Active telephone surveillance to evaluate adverse events among civilian smallpox vaccine recipients.
ABSTRACT 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.
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ABSTRACT: This study was conducted to explore a telephone-based approach for identifying and quantifying the occurrence of adverse events following immunization (AEFIs) during an MF59(®)-adjuvanted H5N1 vaccination program in Taiwan. From March to August 2011, each H5N1 vaccine recipient who voluntarily registered as participants within 72 h of vaccination was phone interviewed at postvaccination 7-10 and 21-24 d. Among the 292 participants, 270 and 263 interviews were completed at 7-10 and 21-24 d. Overall, 127 (48%) respondents reported local and 86 (33%) reported systemic reactions. Females (odds ratio [OR] 2.06, 95% confidence interval [CI] 1.18-3.63), nonelderly adults aged 18-59 y (OR 3.08, 95% CI 1.11-9.45), and first-dose recipients (OR 2.16, 95% CI 1.22-3.86) were independently associated with having an AEFI within the first 7-10 d. None of the AEFIs reported were serious adverse events. In conclusion, most AEFIs to H5N1 vaccine were anticipated but varied with sex, age, and vaccine dose number. The use of modern information technologies will be a scalable alternative to efficiently enroll and monitor recipients with possible AEFIs in large campaigns involving influenza or other emerging vaccines. Further studies should compare the detection of AEFIs using telephone monitoring and standard pharmacovigilance reporting.Human Vaccines & Immunotherapeutics 10/2013; 10(2). DOI:10.4161/hv.26737 · 3.64 Impact Factor
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ABSTRACT: Smallpox, when used as a biological weapon, presents a serious threat to civilian populations. Core components of the public health management of a terrorism attack using smallpox are: vaccination (ring vaccination and mass vaccination), adverse event monitoring, confirmed and suspected smallpox case management, contact management, identifying, tracing, monitoring contacts, and quarantine. Above all, pre-event and post-event vaccination is an indispensable part of the strategies. Since smallpox patients are most infectious from onset of the rash through the first 7-10 days of the rash, vaccination should be administered promptly within a limited time frame. However, vaccination can accompany complications, such as postvaccinial encephalitis, progressive vaccinia, eczema vaccinatum, and generalized vaccinia. Therefore, vaccination is not recommended for certain groups. Public health professionals, as well as physicians and government officials, should also be well equipped with all information necessary for appropriate and effective smallpox management in the face of such a bioterrorism attack.Environmental Health and Preventive Medicine 12/2010; 16(5):281-9. DOI:10.1007/s12199-010-0200-z
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ABSTRACT: The Clinical Immunization Safety Assessment (CISA) Network is a collaboration between the Centers for Disease Control and Prevention (CDC) and 6 academic medical centers to provide support for immunization safety assessment and research. The CISA Network was established by the CDC in 2001 with 4 primary goals: (1) develop research protocols for clinical evaluation, diagnosis, and management of adverse events following immunization (AEFI); (2) improve the understanding of AEFI at the individual level, including determining possible genetic and other risk factors for predisposed people and subpopulations at high risk; (3) develop evidence-based algorithms for vaccination of people at risk of serious AEFI; and (4) serve as subject-matter experts for clinical vaccine-safety inquiries. CISA Network investigators bring in-depth clinical, pathophysiologic, and epidemiologic expertise to assessing causal relationships between vaccines and adverse events and to understanding the pathogenesis of AEFI. CISA Network researchers conduct expert reviews of clinically significant adverse events and determine the validity of the recorded diagnoses on the basis of clinical and laboratory criteria. They also conduct special studies to investigate the possible pathogenesis of adverse events, assess relationships between vaccines and adverse events, and maintain a centralized repository for clinical specimens. The CISA Network provides specific clinical guidance to both health care providers who administer vaccines and those who evaluate and treat patients with possible AEFI. The CISA Network plays an important role in providing critical immunization-safety data and expertise to inform vaccine policy-makers. The CISA Network serves as a unique resource for vaccine-safety monitoring efforts conducted at the CDC.PEDIATRICS 05/2011; 127 Suppl 1:S65-73. DOI:10.1542/peds.2010-1722J · 5.30 Impact Factor