Cynthia A. Janak
Gardasil - - a different way of looking at the reactions
By Cynthia A. Janak
Merck in their infinite wisdom has decided to make some comments on their Prescribing Information that they give to the doctors. I have found this to be laughable to the extent that it would not be recommended for me to be in the same room with these dolts.
But first I want to give you the latest stats that I have found. I have found an additional 879 reports of adverse events that were listed under "Non Domestic VAERS Data." You will find it when you scroll down almost to the bottom of the page.
This number just keeps going up and up and up. The other thing I want to mention in regards to the VAERS Data is that there is no report for September, 2008. You would think that after a month + they would have that published on their web site. It makes me wonder what they are trying to hide by stalling.
Here are the stats as of August 2008 from the NVIC as stated in my October 12th article.
8919 reported incidents + 2141= 11060 (multiple incidents-I will update as time is available)
131 were considered life threatening
371 were hospitalized
4445 were taken to the ER
1678 had not recovered at the time of the report
2485 recovery is unknown at the time of the report
229 are disabled at the time of the report
27 have died as of August, 2008 +1=28 (multiple incidents)
21 incidents blood clots reported and 8 additional incidents with embolism
Hold on to your hats boys and girls and check out these new numbers as of VAERS August, 2008 with the non domestic (whatever the heck that means) included.
8919 reported incidents + 2141= 11060 +879 = 11939
131 were considered life threatening +27 = 158
371 were hospitalized +488 = 859
4445 were taken to the ER +4 = 4449
1678 had not recovered at the time of the report +237 = 1915
2485 recovery is unknown at the time of the report +208 = 2693
229 are disabled at the time of the report +48 = 277
27 have died as of August, 2008 +1 = 28 + 4 = 32
Now let us look at this logically. The HPV vaccine was approved June of 2006. That means that the vaccine would have been delivered to the doctors by the beginning of July 2006. So that means that this vaccine has been on the market for 25 months and we have 11939 reports. You have to consider the unlikely likelihood that only 10% of the doctors are going to call in a report. I know that my 10% is high because the majority of the families that I have spoke with their doctors refused to call in the report so the families had to do it themselves. (I underlined the last part because it is pertinent later).
What we have here is the fact that at an average we have 478 girls being adversely affected by this vaccine a month. If we break that down even further we have 10 girls in every state that are having a reaction to this vaccine a month.
Let me show you this little blurb about measles.
Vaccination: Avoiding Immunization Puts Children at Risk of Serious Illness
Measles has once again been declared an epidemic, and deaths have been reported in the United Kingdom. In the U.S., 11 new cases of measles were recently reported in the San Diego area, all among non-immunized children. David Tayloe, Jr. M.D, FAAP, President-elect, American Academy of Pediatrics warns that unproven concerns about vaccine safety have created a backlash that threatens to unleash, once again, deadly diseases on our children.
Asheville, NC (PRWEB) October 29, 2008 — David Tayloe, Jr. M.D, FAAP, President-elect, American Academy of Pediatrics warns that unproven concerns about vaccine safety have created a backlash that threatens to unleash, once again, deadly diseases on our children. In the past year, over 130 new cases have occurred, all in children who had not been vaccinated. In Dr. Tayloe's article in Sixty Second Parent's newsletter, he writes, "If this trend continues to grow, measles, mumps and whooping cough will return, and our children will be added to the 250,000 deaths per year from measles that now occur in under-developed and non-immunized parts of the world."
http://www.prweb.com/releases/measlesvaccine/pediatricimmunization/prweb1515534.htm
This article is laughable because here they are screaming epidemic, epidemic for 130 measles cases in one year yet 478 girls in one month are affected by one vaccine is going un-noticed and unspoken. What is this nonsense? And what about Autism, we now have a ratio of 1 in 150 children are now diagnoses with Autism Spectrum Disorder and he has the nerve to say "unproven concerns." How the heck do these people sleep at night telling the lies and half truths about what is going on out there with the HPV vaccine and Autism? Sorry, I got upset. I will calm down now.
