Autism listed as adverse event on DTAP vaccine insert on fda website.. - Mothering Forums

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#1 of 79 Old 08-22-2009, 12:10 AM - Thread Starter
 
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Hi all... Well I have to say I was really surprised to see this.

This is from the fda package insert for the tripedia vaccine.

Adverse events reported during post-approval use of Tripedia vaccine include idiopathic thrombocytopenic purpura, SIDS, anaphylactic reaction, cellulitis, autism, convulsion/grand mal convulsion, encephalopathy, hypotonia, neuropathy, somnolence and apnea

http://www.fda.gov/downloads/Biologi.../UCM101580.pdf

I wish I could have seen the vaccine inserts before my son received his vaccines. He has autism, which I believe vaccines played a role in. I just wanted to post this. I wish these adverse events were more widely known...
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#2 of 79 Old 08-22-2009, 12:21 AM
 
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Wow.

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#3 of 79 Old 08-22-2009, 12:33 AM - Thread Starter
 
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Wow.
Exactly what I said!!


If parents were able to read this at the dr's office, would there even be a question as to whether or not to get the shot? Probably why they dont show it!
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#4 of 79 Old 08-22-2009, 12:43 AM
 
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What gets me the most is they knew it before putting it on the market and approved it anyway

 
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#5 of 79 Old 08-22-2009, 12:48 AM
 
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I'm speechless also.
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#6 of 79 Old 08-22-2009, 12:53 AM - Thread Starter
 
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What gets me the most is they knew it before putting it on the market and approved it anyway


Not suprising to me at all that they would do this!! :
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#7 of 79 Old 08-22-2009, 02:43 AM
 
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This particular vax has been on the market since 1996. And what has happened to the autism rate since then?
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#8 of 79 Old 08-22-2009, 09:27 AM
 
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Very interesting but not surprising... I'm so thankful for this board.
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#9 of 79 Old 08-22-2009, 09:35 AM
 
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Wow. I'm not surprised though. At least they admit that vaccines may cause autism!

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#10 of 79 Old 08-22-2009, 05:14 PM
 
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They have to list everything that has ever been reported as a potential adverse effect. So if I reported that I experienced a craving for poached egg on toast after being vaccinated they'd have to list it. It doesn't mean there is any evidence that the alleged adverse effect was caused by the vax.
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#11 of 79 Old 08-22-2009, 08:49 PM
 
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They have to list everything that has ever been reported as a potential adverse effect. So if I reported that I experienced a craving for poached egg on toast after being vaccinated they'd have to list it. It doesn't mean there is any evidence that the alleged adverse effect was caused by the vax.
So autism is a potential adverse effect.

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#12 of 79 Old 08-22-2009, 11:02 PM
 
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Its law to give the consumer/patient the side effects of perscription pills, so why is it not the law to do the same with vaccines? That doesn't make sense to me at all.

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#13 of 79 Old 08-23-2009, 12:20 PM
 
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So autism is a potential adverse effect.
No. It means that someone, somewhere, had the vax and was then diagnosed with autism. It doesn't mean that the vax caused the autism but because it's been reported as a possibility they have to list it.

If I had a vax for tetanus then caught a cold you could say that the vax must have been the cause, rather than the two things being coincidental.
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#14 of 79 Old 08-23-2009, 02:14 PM - Thread Starter
 
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No. It means that someone, somewhere, had the vax and was then diagnosed with autism. It doesn't mean that the vax caused the autism but because it's been reported as a possibility they have to list it.

If I had a vax for tetanus then caught a cold you could say that the vax must have been the cause, rather than the two things being coincidental.
Not someone, somewhere reported it, try thousands and thousands of parents who have seen their child develop autism after vaccines.... They can put it out there in plain writing and there are still some who will not believe it. I know, my husband's family is this way, saying their is no connection between autism and vaccines. Im sure they would debate with me after showing them this vaccine insert also.
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#15 of 79 Old 08-23-2009, 02:58 PM
 
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Reading this gave me chills and sent me hunting down DS's shot info.

Dec 27th 2006 my son quit breathing. He was later Diagnosed with apena. When asked at the hospital about anything new, and a zillion other question I remember saying he got shots today, to which I was told shots would not make your child quit breathing. After staying @ the hospital 3 days they sent him home on a apena monitor. And I never thought about shots hurting my child and continued to vax DS until recently. My son received this shot the day he quit breathing among other shots ( a total of 6 vax that day )

Anyhow I just wanted to kinda say that MDC has helped me learn alot and share my story. And maybe it will help another child..
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#16 of 79 Old 08-24-2009, 12:16 AM - Thread Starter
 
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Reading this gave me chills and sent me hunting down DS's shot info.

