Review of the Vaccine Adverse Event Reporting System (VAERS)
Vaccine Adverse Event Definition
Vaccine Adverse Event Reporting System (VAERS)
Purpose of VAERS
VAERS Strengths
VAERS Limitations
VAERS Uses (Examples)
VAERS Uses (Examples) continued
What to Report to VAERS
What to Report to VAERS (continued)
How to Submit a VAERS Report: One of Several Methods May Be Used
VAERS Follow-up
How Does VAERS Define a “Serious” Report?*
Selected Questions and Answers about VAERS
How are VAERS Reports Analyzed? CDC and FDA have primary responsibility for analysis
How Can Public VAERS Data Be Obtained?
What Are the Best Resources for Vaccine Safety?
How Can Healthcare and Vaccine Providers Contribute to Vaccine Safety?
Continued: How Can Healthcare and Vaccine Providers Contribute to Vaccine Safety?
HHS Vaccine Safety Resources
VAERS Selected Bibliography
Summary
Questions
Flow of a VAERS report
VAERS Background
VAERS “Non-Serious” Reports*
VAERS “Serious” Reports*
2.39M
Категория: МедицинаМедицина

Review of the Vaccine Adverse Event Reporting System (VAERS)

1. Review of the Vaccine Adverse Event Reporting System (VAERS)

Beth Hibbs RN, MPH; Elaine Miller RN, MPH
Immunization Safety Office (ISO)
Division of Healthcare Quality Promotion (DHQP)
Centers for Disease Control and Prevention
National Immunization Conference
April 21, 2010
1

2.

Educational Objectives
• By the end of this presentation viewers
should be able to describe the following
about the Vaccine Adverse Event
Reporting System (VAERS):
– Role in vaccine safety surveillance
– Strengths and limitations
– Which adverse events should be reported to
VAERS
– How to report to VAERS
– How to perform a search of the VAERS data
• Identify resources for vaccine safety
2

3. Vaccine Adverse Event Definition

Adverse events are defined as health
effects that occur after immunization
that may or may not be causally
related to the vaccine.
3

4. Vaccine Adverse Event Reporting System (VAERS)

• National spontaneous reporting system for adverse
events after US-licensed vaccines
– Received over 38,000 reports in 2009, (2005-2009
average per year ~29,000)
– Requires a report be filed; accepts reports from healthcare
providers, manufacturers and others
• Jointly administered CDC and FDA, Authorized by
National Childhood Vaccine Injury Act of 1986
– First reports accepted in 1990
• VAERS data publicly available on VAERS web site
or CDC Wide-ranging Online Data for
Epidemiologic Research (WONDER)
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5. Purpose of VAERS

VAERS is used to:
• Identify new and/or rare adverse events
following immunization
• Monitor trends of known adverse events
• Identify potential patient risk factors for
particular types of adverse events
• Generate hypotheses
• Provide information for public health policies
on vaccine safety
• Monitor vaccine lot safety
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6. VAERS Strengths

• Can detect very rare adverse
events that may not be detected
before licensure
• Generates hypotheses
– Helps identify new and/or rare
adverse events following
immunization
– Helps determine if further
investigations are needed
• Monitors trends of already known
adverse events
• Monitors vaccine lot safety
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7. VAERS Limitations

• Underreporting
• Stimulated reporting due to
media attention and other factors
• Possibly incomplete and
inaccurate data on report form
• Lack of availability of
denominator data
– No information on number of
persons vaccinated
– No information on background rates
of adverse events in the population
• VAERS generally cannot determine if
an adverse event report was
coincidental or caused by a vaccine
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8. VAERS Uses (Examples)

– General Safety of Vaccines
• H1N1 influenza vaccines
Safety of Influenza A (H1N1) 2009 Monovalent Vaccines-US., Oct .1Nov. 24, 2009. MMWR 2009 Dec 11;58(48): 1351-1356.
– New signal, rare adverse events
• Intussusception after rotashield vaccine
Withdrawal of Rotavirus Vaccine Recommendation. MMWR 1999 Nov
5; 48(43): 1007.
• Myopericarditis after smallpox vaccine
Update: Cardiac and Other Adverse Events Following Civilian Smallpox
Vaccination --- United States, 2003. MMWR 2003 July 11; 52 (27):
639-642.
• Syncope following Vaccination
Syncope After Vaccination --- United States, January 2005--July 2007. MMWR
2008 May 2; 57(17): 457-60.
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9. VAERS Uses (Examples) continued

