Gardasil

[vip1 8]

The fact that it was realized gives you guarantees it is actually safe, there have been plenty of medicines realized for over 10 years, and then they decided that they were actually bad and took them off the market. So that really doesn't give me any confort at all.

Has anyone here been ask at the interview or later for the record of the other two shots?

[Usui Takumi 1,562]

I agree with most everyone in this thread. Its one thing to require a vaccine that you can be exposed to just by being in public. Its another to force a vaccine on a person which is related to a lifestyle choice. For instance imagine if a woman from the MENA region who has lived a strict Islamic lifestyle has made the choice not to be exposed to HPV yet is forced to take it by USCIS and happens to be killed by the vaccine (I know statistically its very low) then thats practically murder on the part of the government.

The other major danger is related to someone already with HPV who gets it (someone touched on it earlier) they don't know the effects. Some websites (which I'm not sure are accurate or not) even claim that the vaccine will activate the HPV in woman already with it raising the risk of cancer.

We basically waited for USCIS to tell us through an RFE that we needed the vaccine. Luckily the RFE never came.

[Hannah+Vito 0]

the sheet of paper i got when i had my shot done really downplays the reactions that people have been getting from the shot heres an example of what my paper said lol

Several mild problems may occur with HPV vaccine:

Pain at the injection site (about 8 people in 10) so i am 8 in 10 then?

Redness or swelling at the injection site (about 1 person in 4) and one in 4

Mild fever (100 degrees Fahrenheit) (about 1 person in 10)and now 1 in 10

Itching at the injection site (about 1 person in 30) ok 1 in 30 too

Moderate fever (102 degrees Fahrenheit) (about 1 person in 65) ok i think this vaccine hates me

Similarly, adverse reactions were reported when GARDASIL was administered with eight other vaccines: Hepatitis A, MNQ (?), MEN (Menactra), TD (Tetanus and Diptheria Toxoids), DPP (Diptheria/Pertussis/Polio), PNC Prevnar (Heptavalent pneumococcal conjugate), DTaP (Diphtheria And Tetanus Toxoids and Acellular Pertussis Vaccine), and TDAP (Tetanus, Diptheria and Pertussis). Because Merck does not state that it is safe to administer simultaneously GARDASIL with any vaccine other than Hepatitis B, consumers and clinicians should question whether co-administration of GARDASIL and other vaccines is safe.

I wish i knew this in may i had my tet/dip booster lest than 7 days before my first hpv the doctor never said any of this though he did try and make me wait two weeks before i took the mmr after hpv because i passed out. but the civil surgeon in london was gunna give me mmr and hpv on the same day so I assumed it was safe. but then i can't be too shocked i mean my husband said to him its been over a month and since that shot shes been having this problem and that problem and all the doctor said was"oh really? "

I have to say though my sister had it and she seems fine. she did say it burnt like a b@@@@er and the acidic feeling she described was spot on especially when they put the swab on after but she didnt pass out or report the the same problems i have had and she has had all three now.

I don't think the vaccine is bad overall i just disagree with who they are targeting as i don't believe its gunna be that beneficial to many married people. (unless you find someone yet to sleep with their so who hasn't been exposed to the virus before and their so has hpv. ) and i think its not just unnecessary to force it but at this stage in the vaccines life silly to force individuals to take it, it should be a choice made by they individual and their doctor.

[Wei&Shu(Joe) 2]

Gardasil vaccine ingredients include amorphous aluminum hydroxyphosphate sulfate, sodium chloride, L-histidine, polysorbate 80, sodium borate, (roach killer), and water for injection.

Safe ingredients eh?

And a question for myself.

Since my hubbie and I have applied for the CR1, can I get away with only the first of three shots or will they want all 3? I want to avoid the entire 3 if I can. >_<

Oh my god! Sodium Chloride? How can they? Those evil pharmaceutical companies! Trying to kill us all with minute amounts of table salt! They are so crafty! And L-Histidine, a common amino acid essential to life that everyone who ingests protein is loaded with! How shameful!

I'm irate about the sodium borate. It is lethal 50% of the time at a dose of only 2,660 mg/kg. Oh, and it kills by inhibiting bacterial action in the stomach of roaches but since us mammals don't keep bacteria in our stomach for digestion it kills when the dose is high enough to irritate the stomach and cause vomiting, diarrhea, dehydration and shock. Since each vaccine dose has about 0.0007 mg of borate in it, that means if we assume you are about 50 kg that you only have to be forced to DRINK 190 million doses of Gardisil and your life is in serious danger. There is no doubt that Gardisil is routinely administered as 190 million oral doses. They just want you to think they're injecting it. The current allowable limit for borate according to the WHO is 0.5 mg/liter. So it is likely that you may ingest much more borate than this every day from your drinking water, by the route that it actually causes toxicity! That shouldn't be a problem but taking 0.14 percent of the amount allowable in a liter of drinking water

And Water for injection! Oh the humanity! I heard that they sometimes use Dihydrogen Monoxide in place of the water because it's cheaper.

So yes, if big chemical names scare you into making silly decisions, you have a point. If you cared to actually research what you are talking about then fear wouldn't need to be making decisions for you. Nothing in the list you wrote is harmful to humans, especially not in the dose you would receive, even from a lifetime of vaccines. Possibly, you would expound on why you felt that salt, water and protein ought to strike fear into our hearts?

If you are, in fact, a small invertebrate insect, you could be in serious trouble. I assume that the readers of VJ are vertebrate mammals but that may be my own prejudice shining through.

And all of this just to prevent just 15,000 slow agonizing deaths from cervical cancer each year (that is from 2005 and the incidence and mortality has risen every year prior so the number is very likely higher now).

