January 31, 2014
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sábado, 1 de febrero de 2014
The ICD-10 Transition and Public Health Surveillance - What You Need to Know
CDC Influenza News and Highlights
CDC Influenza News and Highlights
Centers for Disease Control and Prevention (CDC) sent this bulletin at 01/31/2014 03:00 PM EST
CDC has provided buttons and badges for public use. The graphics can be placed in any way that works best for your particular site. We are hoping to see these graphics on as many sites as possible to promote the importance of flu vaccination.
Many of the free seasonal flu materials, including videos and PSAs, are available in broadcast quality to download.
New CDC Flu Data
Report estimates flu illnesses and hospitalizations prevented by vaccination last season
Learn More >>
FluVaxView
How many people got their flu vaccination already? View estimates with FluVaxView!
Learn More >>
CDC Influenza Application
for Clinicians and Health Care Professionals
Learn More >>
FluView Interactive
Influenza Surveillance Data the Way You Want it!
Learn More >>
Centers for Disease Control and Prevention (CDC) sent this bulletin at 01/31/2014 03:00 PM EST
What's New
01/31/2014 11:15 AM EST 01/30/2014 06:18 PM EST 01/28/2014 04:09 PM EST 01/27/2014 03:19 PM EST 01/24/2014 05:11 PM EST |
Weekly Influenza Surveillance
Flu activity is increasing nationally and is high in some states. Additional increases are expected in the coming weeks. If you have not gotten your flu vaccination yet this season, you should get one now. A flu vaccine is the first and best way to protect yourself and the people around you from influenza and its potentially serious complications.
What you need to know for the 2013-2014 Season
- Should I still get vaccinated since flu season has started?
- Should I still get vaccinated even if I have already gotten sick with the flu?
- Can I get vaccinated and still get the flu?
- Has CDC received reports of people who have gotten a flu vaccine and then tested positive for flu?
Flu Season Buttons and Badges
There are podcasts, ecards and other e-health activities to support this effort as well. You can help in promoting the ongoing flu vaccine efforts by placing these graphics on your web pages.
Seasonal Flu Free Resources
Select print materials are available to order as well!
EHC Program Update: New Draft Report
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The following has been posted to the EHC Program Web site: |
Draft Report
A draft report for the following topic is available for comment until February 26, 2014:
Core Needle and Open Surgical Biopsy for Diagnosis of Breast Lesions: An Update to the 2009 Report. To access and comment, visit: http://www.effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=displayProduct&productID=1849.
To access all EHC Program topics currently available for comment, visit:http://effectivehealthcare.ahrq.gov/index.cfm/research-available-for-comment/.
Effective Health Care Program
http://effectivehealthcare.ahrq.gov
EHC Program Update: New Draft Report
CDC - CISA - Vaccine Safety
CDC - CISA - Vaccine Safety

CISA Current Activities
Clinical Immunization Safety Assessment (CISA) Project
CDC’s Clinical Immunization Safety Assessment (CISA) Project was established in 2001 to address the unmet vaccine safety clinical research needs of the United States.
CISA is a national network of vaccine safety experts from the CDC’s Immunization Safety Office (ISO), seven medical research centers, and other partners, which provides a comprehensive vaccine safety public health service to the nation.
To request a CISA Clinical Consultation:
If you are a US healthcare provider with a vaccine safety question about a specific patient residing in the US, you can contact CISA at CISAeval@cdc.gov to request a case evaluation. This service is provided free of charge. View herefor more information.
Current CISA Project Sites
- Boston Medical Center
- Cincinnati Children's Hospital Medical Center
- Columbia University
- Duke University
- Johns Hopkins University
- Kaiser Permanente Northern California
- Vanderbilt University
CISA addresses vaccine safety issues, conducts high quality clinical research, and assesses complex clinical adverse events following vaccination. CISA facilitates CDC’s collaboration with vaccine safety experts at leading academic medical centers and strengthens national capacity for vaccine safety monitoring. The CISA Project provides consultation to US clinicians who have vaccine safety questions about a specific patient residing in the US. In addition, CISA provides consultation to US healthcare providers and public health partners on vaccine safety issues, and reviews clinical adverse events following immunization ( AEFI) involving the US-licensed vaccines.
