VAERS Data: A possible source of bias

PEDIATRICS Vol. 117 No. 2 February 2006, pp. 387-390
(doi:10.1542/peds.2004-2687) This Article


Vaccine Adverse Event Reporting System Reporting Source: A Possible
Source of Bias in Longitudinal Studies
Michael J. Goodman, PhD and James Nordin, MD, MPH

HealthPartners Research Foundation, Minneapolis, Minnesota

OBJECTIVE. The US Vaccine Adverse Event Reporting System (VAERS) is a
passive reporting system to which anyone can report an event. Publicity
related to potential adverse events may change reporting patterns. The
objective of this paper is to show how litigation-related reports have
influenced the trends in possible adverse event reports to VAERS.

METHODS. The VAERS public-use data files were downloaded in July 2004
and translated into identical SAS data sets for analysis. Cases that
were related to litigation were identified using a word search
algorithm. All cases for the most frequently reported symptoms in
litigation (overdose, neuropathy, autism, "mental retardation,"
arthralgia, and "speech disorder") were reviewed.

RESULTS. In recent years, most case reports to VAERS that were related
to overdose, neuropathy, and thimerosal were related to litigation. Many
cases that were related to autism and mental retardation were as well.

CONCLUSIONS. This review shows a previously undisclosed rise in the
number of reports to the VAERS related to pending litigation for vaccine
injury. The implications of this for understanding longitudinal
reporting patterns are discussed.

---------------

Documentation of the fact that the Geiers use of VAERS data is bogus.

Mark Probert wrote:
PEDIATRICS Vol. 117 No. 2 February 2006, pp. 387-390
(doi:10.1542/peds.2004-2687) This Article


Vaccine Adverse Event Reporting System Reporting Source: A Possible
Source of Bias in Longitudinal Studies
Michael J. Goodman, PhD and James Nordin, MD, MPH

HealthPartners Research Foundation, Minneapolis, Minnesota

OBJECTIVE. The US Vaccine Adverse Event Reporting System (VAERS) is a
passive reporting system to which anyone can report an event. Publicity
related to potential adverse events may change reporting patterns. The
objective of this paper is to show how litigation-related reports have
influenced the trends in possible adverse event reports to VAERS.

METHODS. The VAERS public-use data files were downloaded in July 2004
and translated into identical SAS data sets for analysis. Cases that
were related to litigation were identified using a word search
algorithm. All cases for the most frequently reported symptoms in
litigation (overdose, neuropathy, autism, "mental retardation,"
arthralgia, and "speech disorder") were reviewed.

RESULTS. In recent years, most case reports to VAERS that were related
to overdose, neuropathy, and thimerosal were related to litigation. Many
cases that were related to autism and mental retardation were as well.

CONCLUSIONS. This review shows a previously undisclosed rise in the
number of reports to the VAERS related to pending litigation for vaccine
injury. The implications of this for understanding longitudinal
reporting patterns are discussed.

---------------

Documentation of the fact that the Geiers use of VAERS data is bogus.


Pathetic, Markey. We are to believe that a rise in vaccine damage
reports using the only vaccine respository available to the public is
suddenly not reliable because people are using it? I suppose we should
just ignore the various side effects that vaccine damage apologists
(like you) have said are not "real." Hey, here's an idea. Just waive
liability for the vaccine makers so no matter how many people suffer
vaccine damage, the VAERS data can simply be ignored. What? You're
telling me that's already happened? Well, there you have it -- shaft
the public often enough and they won't feel a thing.

PeterB

Nope, it's dead-on right. I could have predicted this before they did
it. When you do epidemiology studies you *always* want random samples.
Volunteering information selects for those who are *interested*, and
this is not a random sample. When we were doing West Nile prevalence
testing a few years ago we went to the blood bank for our samples,
because that's a more random way of getting samples, thus your data are
more reflective of the general population. You never want to solicit
the public for volunteers - you get biased sample collection.

This is an old rule of epidemiology.

PeterB wrote:
Mark Probert wrote:
PEDIATRICS Vol. 117 No. 2 February 2006, pp. 387-390
(doi:10.1542/peds.2004-2687) This Article


Vaccine Adverse Event Reporting System Reporting Source: A Possible
Source of Bias in Longitudinal Studies
Michael J. Goodman, PhD and James Nordin, MD, MPH

HealthPartners Research Foundation, Minneapolis, Minnesota

OBJECTIVE. The US Vaccine Adverse Event Reporting System (VAERS) is a
passive reporting system to which anyone can report an event. Publicity
related to potential adverse events may change reporting patterns. The
objective of this paper is to show how litigation-related reports have
influenced the trends in possible adverse event reports to VAERS.

