Review of the Vaccine Adverse Event Reporting System (VAERS)

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Review of the Vaccine Adverse Event Reporting System (VAERS)

Содержание

2. By the end of this presentation viewers should be able to describe the following about the
3. Vaccine Adverse Event Definition Adverse events are defined as health effects that occur after immunization that
4. Vaccine Adverse Event Reporting System (VAERS) National spontaneous reporting system for adverse events after US-licensed vaccines
5. Purpose of VAERS VAERS is used to: Identify new and/or rare adverse events following immunization Monitor
6. VAERS Strengths Can detect very rare adverse events that may not be detected before licensure Generates
7. VAERS Limitations Underreporting Stimulated reporting due to media attention and other factors Possibly incomplete and inaccurate
8. VAERS Uses (Examples) General Safety of Vaccines H1N1 influenza vaccines Safety of Influenza A (H1N1) 2009
9. VAERS Uses (Examples) continued Reassuring Evidence Supporting Vaccine Safety Guillain-Barre Syndrome risk identified following 1976 influenza
10. What to Report to VAERS Report any clinically significant adverse event following immunization (www.vaers.hhs.gov) Even if
11. What to Report to VAERS (continued) The report asks for information about pt, provider and reporter
12. How to Submit a VAERS Report: One of Several Methods May Be Used Online via a
13. VAERS Follow-up VAERS staff follow up with health care providers on serious reports and certain selected
14. How Does VAERS Define a “Serious” Report?* Death Life-threatening illness Hospitalization Prolongation of hospitalization Persistent or
15. Selected Questions and Answers about VAERS
16. How are VAERS Reports Analyzed? CDC and FDA have primary responsibility for analysis Assess for signals
17. How Can Public VAERS Data Be Obtained? VAERS data (without identifiable personal information) are accessible to
18. What Are the Best Resources for Vaccine Safety? Publications updated with vaccine safety research findings and
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
20. Continued: How Can Healthcare and Vaccine Providers Contribute to Vaccine Safety? Patient Education Materials CDC Vaccine
21. HHS Vaccine Safety Resources CDC Immunization Safety Office Web site www.cdc.gov/vaccinesafety 800-CDC-INFO (232-4636) CDCinfo@cdc.gov VAERS -CDC/FDA
22. VAERS Selected Bibliography Varricchio F, Iskander J, Destefano F, Ball R, Pless R, Braun MM, Chen
23. Summary VAERS is a front-line mechanism to monitor the safety of US Licensed vaccines The first
24. Questions
25. Flow of a VAERS report Report Submitted ID number Data Coded Serious Medical records Data sent
26. VAERS Background US post licensure vaccine safety surveillance Collects voluntary reports of adverse events following immunization
27. VAERS “Non-Serious” Reports* 92% of VAERS reports are “non-serious” Most frequent adverse events** Local reactions Fever
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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

Educational Objectives

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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.

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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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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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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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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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VAERS Uses (Examples)
General Safety of Vaccines
H1N1 influenza vaccines
Safety of Influenza

A (H1N1) 2009 Monovalent Vaccines-US., Oct .1-Nov. 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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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 vaccines-Recommendations 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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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_ReportableEventsTable.pdf
Events listed in the vaccine package insert as a contraindication to further doses of vaccine

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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.
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

demographics

vax

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How to Submit a VAERS Report: One of Several Methods May

Be Used
Online via a secure website at
https://vaers.hhs.gov
2) Download a reporting form: http://vaers.hhs.gov/resources/vaers_form.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: info@vaers.org

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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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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

Box 8 of VAERS form

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Selected Questions and Answers about VAERS

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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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How Can Public VAERS Data Be Obtained?
VAERS data (without identifiable

personal information)
are accessible to the public through 2 systems:
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
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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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/ApprovedProducts/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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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/vac-admin/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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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

Example MMR VIS

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HHS Vaccine Safety Resources
CDC
Immunization Safety Office Web site www.cdc.gov/vaccinesafety
800-CDC-INFO (232-4636)
CDCinfo@cdc.gov
VAERS

-CDC/FDA
800-822-7967
http://vaers.hhs.gov
Vaccine Injury Compensation- HRSA
800-338-2382
www.hrsa.gov/vaccinecompensation/
Food and Drug Administration
www.fda.gov/cber

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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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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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Questions

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Flow of a VAERS report
Report
Submitted
ID number
Data Coded
Serious
Medical
records
Data sent to

CDC/ FDA
daily

FDA

CDC

Follow
Up
letter

VSD

CISA

Manf

ACIP

Reporters
Patients
Providers
Manufacturers
States
DOD
others

Web
Mail
Fax

Acknowledge
Request missing info

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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 (2005-2009 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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VAERS “Non-Serious” Reports*
92% of VAERS reports are “non-serious”
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

Review of the Vaccine Adverse Event Reporting System (VAERS)

Содержание

By the end of this presentation viewers should be able to

Vaccine Adverse Event DefinitionAdverse events are defined as health effects that

Vaccine Adverse Event Reporting System (VAERS) National spontaneous reporting system for

Purpose of VAERSVAERS is used to: Identify new and/or rare adverse

VAERS StrengthsCan detect very rare adverse events that may not be

VAERS Limitations UnderreportingStimulated reporting due to media attention and other factorsPossibly

VAERS Uses (Examples)General Safety of VaccinesH1N1 influenza vaccines Safety of Influenza

VAERS Uses (Examples) continuedReassuring Evidence Supporting Vaccine SafetyGuillain-Barre Syndrome risk identified

What to Report to VAERSReport any clinically significant adverse event following

What to Report to VAERS (continued)The report asks for information about

How to Submit a VAERS Report: One of Several Methods May

VAERS Follow-upVAERS staff follow up with health care providers on serious

How Does VAERS Define a “Serious” Report?* DeathLife-threatening illnessHospitalizationProlongation of hospitalizationPersistent