Smallpox vaccine adverse events among civilians--United States,February 18-24, 2003

During the civilian smallpox vaccination program, CDC 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 (Table). 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 February 21, 2003, and received by CDC from the Vaccine Adverse Event Reporting System (VAERS) as of February 24.     

Smallpox vaccine adverse events among civilians--United States,February 25-March 3, 2003

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 (Table). 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 February 28, 2003, and among contacts of vaccinees, received by CDC from the Vaccine Adverse Event Reporting System (VAERS) as of March 3.     

Smallpox vaccine adverse events among civilians--United States,March 4-10, 2003

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 (Table). 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.     

Update: adverse events following smallpox vaccination--United States, 2003

During January 24-March 28, 2003, smallpox vaccine was administered to 29,584 civilian health-care and public health workers in 54 jurisdictions as part of an effort to prepare the United States for a terrorist attack using smallpox virus. This report summarizes data on ten cases of cardiac adverse events reported among civilian vaccinees since the beginning of the smallpox vaccination program, including three new cardiac adverse events reported to CDC from the Vaccine Adverse a fall Event Reporting System (VAERS) during March 24-30. Fourteen cases of myocarditis and one fatal myocardial infarction have been reported among military personnel. This report summarizes data on the three new cases of cardiac adverse events, updates data on seven previously reported cases among civilian vaccinees (Table 1), summarizes selected cases of cardiac adverse events among military vaccinees, and updates information on all adverse events reported in the civilian vaccination program as of March 30.     

Update: cardiac-related events during the civilian smallpox vaccination program--United States, 2003

During the pre-event smallpox vaccination program, the U.S. Department of Defense (DOD) and CDC have received reports of cardiac events after vaccination. A case definition for myo/pericarditis as a smallpox vaccine--associated adverse event has been developed in conjunction with DOD, the joint Smallpox Vaccine Safety Working Group of the Advisory Committee on Immunization Practices (ACIP) and the Armed Forces Epidemiology Board (AFEB), and consulting cardiologists, immunologists, and epidemiologists. The term myo/pericarditis is used for surveillance purposes to refer to patients who have myocarditis, pericarditis, or both (myopericarditis). Myo/pericarditis cases are classified into suspected, probable, and confirmed categories. Suspected cases include those that are investigated and reported, although the level of certainty for the diagnosis is lower. These definitions were used to categorize all cardiac-related reports among civilian vaccinees received through May 9, 2003; a total of 21 cases of myo/pericarditis were ascertained. All have been reported previously; however, some have been reclassified. In addition, nine cases of ischemic cardiac events (i.e., myocardial infarction [MI] or angina) among civilian vaccinees have been reported previously. This report includes the case definition of myo/pericarditis and updates information on all reports of cardiac adverse events among 36,217 civilian vaccinees since the beginning of the civilian smallpox vaccination program reported through May 9 to CDC from the Vaccine Adverse Event Reporting System (VAERS).     

Cardiac adverse events following smallpox vaccination--United States, 2003

During January 24-March 21, smallpox vaccine was administered to 25,645 civilian health-care and public health workers in 53 jurisdictions as part of an effort to prepare the United States in the event of a terrorist attack using smallpox. Seven cases of cardiac adverse events have been reported among civilian vaccinees since the beginning of the smallpox vaccination program. In addition, 10 cases of myopericarditis have been reported among military vaccinees. This report summarizes data on the seven cases reported among civilians and provides background information on recent military vaccinees. Although a causal association between vaccination and adverse cardiac events in the civilian population is unproven, as a precautionary measure, CDC recommends that persons with physician-diagnosed cardiac disease with or without symptoms (e.g., previous myocardial infarction, angina, congestive heart failure, or cardiomyopathy) be excluded from vaccination during this smallpox preparedness program.     