About CISA
Mission
- To improve understanding of AEFI at the individual-patient level
CISA Goals
- To serve as a vaccine safety resource for consultation on clinical vaccine safety issues, including individual case reviews, and to assist with immunization decision-making
- To assist the Centers for Disease Control and Prevention (CDC) / Health and Human Services (HHS) and partners in developing strategies to assess individuals who may be at increased risk for AEFI
- To conduct studies to identify risk factors and preventive strategies for AEFI, particularly in special populations
CISA Current Activities
Clinical Case Reviews: CISA provides a clinical case evaluation service for US healthcare providers who have vaccine safety questions about a specific patient residing in the US. CISA provides clinical expertise in various disciplines, including neurology, allergy, immunology, pediatrics, hematology, and obstetrics/gynecology.
Expert Evaluation of Vaccine Safety Issues: CISA experts provide advice that has led to a broader understanding of vaccine safety issues and informs clinical or public health practices. CISA has also reviewed technical issues and contributed to Advisory Committee on Immunization Practices (ACIP) recommendations.
Research: To advance knowledge of vaccine safety and inform clinical and public health practice clinical research is essential. CISA has published and continues to develop research studies that address vaccine safety priorities, such as those identified in the US National Vaccine Plan
.
Current priority areas for CISA research studies include influenza vaccine safety, vaccine safety in persons with autoimmune diseases, and vaccine safety in pregnant women. CISA complements other vaccine safety systems and focuses its efforts on scalable, prospective studies for US-licensed vaccines. These studies are designed to address clinical vaccine safety questions in targeted or special populations that are often excluded from pre-licensure clinical trials. CISA is well suited to study more common, non-medically attended events (e.g., fever) and to collect biological specimens after vaccination. CISA investigators also have access to special populations (e.g., persons with autoimmune diseases) and specialists who care for these patients.
Public Health Response: CISA has procedures in place to assist in response to vaccine safety emergencies, such as a pandemic, and to assist state health departments during an emergency.
CDC - Summary of Adverse Events in Pregnant Women - VAERS - Vaccine Safety
CDC - Summary of Adverse Events in Pregnant Women - VAERS - Vaccine Safety
Summary of Adverse Events in Pregnant Women Following Administration of TIV and LAIV in VAERS, 1990-2009
On this Page
The Centers for Disease Control and Prevention (CDC) recently conducted a review of reports to the Vaccine Adverse Event Reporting System (VAERS) of pregnant women who received seasonal flu vaccines. The review was done to assess potential vaccine safety concerns. The results of this study were published in the article, “Adverse Events in Pregnant Women Following Administration of TIV and LAIV in VAERS, 1990-2009
” and are available in the American Journal of Obstetrics and Gynecology.
Overall, the study concluded that no unusual patterns of pregnancy complications or fetal outcomes were observed in the VAERS reports of pregnant women after the administration of trivalent inactivated influenza vaccine (TIV) or the flu shot, or the live attenuated influenza vaccine (LAIV) or the flu nasal spray. Data from CDC’s 19-year review of VAERS add to an existing body of evidence supporting the safety of the flu shot in pregnant women; the nasal spray vaccine is not recommended for use in pregnant women.
CDC and the Food and Drug Administration (FDA) will continue to monitor vaccine safety during the 2010-11 flu season.
Below are additional results of this study.
Study Results:
- CDC searched for VAERS reports of adverse events in pregnant women who were administered the flu shot from July 1, 1990 through June 30, 2009, or nasal spray vaccine from July 1, 2003 through June 30, 2009.
- Two medical officers conducted an independent clinical review of all VAERS reports retrieved to distinguish between pregnancy-related and non-pregnancy-related reports.
- CDC identified a total of 148 reports of AEs in pregnant women following administration of the flu shot and 27 reports after the inadvertent administration of nasal spray vaccine.
- No maternal deaths were reported.
