VAERS Event Reporting System

The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS collects and analyzes information from reports of adverse reactions after immunization. Anyone can report to VAERS, and reports are sent in by vaccine manufacturers, health care providers, and vaccine recipients and their parents or guardians. An example of the VAERS and instructions for completing the form are found in Appendix F. Any clinically significant adverse event that occurs after the administration of any vaccine should be reported. Individuals are encouraged to provide the information on the form even if the individual is uncertain if the event was related to the... 

Vaccine safety is monitored by the FDA and CDC through a passive reporting system that allows anyone, health professionals or lay public, to report any event. Health care professionals are bound by federal regulation to report certain adverse events (Table 83-2). Additionally, any serious, life-threatening or unusual reactions should also be reported. The Vaccine Adverse Event Reporting System (VAERS) can be found at http //vaers.hhs.gov. 

VAERS Vaccine Adverse Event Reporting System... 

In any case, injection site responses (erythemia, edema, pain, and tenderness) and systemic responses are both evaluated in subjects (Mathieu, 1997). USFDA also has specific guidance on the tracking and reporting of adverse clinical responses to vaccines. Any adverse events or product problems with vaccines should not be sent to MedWatch but to the Vaccine Adverse Event Reporting System (VAERA), operated jointly by FDA and the national Centers for Disease Control and Prevention. For a copy of the VAERS form, call 1-800-822-7967, or download the form (in PDF format) from www.fda.gov/cber/vaers/vaersl.pdf on FDA s Website. 

Vaccine Adverse Event Reporting System (VAERS) form. For drugs and therapeutic biologies, the MedWatch (3500A) form replaces the 1639 reporting form. 

In response to the National Childhood Vaccine Injury Act of 1988, which required health workers to report vaccine adverse events, the CDC and the FDA collaborated in 1990 to implement the Vaccine Adverse Event Reporting System (VAERS) to monitor the safety of vaccines in both sectors. Health care professionals and parent or other caretakers are encouraged to report all clinically significant vaccine adverse events. Narrative diagnostic reports are reviewed and assigned standard codes using Coding Symbols for a Thesaurus of Adverse Reaction Terms. The source of the vaccines (public versus private provider) is recorded on the form. 

LYMErix safety data reported to the Vaccine Adverse Event Reporting System (VAERS) from 21 December 1998 to 31 October 2000 mentioned reports of adverse events associated with Lyme vaccine in prelicensure trials, including injection site reactions, transient arthralgia and myalgia within 30 days of vaccination, fever, and a flu-like illness (7). Allergic reactions were reported to the VAERS and some could have plausibly been linked to the vaccine because of the short latency between vaccination and reaction onset. No clear patterns in age, sex, time to onset, or vaccine dose were identified, although the unexpected predominance of reports of arthrosis in men might warrant further consideration. 

FDA. LYMErix Safety Data Reported to the Vaccine Adverse Event Reporting System (VAERS) from December 21, 1998 through October 31, 2000. http // www.fda.gOv/ohrms/dockets/ac/01/briefing/3680b2 06.pdf. 

Geier DA, Geier MR. Rubella vaccine and arthritic adverse reactions an analysis of the Vaccine Adverse Events Reporting System (VAERS) database from 1991 through 1998. Clin Exp Rheumatol 2001 19(6) 724-6. 

SurveiUence for safety after immunization Vaccine Adverse Event Reporting System (VAERS)-United States, 1991-2001. MMWR Morb Mortal Wkly Rep 2003 52(SS-1) 1. 

Chen RT, Rastogi SC, Mullen JR, Hayes SW, Cochi SL, Donlon JA, Wassilak SG. The Vaccine Adverse Event Reporting System (VAERS). Vaccine 1994 12(6) 542-50. 

Singleton JA, Lloyd JC, Mootrey GT, Salive ME, Chen RT. An overview of the vaccine adverse event reporting system (VAERS) as a surveillance system. VAERS Working Group. Vaccine 1999 17(22) 2908-17. 

Braun, M.M. Ellenberg, S.S. Descriptive epidemiology of adverse events after immunization Reports to the Vaccine Adverse Event Reporting System (VAERS), 1991-1994. J. Pediatr. 1997, Oct., 131 (4), 529-535. 

MedWatch program, the FDA runs a program for adverse events related to veterinary products and in conjunction with the Center for Disease Control and Prevention, a program for adverse events with vaccines, the Vaccine Adverse Event Reports System (VAERS). 

VAERS = Vaccine Adverse Event Reports System. 