Supplemental recommendations on adverse events following smallpox vaccine in the pre-event vaccination program: recommendations of the Advisory Committee on Immunization Practices

The Advisory Committee on Immunization Practices (ACIP) has issued recommendations previously for use of smallpox vaccine and supplemental recommendations for use of smallpox vaccine in the pre-event civilian vaccination program. On March 28, 2003, CDC reported cases of cardiac adverse events among persons vaccinated recently with smallpox vaccine. In response to these reports, ACIP held an emergency meeting on March 28 to make recommendations to CDC about medical screening of potential vaccinees and follow-up of persons with cardiovascular risk factors after vaccination. These recommendations supplement those previously issued by ACIP.     

Update on adverse events following civilian smallpox vaccination--United States, 2003

During January 24-April 4, 2003, smallpox vaccine was administered to 31,297 civilian health-care and public health workers in 54 jurisdictions as part of an effort to prepare the United States for a possible terrorist attack using smallpox virus. This report updates information on all vaccine-associated adverse events among civilians vaccinated since the beginning of the smallpox vaccination program and among contacts of vaccinees, received by CDC from the Vaccine Adverse Event Reporting System (VAERS) as of April 4.     

Update: adverse events following civilian smallpox vaccination--United States, 2003

During January 24-August 8, 2003, smallpox vaccine was administered to 38,257 civilian health-care and public health workers in 55 jurisdictions to prepare the United States for a possible terrorist attack using smallpox virus. This report updates information on vaccine-associated adverse events among civilians vaccinated since the beginning of the program and among contacts of vaccinees, received by CDC from the Vaccine Adverse Event Reporting System (VAERS) as of August 8.     

Update: Adverse events following civilian smallpox vaccination--United States, 2003

During January 24-April 18, 2003, smallpox vaccine was administered to 33,444 civilian health-care and public health workers in 54 jurisdictions to prepare the United States for a possible terrorist attack using smallpox virus. This report updates information on vaccine-associated adverse events among civilians vaccinated since the beginning of the program and among contacts of vaccinees, received by CDC from the Vaccine Adverse Event Reporting System (VAERS) as of April 18.     

Update: adverse events following civilian smallpox vaccination--United States, 2003

During January 24-April 25, 2003, smallpox vaccine was administered to 34,541 civilian health-care and public health workers in 54 jurisdictions to prepare the United States for a possible terrorist attack using smallpox virus. This report updates information on vaccine-associated adverse events among civilians vaccinated since the beginning of the program and among contacts of vaccinees, received by CDC from the Vaccine Adverse Event Reporting System (VAERS) as of April 25.     

Update: adverse events following civilian smallpox vaccination--United States, 2003

During January 24-May 9, 2003, smallpox vaccine was administered to 36,217 civilian health-care and public health workers in 55 jurisdictions to prepare the United States for a possible terrorist attack using smallpox virus. This report updates information on vaccine-associated adverse events among civilians vaccinated since the beginning of the program and among contacts of vaccinees, received by CDC from the Vaccine Adverse Event Reporting System (VAERS) as of May 9.     

Update: adverse events following civilian smallpox vaccination--United States, 2003

During January 24--May 2, 2003, smallpox vaccine was administered to 35,903 civilian health-care and public health workers in 55 jurisdictions to prepare the United States for a possible terrorist attack using smallpox virus. This report updates information on vaccine-associated adverse events among civilians vaccinated since the beginning of the program and among contacts of vaccinees received by CDC from the Vaccine Adverse Event Reporting System (VAERS) as of May 2.     

Update: Adverse events following civilian smallpox vaccination--United States, 2003

During January 24-April 13, 2003, smallpox vaccine was administered to 32,644 civilian health-care and public health workers in 54 jurisdictions as part of an effort to prepare the United States for a possible terrorist attack using smallpox virus. This report updates information on all vaccine-associated adverse events among civilians vaccinated since the beginning of the vaccination program and among contacts of vaccinees, received by CDC from the Vaccine Adverse Event Reporting System (VAERS) as of April 13.     

Update: adverse events following civilian smallpox vaccination--United States, 2003

During January 24-December 31, 2003, smallpox vaccine was administered to 39,213 civilian health-care and public health workers in 55 jurisdictions to prepare the United States for a possible terrorist attack using smallpox virus. This report updates information on vaccine-associated adverse events among civilians vaccinated since the beginning of the program and among contacts of vaccinees, received by CDC from the Vaccine Adverse Event Reporting System (VAERS) during August 9-December 31.     