Now, on to that little tidbit I was telling you about earlier. This will knock your socks off.
http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf
5.3 Managing Allergic Reactions
Appropriate medical treatment and supervision must be readily available in case of anaphylactic reactions following the administration of GARDASIL.
6 ADVERSE REACTIONS
Overall Summary of Adverse Reactions
Headache, fever, nausea, and dizziness; and local injection site reactions (pain, swelling, erythema, pruritus, and bruising) occurred after administration with GARDASIL.
Syncope has been reported following vaccination with GARDASIL and may result in falling with injury; observation for 15 minutes after administration is recommended.
Anaphylaxis has been reported following vaccination with GARDASIL.
Serious Adverse Reactions in the Entire Study Population
A total of 237 subjects out of 25,274 total subjects (9- through 45-year-old girls and women; and 9-through 15-year-old boys) who received both GARDASIL (N = 13,686) and AAHS control (N = 11,004) or saline placebo (N = 584) reported a serious systemic adverse reaction following any vaccination visit during the clinical trials for GARDASIL.
Out of the entire study population (25,274 subjects), only 0.05% of the reported serious systemic adverse reactions were judged to be vaccine related by the study investigator. The most frequently reported serious systemic adverse reactions for GARDASIL compared to AAHS control or saline placebo and regardless of causality were:
Headache [0.02% GARDASIL (3 cases) vs. 0.02% AAHS Control (2 cases)],
Gastroenteritis [0.02% GARDASIL (3 cases) vs. 0.02% AAHS Control (2 cases)],
Appendicitis [0.03% GARDASIL (4 cases) vs. 0.01% AAHS Control (1 case)],
Pelvic inflammatory disease [0.02% GARDASIL (3 cases) vs. 0.04% AAHS Control (4 cases)],
Urinary tract infection [0.02% GARDASIL (2 cases) vs. 0.02% AAHS Control (2 cases)],
Pneumonia [0.02% GARDASIL (2 cases) vs. 0.02% AAHS Control (2 cases)],
Pyelonephritis [0.02% GARDASIL (2 cases) vs. 0.03% AAHS Control (3 cases)],
Pulmonary embolism [0.02% GARDASIL (2 cases) vs. 0.02% AAHS Control (2 cases)].
One case (0.007% GARDASIL: 0.0% AAHS Control or Saline Placebo) of bronchospasm; and
2 cases (0.02% GARDASIL: 0.0% AAHS Control or Saline Placebo) of asthma were reported as serious systemic adverse reactions that occurred following any vaccination visit.
In addition, there was 1 subject in the clinical trials, in the group that received GARDASIL, who reported two injection-site serious adverse reactions (injection-site pain and injection-site joint movement impairment).
Deaths in the Entire Study Population
Across the clinical studies, 24 deaths were reported in 25,274 (GARDASIL N = 13,686; AAHS Control N = 11,004, saline placebo N = 584) subjects (9- through 45-year-old girls and women; and 9- through 15-year-old boys). The events reported were consistent with events expected in healthy adolescent and adult populations. The most common cause of death was motor vehicle accident (4 subjects who received GARDASIL and 3 AAHS Control subjects), followed by overdose/suicide (2 subjects who received GARDASIL and 2 subjects who received AAHS Control), and pulmonary embolus/deep vein thrombosis (1 subject who received GARDASIL and 1 AAHS Control subject).
In addition, there were
2 cases of sepsis,
1 case of pancreatic cancer,
1 case of arrhythmia,
1 case of pulmonary tuberculosis,
1 case of hyperthyroidism,
1 case of post-operative pulmonary embolism and acute renal failure, and
1 case of systemic lupus erythematosus in the group that received GARDASIL;
1 case of asphyxia, and
1 case of acute lymphocytic leukemia in the AAHS Control; and
1 case of medulloblastoma in the saline placebo group.