Dec 27th 2006 my son quit breathing. He was later Diagnosed with apena. When asked at the hospital about anything new, and a zillion other question I remember saying he got shots today, to which I was told shots would not make your child quit breathing. After staying @ the hospital 3 days they sent him home on a apena monitor. And I never thought about shots hurting my child and continued to vax DS until recently. My son received this shot the day he quit breathing among other shots ( a total of 6 vax that day )

Anyhow I just wanted to kinda say that MDC has helped me learn alot and share my story. And maybe it will help another child..

That is so scary. I am not surprised at any serious side effect that a vaccine might cause. I am glad to have MDC also!
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#17 of 79 Old 08-24-2009, 02:03 PM
 
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No. It means that someone, somewhere, had the vax and was then diagnosed with autism. It doesn't mean that the vax caused the autism but because it's been reported as a possibility they have to list it.

If I had a vax for tetanus then caught a cold you could say that the vax must have been the cause, rather than the two things being coincidental.
And how is that any different than what I said? Not understanding where your "NO" is coming from in relation to my post.

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#18 of 79 Old 08-24-2009, 02:12 PM
 
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And how is that any different than what I said?
It's different statistically. I think that b/c the anti-vax / vaccine-choice side relies so heavily on pointing out the untruths, half-truths, statistics, and poor-quality research of the pro-vaccine side, that we need to be very careful to not exaggerate and to understand what we are talking about.

Having autism listed on the package insert as a condition that happened post-vaccination is a great step in the right direction of informed consent. It DOES NOT mean that the vaccine cause the autism. It DOES NOT mean that a vaccinated and unvaccinated group were compared and it was shown that the vaccinated group developed autism in higher numbers following the vaccination. If you read more package inserts, you will find deaths from car wrecks listed as events that happened post vaccination. I *think* that the manufacturers are required to list any poor outcome that occurs within a limited time period after the vaccine is administered.

If we take these inserts and say that they show that autism is caused by DTaP, doctors and others will dismiss our valid vaccine concerns as coming from uneducated parents who don't understand study design, methodology, and statistics.

Please spread that package inserts and encourage your friends to read them! But don't attribute incorrect statistical strength to the post-vaccination events.

DTA: This is coming from a mom of a totally unvaccinated child who does believe that many neurological and autoimmune disorders are likely caused by vaccines. I'm only advocating for correct use of terminology so as to protect our credibility. I'm not debating weather or not autism is caused by DTaP.
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#19 of 79 Old 08-24-2009, 02:30 PM
 
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You also get things like teething, Anorexia, uteropelvic junction obstruction, and testicular atrophy listed in some vaccines; it just a serial collection of everything that happened. In the largest rotavirus trial they list death because one kid in the vaccine group died. But if you read the actual paper you see he died in a car accident-- still had to be listed though.

Some of this stuff simply comes from VAERS- everything that is posted there post licensing.

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#20 of 79 Old 08-24-2009, 04:17 PM - Thread Starter
 
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If autism were rare and not 1 in 100, then I probably would not have thought much of seeing autism on the adverse events list. But the fact is, going from 1 in 10,000 cases of autism when there were 10 vaccines to 1 in 100 cases when there are now 36 vaccines is a little bit too much to be just a coincidence or "better diagnosing." JMO I know not everyone agrees!
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#21 of 79 Old 08-24-2009, 04:23 PM
 
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I Agree. But I also think it isn't the only factor. There is more to it then just vaccines.

Wife to DH, Mom to my Intact Boys DS1: Born 02 Pain Med Free Hospital Birth, BF'ed for 9 Months, Partially Vax'd DS2: Born 06 via UC, BF'ed 3 years 10 months, and UnVax'd
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#22 of 79 Old 08-24-2009, 04:27 PM - Thread Starter
 
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I Agree. But I also think it isn't the only factor. There is more to it then just vaccines.
There is probably also a genetic predisposition. There are some kids who can be completely fine with all the vaccines (they are very lucky)!
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#23 of 79 Old 08-24-2009, 06:27 PM
 
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What I find perplexing is that this is the only vaccine that lists autism as a possible adverse event . I mean, if it were listed in the package inserts of several vaccines then I would be inclined to agree that its not some "smoking gun" and it may be the by-product of our reporting system. Interesting that Tripedia is also one of the few left that contains thimerosal.

Signed,
the mother of an autistic child who received Tripedia


 

 

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#24 of 79 Old 08-24-2009, 10:39 PM
 
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What I find perplexing is that this is the only vaccine that lists autism as a possible adverse event . I mean, if it were listed in the package inserts of several vaccines then I would be inclined to agree that its not some "smoking gun" and it may be the by-product of our reporting system. Interesting that Tripedia is also one of the few left that contains thimerosal.

Signed,
the mother of an autistic child who received Tripedia
I'm so sorry that you are dealing with autism in your family!