Smallpox Vaccine Adverse Events Monitoring and Response System for the first stage of the smallpox vaccination program

Smallpox vaccination of civilian volunteer health-care workers began on January 24, 2003. As of February 4, a total of 37 states and counties have received shipments of smallpox vaccine, and 18 states and counties have begun smallpox vaccination; no serious adverse events have been reported. To monitor the occurrence of adverse events associated with vaccination, both those expected on the basis of previous experience and possible new unexpected adverse events, CDC and state health departments have established the Smallpox Vaccine Adverse Events Monitoring and Response System. The system also will be used to monitor the effectiveness of contraindication screening, identify new contraindications, and coordinate the distribution of vaccinia immune globulin (VIG) and cidofovir to the civilian population. This notice describes the components of the system, delineates roles and responsibilities, and explains how data from the system will be compiled and communicated.     

Update: cardiac and other adverse events following civilian smallpox vaccination--United States, 2003

During January 24-June 20, 2003, smallpox vaccine was administered to 37,802 civilian health-care and public health workers in 55 jurisdictions to prepare the United States for a possible terrorist attack using smallpox virus. This report updates information on vaccine-associated adverse events among civilians vaccinated since the beginning of the program and among contacts of vaccinees, received by CDC from the Vaccine Adverse Event Reporting System (VAERS) as of June 20. Two cases of dilated cardiomyopathy (DCM) were diagnosed 3 months after vaccination. For the potential relation between smallpox vaccine and DCM to be assessed, identification of additional cases of DCM among vaccinees will be essential. Physicians who treat smallpox vaccine recipients are encouraged to evaluate and report patients with symptoms compatible with DCM, including those that occur several months after vaccination.     

Recommendations for using smallpox vaccine in a pre-event vaccination program. Supplemental recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Healthcare Infection Control Practices Advisory Committee (HICPAC).

