Gardasil and Cervarix - The Cervical Cancer Vaccines

THE NEW HPV VACCINE – Miracle or Menace?

Human Papilloma Virus is what doctors believe is responsible for triggering cervical cancer in women, some forms of genital warts and vulval intraepithelial neoplasia (VIN). A new experimental vaccine called Gardasil is being developed against 4 types of HPV, 2 of which are thought to cause 70% of cervical cancers.
However, HPV is extremely common and is present in upto 80% of people by the time they are 50, and it rarely develops into cancer. Cancer will only develop if the person is already in a state of dis-ease.

‘HPV, by itself, does not kill anyone. According to the Daily, 5,000 people die of HPV each year. However, according to the National Institute of Health (NIH), this is
the number of women who die from cervical cancer in the United States. Also,
there are over 100 strains of HPV, 30 of which are transmitted sexually, and
only two of which are pre-cancerous. It is only those two strains that are
responsible for most cases of cervical cancer….but that rate for cancer is actually very low.’ ( Letter to the Stanford Daily, February 10, 2006).

What Is VIN?

As a woman who has suffered since the age of 12 with a vulval pain syndrome, I myself was recently suspected of having VIN, which is a pre-cancer of the vulva. After living with my vulval disorder for 17 years, and reading everything I can about these conditions, I can tell you that VIN isn’t cancer. It is simply abnormal cells in the vulva which MAY potentially develop into cancer.
According to the Vulval Pain Society, ‘We use the word pre-cancer, NOT because the cells are cancerous or you have cancer, but because the cells MAY (or MAY NOT) develop into cancer over a period of years. The exact relationship between VIN and vulval cancer remains unknown because so few studies have been done…..Very little is known about women with VIN I or II. The VPS has recently been contacted by a vulval pain sufferer whose consultant gynaecologist told her that, according to new research, neither VIN I nor VIN II exist. We hope to post further research findings..’

The most common form of treatment for this is to do nothing and wait and see, as most people with abnormal findings do not develop cancer.

It hardly seems worth having a vaccine, with these incredibly low risks.

The cancer vaccine that GIVES you cancer

The new vaccine was tested on both males and females, but is expected to be used primarily against cervical cancer. Five women involved in the tests, gave birth to children with birth defects, as they were vaccinated near to conception of their babies. The plan is to vaccinate girls aged 9 to 12 who are not yet sexually active, but the FDA is also considering recommendations of whether to give the vaccine to 13-26 year old’s. If the vaccine is given to this age group, there is no guarantee that should a pregnancy occur, the foetus would not develop birth defects and abnormalities.
There have also been no long term studies into fertility and whether or not vaccinating young girls with HPV would have any affect on their future ability to have children.

Another concern the FDA have is that the vaccine may pre-dispose women to cancer if they already have traces of HPV in their body (as most people do!).

Also, the vaccine is only meant for 4 types of HPV, and there are many other types the vaccine does not cover, which can still cause disease. I can imagine this being a useful excuse for doctors in the event of vaccine caused cancer. They could simply say that the jab didn’t protect against the strain of cancer you’ve got, rather than admitting the jab had pre-disposed you to getting it.

"If it works, it's great; if it has side effects we don't yet know about, it could be bad," said Dr. George Davis, a physician at the Callan Family Care Center in Copake, "Although it has been tested for FDA approval, we sometimes don't know all of the side effects until a certain amount of time has passed," he said. (indenews.com).

Other side-effects reported are: Pain (83.9%), swelling (25.4%), erythema (24.6%), fever (10.3%) and pruritis (3.1%).

The Merck press release where I obtained details of side-effects, also states that ‘GARDASIL is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine’, but failed to state on this particular release, what those ingredients are. Most parents, as a general rule, do not think to ask for a list of the ingredients prior to their children being vaccinated, so it would not be known if a child was contraindicated until after the event.

Basically they will be testing on the nation’s daughters, without adequate knowledge of the possible sequelae that could arise from that.

There are also suggestions of targeting black African women, on account of them having a slightly higher rate of cervical cancer. It seems reminiscent to the Hepatitis B vaccine campaigns of the 1970’s on black and gay people, after which AIDS swept through these communities.

