Under-reporting of Adverse Events

iVillage Member
Registered: 12-14-2005
Under-reporting of Adverse Events
5
Wed, 12-10-2008 - 11:54am

The Clinical Impact of Adverse Event Reporting
http://www.fda.gov/medwatch/articles/medcont/postrep.htm

Underreporting

Another major concern with any spontaneous reporting system is underreporting of adverse events (16, 30-32). It has been estimated that rarely more than 10% of serious ADRs, and 2-4% of non-serious reactions, are reported to the British spontaneous reporting program (30). A similar estimate is that the FDA receives by direct report less than 1% of suspected serious ADRs(32). This means that cases spontaneously reported to any surveillance program, which comprise the numerator, generally represent only a small portion of the number that have actually occurred. The effect of underreporting can be somewhat lessened if submitted reports, irrespective of number, are of high quality.

(16) Chen RT, Rastogi SC, Mullen JR, Hayes SW, Cochi SL, Donlon JA, et al. The Vaccine Adverse Event Reporting System (VAERS). Vaccine 1994;12:542-550

(30) Rawlins MD. Pharmacovigilance: paradise lost, regained or postponed? The William Withering Lecture 1994. J R Coll Physicians Lond 1995;29:41-49

(31) Strom BL, Tugwell P. Pharmacoepidemiology: current status, prospects, and problems. Ann Intern Med 1990;113:179-181

(32) Scott HD, Rosenbaum SE, Waters WJ, Colt AM, Andrews LG, Juergens JP, et al. Rhode Island physicians' recognition and reporting of adverse drug reactions. R I Med J 1987;70:311-316

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Vaccine Adverse Event Reporting System (VAERS): Usefulness and Limitations
by M. Miles Braun, MD MPH
http://www.vaccinesafety.edu/VAERS.htm

Underreporting.

Underreporting is an inherent problem of passive surveillance systems, including VAERS. The degree of underreporting varies according to the adverse event. For example, one study estimated that 68% of cases of vaccine-associated polio are reported to VAERS, but only 4% of MMR-associated thrombocytopenia are reported (9). This variability in undereporting can make it hazardous to assume that the relative frequencies of adverse events in VAERS reflects their relative rates of occurrence. In addition, for new products on the market, increased reporting of adverse events may occur; this has been termed the "Weber effect" (10).

(9) Rosenthal S, Chen R. The reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am J Public Health 1995;85:1706-9.

(10) Weber JCP. Epidemiology of adverse reactions to non-steroidal antiinflammatory drugs. Advances in Inflammation Research 1984;6:1-7.






iVillage Member
Registered: 04-09-2008
Wed, 12-10-2008 - 1:44pm

This is the main argument I have against those that tout "benefits of vacc's outweigh the risk". Prior, the FDA acknowledged less than 10% that were reported, while the GAO was a little more less forgiving and touted 1-3%. I guess the answer lies somewhere inbetween, but the bottom line - AE's are in the majority, UNREPORTED. Which then, IMHO begs the question, what are the true ramifications of this (or that) vaccination. We just plain have no idea yet we're shooting them up left and right. I weep for our future.

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Rands

iVillage Member
Registered: 06-05-2008
Thu, 12-11-2008 - 10:51am

It can't be *that* bad. Just ask any pediatrician and they'll tell you they've *never* seen an adverse reaction to a vaccine.

(Um, yeah, this would be sarcasm in case you're wondering.)

re
iVillage Member
Registered: 04-09-2008
Thu, 12-11-2008 - 1:04pm

Nah, I've seen enough of your posts to know facetious when I see it. ;-)


There are many problems with the reporting system - so many that it goes beyond comprehension - but what the main problem is, is that people get trained (doctors, and no offense to the doctors) of what is "deemed normal" which in many cases are systemic reactions which are an indication that other problems may be emerging, however, because it's brought out as "normal" it's blown off. Further challenges may result in further complications however that's not brought to the chalk board and it gets blown off.


Much of these problems stem from what's being taught, which hasn't caught up to (or even acknowledged) current day standards, experiences and post trial AE's

Rands

iVillage Member
Registered: 03-25-2004
Sat, 12-13-2008 - 1:39pm
My mom developed a BAD case of cellulitis after receiving the pneumonia vaccine.
    Apraxia Awareness
iVillage Member
Registered: 04-09-2008
Mon, 12-15-2008 - 8:57am

She can do it from their website, which is supposed to be a secure site, here: http://vaers.hhs.gov/


I'd suggest that either her, or someone on her behalf do so; one thing that they'll at least associate with a vaccination is a local reaction at the injection site (and the one that you're describing could be one for concern).

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Rands