This report supplements the 2001 statement by the Advisory Committee on Immunization Practices (ACIP) (CDC. Vaccinia [smallpox] vaccine: recommendations of the Advisory Committee on Immunization Practices [ACIP], 2001. MMWR 2001;50[No. RR-10]:1-25). This supplemental report provides recommendations for using smallpox vaccine in the pre-event vaccination program in the United States. To facilitate preparedness and response, smallpox vaccination is recommended for persons designated by public health authorities to conduct investigation and follow-up of initial smallpox cases that might necessitate direct patient contact. ACIP recommends that each state and territory establish and maintain > or = 1 smallpox response team. ACIP and the Healthcare Infection Control Practices Advisory Committee (HICPAC) recommend that each acute-care hospital identify health-care workers who can be vaccinated and trained to provide direct medical care for the first smallpox patients requiring hospital admission and to evaluate and manage patients who are suspected as having smallpox. When feasible, the first-stage vaccination program should include previously vaccinated health-care personnel to decrease the potential for adverse events. Additionally persons administering smallpox vaccine in this pre-event vaccination program should be vaccinated. Smallpox vaccine is administered by using the multiple-puncture technique with a bifurcated needle, packaged with the vaccine and diluent. According to the product labeling, 2-3 punctures are recommended for primary vaccination and 15 punctures for revaccination. A trace of blood should appear at the vaccination site after 15-20 seconds; if no trace of blood is visible, an additional 3 insertions should be made by using the same bifurcated needle without reinserting the needle into the vaccine vial. If no evidence of vaccine take is apparent after 7 days, the person can be vaccinated again. Optimal infection-control practices and appropriate site care should prevent transmission of vaccinia virus from vaccinated health-care workers to patients. Health-care personnel providing direct patient care should keep their vaccination sites covered with gauze in combination with a semipermeable membrane dressing to absorb exudates and to provide a barrier for containment of vaccinia virus to minimize the risk of transmission; the dressing should also be covered by a layer of clothing. Dressings used to cover the site should be changed frequently to prevent accumulation of exudates and consequent maceration. The most critical measure in preventing contact transmission is consistent hand hygiene. Hospitals should designate staff to assess dressings for all vaccinated health-care workers. When feasible, staff responsible for dressing changes for smallpox health-care teams should be vaccinated, all persons handling dressings should observe contact precautions. Administrative leave is not required routinely for newly vaccinated health-care personnel unless they are physically unable to work as a result of systemic signs and symptoms of illness; have extensive skin lesions that cannot be adequately covered or if they are unable to adhere to the recommended infection-control precautions. Persons outside the patient-care setting can keep their vaccination sites covered with a porous dressing hand hygiene remains key to preventing inadvertent inoculation. FDA has recommended that recipients of smallpox vaccine be deferred from donating blood for 21 days or until the scab has separated. Contacts of vaccinees, who have inadvertently contracted vaccinia, also should be deferred from donating blood for 14 days after complete resolution of their complication. In the pre-event vaccination program, smallpox vaccination is contraindicated for persons with a history or presence of eczema or atopic dermatitis; who have other acute, chronic, or exfoliative skin conditions; who have conditions associated with immunosuppression; are aged < 1 year; who have a serious allergy to any component of the vaccine; or who are pregnant or breastfeeding. ACIP does not recommend smallpox vaccination for children and adolescents aged < 18 years during the pre-event vaccination program. Pre-event vaccination also is contraindicated among persons with household contacts who have a history or presence of eczema or atopic dermatitis; who have other acute, chronic, or exfoliative skin conditions; who have conditions associated with immunosuppression; or who are pregnant. For purposes of screening for contraindications for pre-event vaccination, household contacts include persons with prolonged intimate contact (e.g., sexual contacts) with the potential vaccinee and others who might have direct contact with the vaccination site. Persons with inflammatory eye disease might be at increased risk for inadvertent inoculation as a result of touching or rubbing the eye. Therefore, deferring vaccination is prudent for persons with inflammatory eye diseases requiring steroid treatment until the condition resolves and the course of therapy is complete. Eczema vaccinatum, a serious form of disseminated vaccinia infection, can occur among persons with atopic dermatitis and other dermatologic conditions. Potential vaccinees should be queried regarding the diagnosis of atopic dermatitis or eczema in themselves or any member of their household, or regarding the presence of chronic or recurrent rashes consistent with these diagnoses. Persons reporting such a rash in themselves or household members should not be vaccinated, unless a health-care provider determines that the rash is not eczema or atopic dermatitis. Before vaccination, women of childbearing age should be asked if they are pregnant or intend to become pregnant during the next 4 weeks; women who respond positively should not be vaccinated. Any woman who thinks she might be pregnant or who wants additional assurance that she is not pregnant should perform a urine pregnancy test on the day scheduled for vaccination. If a pregnant woman is inadvertently vaccinated or if she becomes pregnant within 4 weeks after smallpox vaccination, she should be counseled regarding concerns for the fetus. Vaccination during pregnancy should not ordinarily be a reason to terminate pregnancy. CDC has established a pregnancy registry to prospectively follow the outcome of such pregnancies and facilitate the investigation of any adverse pregnancy outcome among pregnant women who were inadvertently vaccinated. For enrollment in the registry, contact CDC at 404-639-8253. Smallpox vaccine should not be administered to persons with human immunodeficiency virus infection (HIV) or acquired immunodeficiency syndrome (AIDS) as part of a pre-event program because of their increased risk for progressive vaccinia. HIV testing is recommended for persons who have any history of a risk factor for HIV infection or for anyone who is concerned that he or she might have HIV infection. HIV testing should be available in a confidential or anonymous setting, in accordance with local laws and regulations, with results communicated to the potential vaccinee before the planned date of vaccination. Smallpox vaccine can be administered simultaneously with any inactivated vaccine. With the exception of varicella vaccine, smallpox vaccine can be administered simultaneously with other live-virus vaccines. To avoid confusion in ascertaining which vaccine might have caused postvaccination skin lesions or other adverse events, varicella vaccine and smallpox vaccine should be administered >4 weeks apart. Health-care workers scheduled to receive an annual purified protein derivative (PPD) skin test for tuberculosis screening should not receive the skin test until >1 month after smallpox vaccination. Persons with progressive vaccinia, eczema vaccinatum, and severe generalized vaccinia or inadvertent inoculation might benefit from therapy with VIG or cidofovir, although the latter has not been approved by FDA for this indication. Suspected cases of these illnesses or other severe adverse events after smallpox vaccination should be reported immediately to state health departments. VIG and cidofovir are available from CDC under Investigational New Drug protocols. Clinically severe adverse events after smallpox vaccination should be reported to the Vaccine Adverse Event Reporting System. Reports can be made online at https://secure.vaers.org/VaersDataEntryintro.htm, or by postage-paid form, which is available by calling 800-822-7967 (toll-free). ACIP will review these recommendations periodically as new information becomes available related to smallpox disease, smallpox vaccines, the risk of smallpox attack, smallpox vaccine adverse events, and the experience gained as recent recommendations are implemented. Revised recommendations will be developed as needed.     