And why does it have to be making money and not about the 15,000 women who die every year. It's obvious...because the NVIC, funded by the Citizens Commission on Human Rights, established and funded by the Church of Scientology tells us so. And who wouldn't believe the Church of Scientology. It's not like they have an agenda against western medicine to make money for their own "treatments", right?.......Sorry I gagged after that last statement. They were kind enough to tell us about all those evil spirits clinging to volcanoes! And just because their founder expressly stated that the way to make real money was to start one's own religion, we wouldn't have any reason to suspect that they're in it for the money!

So Scientology videos not withstanding, and they do make some darn good propaganda flicks, take a look at the reality of Gardisil before you do Scientology's work for them. I'm sure many of you have your own religions and are unaware that you are spreading Scientology propaganda because you haven't looked into the claims or where they are coming from. Spreading Scientology's beliefs may not be consistent with the religion you practice so you should check into what you are repeating.

If you feel that 15,000 painful deaths a year is not enough to do something about, OK, we can disagree about that. Please don't pretend that preventing those deaths is worthless, however, and the only possible motive is cash.

[Rhiannercakes 14]

I'm not worried about the shot, what's in it or the reactions I may get.

It's the fact that they don't have any long term proof (or none I can find) to what this can do in the future, whether it's good or bad proof.

Also the fact that we're not really given a choice to take this shot or not passively irritates me. I've been against it every since it's been out in Canada (Due to the lack of long term evidence), so seeing that I have to get it has irritated me just a tiny bit.

But that's just my thoughts.

[Gary and Alla 3,694]

Interesting-

I can understand getting vaccinations for diseases that the US does not want to spread... but Gardisal? That isn't a contagious disease. That should TOTALLY be your choice whether or not to have it. What is their reasoning on that??

They are trying to make it mandatory here also for girls as young as 12 years old. As usual, the reason is government control of your life in any way they can find or sell to you as "good for you".

[Gary and Alla 3,694]

Gardasil vaccine ingredients include amorphous aluminum hydroxyphosphate sulfate, sodium chloride, L-histidine, polysorbate 80, sodium borate, (roach killer), and water for injection.

Safe ingredients eh?

And a question for myself.

Since my hubbie and I have applied for the CR1, can I get away with only the first of three shots or will they want all 3? I want to avoid the entire 3 if I can. >_<

Oh my god! Sodium Chloride? How can they? Those evil pharmaceutical companies! Trying to kill us all with minute amounts of table salt! They are so crafty! And L-Histidine, a common amino acid essential to life that everyone who ingests protein is loaded with! How shameful!

I'm irate about the sodium borate. It is lethal 50% of the time at a dose of only 2,660 mg/kg. Oh, and it kills by inhibiting bacterial action in the stomach of roaches but since us mammals don't keep bacteria in our stomach for digestion it kills when the dose is high enough to irritate the stomach and cause vomiting, diarrhea, dehydration and shock. Since each vaccine dose has about 0.0007 mg of borate in it, that means if we assume you are about 50 kg that you only have to be forced to DRINK 190 million doses of Gardisil and your life is in serious danger. There is no doubt that Gardisil is routinely administered as 190 million oral doses. They just want you to think they're injecting it. The current allowable limit for borate according to the WHO is 0.5 mg/liter. So it is likely that you may ingest much more borate than this every day from your drinking water, by the route that it actually causes toxicity! That shouldn't be a problem but taking 0.14 percent of the amount allowable in a liter of drinking water

And Water for injection! Oh the humanity! I heard that they sometimes use Dihydrogen Monoxide in place of the water because it's cheaper.

So yes, if big chemical names scare you into making silly decisions, you have a point. If you cared to actually research what you are talking about then fear wouldn't need to be making decisions for you. Nothing in the list you wrote is harmful to humans, especially not in the dose you would receive, even from a lifetime of vaccines. Possibly, you would expound on why you felt that salt, water and protein ought to strike fear into our hearts?

If you are, in fact, a small invertebrate insect, you could be in serious trouble. I assume that the readers of VJ are vertebrate mammals but that may be my own prejudice shining through.

And all of this just to prevent just 15,000 slow agonizing deaths from cervical cancer each year (that is from 2005 and the incidence and mortality has risen every year prior so the number is very likely higher now).

And why does it have to be making money and not about the 15,000 women who die every year. It's obvious...because the NVIC, funded by the Citizens Commission on Human Rights, established and funded by the Church of Scientology tells us so. And who wouldn't believe the Church of Scientology. It's not like they have an agenda against western medicine to make money for their own "treatments", right?.......Sorry I gagged after that last statement. They were kind enough to tell us about all those evil spirits clinging to volcanoes! And just because their founder expressly stated that the way to make real money was to start one's own religion, we wouldn't have any reason to suspect that they're in it for the money!

So Scientology videos not withstanding, and they do make some darn good propaganda flicks, take a look at the reality of Gardisil before you do Scientology's work for them. I'm sure many of you have your own religions and are unaware that you are spreading Scientology propaganda because you haven't looked into the claims or where they are coming from. Spreading Scientology's beliefs may not be consistent with the religion you practice so you should check into what you are repeating.

If you feel that 15,000 painful deaths a year is not enough to do something about, OK, we can disagree about that. Please don't pretend that preventing those deaths is worthless, however, and the only possible motive is cash.

All of that notwithstanding...cervical cancer is not contagious so it is not a public health risk to others. If 15,000 per year die from it because they choose not to get an easily available vaccine...so be it. Were I a woman, I would DEMAND my right to refuse the injection and DIE of cervical cancer. To quote the often stated liberal rant..."Keep your hands off my uterus (cervix)!!!!!!!!!" Funny that those same people want the government hands all over their healthcare, injections, etc.

