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Topic: Vaccine Adverse Event Reporting System


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In the News (Sat 28 Nov 09)

  
  Surveillance for Safety After Immunization: Vaccine Adverse Event Reporting System (VAERS) --- United States, ...
Some adverse events are unlikely to be detected in prelicensure clinical trials because of their low frequency, the limited numbers of enrolled subjects, and other study limitations.
Reports may be submitted by anyone suspecting that an adverse event might have been caused by vaccination and are usually submitted by mail or fax.
During 1991--2001, reports of deaths ranged from 1.4%--2.3%, and reports of life-threatening illness ranged from 1.4%--2.8% of all adverse event reports.
www.cdc.gov /mmwr/preview/mmwrhtml/ss5201a1.htm   (6811 words)

  
 Anthrax Vaccine
The Vaccine Adverse Event Reporting System (VAERS) resulted from enactment of the National Childhood Vaccine Injury Act of 1986 (NCVIA), 42 U.S.C. 300aa-1 et seq., as amended, which was aimed at improving childhood vaccine safety and mandated reporting of certain adverse events associated with vaccines.
It is the only surveillance system that covers the entire U.S. population and therefore includes the largest number of case reports of events temporally associated with vaccination in the U.S. It provides timely availability of data from a geographically diverse population, allowing rapid detection of possible new, unusual or rare adverse events.
Reporting of adverse events associated with the use of anthrax vaccine is voluntary for individual healthcare providers but, as stated above, the vaccine manufacturer must report to FDA all reports of adverse events of which they are aware.
www.hhs.gov /asl/testify/t990721b.html   (3014 words)

  
 What is the Vaccine Adverse Event Reporting System (VAERS)?
Vaccines protect many people from dangerous illnesses, but vaccines, like drugs, can cause side effects, a small percentage of which may be serious.
DHHS established the Vaccine Adverse Event Reporting System (VAERS), which is co-administered by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), to accept all reports of suspected adverse events, in all age groups, after the administration of any U.S. licensed vaccine.
The primary purpose for maintaining the data base is to serve as an early warning or signaling system for adverse events not detected during pre-market testing.
www.vaccinationnews.com /Rally/VAERS.htm   (1051 words)

  
 Institute for Vaccine Safety -Smallpox Vaccine Issues
Reports of adverse event are accepted by VAERS regardless of whether the vaccination is shown to have caused the adverse event.
Adverse events may be included in the VAERS database that are not accurate descriptions of the event that occurred, and erroneous diagnoses may be reported.
For example, VAERS reports reflect the current trend of a decline in usage of whole-cell pertussis-containing vaccines and a simultaneous increase in the use of acellular pertussis vaccines; however, it would be incorrect to draw conclusions about the relative safety of these vaccines from such trend data.
www.vaccinesafety.edu /VAERS.htm   (1756 words)

  
 Policy for Reporting Adverse Events Associated with the Anthrax Vaccine
For the purposes of reporting anthrax vaccine adverse events, a Form VAERS-1 (Attachment 1) must be completed and submitted using Service reporting procedures for those events resulting in a hospital admission or time lost from duty for greater than 24 hours or for those events suspected to have resulted from contamination of a vaccine lot.
Reports are submitted by the chairman, MTF Pharmacy and Therapeutics Committee, to the FDA's Vaccine Adverse Event Reporting System and copies of the Form VAERS-1 are provided to the reportable disease project officer at AMSA, DSN: 662-0471 or commercial: 202-782-0471.
Adverse events that are deemed life-threatening (such as anaphylaxis), result in death, or are suspected to be the result of contaminated lots must be reported telephonically to each Services' reportable disease project officer within 24 hours of the occurrence of the event.
www.tricare.osd.mil /policy/ha99pol/clin9931.htm   (1137 words)

