolongation of hospitalization, death, or reported life-
threatening illness or permanent disability. Food and Drug Administration.
21 CFR Part 600.80. Postmarketing reporting of adverse experiences.
Federal Register 1997;62:52252–3.
0
500
1,000
1,500
2,000
2,500
3,000
1995 1996 1997 1998 1999 2000 2001
Date of vaccination (yr)
0.00
1.00
2.00
3.00
4.00
5.00
6.00
7.00
Serious
†
Doses
Number of reports
Net doses distributed* (millions)
Nonserious
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