We are adults, give us the information (such as you did) and let us decide for ourselves and our children. I do not need (or want) the government to decide for me. And I do not believe the "government knows best" and really don't care if they do, you do, or not. I do not need others making choices for me.

[Gary and Alla 3,694]

Interesting-

I can understand getting vaccinations for diseases that the US does not want to spread... but Gardisal? That isn't a contagious disease. That should TOTALLY be your choice whether or not to have it. What is their reasoning on that??

Gardasil is the vaccine not the disease. The disease is HPV and it is highly contagious.

No, wrong.

HPV is the virus, cervical cancer is the disease. Cervical cancer, is NOT contagious and the Gardisil injection does NOT prevent the spread of the HPV virus, it prevents the virus from causing cervical cancer in the recipient of the injection. The injection provides NO benefit or protection to anyone, except the recipient, and there is no claim that it does anything else. Unlike vaccines for contagious diseases which protect others, the gardisil vaccine does not protect ME from YOU, therefore it is nothing but a forced government intrusion on your life.

[Wei&Shu(Joe) 2]

http://www.nvic.org/_borders/images/nvic_logo.gif

http://www.nvic.org/Diseases/HPV/HPVrpt.htm

National Vaccine Information Center

www.NVIC.org (http://www.nvic.org/)

Human Papilloma Virus Vaccine Safety

Analysis of Vaccine Adverse Events Reporting System Reports:

Adverse Reactions, Concerns and Implications

On June 8th 2006, the Food and Drug Administration (FDA) announced the approval of GARDASIL, and on June 29th the Advisory Committee on Immunizations Practices (ACIP) voted to recommend adding GARDASIL human papilloma virus vaccine to the Centers for Disease Control's national childhood recommended immunization schedule. On July 14th the first report of a serious reaction to the vaccine was filed with the federal Vaccine Adverse Event Reporting System (VAERS).

A 16-year-old Illinois girl was vaccinated July 7th and 13 days later developed symptoms eventually diagnosed as Guillian-Barre Syndrome. A 14-year-old girl in the District of Columbia was vaccinated on July 11th and complained of severe pain immediately following the injection, fell off the examining table and experienced a 10 to 15 second fainting spell ending up in the emergency room with a headache and speech problems. The report of this reaction, the first in the nation, was filed on July 14th, 15 days after the ACIP vote.

Six months later, 82 reports of GARDASIL reactions have been submitted to VAERS on behalf of at least 84 young girls and 2 boys.[1] Reaction reports have come in from 21 states and the District of Columbia.[2] Reactions were reported for children and young adults ranging in age from 11 to 27. Of the reports indicating what day the vaccine was given and the reaction occurred, 63 percent stated that the reaction occurred the same day the vaccine was given. All but three of the reports were for reactions that occurred within one week of vaccination.

This document is divided into three sections. The first section describes reaction reports for a number of reported adverse events: neurological symptoms including syncopal episodes and seizures, arthralgia and joint pain, Guillian-Barre Syndrome, and other immunological reactions. The second section addresses concerns related to vaccinating individuals already infected with HPV. The last section discusses issues that need to be addressed by government regulators and the manufacturer and considerations for clinicians and consumers.

Reported Adverse Events

Presumably, the reactions described below occurred after the first dose of GARDASIL. GARDASIL is given in a three-dose series. None of the reports stated that the children and adults experiencing problems had previously been vaccinated with GARDASIL.

Syncopal Episodes and Seizures. One-quarter of all reports filed after GARDASIL vaccination were for neurologic adverse events including loss of consciousness, syncope, syncopal events and seizures. An additional five reports included symptoms of dizziness and feeling faint.

Syncope is defined as a temporary suspension of consciousness due to generalized cerebral ischemia (inadequate blood flow and lack of oxygen). The reports of syncopal episodes and their descriptions are remarkable. A physician from Washington State reported that in one morning, three patients experienced syncopal episodes. On August 8th another physician's office reported that two patients experienced syncopal episodes on the same day.

Although these reports did not detail what happened to the individuals experiencing these syncopal episodes, other reports did. The 14-year-old DC girl mentioned earlier experienced a syncopal episode combined with amblyopia (poor vision in one eye), abnormal speech, vomiting, and headache. Also experiencing vision problems, a 17-year-old New York girl reported feeling dizzy and her vision went "black for a few seconds" and she turned pale and lips turned purple and she also had fever and chills. Similar to the DC girl, on July 18th immediately after being vaccinated, a 22-year-old Kentucky woman experienced slurred speech accompanied by pallor and shock. On August 29th, two hours after being vaccinated, a 15-year-old New York girl who had a history of asthma and was on four asthma medications experienced difficulty swallowing prompting a visit to the emergency room. On August 17th, 15 minutes after being vaccinated, a 14-year-old Pennsylvania girl passed out in the car on the way home.

Most of the reports do not describe what happened as a result of the syncopal episode but a few do. One 11-year-old Florida girl fell from the examining table and two Washington girls fell - a 16-year-old girl fell and hit her head on a carpeted concrete surface and a 14-year-old girl fell down and broke her nose.

Whether the 22 girls who experienced syncopal episodes actually experienced atonic seizures cannot be determined from these reports. Four girls, however, displayed observable seizure activity. The 11-year-old Florida girl who fell from the table also displayed "tonic posturing." Tonic posturing is a type of seizure where sustained contraction of muscles in the legs and arms occurs and consciousness is impaired. The 16-year-old Washington girl who fell and hit her head on the floor lost consciousness for one minute and displayed tonic posturing of her right hand. Additionally, a 15-year-old girl from Virginia was described as having "a mild seizure." In California, a 13-year-old girl was walking down the hall after her vaccination, fell and had a 15-second tonic/clonic seizure. Tonic/clonic seizures are also known as "grand mal" seizures.

