Vaccine Adverse Event Reporting

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... 

Appendix F is a Vaccine Adverse Event Reporting Form. 

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. 

Niu, M.T., Saline, M.E. and Ellenberg, S.S. (1999). Neonatal deaths after hepatitis B vaccine The vaccine adverse event reporting system, 1991-1998. Arch. Pediatr. Adolesc. Med. 153 1279-1282. 

Varrincchio, F. (1998). The vaccine adverse event reporting system. Clin. Toxicology 36 765-768. 

United States Adopted Name Council United States Department of Agriculture United States Environmental Protection Agency United States Pharmacopoeia Vaccine Adverse Event Reporting System Vaccine Safety Data Link World Health Organization... 

Before a vaccine is given to the general population, all potential adverse events cannot be anticipated. Thus, many vaccines undergo phase IV studies—formal studies on a vaccine once it is on the market. Also the government relies on the Vaccine Adverse Event Reporting System to identify problems after marketing begins. Adapted from an FDA document)... 

NDA requires manufacturers to submit product-labeling language, which describes the proper use, benefits, and risks of the product in question. FDA may also require, as a condition of approval of an NDA or BLA application, that postmarketing studies be conducted to monitor and confirm the safety and efficacy of a product as it is used more widely in clinical practice. In addition, all sponsors or manufacturers are required to monitor and report adverse effects, defined as health effects that may or may not be related to the drug in question. For vaccines, adverse events that occur after immunization must be reported to the Vaccine Adverse Event Reporting System. 

Vaccine Adverse Event Report (VAERS) forms ... 

Adverse events after hepatitis B vaccine reported between 1 January 1991 and 31 May 1995 to the US Vaccine Adverse Events Reporting System have been reviewed (6). The patients included 58 neonates and 192 infants who were immunized with hepatitis B... 

Niu MT, Davis DM, Ellenberg S. Recombinant hepatitis B vaccination of neonates and infants emerging safety data from the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J 1996 15(9) 771-6. 

The number of reports of influenza vaccine-associated Guillain-Barre syndrome to the US Vaccine Adverse Event Reporting System increased from 37 in 1992-93 to 74 in 1993-94, raising concerns about a possible increase in vaccine-associated risk. Detailed data analyses... 

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. 

Centers for Disease Control (CDC). Vaccine Adverse Event Reporting System—United States. MMWR Morb Mortal Wkly Rep 1990 39(41) 730-3. 

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. 

Silvers LE, Ellenberg SS, Wise RP, Varricchio FE, Mootrey GT, Salive ME. The epidemiology of fatalities reported to the vaccine adverse event reporting system 1990-1997. Pharmacoepidemiol Drug Saf 2001 10(4) 279-85. 

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. 

Current trends vaccine adverse event reporting system— United States. MMWR, Morb. Mortal. Wkly. Rep. 1990, Oct. 19, 39 (41), 730-733,... 

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. 

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