- No specific AEs were recorded in 20.3% of flu shot and 59% of nasal spray vaccine reports.
- Twenty flu shot (13.5%) and 1 nasal spray vaccine (4%) related reports were classified as serious.
- According to the Code of Federal Regulations, a report is considered serious if an adverse event results in death, life-threatening illness, hospitalization or prolongation of hospitalization, permanent disability or a birth defect to the vaccine recipient.
- The most common pregnancy-related adverse event was spontaneous abortion - 17 reports (11.5%) after the flu shot and 3 reports (11%) following administration of the nasal spray vaccine.*
- The reporting rate of spontaneous abortion was 1.9 per million pregnant women vaccinated with both the flu shot and flu nasal spray vaccine.*
- The second most common pregnancy-specific adverse event following administration of the flu shot was stillbirth—6 reports (4%).*
- A total of 7 (4.7%) congenital malformations were reported as the main diagnosis.
- Three reports described women with Guillian-Barre syndrome (GBS); medical records allowed verification of this diagnosis in 2 cases.
- Three reports of Bell’s palsy were identified, but information was not sufficient to verify this diagnosis.
Limitations of VAERS
- When reviewing data from VAERS, please keep in mind what the system is designed to do and what it is unable to do:
- VAERS is a national reporting system, in which reports are submitted voluntarily by people who think an adverse event occurred after vaccination. VAERS does not solicit reports in any systematic way from all people who have been vaccinated. Reports can be submitted by anyone, including health care providers, patients, or family members. Because of this feature, VAERS reports may and often do include incorrect and incomplete information. VAERS reports often lead to more complete follow-up and review of medical records.
- VAERS staff follow-up on all serious and other selected adverse event reports and obtain additional medical, laboratory, and/or autopsy records when available. As a result of the follow-up/review process, coding terms for individual VAERS reports may change based on the information received. VAERS data are publicly available through the U.S. Vaccine Adverse Event Reporting System (VAERS; http://vaers.hhs.gov) and CDC’s website, WONDER (http://wonder.cdc.gov/vaers.html); the public VAERS data should be used with caution because the numbers and conditions do not reflect data collected during follow-up. Events reported in VAERS should not be viewed as evidence that the vaccine directly caused the event. Reports do not infer causality; further investigation is required.
- Underreporting, or failure to report events, is also one of the main limitations of VAERS. Serious medical events are more likely to be reported than minor events.
- Most importantly, VAERS cannot usually determine cause-and-effect. VAERS accepts all reports without regard to whether or not the event was caused by the vaccine. The report of an adverse event to VAERS does not mean that a vaccine caused the event. It only indicates that the event occurred sometime after administration of the vaccine. Proof that the event was caused by the vaccine is not required in order for VAERS to accept the report.
- No reports are deleted from VAERS. Therefore, it is possible to have more than one VAERS report on an individual case (e.g., a physician and a patient may have filed separate reports for the same case).
- For all serious reports, VAERS staff seeks follow-up medical records on each case, and medical officers review them closely to determine if any additional action or studies may be needed.
- The most reliable information about vaccine side effects can be found in the manufacturers’ vaccine package insert
, vaccine information statements (VISs), or the Advisory Committee on Immunizations Practice’s (ACIP's) statements on vaccines.
* Previous studies have shown that approximately 10.4% - 22.4% of all pregnancies result in spontaneous abortion and almost 0.5% of pregnancies result in stillbirth regardless of vaccination.
CDC - VAERS - Vaccine Safety
CDC - VAERS - Vaccine Safety


Vaccine Adverse Event Reporting System (VAERS)
Vaccines are developed with the highest standards of safety. However, as with any medical procedure, vaccination has some risks. Individuals react differently to vaccines, and there is no way to predict how individuals will react to a particular vaccine.