FDAMA Food and Drug Administration Modernization Act HMOs, health maintenance organizations VAERS, Vaccine Adverse Event Reporting System CERTs, Centers for Education and Research on Therapeutics ADR, adverse drug reaction... 

Health care providers must report all events requiring medical attention within 30 days of vaccination to the Vaccine Adverse Event Reporting System (VAERS), which serves as a central depot for vaccine-related adverse effects. Only a temporal association between the adverse event and vaccine administration needs to be made. No adverse event rates can be determined because only the number of adverse events reported is known the number of vaccines administered is not known. This database can be used to determine changes in adverse-event frequencies, to evaluate risk factors for adverse events, and to find rare adverse events VAERS report forms can be obtained by calling 1-800-822-7967, or reports can be made online at www.vaers.com. 

Report all clinically significant post-vaccination reactions to the Vaccine Adverse Event Reporting System (VAERS). Reporting forms and instructions on filing a VAERS report are available by calling 800-822-7967 or from the VAERS website at... 

Hypersensitivity. Hypersensitivity reactions, considered to be vaccine-related based on the timing and specificity of the reactions, were reported to the United States Vaccine Adverse Event Reporting System (VAERS) following vaccination for Lyme disease and subsequently evaluated (Burmester et al., 1995 Lathrop et al., 2002). Other reported immune system-related events to vaccines included rheumatoid arthritis, immune system disorders, detection of antinuclear antibodies, lupus syndrome, and lymphocytosis (Zhou et al., 2003). These were very rare events, with each condition comprising 0.2% or fewer of the total reports. Anaphylactic responses to vaccines were also rare and were estimated at less than one case per miUion administered vaccine doses (Bohlke et al., 2003). A number of studies evaluated anaphylactic responses to the measles-mumps-rubella (MMR), hepatitis B, diphtheria or tetanus vaccines with similar findings (Dobson et al., 1995 D Souza et al., 2000 Patja et al, 2000 Pool et al., 2002). However, some of the vaccine-induced hypersensitivity reactions are attributed to components of the formulation, such as gelatin or egg, rather than the antigen itself (Patja et al., 2001 Pool et al., 2002). 

Pool V, Braun MM, Kelso JM, Mootrey G, Chen RT, Yunginger JW, Jacobson RM, Gargiullo PM, VAERS Team. US Vaccine Adverse Event Reporting System. Prevalence of anti-gelatin IgE antibodies in people with anaphylaxis after measles-mumps rubella vaccine in the United States. Pediatrics 2002 110(6) e71. 

Zhou W, Pool V, Iskander JK, English-Bullard R, Ball R, Wise RP, Haber P, Pless RP, Mootrey G, Ellenberg SS, Braun MM, Chen RT. Surveillance for safety after immunization Vaccine Adverse Event Reporting System (VAERS)-United States, 1991-2002. MMWR 2003 52/SS-l l-24. 

Healthcare providers are expected to report vaccine adverse events to public health officials who report these to the CDC every week using the Vaccine Adverse Events Reporting System (VAERS), which is used to provide compensation for injury and death caused by vaccination. 

Observational studies Anthrax vaccine adsorbed (AVA) is the only US licensed AVA vaccine approved by the Food and Drug Administration. In recent years, the safety of anthrax vaccine has been controversial, stimulating reviews of its safety and efficacy. During 1 March 1998 to 14 January 2007, about 6 milhon doses of AVA vaccine were administered. As of 16 January 2007, 4753 reports of adverse events after the use of AVA had been submitted to the Vaccine Adverse Event Reporting System (VAERS) [ll ]. The most commonly reported were myalgia, arthralgia, pain, headache, depression, asthenia , rash, anxiety and insomnia, and back pain. Reports to VAERS did not definitively link any serious unexpected risks to this vaccine, and a review of deaths... 

Observational studies In October 2003 the Advisory Committee on Immunization Practices (ACIP) recommended influenza immunization for all children aged 6-23 months [30 ]. The safety of this recommendation has been evaluated using the Vaccine Adverse Event Reporting System (VAERS) to study serious adverse events reported between 1 July 2003 and 30 June 2006 in children aged 6-23 months who had been given trivalent inactivated influenza vaccine. There were 104 serious adverse events at a median time after immunization of 1 day. The two most common serious adverse events were fever (52 reports) and seizures (35 reports). Causality assessment suggested that none was definitely related to influenza vaccine. No new or unexpected concerns were identified. 

Niu MT, Ball R, Woo EJ, Burwen DR, Knippen M, Braun MM. Adverse events after anthrax vaccination reported to the Vaccine Adverse Event Reporting System (VAERS), 1990-2007. Vaccine 2009 27 290-7. 

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