Additionally, there were reports of dyskinesia (difficulty or distortion in performing voluntary movements) and hypokinesia (slow or diminished movement of the body musculature) both of which have neurological implications.

Arthralgia, Joint Pain and Fever. Arthralgia is defined as pain in the joints. Concerns about arthritis were raised during the GARDASIL clinical trials. Reports of arthralgia in one or more joints accompanied by fever were noted in five instances from four young girls and women in Wisconsin, Texas and New York, and one 18-year-old New York male.

Guillain-Barre Syndrome. Reports state that two recently vaccinated 16-year-old girls - one from Illinois and the other from Mississippi - were diagnosed with Guillian-Barre Syndrome (GBS) following vaccination with GARDASIL. In both cases, the onset of symptoms occurred 13 days after vaccination. According to the National Institute for Neurological Disorders and Stroke: GBS is a serious disorder in which the body's immune system attacks part of the peripheral nervous system. The first symptoms of this disorder include varying degrees of weakness or tingling sensations in the legs. In many instances, the weakness and abnormal sensations spread to the arms and upper body. These symptoms can increase in intensity until certain muscles cannot be used at all and, when severe, the patient is almost totally paralyzed. … Vaccinations can trigger onset of GBS.[3]

The Illinois girl described earlier was vaccinated on July 7th and symptoms were evident by July 20th. The girl also experienced gait abnormalities (trouble walking properly), asthenia (weakness without loss of strength), paresthesia (burning, prickling, tingling or numbness sensation usually felt in the hands, arms, feet and legs), and hyperkinesia (abnormal increase in muscle movement). The Mississippi girl was vaccinated on July 31st and by August 13th she had increasing numbness and tingling in her feet and hands and was subsequently evaluated by a neurologist and diagnosed with GBS. The current health status of these girls is not known.

In both of these cases, the girls were also vaccinated with Aventis Pasteur's Menactra, a vaccine for meningococcal infections. Menactra has previously been associated with Guillain-Barre Syndrome, and the FDA and others have issued alerts.

Other Adverse Reactions. Additionally, a number of other reactions to GARDASIL are noted in VAERS reports and they include: urticaria (hives); pruritus (itching); macular and papular rashes; blisters and vesicles near the injection site; swollen arms; lymphadenopathy (swollen lymph nodes); red, hot swollen knots at injection site; burning, stabbing, severe and radiating pain at the injection site and in the affected limb during and after injection; nausea and vomiting; infections and skin ulcers, and other allergic reactions.

Other Considerations

GARDASIL is marketed as a "cervical cancer vaccine" and intended to prevent infection with specific HPVs - common viruses among sexually active women. It isn't clear what benefits or potential harms could arise from vaccinating sexually active women who have already contracted HPV. Of the 86 reaction reports filed with VAERS so far, 12 reports were generated by young women 18 and older who were taking hormonal contraceptives and presumably sexually active.

With respect to concerns related to vaccinating women with known HPV infections, adverse reaction reports were filed on behalf of a 17-year-old Texas girl who was already diagnosed with HPV and genital warts. Similarly, the 22 year-old Kentucky woman who experienced slurred speech following vaccination already had an abnormal pap smear with evidence of cervical dysplasia.

Implications

The early reports of potential safety problems with GARDASIL raise concerns and questions that need to be addressed by government regulators, manufacturers and prescribing physicians. Specifically, the following concerns need to be addressed:

Syncope, seizures and Guillian-Barre Syndrome have now been reported with hours to a week after GARDASIL vaccination. GARDASIL manufacturer, Merck, should add these serious adverse events to the product manufacturer insert.

Considering that over 20 girls have experienced syncopal episodes sometimes combined with seizures and serious injuries, physicians should consider only giving GARDASIL when the patient is safely laying down on the examining table. Because there seems to be syncopal reactions up until 15 minutes after vaccination, patients should be asked to lie down for 15 minutes after receipt of GARDASIL.

The information provided by Merck indicates that it is safe to administer GARDASIL with Hepatitis B vaccine. The prescribing information states, "Results for clinical studies indicate that GARDASIL may be administered concomitantly (at a separate injection site) with hepatitis B vaccine (recombinant). Co-administration of GARDASIL with other vaccines has not been studied." [4] Due to the small number of girls aged 9 to 15 who appear to have been evaluated for GARDASIL safety in Merck clinical trials (fewer than 2,000) and lack of publicly available information about how many of these girls were given GARDASIL and hepatitis B vaccine simultaneously, the safety of administering GARDASIL and hepatitis B vaccine to all pre-adolescent girls is uncertain.[5]

Aside from Hepatitis B, Merck does not state that it is safe to simultaneously administer GARDASIL with any other vaccine. Considering that there are ongoing evaluations of a reported association between Menactra (meningococcal vaccine) and Guillain-Barre Syndrome, and Merck does not explicitly indicate that it is safe to administer to administer GARDASIL and Menactra simultaneously, consumers and clinicians should question whether administering both GARDASIL and Menactra at the same time is safe.