The National Childhood Vaccine Injury Act (NCVIA) requires health care providers to report adverse events (possible side effects) that occur following vaccination, so the Food and Drug Administration (FDA)
and Centers for Disease Control and Prevention (CDC) established the Vaccine Adverse Events Reporting System (VAERS)
in 1990. VAERS is a national passive reporting system that accepts reports from the public on adverse events associated with vaccines licensed in the United States. VAERS data are monitored to–
- Detect new, unusual, or rare vaccine adverse events
- Monitor increases in known adverse events
- Identify potential patient risk factors for particular types of adverse events
- Identify vaccine lots with increased numbers or types of reported adverse events
- Assess the safety of newly licensed vaccines
Approximately 30,000 VAERS reports are filed annually, with 10-15% classified as serious (resulting in permanent disability, hospitalization, life-threatening illnesses or death). Anyone can file a VAERS report, including health care providers, manufacturers, and vaccine recipients or their parents or guardians. The VAERS form requests the following information:
- The type of vaccine received
- The timing of the vaccination
- The onset of the adverse event
- Current illnesses or medication
- Past history of adverse events following vaccination
- Demographic information about the recipient
VAERS forms can be completed online, or you can complete a paper form and mail or fax it to VAERS.
A contractor, under the supervision of FDA and CDC, enters the information from VAERS forms into a database. Those reporting an adverse event to VAERS receive a confirmation letter containing a VAERS identification number. Additional information may be submitted to VAERS using the assigned identification number. Selected cases of serious adverse reactions are followed up at 60 days and one year post-vaccination to check the recovery status of the patient. FDA and CDC use VAERS data to monitor vaccine safety and conduct research studies. VAERS data (without identifying personal information) are also available to the public.
While VAERS provides useful information on vaccine safety, the data are somewhat limited. For example, VAERS reports may provide incomplete information. Specifically, judgments about whether the vaccine was truly responsible for an adverse event cannot be made from VAERS reports.
Reporting Vaccine Adverse Events
Anyone who gives or receives a licensed vaccine in the U.S. is encouraged to report any significant health problem or unexpected event (even if uncertain that the vaccine caused the event) for any vaccine. The Reportable Events Table (RET) lists and explains injuries and conditions that are believed to be caused by vaccines, and time periods in which the first symptom must occur after receiving the vaccine. It is used by the Vaccine Injury Compensation Program, which is operated by the U.S. Health Resources and Services Administration. Health care providers are required by law to report to VAERS any conditions on the RET, vaccine adverse events that are listed in the manufacturer's package insert, and clinically significant or unexpected events following vaccination.
National Surveillance Data for Vaccine Adverse Events
When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. VAERS receives reports on all potential associations between vaccines and adverse events. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The report of an adverse event to VAERS is not documentation that vaccine caused the event.
CDC MMWR: Rotavirus Vaccine Administration Errors; Reminders to Clinicians
CDC MMWR: Rotavirus Vaccine Administration Errors; Reminders to Clinicians
CDC MMWR: Rotavirus Vaccine Administration Errors; Reminders to Clinicians
Centers for Disease Control and Prevention (CDC) sent this bulletin at 01/31/2014 11:58 AM ESTIn the January 31, 2014, issue of CDC’s MMWR, “Rotavirus Vaccine Administration Errors” looks closely at reports submitted to the Vaccine Adverse Events Reporting System (VAERS) of administration of rotavirus vaccines by injection. VAERS found 39 reports of incorrect administration of rotavirus vaccines by injection and 27 reports of eye splashes. The report reminds clinicians that rotavirus vaccines should not be injected into a child. Vaccine providers should follow instructions in package inserts (Rotateqand Rotarix) on proper administration using the manufacturers’ oral applicator devices (squirted gently and slowly into the child’s cheek).
To view the report in its entirety, click here.
CDC offers a number of educational resources to help providers improve how their practice administers vaccines:
- “Make No Mistake: Vaccine Administration, Storage, and Handling”
- ACIP’s General Recommendations on Immunization
- Immunization Encounters video
- Vaccine administration appendix in the Pink Book
- Vaccine administration in the Epidemiology and Prevention of Vaccine Preventable Diseases (sessions 1-3)
- Interactive module: General Recommendations for Immunization “You Call the Shots” series
- Onsite state health department training
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