  
 Vaccine Adverse Events Reporting System (VAERS) Help
Event characteristics include symptoms reported, vaccine type, name and manufacturer, number of days between vaccination and the adverse event, vaccination date, report date, whether the event was considered serious, how the event outcome was categorized, whether the patient recovered, and the patient's age group, gender and home state.
The first report ends in "-1" and subsequent reports are indicated in the order received, ending in "-2" for the second report, etc. When a report is later determined to refer to a previously reported event, then the VAERS ID is re-assigned, and the initial VAERS ID is shown in parenthesis.
While some events reported to VAERS are truly caused by vaccines, others may be related to an underlying disease or condition, to drugs being taken concurrently, or may occur by chance shortly after a vaccine was administered.
wonder.cdc.gov /wonder/help/vaers.html   (3897 words)

  
 Vaccine Adverse Event Reporting System (VAERS) & "Hot Lots"
Evaluating adverse event reports from more than 90 families, we found multiple serious reports were from the same vaccine lot numbers.
Vaccine manufacturers and the FDA will not release the number of doses in each lot of DPT vaccine to the public.
In the past fifty years reports of "hot lots" of vaccines, those that appear to be associated with more injuries and deaths than others, have been reported in the United States and Europe.
www.vaccinationnews.com /DailyNews/August2001/HotLots.htm   (535 words)

  
 [No title]
Reporting of adverse events is the most important element in vaccine safety surveillance.
Reporting by telephone is required immediately for any serious smallpox vaccine adverse event that is life-threatening, requires CDC consultation or treatment with investigational drugs (vaccinia immune globulin or the antiviral cidofovir), either in a vaccinee or a contact.
Reporting adverse events to DOH is the most timely and efficient method of 1) assuring appropriate medical management and follow-up for patients with serious adverse events related to smallpox vaccination, and 2) collecting safety data on Stage 1 of our smallpox vaccination program in Washington.
www.doh.wa.gov /Notify/other/vaersqa.doc   (967 words)

  
 The DTP Vaccine   (Site not responding. Last check: 2007-10-13)
In February 2002, the CDC published an analysis of current pertussis vaccination rates and incidence of the disease, suggesting that pertussis is on the rise again.
The CDC says "Whole-cell DTP vaccines are commonly associated with several local adverse events (e.g., erythema, swelling, and pain at the injection site), fever, and other mild systemic events (e.g., drowsiness, fretfulness, and anorexia).
The package insert reports an interesting study from Germany, where vaccination with DTP is less common than in the USA: "Pediatricians were asked to monitor households with a first potential case (index case) of pertussis which was identified by spontaneous presentation to a physician.
www.larkfarm.com /AP/dtap_vaccine.htm   (2002 words)

  
 When a Doctor Won't Report a Vaccine Reaction   (Site not responding. Last check: 2007-10-13)
The doctor or other health care provider that administered the vaccination is not supposed to make a judgment as to whether the adverse event that occurred following vaccination was caused by the vaccine or not caused by the vaccine.
The law says it is the duty of all vaccine administrators to report the event to the federal government regardless of whether they believe the vaccine caused the event.
By reporting to NVIC, they can better monitor the effectiveness of the government's Vaccine Adverse Events Reporting System and gather important data on vaccine reactions for analysis that the government and vaccine manufacturers do not do.
www.vaccineinfo.net /yourrights/doctor_no_report.shtml   (383 words)

  
 Vaccine Adverse Event Reporting System (VAERS) FAQ's
The remaining 15% of the reports reflect serious adverse events involving life-threatening conditions, hospitalization, permanent disability, or death, which may or may not have been truly caused by an immunization.
VAERS reports may signal that there is the potential for a safety risk, which would prompt a wider evaluation of the safety of the vaccine lot.
An occurrence of an adverse event following the administration of a vaccine is not conclusive evidence that the event was caused by the vaccine.
www.fda.gov /cber/vaers/faq.htm   (816 words)