Systemic Autoimmune Disorders in Girls and Women 9 Through 26 Years of Age
In the clinical studies, 9- through 26-year-old girls and women were evaluated for new medical conditions that occurred over the course of follow-up. New medical conditions potentially indicative of a systemic autoimmune disorder seen in the group that received GARDASIL or AAHS control or saline placebo are shown in Table 5. This population includes all subjects who received at least one dose of GARDASIL or AAHS control or saline placebo, and had safety data available.
Look at these reactions to Gardasil and the AAHS (virus like particles are omitted) Control group and you tell me that I should not worry because some doctor tells me that they are "unproven concerns"! The proof is right here and I am sorry but I would be concerned as to the safety of the vaccine and any vaccine at this point. I would be concerned that one of my loved ones might be the 1 in 100,000 that might have a severe reaction. I believe that the concerns of the people are founded and this is just further proof to the dangers we face in regards to vaccination.
I want to point out that they mention pulmonary embolism was reported as one of the side effects. How many girls have died because of this? I know of one family personally that was destroyed because of this and that is the family of Brooke Petkevicius. And what does Merck say about this, they say it was the birth control pills she was on and not their sacred cow Gardasil. Go back and look at the side effects and you tell me if you think it was the birth control. It is my opinion that Brooke and all those other girls that have died happened to fall in the 0.02% category. I guess they are collateral damage and to Merck just another statistic.
Do you know what I would like to see happen to all these people that create all these dangerous drugs and vaccines? Have you seen that movie Ghost with Patrick Swayze? If you have, do you remember the part where the evil dude dies and gets taken to hell by the black things? That is what I want to see happen to those people. When their time comes and their ticket is punched I want the black things to come for them.
Please come visit my website at www.cynthiajanak.com for more information that the mainstream media will not touch with a ten foot pole.
6.2 Post-Marketing Experience
The following adverse events have been spontaneously reported during post-approval use of
GARDASIL. Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish a causal relationship to vaccine exposure.
Blood and lymphatic system disorders: Autoimmune hemolytic anemia, lymphadenopathy.
Gastrointestinal disorders: Nausea, pancreatitis, vomiting.
General disorders and administration site conditions: Asthenia, death, fatigue, malaise.
Immune system disorders: Autoimmune diseases, hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.
Nervous system disorders: Dizziness, Guillain-Barré syndrome, headache, motor neuron disease, paralysis, seizures, syncope sometimes resulting in falling with injury, transverse myelitis.
Vascular Disorders: Deep venous thrombosis, pulmonary embolus.
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
GARDASIL has not been evaluated for the potential to cause carcinogenicity or genotoxicity.
What I find interesting is that with all the other statistics they mention the ages of 9 through 26 and in the area of serious adverse reactions they mention 9 through 45. I would like to know the total figures for the 9 through 26 year old group.
For your information the chart above has listed NEW medical conditions that occurred because of the vaccine. These "test subjects" did not have these conditions before the trials. I wonder what Merck is doing for these "test subjects"?
The other thing I find of interest is the fact that they did not test to see if the ingredients could be cancer causing agents. Interesting, here you have a vaccine touted to prevent cancer but has never been tested to see if it causes cancer. I find that to be laughable.
With this paragraph I want to show you how ludicrous Merck is when dealing with the reports to VAERS. They do not think, in my opinion that the concerned parents reporting about their daughters is of any worth to them. Here is what they say.
The following adverse events have been spontaneously reported during post-approval use of
GARDASIL. Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish a causal relationship to vaccine exposure.
What a crock this statement is. You mean that because it is a parent calling because a doctor refuses to report the incident you cannot establish a causal relationship or estimate their frequency. Maybe the people at Merck should push for the doctors to report any problems then the parents would not have to. This also makes me wonder if Merck is really looking into any of the reports of the parents.
It makes me sad to think of all the girls that have died and are disabled that have been in the news and all the girls and parents that I have spoken with. For Merck to be so blasé about this whole thing but then you need to think about how they reacted when the VIOXX adverse reactions started to surface from this "safe" drug.
Proof is in the pudding but in this case I would say history of Merck.