I searched for manufacturer's information on the drug and managed to find the following from Hall Health Primary Care Center in Seattle, USA:

Ingredients: The main ingredients are purified inactive proteins that come from HPV Types 6, 11, 16 and 18. The vaccine also contains amorphous aluminum hydroxyphosphate sulfate, sodium chloride, L-histidine, polysorbate 80, sodium borate, and water for injection.

Effectiveness: The length of vaccine protection (immunity) is usually not known when a vaccine is first introduced. So far, studies have found that vaccinated persons are protected for five years. More research is being done to find out how long protection will last, and if a booster dose of vaccine will be needed.

Contraindications (reasons you should not have the vaccine):

Who should not receive the HPV vaccine?

Anyone who:

· is allergic to any components of the vaccine

· has an allergic reaction after getting a dose of the vaccine

What are other possible reasons that patients cannot receive this vaccine?

It is very important that patients let their provider know if they have had any of the following before receiving the HPV vaccine:

· allergic reaction to the vaccine

· bleeding disorder such that the patient cannot receive vaccines in the arm

· weakened immune system

· pregnant or planning pregnancy

· current illness with a fever greater than 100 degrees Fahrenheit



Just Who Owns Your Child’s Body?

Your child herself and you as parental guardian, or the government?
Doctors at Brown Medical School, Miriam Hospital, US, are pushing for HPV vaccines to be mandated.

‘"Parental consent ought to be waived for HPV vaccination as it is for other sexually transmitted infection-related health care." (The Lancet, Infectious Diseases, July 2005).

No further explanation as to why is offered.

Does the Vaccine Even Work?

As well as heightening the risk of cancer in women with HPV already present in their bodies, the CDC say that tests show the vaccine will ‘protect’ for just 4 years. No long-term results are known yet. This means repeat doses will be needed regularly throughout adult life. The initial vaccination is also not just one shot, but three, given over a period of 6 months, so this whole course would have to be done again after the 4 years was up.
The CDC state that:
‘The vaccine only prevents infection but cannot prevent the disease once a person is already infected. They urged women to remain vigilant. "The vaccine should not take the place of a yearly exam and pap smear,"

As the Hall Health Primary Care Center stated, they don't know if the vaccine works and even if it did, only for a maximum of 5 years.

Men also carry HPV and can pass it onto others through sexual contact, so there is a question mark over whether they should be vaccinated too.

There are also ethical dilemmas over whether gynaecologists or paediatricians should be administering the shots since the vaccine is aimed at girls not yet sexually active.

Many paediatricians are uneasy about injecting a vaccine for cervical cancer and sexually transmitted genital warts, into children.

So the plan is to vaccinate your daughter by force with a jab whose side-effects are unknown, that has caused birth defects in clinical trials and that has the potential to pre-dispose her to cancer, with absolutely no regard for choice or whether parental consent has been given, and without even accurate indication or long term studies to suggest it even works.

Why would the medical profession take such risks?

Certainly not for your daughter’s benefit!

Jean Stephenne, vaccines head at GlaxoSmithKline PLC, said he was particularly excited by experimental vaccines to prevent infection by the human papilloma virus (HPV) that causes cervical cancer.
Both Merck and GSK have HPV vaccines in development that will compete in a market that Stephenne estimated would eventually be worth some $3 billion pounds a year. His company takes a 24% share of the $6.5 billion a year global vaccine industry.
Most of this money is being fuelled by new combination jabs, such as the 5-in-1, and new jabs for adolesants and adults, such as flu shots and the new HPV vaccine. (Reuters, Ben Hirschler, European Pharmaceuticals Correspondent).
They stand to make a LOT of profit from your child, even if that shot carries risks, they are risks the drug companies don’t mind making.
The question is, do YOU?

Update To Article - 6th May 2008

The FDA's VAERS database now shows more than 1,637 adverse events associated with the vaccine since it was introduced to the US in June 2006. This figure is just for America and does not include UK adverse reactions. Of these, there were 371 serious adverse reactions and 3 deaths.
In one report, a girl died just three hours after getting a Gardasil vaccine when she developed a blood clot. Two other girls, aged 12 and 19 also died after vaccination when they developed blood clotting and heart problems.

