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• 05-25-2007 Andy M wrote:
  

  From Andy M. Reactions to Gardasil What you already knew, or could have guessed... Sent: Thu 5/24/2007 9:59 AM Immediate Release May 23, 2007 Contact: Press Office 202-646-5188 Judicial Watch Uncovers Three Deaths Relating to HPV Vaccine Event Reports Obtained from FDA Detail 1,637 Adverse Reactions to Gardasil (Washington, DC) Judicial Watch, the public interest group that investigates and prosecutes government corruption, today released documents obtained from the U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act, detailing 1,637 reports of adverse reactions to the vaccination for human papillomavirus (HPV), Gardasil. Three deaths were related to the vaccine. One physician's assistant reported that a female patient "died of a blood clot three hours after getting the Gardasil vaccine." Two other reports, on girls 12 and 19, reported deaths relating to heart problems and/or blood clotting. As of May 11, 2007, the 1,637 adverse vaccination reactions reported to the FDA via the Vaccine Adverse Event Reporting System (VAERS) included 371 serious reactions. Of the 42 women who received the vaccine while pregnant, 18 experienced side effects ranging from spontaneous abortion to fetal abnormities. Side effects published by Merck & Co. warn the public about potential pain, fever, nausea, dizziness and itching after receiving the vaccine. Indeed, 77% of the adverse reactions reported are typical side effects to vaccinations. But other more serious side effects reported include paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures. "The FDA adverse event reports on the HPV vaccine read like a catalog of horrors," stated Judicial Watch President Tom Fitton. "Any state or local government now beset by Merck's lobbying campaigns to mandate this HPV vaccine for young girls ought to take a look at these adverse health reports. It looks as if an unproven vaccine with dangerous side effects is being pushed as a miracle drug." Judicial Watch filed its request on May 9, 2007, and received the adverse event reports from the FDA on May 15, 2007. Judicial Watch has posted the adverse event reports below. (A recent study, published in the New England Journal of Medicine, also questioned the general effectiveness of Gardasil.) Click Here for Links: (1) Judicial Watch (2) Gardisil Deaths (3) Gardisil Adverse Reports (4) March 2007 Human Papilloma Virus Vaccine Safety Report  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. 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: 1. Syncope, seizures and Guillian-Barre Syndrome have now beenreported with hours to a week after GARDASIL vaccination. GARDASIL manufacturer, Merck, should add these serious adverse events to the product manufacturer insert. 2. 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. 3. 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." 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. 4. 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. 5. 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 pneumococca 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. 6. 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." 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. 7. What were the short and longer-term outcomes for the individualswho 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? 8. 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. 9. 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. Posted by Andy.M.

  
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• 07-05-2007 Michael D wrote:
  

  Dear Dr. Dach: Thank you for this very informative blog. I enjoyed reading through it. Just thought I'd bring to the forum's attention that Di-indolylmethane (DIM) from Brassica vegetables has also been shown to be very effective against HPV and scientists at UC Berkeley have recently found why--it modulates the immune system through the potentiation of Interferon-Gamma sesitivity and production, resulting in potent anti-viral properties (in addition to anti-bacterial and anti-cancer properties). DIM is currently being used to treat RRP tumors and has reached Phase III Clinical trials for Cervical Dysplasia. It is also in the clinic for numerous forms of cancer. Regards, from Mike D References: http://www.diindolylmethane.org/ http://www.activamune.com/

  
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• 07-10-2007 Kevin MD wrote:
  

  Posted from Kevin M.D. Weblog ,   Originally from the Wall Street Jounal April 16, 2007 "But behind the scenes, Gardasil has been dogged by uncertainty about how effective it really is. Merck won approval for the vaccine based on research that showed it protected against two strains of the human papillomavirus, known as HPV 16 and 18, that are thought to cause 70% of cervical-cancer cases. The Food and Drug Administration didn't ask its panel of experts advising on Gardasil to rule on whether the vaccine specifically prevented the cancer itself. In clinical trials, 361 of 8,817 women who received at least one shot of Gardasil went on to develop precancerous lesions on their cervixes within three years of vaccination, just 14% fewer than in a placebo control group." "Scott Emerson, a professor of biostatistics at the University of Washington who sat on the FDA advisory committee, says he's not persuaded the vaccine is worth the billions of dollars likely to be spent on it in coming years." "I do believe that Gardasil protects against HPV 16 and 18, but the effect it will have on cervical-cancer rates in this country is another question entirely," says Dr. Emerson. "There is a leap of faith involved."