Anerkannte Impfschäden in der Bundesrepublik Deutschland 1990–1999

The decrease in infectious diseases preventable by immunisation and the absence of complications caused by these diseases leads to an increased awareness of vaccine-associated adverse events. The analysis of a survey of the vaccine injury compensation data from the German Bundesländer shows the decrease in accepted and demanded compensation from 1991 to 1999. From 1976 to 1990 1139 of 4569 demands were accepted, whereas from 1991 to 1999, acceptance of only 389 of 2543 demands was reported. In all, 38% of the accepted compensations refer to the smallpox vaccine which is not longer recommended by the STIKO (Permanent Vaccination Commission in Germany) since immunisation against smallpox was stopped in the 1980s. Regional differences show that process elements of the German healthcare system as well as political and social reasons express most of the differences in rates and prevalence of vaccine associated adverse events. Epidemiological questions and questions of causality cannot be answered by the analysis of data collected in vaccine injury programs. Valid analysis needs a register of individual documented cases of vaccine adverse events. The surveillance of adverse events following immunisation will make progress by the analysis of data reported according to the Protection against Infection Act (IfSG) and by further surveillance systems that should be implemented in the near future. A centralised commission with expert opinion concerning causality could increase transparency and homogeneity within judgement and documentation of vaccine associated adverse events.     

COVID-19 vaccine safety monitoring in the Republic of Korea: February 26, 2021 to April 30, 2021

ObjectivesOn February 26, 2021, coronavirus disease 2019 (COVID-19) vaccination was started for high-priority groups based on the recommendation of the Advisory Committee on Immunization Practices with 2 available COVID-19 vaccines (AstraZeneca and Pfizer-BioNTech) in Korea. This report provides a summary of adverse events following COVID-19 vaccination as of April 30, 2021.Methods Adverse events following immunization are notifiable by medical doctors to the Korea Immunization Management System (KIMS) under the national surveillance system. We analyzed all adverse events reports following COVID-19 vaccination to the KIMS from February 26 to April 30, 2021. Results In total, 16,196 adverse events following 3,586,814 administered doses of COVID-19 vaccines were reported in approximately 2 months (February 26 to April 30, 2021). Of these, 15,658 (96.7%) were non-serious adverse events, and 538 (3.3%) were serious adverse events, including 73 (0.5%) deaths. The majority of adverse events (n=13,063, 80.7%) were observed in women, and the most frequently reported adverse events were myalgia (52.2%), fever (44.9%), and headache (34.9%). Of the 73 deaths following the COVID-19 vaccination, none were related to the vaccines.ConclusionBy April 30, 3.6 million doses of the COVID 19 vaccine had been given in Korea, and the overwhelming majority of reports were for non-serious events. The Korea Disease Control and Prevention Agency continues to monitor the safety of COVID-19 vaccination.