Similarly, adverse reactions were reported when GARDASIL was administered with eight other vaccines: Hepatitis A, MNQ (?), MEN (Menactra), TD (Tetanus and Diptheria Toxoids), DPP (Diptheria/Pertussis/Polio), PNC Prevnar (Heptavalent pneumococcal conjugate), DTaP (Diphtheria And Tetanus Toxoids and Acellular Pertussis Vaccine), and TDAP (Tetanus, Diptheria and Pertussis). Because Merck does not state that it is safe to administer simultaneously GARDASIL with any vaccine other than Hepatitis B, consumers and clinicians should question whether co-administration of GARDASIL and other vaccines is safe.

Most, if not all, of the reactions reported to VAERS were in response to the first of the three doses of GARDASIL. The Centers for Disease Control (CDC) Vaccine Information Sheet (VIS) developed for HPV vaccine states that severe reactions include "any unusual condition, such as a high fever or behavior changes. Signs of a serious allergic reaction can include difficulty breathing, hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or dizziness." [6] The CDC also states that "anyone who has ever had a life-threatening allergic reaction to yeast, to any other component of HPV vaccine, or to a previous dose of HPV vaccine should not get the vaccine." Which of the reactions reported to VAERS constitute a "life-threatening allergic reaction" and which, if any, of the children and young adults who experienced reactions should receive additional doses of vaccine? At the October 2006 ACIP meeting, CDC staff stated that only "three serious reports were reported to VAERS after HPV vaccination in females 14 and 16 years of age. One of these patients had vasovagal syncope and was hospitalized overnight for observation." [7]CDC's summary of the first 76 VAERS reports suggests that CDC doesn't regard the remaining reports as "serious." CDC needs to clarify which of the reactions reported to VAERS constitute contraindications to further vaccination with GARDASIL and make this information available to the public and to prescribing physicians.

What were the short and longer-term outcomes for the individuals who experienced the reactions reported to VAERS? Is there information available that would help to predict the characteristics that predispose one to be at greatest risk of experiencing a serious reaction?

The CDC's Vaccine Information Sheet indicates that allergy to yeast is a reason to avoid taking GARDASIL. Merck notes that contraindications to the vaccine include "hypersensitivity to the active substances or to any of the excipients of the vaccine. Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of GARDASIL should not receive further doses of GARDASIL." The prescribing information provided by Merck does not specifically note that yeast allergy is a contraindication to taking GARDASIL. Government regulators and the manufacturer need to address the discrepancy between these documents and clarify the issues related to yeast allergy and make this information readily available to the public and prescribing physicians.

Additionally, Merck notes that vaccine ingredients include 225 mcg of aluminum (as amorphous aluminum hydroxyphosphate sulfate adjuvant), 0.78 mg of L-histidine, 50 mcg of polysorbate 80, and 35 mcg of sodium borate. These ingredients are not listed on the CDC's VIS sheet. The public needs this information so that they can identify whether they have "hypersensitivities" to any of the ingredients and whether they are at risk of experiencing a serious allergic reaction. Hypersensitivities and known allergic reactions are critical pieces of information that need to be communicated to prescribing physicians in order to make the safest possible vaccination decisions.

Government regulators including the CDC and FDA, in combination with Merck, should address the above safety concerns as soon as possible. Medical groups advocating use of GARDASIL should effectively communicate to physicians and patients the potential risks of using GARDASIL along with precautions to improve the safety of patient care.

Just so you're aware, all the dizziness, pre-syncope, syncope, tonic posturing and other brief seizure activity is a common reaction to being stuck by a needle and all occur frequently when blood is being drawn with absolutely nothing being injected into the body. It sometimes occurs immediately after a blood draw, it sometimes occurs after the patient returns to the waiting room and occasionally happens when they have already left the building. Anyone who has stuck someone for a blood draw sees this all the time. I once had a mother yell at me not to put a band-aid at the needlestick site because her child was allergic to them and would have seizures. I stopped to listen to mom and the child had her seizure about the time I would have been getting the Band-aid on her. Anyone want to make the case that this proves that band-aids cause neurologic problems?

All of the "episodes" described are consistent with post needle stick syncopes and seizures. In children studies have shown that these are true anoxic (no oxygen in the brain) seizures precipitated by breath holding. They have a name, "venipuncture fits". They are not associated with a higher risk of seizure disorder or other neurologic diseases, but when NVIC adds a statement about "neurologic implications" without the context that these are needle-stick related for the most part, it sure sounds scarey, eh?

Does the anti-vaccine crowd have some ideas about what toxic substance is causing this when we only take blood out?

[Rhiannercakes 14]

What'd I'd like to know is if you can just get the first shot and give up on the program, since they don't seem to enforce all 3 shots, just 1 to prove you "started it".

[Gary and Alla 3,694]

Thanks Inky

I guess because he is male it did not register with me...

I still can't believe they are mandating this for immigrants when it is not even mandatory for US Citizens.

I'll get off my soap box now

You forgot to add "yet" to the end of your sentence, there is a strong movement to make this vaccine mandatory in the USA.

[notmrshamiltonnow 0]

I have never personally gotten the shot, but I did have all three of my daughters vaccinated. I do think it should be Pro- Choice, and not a required vaccine to enter the states.

[Wei&Shu(Joe) 2]

Interesting-

I can understand getting vaccinations for diseases that the US does not want to spread... but Gardisal? That isn't a contagious disease. That should TOTALLY be your choice whether or not to have it. What is their reasoning on that??

Gardasil is the vaccine not the disease. The disease is HPV and it is highly contagious.

No, wrong.

HPV is the virus, cervical cancer is the disease. Cervical cancer, is NOT contagious and the Gardisil injection does NOT prevent the spread of the HPV virus, it prevents the virus from causing cervical cancer in the recipient of the injection. The injection provides NO benefit or protection to anyone, except the recipient, and there is no claim that it does anything else. Unlike vaccines for contagious diseases which protect others, the gardisil vaccine does not protect ME from YOU, therefore it is nothing but a forced government intrusion on your life.