– Reassuring Evidence Supporting
Vaccine Safety
• Guillain-Barre Syndrome risk identified
following 1976 influenza vaccine since then
VAERS has not identified a clear increase
in risk Prevention and Control of seasonal Influenza with vaccinesRecommendations of the ACIP, MMWR 2009 July 31;58(RR08): 1-52.
• Decreased risk of fever and seizures after
acellular compared to whole cell pertussis
vaccines Infant Immunization with Acellular Pertussis Vaccines in
the US: Assessment of the First Two Years’ Data from the Vaccine
Adverse Event Reporting System (VAERS). Braun et al. Pediatrics
2000 Oct;106(4): E51.
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10. What to Report to VAERS

• Report any clinically significant
adverse event following immunization
(www.vaers.hhs.gov)
– Even if you are not certain the vaccine
caused the event
• The National Childhood Vaccine
Injury Act of 1986 mandates that
healthcare providers also report
specific adverse events that occur
after vaccination
– Events listed in the Table of Reportable Events
https://kids.phila.gov/Docs/VAERS_Reportable
EventsTable.pdf
– Events listed in the vaccine package insert as
a contraindication to further doses of vaccine
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11. What to Report to VAERS (continued)

• The report asks for information
about pt, provider and reporter
demographics, adverse event ,
vaccines received and any
preexisting conditions.
demographics
AE
• Include as much information as
possible in the report (e.g.,
vaccination location, date, vaccine
type, lot number and dose number)
– Reports with incomplete
information accepted
• Report as soon as possible but no
time limit on reporting
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vax

12. How to Submit a VAERS Report: One of Several Methods May Be Used

1) Online via a secure website at
https://vaers.hhs.gov
2) Download a reporting form:
http://vaers.hhs.gov/resources/vaers_for
m.pdf
• Fax a completed form: 877-721-0366
• Mail a completed VAERS form to VAERS,
P.O. Box 1100, Rockville, MD, 20849
To request a reporting form or for other VAERS
assistance: call 800-822-7967 or email:
[email protected]
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13. VAERS Follow-up

• VAERS staff follow up with
health care providers on serious
reports and certain selected
reports of interest by phone to
obtain:
– Medical records
– Autopsy reports
• Letter sent to reporters to check
recovery status for all reports
with “no” or “unknown” recovery
listed on initial VAERS form (60
days and 1 year)
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14. How Does VAERS Define a “Serious” Report?*

Death
Life-threatening illness
Hospitalization
Prolongation of hospitalization
Persistent or significant
disability
Certain other medically
important conditions
*Code of Federal Regulations
Title 21
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Box 8 of VAERS form

15. Selected Questions and Answers about VAERS

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16. How are VAERS Reports Analyzed? CDC and FDA have primary responsibility for analysis

• Assess for signals for new or unexpected adverse events
of concern
– Use Medical Dictionary for Regulatory Activities (MedDRA) terms to
analyze frequencies of reported adverse events (focus on serious
adverse events)
– Doses distributed data are commonly used as a proxy for doses
administered
– Assess and compare reporting rates among vaccines and health
events of interest (observed in VAERS versus expected in general
population)
• Review individual reports for serious adverse events and
selected other conditions
– Additional information available from follow-up medical records and
autopsy reports
• Closely monitor safety of vaccine lots (FDA lead)
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17. How Can Public VAERS Data Be Obtained?

VAERS data (without identifiable personal information)
are accessible to the public through 2 systems:
1.
CDC Wide-ranging Online Data for Epidemiologic Research
(WONDER) online search tool: data available about 1
month after VAERS receives the report.
http://wonder.cdc.gov/vaers.html
2.
Download raw data files for import into a database,
spreadsheet, or text editing program; data available about
4 to 6 weeks after VAERS receives the report.
http://vaers.hhs.gov/
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18. What Are the Best Resources for Vaccine Safety?

Publications updated with vaccine safety
research findings and recommendations:
• Manufacturer Vaccine Package Insert
– http://www.fda.gov/BiologicsBloodVaccines/Vaccines/Approv
edProducts/UCM093833
• Advisory Committee on Immunization
Practices Statements
– http://www.cdc.gov/vaccines/pubs/ACIP-list.htm
• Vaccine Information Statements
– http://www.cdc.gov/vaccines/pubs/vis/default.htm
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19. How Can Healthcare and Vaccine Providers Contribute to Vaccine Safety?

