Active telephone surveillance to evaluate adverse events among civilian smallpox vaccine recipients

National Immunization Program, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Vaccine (Impact Factor: 3.62). 01/2006; 24(4):476-84. DOI: 10.1016/j.vaccine.2005.07.089
Source: PubMed


Better characterize and monitor adverse events following Dryvax vaccinia vaccination in civilian health care workers and other first responders.
Telephone interviews to ascertain adverse events experienced.
Eight hundred twenty-five vaccinees, including 44 in the comparison group, were interviewed. At 10 days, 71.4% reported blisters, 35.1% reported bumps at the vaccination site, 48.5% swelling, 47.3% scab, tiredness/lethargy/fatigue (43.6%), headache (34.2%), lymph node swelling/tenderness (28.5%), muscle pain (23.1%), chills (14.4%), joint pain 11.8%, and fever >100 degrees F (12.5%). The 12.5% reported missing work because of vaccine adverse events. Most adverse events were anticipated and of short duration.

4 Reads
  • [Show abstract] [Hide abstract]
    ABSTRACT: US smallpox vaccination (SMA) started most recently in December 2002. Military and civilian personnel report adverse events (AEs) to the Vaccine Adverse Event Reporting System (VAERS), a surveillance system that relies on spontaneous reports. Although reported rates of probable myo/pericarditis after SMA in the literature are similar between military personnel and civilian healthcare workers, some civilian AE reporting rates after SMA appeared higher than those in the military. Determine if SMA-associated reporting rates are different in civilians than in the military, considering age, sex, seriousness, and expectedness of the AE, as well as self-reporting. Numerators were SMA reports in VAERS from 12/12/02 to 3/1/04. Limitations of VAERS include underreporting and lack of diagnostic confirmation. Denominators were number of military and civilian vaccinees. Reporting rates stratified by age and sex of serious and non-serious AEs were significantly higher in civilian than military personnel ages <55 years (rate ratios 4-27). These rate ratios decreased with increasing age. Reporting rates in VAERS differed significantly and substantially in civilians compared to military personnel <55 years of age. Differences in stimulated passive surveillance systems, and AE reporting practices, including the 'threshold' for reporting most likely explain these findings. These results suggest that in the case of smallpox vaccine AEs, there may be systematic differences in reporting completeness between the civilian and military sectors, and that passive surveillance data should be interpreted with caution.
    Pharmacoepidemiology and Drug Safety 06/2007; 16(6):597-604. DOI:10.1002/pds.1349 · 2.94 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Variola virus, the cause of smallpox disease, has been deemed a possible bioterrorism agent. Since November 2001, federal, state, and local public health partners implemented activities to prepare for a possible smallpox outbreak. The Centers for Disease Control and Prevention (CDC) produced and delivered training and educational materials for smallpox preparedness in many formats, developed detailed smallpox vaccine information statements about vaccine contraindications and vaccination site care, and established mechanisms to monitor and respond to adverse events after smallpox vaccination. The last included enhancements to the Vaccine Adverse Event Reporting System, a pregnancy registry for inadvertently vaccinated pregnant women, and a Clinician Telephone Information Line to collect reports about adverse events. The civilian responder vaccination program was conducted with rigorous safety procedures, and few historically recognized adverse events were observed. However, myocarditis and/or pericarditis was newly recognized as an adverse event caused by the New York City Board of Health vaccinia vaccine strain. This smallpox preparedness program put into place a number of measures to advance the United States' readiness for a smallpox outbreak that have assisted in preparedness for other threats.
    Clinical Infectious Diseases 04/2008; 46 Suppl 3(s3):S157-67. DOI:10.1086/524751 · 8.89 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: TeleWatch is an automated telephone/Internet-based system that collects medical product adverse event reports in real-time through an algorithm driven by the patient. 1341 patients, who received yellow fever vaccine and were recruited through 15 travel clinics, contacted the system within 48h of vaccination and 765 (57%) made follow-up contacts. Participation rates were higher among females and persons older than 60 years of age. TeleWatch can be expanded for use in large campaigns involving influenza or other vaccines.
    Vaccine 09/2009; 27(44):6143-7. DOI:10.1016/j.vaccine.2009.08.024 · 3.62 Impact Factor
Show more

Similar Publications