© Cynthia A. Janak
November 15, 2008
Merck in their infinite wisdom has decided to make some comments on their Prescribing Information that they give to the doctors. I have found this to be laughable to the extent that it would not be recommended for me to be in the same room with these dolts.
But first I want to give you the latest stats that I have found. I have found an additional 879 reports of adverse events that were listed under "Non Domestic VAERS Data." You will find it when you scroll down almost to the bottom of the page.
-
Non Domestic VAERS Data
Zip file (6.09 MB)
CSV file, VAERS Data (21.60 MB)
CSV file, VAERS Vaccine (1.84 MB)
This number just keeps going up and up and up. The other thing I want to mention in regards to the VAERS Data is that there is no report for September, 2008. You would think that after a month + they would have that published on their web site. It makes me wonder what they are trying to hide by stalling.
Here are the stats as of August 2008 from the NVIC as stated in my October 12th article.
8919 reported incidents + 2141= 11060 (multiple incidents-I will update as time is available)
131 were considered life threatening
371 were hospitalized
4445 were taken to the ER
1678 had not recovered at the time of the report
2485 recovery is unknown at the time of the report
229 are disabled at the time of the report
27 have died as of August, 2008 +1=28 (multiple incidents)
21 incidents blood clots reported and 8 additional incidents with embolism
Hold on to your hats boys and girls and check out these new numbers as of VAERS August, 2008 with the non domestic (whatever the heck that means) included.
8919 reported incidents + 2141= 11060 +879 = 11939
131 were considered life threatening +27 = 158
371 were hospitalized +488 = 859
4445 were taken to the ER +4 = 4449
1678 had not recovered at the time of the report +237 = 1915
2485 recovery is unknown at the time of the report +208 = 2693
229 are disabled at the time of the report +48 = 277
27 have died as of August, 2008 +1 = 28 + 4 = 32
Now let us look at this logically. The HPV vaccine was approved June of 2006. That means that the vaccine would have been delivered to the doctors by the beginning of July 2006. So that means that this vaccine has been on the market for 25 months and we have 11939 reports. You have to consider the unlikely likelihood that only 10% of the doctors are going to call in a report. I know that my 10% is high because the majority of the families that I have spoke with their doctors refused to call in the report so the families had to do it themselves. (I underlined the last part because it is pertinent later).
What we have here is the fact that at an average we have 478 girls being adversely affected by this vaccine a month. If we break that down even further we have 10 girls in every state that are having a reaction to this vaccine a month.
Let me show you this little blurb about measles.
Vaccination: Avoiding Immunization Puts Children at Risk of Serious Illness
Measles has once again been declared an epidemic, and deaths have been reported in the United Kingdom. In the U.S., 11 new cases of measles were recently reported in the San Diego area, all among non-immunized children. David Tayloe, Jr. M.D, FAAP, President-elect, American Academy of Pediatrics warns that unproven concerns about vaccine safety have created a backlash that threatens to unleash, once again, deadly diseases on our children.
Asheville, NC (PRWEB) October 29, 2008 — David Tayloe, Jr. M.D, FAAP, President-elect, American Academy of Pediatrics warns that unproven concerns about vaccine safety have created a backlash that threatens to unleash, once again, deadly diseases on our children. In the past year, over 130 new cases have occurred, all in children who had not been vaccinated. In Dr. Tayloe's article in Sixty Second Parent's newsletter, he writes, "If this trend continues to grow, measles, mumps and whooping cough will return, and our children will be added to the 250,000 deaths per year from measles that now occur in under-developed and non-immunized parts of the world."
http://www.prweb.com/releases/measlesvaccine/pediatricimmunization/prweb1515534.htm
This article is laughable because here they are screaming epidemic, epidemic for 130 measles cases in one year yet 478 girls in one month are affected by one vaccine is going un-noticed and unspoken. What is this nonsense? And what about Autism, we now have a ratio of 1 in 150 children are now diagnoses with Autism Spectrum Disorder and he has the nerve to say "unproven concerns." How the heck do these people sleep at night telling the lies and half truths about what is going on out there with the HPV vaccine and Autism? Sorry, I got upset. I will calm down now.