Other serious reports included paralysis, Bell's Palsy, Guillain-Barre Syndrome and seizures. Of 42 pregnant women who were vaccinated, 18 of them developed complications, mainly miscarriages, and one gave birth to a deformed baby. Indeed, during the clinical trials of the vaccine, 5 women who got pregnant within 30 days of having the vaccine, gave birth to children with abnormalities.

In the UK there have also been two girls die within hours of having the jab, bringing into question its safety.

Editors Comment: What if a teenager or young woman has the vaccine and then gets pregnant? Surely this is a medical timebomb waiting to happen, just like with thalidomide?

Further Update - 13 June 2008

Gardasil is only licenced for use in females aged between 9 and 26 years old. Yet 14 of the VAERS reports were for children younger than 9 and there were 73 adverse event reports for those older than 26. These people should not have been given the vaccine!

Cervical Cancer Vaccine Given To Baby Boys!?!

According to VAERS ID number 273751, a three month old baby boy was vaccinated with Gardasil and had fever, rash and vomiting as a result.

There were 15 other VAERS reports for male patients.

Male Adults Also Given Cervical Cancer Vaccine

Here are some more cases:

VAERS ID 263231: 18 year old male experienced joint pain and fever after the shot.

VAERS ID 278506: 18 year old male experienced dizziness, nausea, vomiting and fatique after the shot.

VAERS ID 279599: 45 year old male got a rash over his entire body after the shot.

VAERS ID 271136: 53 year old male experienced nausea, dizziness and weakness which lasted in excess of six weeks after the shot.

Editor's Comment: Baby boys and men vaccinated for cervical cancer when they don't even have a cervix? It's hard to take the 'immunisation' programme seriously or to believe that these people are supposed to be an 'authority' on our health!

What Does The Inventor of HPV Vaccine Have To Say?

Professor Ian Frazer, inventor of the vaccine, had this advice to give to parents:

"Everybody has the right to say no, that is their right but they also have the right to get cervical cancer and they also have the right to die, it goes with the territory.'

Methinks he needs to see a therapist :) He's so dramatic and emotional. What ever happened to calm and rational argument?

Used As A Guinea Pig For Gardasil

She loved SpaghettiO's, pepperoni, lilies, listening to her iPod and making her pals laugh.

In her senior yearbook, she wrote, "The best things in life aren't things, they're friends."

Now that's the quote chiseled into her gravestone.

Jessica Ericzon, 17, was "an all-American teenager," as described by one of her upstate LaFargeville teachers.

Last February, she was working on her softball pitches, getting ready for a class trip to Universal Studios in Florida and hitting the slopes to snowboard with her older brother.

Then one day, the blond, blue-eyed honors student collapsed dead in her bathroom.

It started with a pain in the back of her head.

On the advice of her family doctor, Jessie had taken a series of three Gardasil shots.

The vaccine, marketed for females ages 9 to 26, is the first found to ward off strains of the sexually transmitted human papillomavirus, or HPV, which can cause cervical cancer.

Jessie got the first injection in July 2007.

After her second shot in September, she complained of a pain in the back of her head, fatigue and soreness in some joints, said her mom, Lisa.

On Feb. 20, while on winter break from school, she got her third and final dose of the vaccine.

The next night, "she told me the spot on the back of her head was bothering her again," her mom said.

The next morning, Feb. 22, Lisa, a hospital technician, left for work just after 5 a.m., leaving Jessie asleep.

Jessie never showed up for the class she was taking at Jefferson Community College.

When her mom got home at 3:20 p.m., she found Jessie sprawled on her back on the bathroom floor, with blood spots on her head where it had hit a flowerpot.

Jefferson County Medical Examiner Samuel Livingstone is stumped.

"She was essentially dead by the time she hit the floor. Whatever it was, it was instantaneous," Livingstone said. His autopsy found no cause.