METHODS. The VAERS public-use data files were downloaded in July 2004
and translated into identical SAS data sets for analysis. Cases that
were related to litigation were identified using a word search
algorithm. All cases for the most frequently reported symptoms in
litigation (overdose, neuropathy, autism, "mental retardation,"
arthralgia, and "speech disorder") were reviewed.

RESULTS. In recent years, most case reports to VAERS that were related
to overdose, neuropathy, and thimerosal were related to litigation. Many
cases that were related to autism and mental retardation were as well.

CONCLUSIONS. This review shows a previously undisclosed rise in the
number of reports to the VAERS related to pending litigation for vaccine
injury. The implications of this for understanding longitudinal
reporting patterns are discussed.

---------------

Documentation of the fact that the Geiers use of VAERS data is bogus.


Pathetic, Markey. We are to believe that a rise in vaccine damage
reports using the only vaccine respository available to the public is
suddenly not reliable because people are using it? I suppose we should
just ignore the various side effects that vaccine damage apologists
(like you) have said are not "real." Hey, here's an idea. Just waive
liability for the vaccine makers so no matter how many people suffer
vaccine damage, the VAERS data can simply be ignored. What? You're
telling me that's already happened? Well, there you have it -- shaft
the public often enough and they won't feel a thing.

PeterB

Vaccine-man wrote:
Nope, it's dead-on right. I could have predicted this before they did
it. When you do epidemiology studies you *always* want random samples.
Volunteering information selects for those who are *interested*, and
this is not a random sample. When we were doing West Nile prevalence
testing a few years ago we went to the blood bank for our samples,
because that's a more random way of getting samples, thus your data are
more reflective of the general population. You never want to solicit
the public for volunteers - you get biased sample collection.

The fact your sponsors didn't properly study the effects or safety of
vaccines before marketing them is why we're in this mess. VAERS is
still a place to start, but the drug makers cannot be trusted to study
the products they intend to market. Debacles like HRT and Vioxx
(so-called "evidence based medicine") should be proof enough of that.
It's a little late, therefore, to ask Mr. fox to carry your eggs.

This is an old rule of epidemiology.

So get busy.

PeterB wrote:
Mark Probert wrote:
PEDIATRICS Vol. 117 No. 2 February 2006, pp. 387-390
(doi:10.1542/peds.2004-2687) This Article


Vaccine Adverse Event Reporting System Reporting Source: A Possible
Source of Bias in Longitudinal Studies
Michael J. Goodman, PhD and James Nordin, MD, MPH

HealthPartners Research Foundation, Minneapolis, Minnesota

OBJECTIVE. The US Vaccine Adverse Event Reporting System (VAERS) is a
passive reporting system to which anyone can report an event. Publicity
related to potential adverse events may change reporting patterns. The
objective of this paper is to show how litigation-related reports have
influenced the trends in possible adverse event reports to VAERS.

METHODS. The VAERS public-use data files were downloaded in July 2004
and translated into identical SAS data sets for analysis. Cases that
were related to litigation were identified using a word search
algorithm. All cases for the most frequently reported symptoms in
litigation (overdose, neuropathy, autism, "mental retardation,"
arthralgia, and "speech disorder") were reviewed.

RESULTS. In recent years, most case reports to VAERS that were related
to overdose, neuropathy, and thimerosal were related to litigation. Many
cases that were related to autism and mental retardation were as well.

CONCLUSIONS. This review shows a previously undisclosed rise in the
number of reports to the VAERS related to pending litigation for vaccine
injury. The implications of this for understanding longitudinal
reporting patterns are discussed.

---------------

Documentation of the fact that the Geiers use of VAERS data is bogus.


Pathetic, Markey. We are to believe that a rise in vaccine damage
reports using the only vaccine respository available to the public is
suddenly not reliable because people are using it? I suppose we should
just ignore the various side effects that vaccine damage apologists
(like you) have said are not "real." Hey, here's an idea. Just waive
liability for the vaccine makers so no matter how many people suffer
vaccine damage, the VAERS data can simply be ignored. What? You're
telling me that's already happened? Well, there you have it -- shaft
the public often enough and they won't feel a thing.

PeterB

PeterB wrote:

The fact your sponsors

Excuse me? What do you mean by my "sponsors"?

didn't properly study the effects or safety of
vaccines before marketing them is why we're in this mess.

There is no mess. A lot of people are alive and well today because of
vaccines. They are effective and safe. There are some risks, just like
driving a car, but they are extremely rare.