• Properly store and administer
vaccine
http://www.cdc.gov/vaccines/recs/storage/default.htm
• Screen for contraindications and
precautions
http://www.cdc.gov/vaccines/recs/vacadmin/contraindications.htm
• Educate vaccinee (or caregiver)
about risks and benefits of vaccine
• Evaluate and treat patient if an
adverse event occurs
• Report clinically significant adverse
events promptly to VAERS
– https://vaers.hhs.gov
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20. Continued: How Can Healthcare and Vaccine Providers Contribute to Vaccine Safety?

Patient Education Materials
• CDC Vaccine Information
Statements (VIS)
http://www.cdc.gov/vaccines/Pubs/vis/
default.htm
Contains Vaccine Safety
information
– Contraindications
– VAERS
– Vaccine Injury Compensation
• Public health law requires
VIS to be distributed to
recipients of recommended
childhood vaccines
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Example MMR VIS

21. HHS Vaccine Safety Resources


CDC



VAERS -CDC/FDA


800-822-7967
http://vaers.hhs.gov
Vaccine Injury Compensation- HRSA


Immunization Safety Office Web site
www.cdc.gov/vaccinesafety
800-CDC-INFO (232-4636)
[email protected]
800-338-2382
www.hrsa.gov/vaccinecompensation/
Food and Drug Administration

www.fda.gov/cber
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22. VAERS Selected Bibliography

• Varricchio F, Iskander J, Destefano F, Ball R, Pless R, Braun
MM, Chen RT. Understanding Vaccine Safety Information from
the Vaccine Adverse Event Reporting System. Pediatric
Infectious Disease Journal 2004;23(4):287-294.
• Iskander JK, Miller ER, Chen RT. The Role of the Vaccine
Adverse Event Reporting System (VAERS) in Monitoring
Vaccine Safety. Pediatr Ann. 2004 Sep;33(9):599-606.
• Iskander J, Pool V, Zhou W, English-Bullard R; The VAERS
Team. Data Mining in the US using the Vaccine Adverse Event
Reporting System. Drug Safety 2006;29(5):375–384.
Zhou W, Pool V, Iskander JK, English-Bullard R, et al. Surveillance for
safety after immunization: Vaccine Adverse Event Reporting System
(VAERS)—United States, 1991–2001. MMWR 2003;52(1):1–24.
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23. Summary

• VAERS is a front-line mechanism to monitor the
safety of US Licensed vaccines
• The first hint of a potential problem usually originates
with the astute clinician and therefore the role of the
health professional is essential in identifying vaccine
adverse events through reports to VAERS
• VAERS report data are used to:
– inform CDC and FDA and others in vaccine safety
surveillance and research,
– identify possible rare or new vaccine side effects or changes
in known vaccine side effects,
– monitor lot safety,
– update the manufacturer package insert, Advisory
Committee on Immunization Practices (ACIP) vaccine
recommendations and Vaccine Information Statements.
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24. Questions

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25. Flow of a VAERS report

Report
Submitted
Reporters
Patients
Providers
Manufacturers
States
DOD
others
Web
Mail
Fax
Serious
ID number
Data Coded
Medical
records
Acknowledge
Request missing info
Data sent to
CDC/ FDA
daily
VSD
Manf
FDA
CDC
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CISA
Follow
Up
letter
ACIP

26. VAERS Background

• US post licensure vaccine safety surveillance
– Collects voluntary reports of adverse events
following immunization
– Co-managed by CDC and the Food and Drug
Administration (FDA)
• Healthcare providers are encouraged to
report clinically significant adverse events
after vaccination*
– Anyone can submit a report to VAERS
• Receives ~23,000 reports per year (20052009 average)
• Data publicly available
*Clinically significant means of concern to the healthcare provider or
vaccinee/ care giver or other VAERS reporter; www.vaers.hhs.gov
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27. VAERS “Non-Serious” Reports*

• 92% of VAERS
reports are “nonserious”
• Most frequent
adverse events**





Local reactions
Fever
Rashes or itching
Headache
Dizziness or nausea
* Data from 91,669 VAERS reports received during 2005 through 2009
**A vaccinee may have had more than one adverse event listed in the
report
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28. VAERS “Serious” Reports*

8% of VAERS reports are
“serious”* (2005-2009)*
Most frequent serious adverse
events**
Fever
Vomiting
Dyspnea
Headache
Pain
Convulsions
Nausea
Fatigue
Diarrhea
*Data from primary , non foreign VAERS reports received during 2005 through 2009
**A vaccinee may have had more than one adverse event listed in the report
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