He speculates she suffered a cardiac arrhythmia, or irregular heartbeat, extremely rare in young people.

Jessie had been on birth-control pills for a year to treat acne, records show.

Livingstone reported Jessie's death to the federal Vaccine Adverse Events Reporting System.

Run by the FDA and the Centers for Disease Control and Prevention, it has collected 8,000 reports of problems after Gardasil shots, including paralysis, seizures and miscarriages.

Seventeen other deaths following the vaccine have been reported since Merck & Co. introduced it in 2006.

Officials have confirmed 11 of the reported deaths so far, said CDC spokesman Curtis Allen.

They have found "no pattern or connection" to Gardasil in eight deaths and are still reviewing three, he said.

Lisa Ericzon now feels her daughter was "a guinea pig" for Gardasil, and is urging parents to research the vaccine before letting their daughters get it.

"I want other mothers to know," said Lisa, the first parent of a girl who died after Gardasil to speak publicly.

"I don't want them to go through what I went through."

Jessie planned to major in psychology at SUNY Plattsburgh and pursue her greatest ambition - to become a New York state trooper.

Just six days before she died, she got to ride along with a trooper canine unit. She was ecstatic.

Her family started the Jessica Ericzon Memorial Fund to award scholarships to her classmates.

By Susan Eldelman, The New York Post, 21 July 2008.

Cervarix Vaccine - The UK's Version of Gardasil

About Cervarix

More than 1 in 10 doses may cause pain, redness and swelling at the injection site, headache, aching muscles and muscle weakness, and tiredness.
More than 1 in 100 doses may cause nausea, vomiting, diarrhoea, abdominal pain, itching, red skin rash, hives, joint pain and high fever.
More than 1 in 1000 doses may cause upper respiratory tract infection, dizziness, a hard lump at the injection site, tingling or numbness.
If the side-effects get serious or you have an affect not mentioned in this leaflet, tell your doctor.
According to a GlaxoSmithKline UK electronic medicines compendium document dated 24 September 2007, subjects in the trial of this product were only monitored for side-effects for 30 days and any occuring after this time were not included in the study.
This vaccine has not been studied to see if it is safe to have during or immediately before pregnancy. It is not known whether the vaccine is excreted in human milk and there have been no studies on its interaction with other drugs (they don't know whether it is safe to have alongside other medicines).

Cervarix is for use against two types of Human Papillomavirus, thought to cause 70% of sexually transmitted cervical cancers. It will NOT protect you against all types of HPV. Duration of 'protection' after vaccination is unknown, but thought to be 5.5 years. So if a 12 year old is vaccinated, it may have worn off by the time she's 17. The need for booster doses has not been studied.

Ingredients:
Two types of HPV Virus (16 and 18)
AS04 (aluminium salts and monophosphoryl liquid to make you produce antibodies)
Sodium Chloride
sodium dihydrogen phosphate dihydrate
Virus like particles from the Trichoplusia ni insect (the cabbage looper)
Water

People who should not have Cervarix vaccine:
Those who are allergic to the ingredients of the vaccine (allergic reactions include those listed in the side-effects and swelling of the face, difficulty breathing etc.)
Those with a severe infection or high temperature
Special care should be taken if you have a bleeding disorder or any kind of immunosuppression such as HIV or cancer.
If you are taking other medications, the safety of this vaccine has not been evaluated.
If you are sexually active, the safety of this vaccine is not known in unborn babies. If a girl or young woman gets pregnant during a course of injections, these should be stopped.

The cabbage looper, from which they have taken 'virus like particles' for use in the Cervarix vaccine

Dr. Diane Harper Says Cervarix Is An Experiment As Scottish Ministers Refuse To Allow The Vaccine

Mass vaccination with Cervarix vaccine has been delayed in Scotland.

Dr. Diane Harper, director of the Gynaecological Cancer Research Group at Dartmouth Medical Center in the US, who in fact was paid by GlaxoSmithKline, the manufacturer's of the shot, to conduct safety trials, says there's no proof the vaccine is safe and that safety trials of the Cervarix vaccine should have been conducted for at least four more years before the decision was taken to give the jabs to thousands of girls in schools.