VAERS is
still a place to start, but the drug makers cannot be trusted to study
the products they intend to market. Debacles like HRT and Vioxx

"Debacles"? Wow you make it sound like doom and gloom. Besides, what do
these have to do with vaccines. Please stay on topic.

(so-called "evidence based medicine") should be proof enough of that.
It's a little late, therefore, to ask Mr. fox to carry your eggs.

You can bury your head in the sand - that is your prerogative. But
keep in mind, if you leave it buried long enough you'll suffer brain
damage, and even death.

Vaccine-man wrote:
PeterB wrote:

The fact your sponsors

Excuse me? What do you mean by my "sponsors"?

You are here defending the vaccine makers and their products in a
newsgroup devoted to the alternatives, which means you are promoting
vaccine. Your sponsors are those who have a vested interest in that
effort. Simple enough?

didn't properly study the effects or safety of
vaccines before marketing them is why we're in this mess.

There is no mess.

Sure there is. Whenever you don't actually know the risk-adjusted
benefit for a particular medical intervention, you have a mess on your
hands. It was the case with HRT, it was the case with Vioxx, and it's
also the case with vaccine.

A lot of people are alive and well today because of
vaccines.

Studies show that not more than 3.5% of the decline in infectious
disease mortality occured after introduction of vaccine, and no proof
exists to show what portion of that 3.5% can be attributed to vaccine.
All you have is tally stroking health surveys, which is little more
than guesswork.

They are effective and safe. There are some risks, just like
driving a car, but they are extremely rare.

What data do you have to back that up?

VAERS is
still a place to start, but the drug makers cannot be trusted to study
the products they intend to market. Debacles like HRT and Vioxx

"Debacles"? Wow you make it sound like doom and gloom. Besides, what do
these have to do with vaccines. Please stay on topic.

My point is that the drug makers are an inappropriate source of safety
data for products they themselves market. And if you don't think an
elevated risk of stroke, breast cancer, heart attack, and attendant
lifespan reductions are a negative for public health, why are you
posting to mha?

(so-called "evidence based medicine") should be proof enough of that.
It's a little late, therefore, to ask Mr. fox to carry your eggs.

You can bury your head in the sand - that is your prerogative. But
keep in mind, if you leave it buried long enough you'll suffer brain
damage, and even death.

The total loss of neuronal activity can be attributed to your comments
in this post. Mission accomplished.

PeterB wrote:
Mark Probert wrote:
PEDIATRICS Vol. 117 No. 2 February 2006, pp. 387-390
(doi:10.1542/peds.2004-2687) This Article


Vaccine Adverse Event Reporting System Reporting Source: A Possible
Source of Bias in Longitudinal Studies
Michael J. Goodman, PhD and James Nordin, MD, MPH

HealthPartners Research Foundation, Minneapolis, Minnesota

OBJECTIVE. The US Vaccine Adverse Event Reporting System (VAERS) is a
passive reporting system to which anyone can report an event. Publicity
related to potential adverse events may change reporting patterns. The
objective of this paper is to show how litigation-related reports have
influenced the trends in possible adverse event reports to VAERS.

METHODS. The VAERS public-use data files were downloaded in July 2004
and translated into identical SAS data sets for analysis. Cases that
were related to litigation were identified using a word search
algorithm. All cases for the most frequently reported symptoms in
litigation (overdose, neuropathy, autism, "mental retardation,"
arthralgia, and "speech disorder") were reviewed.

RESULTS. In recent years, most case reports to VAERS that were related
to overdose, neuropathy, and thimerosal were related to litigation. Many
cases that were related to autism and mental retardation were as well.

CONCLUSIONS. This review shows a previously undisclosed rise in the
number of reports to the VAERS related to pending litigation for vaccine
injury. The implications of this for understanding longitudinal
reporting patterns are discussed.

---------------

Documentation of the fact that the Geiers use of VAERS data is bogus.


Pathetic, Markey. We are to believe that a rise in vaccine damage
reports using the only vaccine respository available to the public is
suddenly not reliable because people are using it?

You may believe whatever you wish. I expected that you would not address
the substantive issues raised.

People are using it. No question. However, with what is reported, there
is a clear chance that there is a significant selection bias. You do
know what a selection bias is, and why it should be avoided, don't you?

I suppose we should
just ignore the various side effects that vaccine damage apologists
(like you) have said are not "real."

Strawman. You should ignore those side effects which have been shown to
not exist, like autism. The rest, you should investigate on a one by one
basis.