Now, on to that little tidbit I was telling you about earlier. This will knock your socks off.
http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf
5.3 Managing Allergic Reactions
Appropriate medical treatment and supervision must be readily available in case of anaphylactic reactions following the administration of GARDASIL.
6 ADVERSE REACTIONS
Overall Summary of Adverse Reactions
Headache, fever, nausea, and dizziness; and local injection site reactions (pain, swelling, erythema, pruritus, and bruising) occurred after administration with GARDASIL.
Syncope has been reported following vaccination with GARDASIL and may result in falling with injury; observation for 15 minutes after administration is recommended.
Anaphylaxis has been reported following vaccination with GARDASIL.
Serious Adverse Reactions in the Entire Study Population
A total of 237 subjects out of 25,274 total subjects (9- through 45-year-old girls and women; and 9-through 15-year-old boys) who received both GARDASIL (N = 13,686) and AAHS control (N = 11,004) or saline placebo (N = 584) reported a serious systemic adverse reaction following any vaccination visit during the clinical trials for GARDASIL.
Out of the entire study population (25,274 subjects), only 0.05% of the reported serious systemic adverse reactions were judged to be vaccine related by the study investigator. The most frequently reported serious systemic adverse reactions for GARDASIL compared to AAHS control or saline placebo and regardless of causality were:
Headache [0.02% GARDASIL (3 cases) vs. 0.02% AAHS Control (2 cases)],
Gastroenteritis [0.02% GARDASIL (3 cases) vs. 0.02% AAHS Control (2 cases)],
Appendicitis [0.03% GARDASIL (4 cases) vs. 0.01% AAHS Control (1 case)],
Pelvic inflammatory disease [0.02% GARDASIL (3 cases) vs. 0.04% AAHS Control (4 cases)],
Urinary tract infection [0.02% GARDASIL (2 cases) vs. 0.02% AAHS Control (2 cases)],
Pneumonia [0.02% GARDASIL (2 cases) vs. 0.02% AAHS Control (2 cases)],
Pyelonephritis [0.02% GARDASIL (2 cases) vs. 0.03% AAHS Control (3 cases)],
Pulmonary embolism [0.02% GARDASIL (2 cases) vs. 0.02% AAHS Control (2 cases)].
One case (0.007% GARDASIL: 0.0% AAHS Control or Saline Placebo) of bronchospasm; and
2 cases (0.02% GARDASIL: 0.0% AAHS Control or Saline Placebo) of asthma were reported as serious systemic adverse reactions that occurred following any vaccination visit.
In addition, there was 1 subject in the clinical trials, in the group that received GARDASIL, who reported two injection-site serious adverse reactions (injection-site pain and injection-site joint movement impairment).
Deaths in the Entire Study Population
Across the clinical studies, 24 deaths were reported in 25,274 (GARDASIL N = 13,686; AAHS Control N = 11,004, saline placebo N = 584) subjects (9- through 45-year-old girls and women; and 9- through 15-year-old boys). The events reported were consistent with events expected in healthy adolescent and adult populations. The most common cause of death was motor vehicle accident (4 subjects who received GARDASIL and 3 AAHS Control subjects), followed by overdose/suicide (2 subjects who received GARDASIL and 2 subjects who received AAHS Control), and pulmonary embolus/deep vein thrombosis (1 subject who received GARDASIL and 1 AAHS Control subject).
In addition, there were
2 cases of sepsis,
1 case of pancreatic cancer,
1 case of arrhythmia,
1 case of pulmonary tuberculosis,
1 case of hyperthyroidism,
1 case of post-operative pulmonary embolism and acute renal failure, and
1 case of systemic lupus erythematosus in the group that received GARDASIL;
1 case of asphyxia, and
1 case of acute lymphocytic leukemia in the AAHS Control; and
1 case of medulloblastoma in the saline placebo group.