Harper believes the safety tests for side effects should have been conducted for at least a decade and doses given to millions of individuals around the world before any mass vaccination began. She described the cervical cancer vaccination scheme in Scotland as an "experiment".

"We can't tell you it's 100% safe because we don't know that. I think we would have been better waiting.'

Source: News.Scotsman.com, 2nd November 2008.

VAN UK's Comment: In an electronic medicines compendium document that we read, dated 24 September 2007, it stated that safety monitoring for Cervarix was only conducted for 30 days, not months or years. This document has now been updated to 2nd September 2008 and now says that girls were followed for side-effects for the duration of the study, but several thousand of these individuals were not followed for more than 30 days:

'In a pre-defined subset of subjects (Cervarix = 8,130 versus control = 5,786), adverse events were followed for 30 days after each injection.'

See:

http://emc.medicines.org.uk/ and type in Cervarix to find both this document and GlaxoSmithKline's data sheet.

Gardasil Has Caused 78 cases of Genital Warts Including 3 in School Children

Earlier this year the Watchdog Judicial Watch reported that from information they obtained from the FDA under the freedom of information act - there have been 9749 adverse reactions to Gardasil vaccine and 21 deaths.

Also reported were 27 life threatening cases and 10 miscarriages. There have also been 78 cases of genital warts including 3 cases in primary aged children.

In Fiji, Ragogo writes, “Effectively, Cabinet approved a vaccine which is still being tested so no one can be sure of its effectiveness or long-term side effects. Our children are guinea pigs for a money-making, I mean, drug-making, machine.”

In a television interview with CBS News in May, Dr. Diane Harper, the specialist who helped develop the Gardasil vaccine, said making the vaccination mandatory is “a real danger zone.”

“The vaccine has not been out long enough for us to have post-marketing surveillance to really understand what all of the potential side effects are going to be,” Harper said. “To put in place a process that says you must have this vaccine means that you must be part of a big public experiment and so we can't do that. We can't have that until we have more data.”

Source: LifeSiteNews.com 18 November 2008.

Editor's Comment: This article makes me feel truly sick. The idea that little primary aged children are getting genital warts when they are years off ever having sex just makes me ill.

It is a very good reason not to give children vaccines for sexually transmitted diseases

MHRA Government Reports Of Adverse Reactions After Cervarix Vaccine

This information comes from the Medicines and Healthcare Products Regulatory Agency of the UK Government.


