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H1N1 Vaccine Safety Data
Are you still questioning the safety of the H1N1 Flu vaccine?
****COMPARE SIDE EFFECTS OF THE H1N1 AND SEASONAL FLU VACCINES*****
View for yourself--the most up-to-date, post-marketing safety surveillance data computed from the U.S. Centers for Disease Control Vaccine Adverse Event Reporting System (VAERS).
ABOUT VAERS
VAERS is a post-marketing safety surveillance program, collecting information about adverse events (possible side effects) that occur after the administration of vaccines licensed for use in the United States.
The primary objectives of VAERS are to:
1. Detect new, unusual, or rare vaccine adverse events (VAEs);
2. Monitor increases in known adverse events;
3. Identify potential patient risk factors for particular types of adverse events;
4. Identify vaccine lots with increased numbers or types of reported adverse events; and
5. Assess the safety of newly licensed vaccines.
VAERS DOES NOT DETERMINE CAUSALITY
Although VAERS can rarely provide definitive evidence of causal associations between vaccines and particular risks, its unique role as a national spontaneous reporting system enables the early detection of signals that can then be more rigorously investigated. VAERS receives reports of many events that occur after immunization. Some of these events may occur coincidentally following vaccination, while others may truly be caused by vaccination. Studies help determine if there is more than a temporal (time) association between immunization and adverse events. The fact that an adverse event occurred following immunization is not conclusive evidence that the event was caused by a vaccine. Factors such as medical history, diagnostic tests, and other medication given near the time of vaccination must be examined to help to determine the cause of adverse events.
LIMITATIONS OF VAERS DATA
1. Underreporting - Underreporting is common to all surveillance systems which require someone to complete and send a report. However we also know that underreporting occurs more often with less serious adverse events and that more serious vaccine adverse event are more likely to be reported to VAERS.
2. Differential reporting - Reporting is increased in the first few years after vaccine licensure, or increased reporting of events occurring soon after vaccination
3. Stimulated reporting - Reporting increases after a known or alleged type of adverse event
4. Reporting of coincidental events - Some of the reports in VAERS are coincidental to vaccination, meaning they would have occurred even if vaccination had not and they are not caused by vaccination.
5. Data quality - Since reports are accepted from anyone, the data reported is not always complete or accurate.
6. No denominator data - VAERS does not provide denominator data. In other words, it does not collect data on the number of doses of vaccines administered and does not allow for calculation of the actual rates of adverse events.
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- Last changed:
- Jan 14, 2010
- Category:
- Medical
- Developer:
- Leslie Pratt
- Version:
- 1.0
- Average Rating:
- No data
- Size:
- 0.1 MB
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