Hey, here's an idea.

HOORAY! That is a first! National Holiday Time!

Just waive
liability for the vaccine makers so no matter how many people suffer
vaccine damage, the VAERS data can simply be ignored. What? You're
telling me that's already happened? Well, there you have it -- shaft
the public often enough and they won't feel a thing.

Here are some quotes from the VAERS website:

"When evaluating data from VAERS, it is important to note that for any
reported event, no cause and effect relationship has been established.
VAERS is interested in 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 a vaccine caused the event." (emphasis mine)

And, most important:

VAERS data have a number of limitations you should remember:

VAERS data are derived from a passive surveillance system and represent
unverified reports of health events, both minor and serious, that occur
after vaccination.

Such data are subject to limitations of under-reporting, simultaneous
administration of multiple vaccine antigens (making it difficult to know
to which of the vaccines, if any, the event might be attributed),
reporting bias, and lack of incidence rates in unvaccinated comparison
groups.

While some events reported to VAERS are truly caused by vaccines, others
may be related to an underlying disease or condition, to drugs being
taken concurrently, or may occur by chance shortly after a vaccine was
administered.

VAERS occasionally receives case reports from US manufacturers that were
reported to their foreign subsidiaries. Under FDA regulations, if a
manufacturer is notified of a foreign case report that describes an
event that is both serious and unexpected (in other words, it does not
appear in the product labeling), they are required to submit it to
VAERS. It is important to realize that these case reports are of
variable data quality and completeness, due to the many differences in
country reporting practices and surveillance system quality. For this
reason they are provided as separate files.

In some media reports and on some web sites on the Internet, VAERS
reports are presented as verified cases of vaccine deaths and injuries.
Statements such as these misrepresent the nature of the VAERS
surveillance system.

----------------------

IOW, Petey, it was NOT designed to be used as Geier, et al, uses it,
and, with the study I posted, it is inherently BAD SCIENCE to do so.

BTW, are you aware of the famous James Laidler report?

It is a basic rule of investigation. Use appropriate data.

Vaccine-man wrote:
Nope, it's dead-on right. I could have predicted this before they did
it. When you do epidemiology studies you *always* want random samples.
Volunteering information selects for those who are *interested*, and
this is not a random sample. When we were doing West Nile prevalence
testing a few years ago we went to the blood bank for our samples,
because that's a more random way of getting samples, thus your data are
more reflective of the general population. You never want to solicit
the public for volunteers - you get biased sample collection.

This is an old rule of epidemiology.

PeterB wrote:
Mark Probert wrote:
PEDIATRICS Vol. 117 No. 2 February 2006, pp. 387-390
(doi:10.1542/peds.2004-2687) This Article


Vaccine Adverse Event Reporting System Reporting Source: A Possible
Source of Bias in Longitudinal Studies
Michael J. Goodman, PhD and James Nordin, MD, MPH

HealthPartners Research Foundation, Minneapolis, Minnesota

OBJECTIVE. The US Vaccine Adverse Event Reporting System (VAERS) is a
passive reporting system to which anyone can report an event. Publicity
related to potential adverse events may change reporting patterns. The
objective of this paper is to show how litigation-related reports have
influenced the trends in possible adverse event reports to VAERS.

METHODS. The VAERS public-use data files were downloaded in July 2004
and translated into identical SAS data sets for analysis. Cases that
were related to litigation were identified using a word search
algorithm. All cases for the most frequently reported symptoms in
litigation (overdose, neuropathy, autism, "mental retardation,"
arthralgia, and "speech disorder") were reviewed.

RESULTS. In recent years, most case reports to VAERS that were related
to overdose, neuropathy, and thimerosal were related to litigation. Many
cases that were related to autism and mental retardation were as well.

CONCLUSIONS. This review shows a previously undisclosed rise in the
number of reports to the VAERS related to pending litigation for vaccine
injury. The implications of this for understanding longitudinal
reporting patterns are discussed.

---------------

Documentation of the fact that the Geiers use of VAERS data is bogus.

Pathetic, Markey. We are to believe that a rise in vaccine damage
reports using the only vaccine respository available to the public is
suddenly not reliable because people are using it? I suppose we should
just ignore the various side effects that vaccine damage apologists
(like you) have said are not "real." Hey, here's an idea. Just waive
liability for the vaccine makers so no matter how many people suffer
vaccine damage, the VAERS data can simply be ignored. What? You're
telling me that's already happened? Well, there you have it -- shaft
the public often enough and they won't feel a thing.