Suspected Adverse Reaction Analysis
CERVARIX Human papillomavirus (HPV) vaccine
04 December 2008
This report summarises the adverse reactions suspected to have been caused by Cervarix human
papillomavirus (HPV) vaccine in the UK. This includes reports received between 14 April 2008 and 3rd
December 2008. These reports have been voluntarily submitted to the MHRA by healthcare
professionals and members of the public via the Yellow Card Scheme (visit www.yellowcard.gov.uk)
and by the manufacturers of the vaccine as part of their legal requirements
It is essential to bear in mind that reports to the MHRA relate only to adverse medical events which the
reporter considered could have been caused by the vaccine (i.e. if there was merely a suspicion of
causality). Therefore, cases may be true side-effects or they may have been purely coincidental events
due to underlying or undiagnosed illness that would have occurred anyway in the absence of
vaccination. Events may also have been psychogenic1 in origin. This report therefore cannot be
considered to represent a list of known side-effects of the vaccine. These data also cannot be used to
determine the frequency, or incidence, of known side-effects because they are often under-reported.
The known side-effects, and their frequencies (based on clinical trial data), are available in the product
information (see http://emc.medicines.org.uk/).
The reactions in this report have been broken down into 5 categories based on scientific assessment of
the cases by MHRA assessors: injection-site reactions; allergic reactions; ‘psychogenic’ events; other
recognised reactions; and ‘suspected adverse reactions not currently recognised’ (reactions in this latter
category are divided into the high-level classification of System Organ Class)2.
A single report may contain more than one reaction, more than one sign or symptom of a single
reaction or reactions in more than one of the above categories. Therefore the total number of listed
reactions is greater than the total number of reports and total reports in each of the 5 tables should not
be added together.
Headline summary:
To date, the vast majority of suspected adverse reactions reported to MHRA in association with
Cervarix vaccine have related either to the signs and symptoms of recognised side effects listed
in the product information or were due to the injection process and not the vaccine itself (i.e.
‘psychogenic’ in nature).
For the isolated cases of other medical conditions reported, the available evidence does not
suggest that the vaccine caused the condition and these may have been coincidental events.
The balance of risks and benefits of Cervarix remains positive.
1 For this analysis, defined as non-allergic events which occurred within minutes of, or soon after, vaccination and were
most likely a psychogenic response to, or anticipation of, the injection. These are not side effects to the vaccine as such
and can occur with any needle injection procedure.
2 Using MedDRA terminology
2
SUMMARY OF UK SAFETY EXPERIENCE
Total number of reports received: 623
Total number of suspected reactions: 1416
Estimated number of doses administered to date: unavailable at present
Overall adverse reaction reporting rate: unavailable at present
A. Injection-site reactions
Injection-site reactions including redness, pain and swelling are recognised side-effects of Cervarix
vaccine and are listed in the product information. These may occur at a frequency3 of more than 1 in 10
persons vaccinated. The reported cases of ‘Pain in extremity’ mainly relate to a sore arm.
The cases reported to the MHRA during use of the vaccine in the UK do not indicate any change in the
severity or nature of injection-site reactions.
Reported event (Preferred Term2) Number of cases
Pain in extremity 36
Injection site erythema 15
Limb discomfort 13
Injection site pain 10
Injection site swelling 10
Oedema peripheral 8
Erythema 5
Injection site reaction 5
Hypoaesthesia 4
Skin discolouration 4
Injection site rash 3
Local swelling 3
Pain 3
Rash macular 3
Feeling hot 2
Injection site mass 2
Injection site pruritus 2
Musculoskeletal stiffness 2
Paraesthesia 2
Injection site induration 1
Injection site inflammation 1
Injection site joint pain 1
Injection site papule 1
Injection site vesicles 1