OK, now you are going from the ridiculous to the sublime. Gardasil is an HPV vaccine. It protects against infection with Human Pappiloma Virus types 6, 11, 16, & 18. The disease this vaccine prevents is only Human Papilloma Virus infection. If you read the indications for the vaccine it clearly states that it offers NO protection against cervical cancer in a women who has already previously acquired HPV through sexual activity. It also prevents other manifestations of HPV, such as genital warts caused by types 6 & 11, BY STOPPING THE SPREAD OF THE HP VIRUS. It does nothing to prevent cancer that isn't caused by acquiring these types of HP viruses.

One of the consequences of infection with the HP virus is that some women will develop cervical cancer. This vaccine is absolutely without any doubt a vaccine that prevents acquisition of 4 types of HPV and has no effect on cervical cancer risk for a women who already has acquired HPV. It only prevents cancer by stopping the spread of the contagious STD - HPV.

[Hannah+Vito 0]

Interesting-

I can understand getting vaccinations for diseases that the US does not want to spread... but Gardisal? That isn't a contagious disease. That should TOTALLY be your choice whether or not to have it. What is their reasoning on that??

Gardasil is the vaccine not the disease. The disease is HPV and it is highly contagious.

No, wrong.

HPV is the virus, cervical cancer is the disease. Cervical cancer, is NOT contagious and the Gardisil injection does NOT prevent the spread of the HPV virus, it prevents the virus from causing cervical cancer in the recipient of the injection. The injection provides NO benefit or protection to anyone, except the recipient, and there is no claim that it does anything else. Unlike vaccines for contagious diseases which protect others, the gardisil vaccine does not protect ME from YOU, therefore it is nothing but a forced government intrusion on your life.

actually i believe gardasil promotes immunity from only 4 strains of many hpv (the virus) known to cause some types (being not all) of cervical cancer. there was another vaccine other than gardasil but it only did two strains.

[Hannah+Vito 0]

http://www.nvic.org/_borders/images/nvic_logo.gif

http://www.nvic.org/Diseases/HPV/HPVrpt.htm

National Vaccine Information Center

www.NVIC.org (http://www.nvic.org/)

Human Papilloma Virus Vaccine Safety

Analysis of Vaccine Adverse Events Reporting System Reports:

Adverse Reactions, Concerns and Implications

On June 8th 2006, the Food and Drug Administration (FDA) announced the approval of GARDASIL, and on June 29th the Advisory Committee on Immunizations Practices (ACIP) voted to recommend adding GARDASIL human papilloma virus vaccine to the Centers for Disease Control's national childhood recommended immunization schedule. On July 14th the first report of a serious reaction to the vaccine was filed with the federal Vaccine Adverse Event Reporting System (VAERS).

A 16-year-old Illinois girl was vaccinated July 7th and 13 days later developed symptoms eventually diagnosed as Guillian-Barre Syndrome. A 14-year-old girl in the District of Columbia was vaccinated on July 11th and complained of severe pain immediately following the injection, fell off the examining table and experienced a 10 to 15 second fainting spell ending up in the emergency room with a headache and speech problems. The report of this reaction, the first in the nation, was filed on July 14th, 15 days after the ACIP vote.

Six months later, 82 reports of GARDASIL reactions have been submitted to VAERS on behalf of at least 84 young girls and 2 boys.[1] Reaction reports have come in from 21 states and the District of Columbia.[2] Reactions were reported for children and young adults ranging in age from 11 to 27. Of the reports indicating what day the vaccine was given and the reaction occurred, 63 percent stated that the reaction occurred the same day the vaccine was given. All but three of the reports were for reactions that occurred within one week of vaccination.

This document is divided into three sections. The first section describes reaction reports for a number of reported adverse events: neurological symptoms including syncopal episodes and seizures, arthralgia and joint pain, Guillian-Barre Syndrome, and other immunological reactions. The second section addresses concerns related to vaccinating individuals already infected with HPV. The last section discusses issues that need to be addressed by government regulators and the manufacturer and considerations for clinicians and consumers.

Reported Adverse Events

Presumably, the reactions described below occurred after the first dose of GARDASIL. GARDASIL is given in a three-dose series. None of the reports stated that the children and adults experiencing problems had previously been vaccinated with GARDASIL.

Syncopal Episodes and Seizures. One-quarter of all reports filed after GARDASIL vaccination were for neurologic adverse events including loss of consciousness, syncope, syncopal events and seizures. An additional five reports included symptoms of dizziness and feeling faint.

Syncope is defined as a temporary suspension of consciousness due to generalized cerebral ischemia (inadequate blood flow and lack of oxygen). The reports of syncopal episodes and their descriptions are remarkable. A physician from Washington State reported that in one morning, three patients experienced syncopal episodes. On August 8th another physician's office reported that two patients experienced syncopal episodes on the same day.

Although these reports did not detail what happened to the individuals experiencing these syncopal episodes, other reports did. The 14-year-old DC girl mentioned earlier experienced a syncopal episode combined with amblyopia (poor vision in one eye), abnormal speech, vomiting, and headache. Also experiencing vision problems, a 17-year-old New York girl reported feeling dizzy and her vision went "black for a few seconds" and she turned pale and lips turned purple and she also had fever and chills. Similar to the DC girl, on July 18th immediately after being vaccinated, a 22-year-old Kentucky woman experienced slurred speech accompanied by pallor and shock. On August 29th, two hours after being vaccinated, a 15-year-old New York girl who had a history of asthma and was on four asthma medications experienced difficulty swallowing prompting a visit to the emergency room. On August 17th, 15 minutes after being vaccinated, a 14-year-old Pennsylvania girl passed out in the car on the way home.