The reporting on the package inserts does not have to do with VAERS and adverse event reports. It's a list of everything bad that happened to people in the clinical trials or possibly other vaccine research studies during a specified time period (maybe about 2 months? I can't remember if it varies by medication or if there is a standard time). Since the reporting time is so short and it's probable that autoimmune problems don't develop quickly, it's understandable that few children would be diagnosed with autism post-vaccination. The "possible side effects" on the package insert may make parents who read them think a little, but the side effect lists aren't good evidence for either side.
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#25 of 79 Old 08-25-2009, 10:18 AM
 
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I understand that, and I don't see it as evidence of anything. I'm just saying how its odd that this is the only vaccine with autism listed; I find it odd that this didn't happen during any other clinical trial, or even with any other brand of DTaP. Makes me wonder just how much cherry-picking is being done.


 

 

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#26 of 79 Old 08-26-2009, 11:38 PM
 
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Maybe this has been said before, but it pains me to see the vaccines-cause-autism debate still being waged so fiercely.

Even Autism Speaks came out very recently with a statement saying that "there is no evidence that thimerosal or the MMR vaccine cause autism" and "evidence does not support the theory that vaccines are causing an autism
epidemic."

Autism is a HUGE concern and a huge issue. I fear that the vaccine debate is a red herring that is forcing us to focus our time and resources on the wrong "cause." Study after study proves no link -- it's time to look somewhere else!

Children with autism deserve better than our unrelenting focus on vaccines as the cause.
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#27 of 79 Old 08-27-2009, 03:41 AM
 
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Originally Posted by ferng View Post
it's different statistically. I think that b/c the anti-vax / vaccine-choice side relies so heavily on pointing out the untruths, half-truths, statistics, and poor-quality research of the pro-vaccine side, that we need to be very careful to not exaggerate and to understand what we are talking about.

Having autism listed on the package insert as a condition that happened post-vaccination is a great step in the right direction of informed consent. It does not mean that the vaccine cause the autism. It does not mean that a vaccinated and unvaccinated group were compared and it was shown that the vaccinated group developed autism in higher numbers following the vaccination. If you read more package inserts, you will find deaths from car wrecks listed as events that happened post vaccination. I *think* that the manufacturers are required to list any poor outcome that occurs within a limited time period after the vaccine is administered.

If we take these inserts and say that they show that autism is caused by dtap, doctors and others will dismiss our valid vaccine concerns as coming from uneducated parents who don't understand study design, methodology, and statistics.

Please spread that package inserts and encourage your friends to read them! But don't attribute incorrect statistical strength to the post-vaccination events.

Dta: This is coming from a mom of a totally unvaccinated child who does believe that many neurological and autoimmune disorders are likely caused by vaccines. I'm only advocating for correct use of terminology so as to protect our credibility. I'm not debating weather or not autism is caused by dtap.
thank you!!!!!!! I agree wholeheartedly!
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#28 of 79 Old 08-27-2009, 04:00 AM
 
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Maybe this has been said before, but it pains me to see the vaccines-cause-autism debate still being waged so fiercely.

Even Autism Speaks came out very recently with a statement saying that "there is no evidence that thimerosal or the MMR vaccine cause autism" and "evidence does not support the theory that vaccines are causing an autism
epidemic."

Autism is a HUGE concern and a huge issue. I fear that the vaccine debate is a red herring that is forcing us to focus our time and resources on the wrong "cause." Study after study proves no link -- it's time to look somewhere else!

Children with autism deserve better than our unrelenting focus on vaccines as the cause.
Have you read those studies?

Megan, mama to her little boy (Feb2008) and introducing our little girl (Dec 2010)
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#29 of 79 Old 08-27-2009, 09:14 AM - Thread Starter
 
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Children with autism deserve better than our unrelenting focus on vaccines as the cause.


I dont agree with this at all. I dont know how it could be more obvious than being on the package insert of DTAP vaccine, JMO. This is exactly what we need to focus on, and whatever other environmental factors there may be. We are doing chelation with our son to get out metals and I am seeing him improve greatly. Other parents I have talked to have told me that their kids are recovering with chelation. I dont know where else the metals would come from other than vaccines. I know alot of you dont agree but I see it with my own eyes from my son's improvements.

By the way, there is a special dateline on Sunday at 7 pm on NBC. Dr Andrew Wakefield will be interviewed to talk about the autism/vaccine link. He is the dr. who first theorized that the MMR vaccine may be linked to autism. I hope they will portray this issue fairly. I think it will be interesting to watch!

Jennifer
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#30 of 79 Old 08-27-2009, 12:53 PM
 
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They have to list everything that has ever been reported as a potential adverse effect. So if I reported that I experienced a craving for poached egg on toast after being vaccinated they'd have to list it. It doesn't mean there is any evidence that the alleged adverse effect was caused by the vax.

And there is no evidence that it was NOT caused by the vax, hence it is a POTENTIAL side effect.

If the people let government decide what foods they eat and what medicines they take, their bodies will soon be in as sorry a state as are the souls of those who live under tyranny." Thomas Jefferson.

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