Injection site warmth 1
Limb immobilisation 1
Local reaction 1
Pruritus 1
Total reactions 141
Total reports 106
3 Based on clinical trial data
3
B. Allergic reactions (including skin reactions not directly related to an injection-site
reaction)
Allergic reactions are recognised side-effect of Cervarix vaccine and are listed in the product
information. These may occur at a frequency4 between 1 in 10 persons (for non-serious types of allergic
reaction such as rash and itching) to less than 1 in 10,000 persons vaccinated. Severe allergic
reactions are very rare.
The cases reported to the MHRA during use of the vaccine in the UK do not indicate any change in the
severity or nature of allergic reactions.
Reported event (Preferred Term2) Number of cases
Rash 23
Pruritus 11
Urticaria 11
Swelling face 9
Lip swelling 7
Oedema peripheral 7
Rash pruritic 7
Eye swelling 6
Erythema 5
Dyspnoea 4
Hypersensitivity 4
Paraesthesia 4
Rash generalised 4
Anaphylactic reaction 3
Paraesthesia oral 3
Throat tightness 3
Eye pruritus 2
Ocular hyperaemia 2
Pharyngeal oedema 2
Pruritus generalised 2
Angioedema 1
Blister 1
Chest discomfort 1
Dizziness 1
Dysphagia 1
Eyelid oedema 1
Flushing 1
Gingival swelling 1
Hypoaesthesia 1
Limb discomfort 1
Malaise 1
Musculoskeletal stiffness 1
Neck pain 1
Pain of skin 1
Pallor 1
Peripheral coldness 1
Purpura 1
Rash erythematous 1
Rash macular 1
Skin inflammation 1
4
Sneezing 1
Swelling 1
Swollen tongue 1
Type I hypersensitivity 1
Wheezing 1
Total reactions 144
Total reports 86
C. ‘Psychogenic’ events
Psychogenic events including vasovagal syncope, faints and panic attacks can occur with any injection
procedure, not just vaccination, and can be common in adolescents. These are due to fear and/or
anticipation of the needle injection and are not side-effects of Cervarix vaccine as such. Such events
can be associated with a wide range of temporary signs and symptoms including loss of consciousness,
vision disturbance, injury, limb jerking (often misinterpreted as a seizure/convulsion), limb numbness or
tingling, difficulty in breathing, hyperventilation etc.
The events in the list below were considered ‘psychogenic’ in nature based on MHRA assessment of
the individual case details reported. The reported cases which do not refer specifically to vasovagal
syncope, faint or panic attack (e.g. convulsion, transient blindness which refers to temporary loss of
vision at the start of a faint) were concurrently reported as signs or symptom of the psychogenic event;
i.e. these also were not side-effects of the vaccine itself.
Reported event (Preferred Term2) Number of cases
Syncope 88
Dizziness 71
Headache 43
Nausea 38
Pallor 21
Flushing 19
Malaise 16
Cold sweat 13
Tremor 13
Syncope vasovagal 9
Vomiting 9
Feeling hot 8
Paraesthesia 8
Rash 7
Vision blurred 7
Hyperhidrosis 6
Hypoaesthesia 6
Loss of consciousness 6
Somnolence 6
Unresponsive to stimuli 6
Chills 5
Abdominal pain upper 4
Dyskinesia 4
Feeling cold 4
Feeling of body temperature change 4
Visual impairment 4
5
Abdominal pain 3
Blindness transient 3
Convulsion 3
Dyspnoea 3
Eye rolling 3
Fatigue 3
Heart rate increased 3
Muscle twitching 3
Muscular weakness 3
Nasopharyngitis 3
Tearfulness 3
Asthenia 2
Chest discomfort 2
Confusional state 2
Dysgeusia 2
Erythema 2
Feeling abnormal 2
Hyperventilation 2
Muscle rigidity 2
Myalgia 2
Nervousness 2
Peripheral coldness 2
Pulse abnormal 2
Rash macular 2
Stomach discomfort 2
Tinnitus 2
Abasia 1
Altered state of consciousness 1
Anxiety 1
Blindness 1
Body temperature increased 1
Bruxism 1
Burning sensation 1
Chest pain 1
Colour blindness 1
Cyanosis 1
Deafness 1
Deafness transitory 1
Discomfort 1
Disorientation 1
Dizziness postural 1
Dry mouth 1
Dry throat 1
Dysphagia 1
Dysstasia 1
Ear pain 1
Eye swelling 1
Eyelid oedema 1
Facial spasm 1
Fall 1
Feeling of despair 1
Grand mal convulsion 1
Heart rate irregular 1
6
Hot flush 1
Hypersomnia 1
Lethargy 1
Lip swelling 1
Musculoskeletal stiffness 1
Mydriasis 1
Neck pain 1
Oropharyngeal pain 1
Pain 1
Panic reaction 1
Photophobia 1
Pruritus 1
Pyrexia 1
Rash generalised 1
Respiratory arrest 1
Respiratory rate decreased 1
Respiratory rate increased 1
Salivary hypersecretion 1
Seizure anoxic 1
Sensory loss 1
Shock 1
Swelling face 1
Tachycardia 1
Throat irritation 1
Throat tightness 1