  
 Vaccine Safety Immunization Program - Washington State Department of Health
Vaccines have reduced and, in some cases, eliminated many diseases that killed or severely disabled children and adults just a few generations ago.
The MMR vaccine is first given between the ages of 12 and15 months; therefore the apparent onset may simply be an expected but unrelated chance occurrence.
Except for some influenza (flu) vaccines, all vaccines routinely given to young children are available without thimerosal.
www.doh.wa.gov /CFH/immunize/vaccinesafety.htm   (777 words)

  
 VAERS REPORTS
For 1995 there were 2071 reports; in 1996 there were 1894 reports; in 1997 there were 1314 reports, and in the first half of 1998 there were 491 reports.
Diphtheria-tetanus-pertussis vaccine (DTP) was cited in 1939 reports, diphtheria-tetanus-whole-cell pertussis-Haemophilus influenzae type b vaccine (DTPH) in 2918 reports, and diphtheria-tetanus-acellular pertussis vaccine (DTaP) in 913 reports.
The annual number of reported events categorized as nonfatal serious (defined as events involving initial hospitalization, prolongation of hospitalization, life-threatening illness, or permanent disability) to VAERS for all pertussis-containing vaccines declined: 334 in 1995, 311 in 1996, 233 in 1997, and 93 in the first half of 1998.
www.whale.to /vaccines/vaers.html   (476 words)

  
 NVIC - Hot Lots
As a result the Vaccine Adverse Events Reporting System (VAERS) to which parents, physicians and vaccine manufacturers could report adverse events was created.
It is estimated that only 1-10% of all doctors report a severe health problem which occurs after a drug or vaccine is given to a patient.
Due to reporting of adverse events, the rotavirus vaccine was removed from the market for causing bowel obstructions in infants and children.
www.909shot.com /Issues/VAERS.htm   (577 words)

  
 Vaccine Adverse Event Reporting System - Wikipedia, the free encyclopedia
The Vaccine Adverse Event Reporting System is a United States program for vaccine safety, co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).
Mark Geier has reported that children exposed to vaccines containing the preservative thimerosal are significantly more likely to develop symptoms of autism.
The purpose of VAERS is to detect possible signals of adverse events associated with vaccines.
en.wikipedia.org /wiki/Vaccine_Adverse_Event_Reporting_System   (718 words)

  
 Vaccine Risk Perception Among Reporters of Autism After Vaccination: Vaccine Adverse Event Reporting System 1990-2001 ...
For example, for reports with a vaccination date in 1996, there were 3 reports with a delay of 2 years (reports received in 1998), 4 reports with a delay of 3 years, 2 with a delay of 4 years, and 1 with a delay of 5 years.
Reporting an adverse event to VAERS implies a temporal association
Inflammatory bowel disease, autism, and the measles, mumps, and rubella vaccine.
www.ajph.org /cgi/content/full/94/6/990   (3657 words)

  
 Rotavirus vaccine monitoring   (Site not responding. Last check: 2007-10-13)
In August 1998, a rotavirus vaccine, Rotashield®, was licensed in the United States, and approximately one million children were vaccinated within nine months.
Today's rotavirus vaccines were tested extensively to determine any risk for adverse events, including intussusception.
Researchers found that the risk of intussusception was similar among children who received the vaccine and those who received a placebo, indicating that the vaccines are safe for use.
www.path.org /vaccineresources/rotavirus-adverse-events.php   (560 words)

  
 VAERS - The Vaccine Adverse Event Reporting System
Resources for adverse events after the Yellow Fever vaccine
The Vaccine Adverse Event Reporting System is a cooperative program for vaccine safety of the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).
This Web site provides a nationwide mechanism by which adverse events following immunization (AEFI) may be reported, analyzed and made available to the public.
vaers.hhs.gov   (205 words)