  
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• 10-21-2007 Meg Wolff wrote:
  

  Dear Dr. Dach, This is good and important information. Thank you. Meg Wolff Author of: Breast Cancer Exposed: The Connection Between Food and Survival

  
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• 05-15-2008 Janet wrote:
  

  New Gardasil Forum: We just read a very interesting comment from one of our readers where she describes her daughter had become numb and fainted after being administered an injection of Merck’s Gardasil, the vaccine for HPV - Human Papillomavirus which is being mandated in some states. While we’re not sure if this is a common reaction to the vaccine or maybe just a phobia about getting “shots”, it was concerning enough to our reader to state she would not allow her daughter any follow-up treatments. Have any of your children been vaccinated with Gardisil yet? If so, tell us their reaction to the vaccine and share your experiences with us. We’d like to know how many of you discussed the vaccination with your children and how you explained the vaccine to them. We’d also like to know if you’ve decided NOT to get the vaccination for your child and what the reasons were for not getting Our poor children that are given this! Read Gardasil Stories Here. from janet _________________________________________________________________________ Jeffrey Dach MD www.drdach.com disclaimer

  
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• 02-10-2009 Annie wrote:
  

  This is yet another good article showing the many issues that arise from this whole vaccine being pushed by Merck. As a young lady, I have personally been insulted by the advertisement for Gardasil that basically assumes that all 16 year olds are sleeping around. Well newsflash Merck! not all young people are like that- so stop banking on cultural promiscuity as your basis. I am married at this time but when I was 19, a nurse at my family doctor's attempted (rather forcefully) to convince me that I NEEDED the Gardasil vaccine. I asked some questions and got the same vague misleading statements that Merck makes about it. I declined and was upset. Is Merck paying doctors to market this?? I know it is not above drug companies to do this but still.... this eclipsing of the truth disgusts me. Keep raising valid concerns Doctor Dach Annie ___________________________________________________ Jeffrey Dach MD  www.drdach.com   disclaimer

  
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• 03-24-2009 JS wrote:
  

  Dear Dr Dach, My daughter has been ill since Feb. 2008. She had her first Gardasil vaccination Nov. 2007. Her second vaccination was in the beginning of Feb. 2008. Immediately after her second vaccination, she experienced severe diarrhea and was nauseous for about eight weeks. She had blood work done many times and doctors thought she had a virus. On March 31, 2008, she had her first seizure. There are quite a few hundred people that I have found over the internet through my numerous postings and through Erin Brockovich, and their daughters are all experiencing the same symptoms, which occurred after the Gardasil vaccination. My daughter has had CT scans, MRI's, MRA's, EEG's, blood work and was hospitalized at video EEG monitoring unit for two separate weeks in May 2008 and SepT. 2008. After the normal EEG results, she was taken off all medications. Her SED rate has always been high and she does have protein in her urine, but doctors do not seem concerned. My daughter has been seen by several neurologists, a psychiatrist, psychologist, several neuropsychologists, an immunologist, several infectious disease doctors, and also treated at a Wellness Center. My daughter currently experiences the following symptoms: non-epileptic seizures, migraines, fainting, tremors, twitches, numbness, intermittent leg paralysis and facial paralysis, tingling, staring or blank episodes, eye pain, joint pain, neck pain, back pain, memory loss, confusion, brain fog, regression, mood swings and chronic fatigue. She continues to have bouts of nausea and diarrhea. She has not been in school since April 2008. My daughter can never be left home alone. She can't go to school, go out with her friends or work or has little "normalcy" in her life. She has very few good days and always says she doesn't feel good. We have seen so many doctors and I can't seem to find anyone willing to help my daughter. There are so many other young girls who have the same exact symptoms as my daughter and the one thing that all of the girls seem to have in common is the Gardasil vaccination. We are on a fixed income, as most people, and we have expended many thousands of dollars in an effort to seek medical opinions and assistance. Although we do have medical insurance, it is difficult to find doctors willing to treat my daughter who will accept our HMO. Also, there are no "traditional medical doctors" who will relate my daughter's symptoms to Gardasil as I am told "there is not enough information available" about the vaccine and doctors believe it to be "safe". Each day, I wonder if Victoria will be next one to die from adverse reactions to Gardasil. We are in desperate need of medical treatment.I have run out of ideas, doctors to treat with and finances have dwindled. Any thoughts are most appreciated, especially from the medical community. The NVIC is in the process of circulating a petition to have Gardasil investigated by the government. Thank you very much. JS _________________________________________________________   www.drdach.com   disclaimer

  
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