Total reactions 540
Total reports 205
D. ‘Other recognised’ reactions
This section includes other events recognised to be side-effects of Cervarix vaccine and not already
included in sections A and B above. This also includes signs and symptoms of recognised side effects.
The frequencies, where known, are listed in the product information.
The cases reported to the MHRA during use of the vaccine in the UK so far do not indicate any change
in the severity or nature of these reactions.
Reported event (Preferred Term2) Number of cases
Headache 102
Nausea 90
Dizziness 88
Vomiting 35
Abdominal pain upper 18
Fatigue 18
Malaise 18
Pyrexia 12
Abdominal pain 10
Myalgia 7
Chills 5
Feeling hot 5
7
Stomach discomfort 5
Arthralgia 4
Diarrhoea 4
Paraesthesia 4
Body temperature increased 3
Oropharyngeal pain 3
Pain 3
Pain in extremity 3
Back pain 2
Feeling of body temperature change 2
Influenza like illness 2
Musculoskeletal stiffness 2
Neck pain 2
Pallor 2
Pruritus 2
Thirst 2
Asthenia 1
Induration 1
Lethargy 1
Listless 1
Local swelling 1
Lower respiratory tract infection 1
Migraine 1
Musculoskeletal chest pain 1
Nasal congestion 1
Pharyngitis 1
Pruritus generalised 1
Rash 1
Respiratory disorder 1
Skin warm 1
Somnolence 1
Tremor 1
Upper respiratory tract infection 1
Urticaria 1
Wheezing 1
Total reactions 472
Total reports 252
8
E. Suspected adverse reactions not currently recognised
This section includes reports which, based on MHRA assessment of the case details provided, do not fit
into one of the above 4 categories.
These suspected ADRs are not currently recognised as side effects of Cervarix vaccine and the
available evidence does not suggest a causal link with the vaccine. These are isolated medical events
which may have been coincidental with vaccination. These reports are continually assessed by the
MHRA.
System Organ Class Reported event (Preferred Term2) Number of cases
Blood and lymphatic
system disorders Lymphadenopathy 4
Cardiac disorders Palpitations 1
Ear and labyrinth
disorders Ear pain 3
Eye disorders Eye swelling 1
Photophobia 1
Vision blurred 3
Gastrointestinal disorders Abnormal faeces 1
Mouth ulceration 1
Nausea 2
Vomiting 3
General disorders and
administration site
conditions
Abasia 1
Chills 1
Fatigue 1
Feeling cold 1
Influenza like illness 5
Local swelling 1
Malaise 3
Oedema peripheral 2
Pain 1
Peripheral coldness 2
Swelling 1
Infections and
infestations Application site pustules 1
Folliculitis 1
Nasopharyngitis 1
Pneumonia viral 1
Injury, poisoning and
procedural complications Contusion 3
Drug exposure during pregnancy 1
Investigations Blood glucose increased 2
Blood pressure increased 1
Respiratory rate increased 1
Weight decreased 1
Metabolism and nutrition
disorders Anorexia 1
Dehydration 1
Diabetes mellitus inadequate
control 1
9
Diabetic ketoacidosis 1
Hypoglycaemia 1
Musculoskeletal and
connective tissue
disorders
Muscular weakness 2
Musculoskeletal stiffness 1
Myalgia 1
Pain in extremity 5
Nervous system
disorders Complex regional pain syndrome 1
Convulsion 2
Dizziness 2
Facial palsy 1
Grand mal convulsion 1
Hemiparesis 1
Hypoaesthesia 2
Lethargy 1
Migraine 1
Paraesthesia 2
Somnolence 5
Status epilepticus 1
Syncope 2
Tremor 1
Unresponsive to stimuli 1
Pregnancy, puerperium
and perinatal conditions Abortion spontaneous 1
Psychiatric disorders Confusional state 1
Insomnia 1
Sleep disorder 2
Reproductive system and
breast disorders Amenorrhoea 1
Respiratory, thoracic and
mediastinal disorders Asthma 1
Dyspnoea 2
Epistaxis 2
Haemoptysis 1
Hypoventilation 1
Nasal congestion 1
Oropharyngeal pain 3
Wheezing 1
Skin and subcutaneous
tissue disorders Eczema 2
Erythema 1
Guttate psoriasis 1
Rash 2
Rash vesicular 1
Skin discolouration 2
Vascular disorders Flushing 1
Pallor 1
Total reactions 119
Total reports 71
10
In relation to safety in pregnancy, during pre-licensing studies of Cervarix it was found that almost
870 women became pregnant before or after receiving the vaccine. The overall rates of
spontaneous abortion in these clinical trials were no greater than the background rates in the
general population (i.e. regardless of vaccination). There is currently no evidence to suggest that
Cervarix vaccine carries any risks during pregnancy. Nonetheless, Cervarix is not recommended
for use in pregnancy.

www.mhra.gov.uk