  
 Vaccine Risk Perception Among Reporters of Autism After Vaccination: Vaccine Adverse Event Reporting System 1990-2001 ...
Vaccine Risk Perception Among Reporters of Autism After Vaccination: Vaccine Adverse Event Reporting System 1990-2001 -- Woo et al.
Woo, R. Ball, S. Shadomy, and M. Braun are from the Vaccine Safety Branch, Division of Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Md. S.
of autism to the Vaccine Adverse Event Reporting System (VAERS).
www.ajph.org /cgi/content/abstract/94/6/990   (331 words)

  
 An Analysis of Rotavirus Vaccine Reports to the Vaccine Adverse Event Reporting System: More Than Intussusception ...
Mean and median interval from receipt of rotavirus vaccine to symptom onset for clinical groups; the range of values from intussusception (IS) to gastroenteritis (GASTRO) are 0 to 152, 0 to 80, 0 to 34, and 0 to 148, respectively, for each of the 4 categories.
The reporting sensitivities of two passive surveillance systems for vaccine adverse events.
The Guillain-Barre syndrome and the 1992–1993 and 1993–1994 influenza vaccines.
pediatrics.aappublications.org /cgi/content/full/113/4/e353   (3686 words)

  
 Search VAERS Database
This database, called the Vaccine Adverse Event Reporting System (VAERS) is available for anyone to download.
Each year's data is split into two different files: one with the details of the case, and another with specific information about the vaccinations that were given.
The difference is, once the records are identified, the system sorts all of the vaccines administered and lists the combination of vaccine, manufacturer, and manufacturer's lot number that appears the most number of times.
www.medalerts.org /vaersdb   (409 words)

  
 Neonatal Deaths After Hepatitis B Vaccine   The Vaccine Adverse Event Reporting System   (Site not responding. Last check: 2007-10-13)
Results Of 1771 neonatal reports, there were 18 deaths in 8 boys and 9 girls
The mean age at vaccination for these 18 cases was
reported, despite the use of at least 86 million doses of pediatric vaccine
www.whale.to /vaccines/hepatitis8.html   (306 words)

  
 Vaccine Adverse Event Reporting System Reporting Source: A Possible Source of Bias in Longitudinal Studies -- Goodman ...
Vaccine Adverse Event Reporting System Reporting Source: A Possible Source of Bias in Longitudinal Studies -- Goodman and Nordin 117 (2): 387 -- Pediatrics
is a passive reporting system to which anyone can report an
In recent years, most case reports to VAERS that were
pediatrics.aappublications.org /cgi/content/abstract/117/2/387   (211 words)

  
 MilVax
Review of VAERS Anthrax Vaccine Reports Received through 8/15/05, and Adverse Event Reports Submitted to Docket No. 1980N-0208 PDF 13 Dec 05
FDA and CDC Issue Alert on Menactra Meningococcal Vaccine and Guillain Barre Syndrome PDF 30 Sep 05
Surveillance Guidelines for Smallpox Vaccine (vaccinia) Adverse Reactions
www.vaccines.army.mil /default.aspx?cnt=adverseEvents/adverseEventsHome   (71 words)

  
 Safety/Adverse Event Info - DoD Smallpox Vaccination Program (SVP)
If you have clinical questions related to vaccination, please contact the DoD Vaccine Clinical Call Center at 1-866-210-6469.
Establishment of Case Management Guidelines for Smallpox Vaccine Associated Myopericarditis [09 JUN 03]
Morbidity and Mortality Weekly Report, January 24, 2003/Vol.
www.smallpox.army.mil /event/default.asp?ste=milvax   (128 words)

  
 healthfinder® — Vaccine Adverse Event Reporting System (VAERS)
healthfinder® — Vaccine Adverse Event Reporting System (VAERS)
This site provides details for reporting adverse events which may be associated with vaccines, and discusses the National Childhood Vaccine Injury Act.
VAERS is a joint program of the Centers for Disease Control and Prevention and the Food and Drug Administration
www.healthfinder.gov /docs/doc02114.htm   (60 words)

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