Most of the reports do not describe what happened as a result of the syncopal episode but a few do. One 11-year-old Florida girl fell from the examining table and two Washington girls fell - a 16-year-old girl fell and hit her head on a carpeted concrete surface and a 14-year-old girl fell down and broke her nose.

Whether the 22 girls who experienced syncopal episodes actually experienced atonic seizures cannot be determined from these reports. Four girls, however, displayed observable seizure activity. The 11-year-old Florida girl who fell from the table also displayed "tonic posturing." Tonic posturing is a type of seizure where sustained contraction of muscles in the legs and arms occurs and consciousness is impaired. The 16-year-old Washington girl who fell and hit her head on the floor lost consciousness for one minute and displayed tonic posturing of her right hand. Additionally, a 15-year-old girl from Virginia was described as having "a mild seizure." In California, a 13-year-old girl was walking down the hall after her vaccination, fell and had a 15-second tonic/clonic seizure. Tonic/clonic seizures are also known as "grand mal" seizures.

Additionally, there were reports of dyskinesia (difficulty or distortion in performing voluntary movements) and hypokinesia (slow or diminished movement of the body musculature) both of which have neurological implications.

Arthralgia, Joint Pain and Fever. Arthralgia is defined as pain in the joints. Concerns about arthritis were raised during the GARDASIL clinical trials. Reports of arthralgia in one or more joints accompanied by fever were noted in five instances from four young girls and women in Wisconsin, Texas and New York, and one 18-year-old New York male.

Guillain-Barre Syndrome. Reports state that two recently vaccinated 16-year-old girls - one from Illinois and the other from Mississippi - were diagnosed with Guillian-Barre Syndrome (GBS) following vaccination with GARDASIL. In both cases, the onset of symptoms occurred 13 days after vaccination. According to the National Institute for Neurological Disorders and Stroke: GBS is a serious disorder in which the body's immune system attacks part of the peripheral nervous system. The first symptoms of this disorder include varying degrees of weakness or tingling sensations in the legs. In many instances, the weakness and abnormal sensations spread to the arms and upper body. These symptoms can increase in intensity until certain muscles cannot be used at all and, when severe, the patient is almost totally paralyzed. … Vaccinations can trigger onset of GBS.[3]

The Illinois girl described earlier was vaccinated on July 7th and symptoms were evident by July 20th. The girl also experienced gait abnormalities (trouble walking properly), asthenia (weakness without loss of strength), paresthesia (burning, prickling, tingling or numbness sensation usually felt in the hands, arms, feet and legs), and hyperkinesia (abnormal increase in muscle movement). The Mississippi girl was vaccinated on July 31st and by August 13th she had increasing numbness and tingling in her feet and hands and was subsequently evaluated by a neurologist and diagnosed with GBS. The current health status of these girls is not known.

In both of these cases, the girls were also vaccinated with Aventis Pasteur's Menactra, a vaccine for meningococcal infections. Menactra has previously been associated with Guillain-Barre Syndrome, and the FDA and others have issued alerts.

Other Adverse Reactions. Additionally, a number of other reactions to GARDASIL are noted in VAERS reports and they include: urticaria (hives); pruritus (itching); macular and papular rashes; blisters and vesicles near the injection site; swollen arms; lymphadenopathy (swollen lymph nodes); red, hot swollen knots at injection site; burning, stabbing, severe and radiating pain at the injection site and in the affected limb during and after injection; nausea and vomiting; infections and skin ulcers, and other allergic reactions.

Other Considerations

GARDASIL is marketed as a "cervical cancer vaccine" and intended to prevent infection with specific HPVs - common viruses among sexually active women. It isn't clear what benefits or potential harms could arise from vaccinating sexually active women who have already contracted HPV. Of the 86 reaction reports filed with VAERS so far, 12 reports were generated by young women 18 and older who were taking hormonal contraceptives and presumably sexually active.

With respect to concerns related to vaccinating women with known HPV infections, adverse reaction reports were filed on behalf of a 17-year-old Texas girl who was already diagnosed with HPV and genital warts. Similarly, the 22 year-old Kentucky woman who experienced slurred speech following vaccination already had an abnormal pap smear with evidence of cervical dysplasia.

Implications

The early reports of potential safety problems with GARDASIL raise concerns and questions that need to be addressed by government regulators, manufacturers and prescribing physicians. Specifically, the following concerns need to be addressed:

Syncope, seizures and Guillian-Barre Syndrome have now been reported with hours to a week after GARDASIL vaccination. GARDASIL manufacturer, Merck, should add these serious adverse events to the product manufacturer insert.

Considering that over 20 girls have experienced syncopal episodes sometimes combined with seizures and serious injuries, physicians should consider only giving GARDASIL when the patient is safely laying down on the examining table. Because there seems to be syncopal reactions up until 15 minutes after vaccination, patients should be asked to lie down for 15 minutes after receipt of GARDASIL.

The information provided by Merck indicates that it is safe to administer GARDASIL with Hepatitis B vaccine. The prescribing information states, "Results for clinical studies indicate that GARDASIL may be administered concomitantly (at a separate injection site) with hepatitis B vaccine (recombinant). Co-administration of GARDASIL with other vaccines has not been studied." [4] Due to the small number of girls aged 9 to 15 who appear to have been evaluated for GARDASIL safety in Merck clinical trials (fewer than 2,000) and lack of publicly available information about how many of these girls were given GARDASIL and hepatitis B vaccine simultaneously, the safety of administering GARDASIL and hepatitis B vaccine to all pre-adolescent girls is uncertain.[5]

Aside from Hepatitis B, Merck does not state that it is safe to simultaneously administer GARDASIL with any other vaccine. Considering that there are ongoing evaluations of a reported association between Menactra (meningococcal vaccine) and Guillain-Barre Syndrome, and Merck does not explicitly indicate that it is safe to administer to administer GARDASIL and Menactra simultaneously, consumers and clinicians should question whether administering both GARDASIL and Menactra at the same time is safe.