PeterB

PeterB wrote:
Vaccine-man wrote:
Nope, it's dead-on right. I could have predicted this before they did
it. When you do epidemiology studies you *always* want random samples.
Volunteering information selects for those who are *interested*, and
this is not a random sample. When we were doing West Nile prevalence
testing a few years ago we went to the blood bank for our samples,
because that's a more random way of getting samples, thus your data are
more reflective of the general population. You never want to solicit
the public for volunteers - you get biased sample collection.

The fact your sponsors didn't properly study the effects or safety of
vaccines before marketing them is why we're in this mess. VAERS is
still a place to start, but the drug makers cannot be trusted to study
the products they intend to market.

BWHAHAHAHAHA!

"The majority of VAERS reports are sent in by vaccine manufacturers
(42%) and health care providers (30%). "

http://vaers.hhs.gov/vaers.htm

With rare events, it is impossible for a pre-marketing testing program
to find all possible problems. VAERS is the database which fills in the
gaps.

Debacles like HRT and Vioxx
(so-called "evidence based medicine") should be proof enough of that.
It's a little late, therefore, to ask Mr. fox to carry your eggs.

If I raised another medication or chemical, etc. your fellow-travelers
would whine about me diverting. Watch the AltNuts remain silent.

This is an old rule of epidemiology.

So get busy.

So, get a clue.

PeterB wrote:
Mark Probert wrote:
PEDIATRICS Vol. 117 No. 2 February 2006, pp. 387-390
(doi:10.1542/peds.2004-2687) This Article


Vaccine Adverse Event Reporting System Reporting Source: A Possible
Source of Bias in Longitudinal Studies
Michael J. Goodman, PhD and James Nordin, MD, MPH

HealthPartners Research Foundation, Minneapolis, Minnesota

OBJECTIVE. The US Vaccine Adverse Event Reporting System (VAERS) is a
passive reporting system to which anyone can report an event. Publicity
related to potential adverse events may change reporting patterns. The
objective of this paper is to show how litigation-related reports have
influenced the trends in possible adverse event reports to VAERS.

METHODS. The VAERS public-use data files were downloaded in July 2004
and translated into identical SAS data sets for analysis. Cases that
were related to litigation were identified using a word search
algorithm. All cases for the most frequently reported symptoms in
litigation (overdose, neuropathy, autism, "mental retardation,"
arthralgia, and "speech disorder") were reviewed.

RESULTS. In recent years, most case reports to VAERS that were related
to overdose, neuropathy, and thimerosal were related to litigation. Many
cases that were related to autism and mental retardation were as well.

CONCLUSIONS. This review shows a previously undisclosed rise in the
number of reports to the VAERS related to pending litigation for vaccine
injury. The implications of this for understanding longitudinal
reporting patterns are discussed.

---------------

Documentation of the fact that the Geiers use of VAERS data is bogus.

Pathetic, Markey. We are to believe that a rise in vaccine damage
reports using the only vaccine respository available to the public is
suddenly not reliable because people are using it? I suppose we should
just ignore the various side effects that vaccine damage apologists
(like you) have said are not "real." Hey, here's an idea. Just waive
liability for the vaccine makers so no matter how many people suffer
vaccine damage, the VAERS data can simply be ignored. What? You're
telling me that's already happened? Well, there you have it -- shaft
the public often enough and they won't feel a thing.

PeterB

Vaccine-man wrote:
PeterB wrote:

The fact your sponsors

Excuse me? What do you mean by my "sponsors"?

Petey cannot engage in reasoned discussion and resorts to
marginalization techniques to dismiss those who he cannot handle. Thus,
he created the idiot term, pharmablogger.

didn't properly study the effects or safety of
vaccines before marketing them is why we're in this mess.

There is no mess. A lot of people are alive and well today because of
vaccines. They are effective and safe. There are some risks, just like
driving a car, but they are extremely rare.

VAERS is
still a place to start, but the drug makers cannot be trusted to study
the products they intend to market. Debacles like HRT and Vioxx

"Debacles"? Wow you make it sound like doom and gloom. Besides, what do
these have to do with vaccines. Please stay on topic.

Petey finds that hard. He has to resort to comments like "sponsors"
"handlers" "pharmablogger", etc. Facts confuse him.

(so-called "evidence based medicine") should be proof enough of that.
It's a little late, therefore, to ask Mr. fox to carry your eggs.

You can bury your head in the sand - that is your prerogative. But
keep in mind, if you leave it buried long enough you'll suffer brain
damage, and even death.

I would not have used the term "sand" to describe where Petey keeps his
head for storage.