Systemic Autoimmune Disorders in Girls and Women 9 Through 26 Years of Age
In the clinical studies, 9- through 26-year-old girls and women were evaluated for new medical conditions that occurred over the course of follow-up. New medical conditions potentially indicative of a systemic autoimmune disorder seen in the group that received GARDASIL or AAHS control or saline placebo are shown in Table 5. This population includes all subjects who received at least one dose of GARDASIL or AAHS control or saline placebo, and had safety data available.
Look at these reactions to Gardasil and the AAHS (virus like particles are omitted) Control group and you tell me that I should not worry because some doctor tells me that they are "unproven concerns"! The proof is right here and I am sorry but I would be concerned as to the safety of the vaccine and any vaccine at this point. I would be concerned that one of my loved ones might be the 1 in 100,000 that might have a severe reaction. I believe that the concerns of the people are founded and this is just further proof to the dangers we face in regards to vaccination.
I want to point out that they mention pulmonary embolism was reported as one of the side effects. How many girls have died because of this? I know of one family personally that was destroyed because of this and that is the family of Brooke Petkevicius. And what does Merck say about this, they say it was the birth control pills she was on and not their sacred cow Gardasil. Go back and look at the side effects and you tell me if you think it was the birth control. It is my opinion that Brooke and all those other girls that have died happened to fall in the 0.02% category. I guess they are collateral damage and to Merck just another statistic.
Do you know what I would like to see happen to all these people that create all these dangerous drugs and vaccines? Have you seen that movie Ghost with Patrick Swayze? If you have, do you remember the part where the evil dude dies and gets taken to hell by the black things? That is what I want to see happen to those people. When their time comes and their ticket is punched I want the black things to come for them.
Please come visit my website at www.cynthiajanak.com for more information that the mainstream media will not touch with a ten foot pole.
6.2 Post-Marketing Experience
The following adverse events have been spontaneously reported during post-approval use of
GARDASIL. Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish a causal relationship to vaccine exposure.
Blood and lymphatic system disorders: Autoimmune hemolytic anemia, lymphadenopathy.
Gastrointestinal disorders: Nausea, pancreatitis, vomiting.
General disorders and administration site conditions: Asthenia, death, fatigue, malaise.
Immune system disorders: Autoimmune diseases, hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.
Nervous system disorders: Dizziness, Guillain-Barré syndrome, headache, motor neuron disease, paralysis, seizures, syncope sometimes resulting in falling with injury, transverse myelitis.
Vascular Disorders: Deep venous thrombosis, pulmonary embolus.
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
GARDASIL has not been evaluated for the potential to cause carcinogenicity or genotoxicity.
What I find interesting is that with all the other statistics they mention the ages of 9 through 26 and in the area of serious adverse reactions they mention 9 through 45. I would like to know the total figures for the 9 through 26 year old group.
For your information the chart above has listed NEW medical conditions that occurred because of the vaccine. These "test subjects" did not have these conditions before the trials. I wonder what Merck is doing for these "test subjects"?
The other thing I find of interest is the fact that they did not test to see if the ingredients could be cancer causing agents. Interesting, here you have a vaccine touted to prevent cancer but has never been tested to see if it causes cancer. I find that to be laughable.
With this paragraph I want to show you how ludicrous Merck is when dealing with the reports to VAERS. They do not think, in my opinion that the concerned parents reporting about their daughters is of any worth to them. Here is what they say.
The following adverse events have been spontaneously reported during post-approval use of
GARDASIL. Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish a causal relationship to vaccine exposure.
What a crock this statement is. You mean that because it is a parent calling because a doctor refuses to report the incident you cannot establish a causal relationship or estimate their frequency. Maybe the people at Merck should push for the doctors to report any problems then the parents would not have to. This also makes me wonder if Merck is really looking into any of the reports of the parents.
It makes me sad to think of all the girls that have died and are disabled that have been in the news and all the girls and parents that I have spoken with. For Merck to be so blasé about this whole thing but then you need to think about how they reacted when the VIOXX adverse reactions started to surface from this "safe" drug.
Proof is in the pudding but in this case I would say history of Merck.
© Cynthia A. Janak
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(See RenewAmerica's publishing standards.)