Similarly, adverse reactions were reported when GARDASIL was administered with eight other vaccines: Hepatitis A, MNQ (?), MEN (Menactra), TD (Tetanus and Diptheria Toxoids), DPP (Diptheria/Pertussis/Polio), PNC Prevnar (Heptavalent pneumococcal conjugate), DTaP (Diphtheria And Tetanus Toxoids and Acellular Pertussis Vaccine), and TDAP (Tetanus, Diptheria and Pertussis). Because Merck does not state that it is safe to administer simultaneously GARDASIL with any vaccine other than Hepatitis B, consumers and clinicians should question whether co-administration of GARDASIL and other vaccines is safe.

Most, if not all, of the reactions reported to VAERS were in response to the first of the three doses of GARDASIL. The Centers for Disease Control (CDC) Vaccine Information Sheet (VIS) developed for HPV vaccine states that severe reactions include "any unusual condition, such as a high fever or behavior changes. Signs of a serious allergic reaction can include difficulty breathing, hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or dizziness." [6] The CDC also states that "anyone who has ever had a life-threatening allergic reaction to yeast, to any other component of HPV vaccine, or to a previous dose of HPV vaccine should not get the vaccine." Which of the reactions reported to VAERS constitute a "life-threatening allergic reaction" and which, if any, of the children and young adults who experienced reactions should receive additional doses of vaccine? At the October 2006 ACIP meeting, CDC staff stated that only "three serious reports were reported to VAERS after HPV vaccination in females 14 and 16 years of age. One of these patients had vasovagal syncope and was hospitalized overnight for observation." [7]CDC's summary of the first 76 VAERS reports suggests that CDC doesn't regard the remaining reports as "serious." CDC needs to clarify which of the reactions reported to VAERS constitute contraindications to further vaccination with GARDASIL and make this information available to the public and to prescribing physicians.

What were the short and longer-term outcomes for the individuals who experienced the reactions reported to VAERS? Is there information available that would help to predict the characteristics that predispose one to be at greatest risk of experiencing a serious reaction?

The CDC's Vaccine Information Sheet indicates that allergy to yeast is a reason to avoid taking GARDASIL. Merck notes that contraindications to the vaccine include "hypersensitivity to the active substances or to any of the excipients of the vaccine. Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of GARDASIL should not receive further doses of GARDASIL." The prescribing information provided by Merck does not specifically note that yeast allergy is a contraindication to taking GARDASIL. Government regulators and the manufacturer need to address the discrepancy between these documents and clarify the issues related to yeast allergy and make this information readily available to the public and prescribing physicians.

Additionally, Merck notes that vaccine ingredients include 225 mcg of aluminum (as amorphous aluminum hydroxyphosphate sulfate adjuvant), 0.78 mg of L-histidine, 50 mcg of polysorbate 80, and 35 mcg of sodium borate. These ingredients are not listed on the CDC's VIS sheet. The public needs this information so that they can identify whether they have "hypersensitivities" to any of the ingredients and whether they are at risk of experiencing a serious allergic reaction. Hypersensitivities and known allergic reactions are critical pieces of information that need to be communicated to prescribing physicians in order to make the safest possible vaccination decisions.

Government regulators including the CDC and FDA, in combination with Merck, should address the above safety concerns as soon as possible. Medical groups advocating use of GARDASIL should effectively communicate to physicians and patients the potential risks of using GARDASIL along with precautions to improve the safety of patient care.

Just so you're aware, all the dizziness, pre-syncope, syncope, tonic posturing and other brief seizure activity is a common reaction to being stuck by a needle and all occur frequently when blood is being drawn with absolutely nothing being injected into the body. It sometimes occurs immediately after a blood draw, it sometimes occurs after the patient returns to the waiting room and occasionally happens when they have already left the building. Anyone who has stuck someone for a blood draw sees this all the time. I once had a mother yell at me not to put a band-aid at the needlestick site because her child was allergic to them and would have seizures. I stopped to listen to mom and the child had her seizure about the time I would have been getting the Band-aid on her. Anyone want to make the case that this proves that band-aids cause neurologic problems?

All of the "episodes" described are consistent with post needle stick syncopes and seizures. In children studies have shown that these are true anoxic (no oxygen in the brain) seizures precipitated by breath holding. They have a name, "venipuncture fits". They are not associated with a higher risk of seizure disorder or other neurologic diseases, but when NVIC adds a statement about "neurologic implications" without the context that these are needle-stick related for the most part, it sure sounds scarey, eh?

Does the anti-vaccine crowd have some ideas about what toxic substance is causing this when we only take blood out?

i think most people you'll find are not anti vaccine just upset that their are being pushed to have something they wouldn't have had in normal circumstances. i am not anti vaccines and i didn't want it because my doctor in the uk told me it wasn't beneficial to give to me. and its expensive and being that i hadn't had it before i didn't know how i would take to it. as it turns out i rather wish i hadn't had it and i still don't understand why this vaccine has to be a requirement for females under 27 who are about to get married? why can't it be be recommended but not required? if i am going to get a vaccine whether it be for my own good or not or whether i am going to have a reaction or not i just want to be my choice whether to put myself in that situation.