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SAFE: officially listed side-effects for the 4 vaccine products routinely given to British infants at 8 weeks of age

CautionInformed consent is every patient's right:

Infanrix hexa https://www.medicines.org.uk/emc/files/pil.2586.pdf

Allergic reactions

If your child has an allergic reaction, see your doctor straight away. The signs may include:

  • rashes that may be itchy or blistering
  • swelling of the eyes and face
  • difficulty in breathing or swallowing
  • a sudden drop in blood pressure and loss of consciousness.

These signs usually start very soon after the injection has been given. Talk to a doctor straight away if they happen after leaving the doctor’s surgery.

See your doctor straight away if your child has any of the following serious side effects:

  • collapse
  • times when they lose consciousness or have a lack of awareness
  • fits – this may be when they have a fever

These side effects have happened very rarely with Infanrix hexa as with other vaccines against whooping cough. They usually happen within 2 to 3 days after vaccination.

Other side effects include:

Very common (these may occur with more than 1 in 10 doses of the vaccine): feeling tired, loss of appetite, high temperature of 38°C or higher, swelling, pain, redness where the injection site was given, unusual crying, feeling irritable or restless.

Common (these may occur with up to 1 in 10 doses of the vaccine): diarrhoea, being sick (vomiting), high temperature of more than 39.5°C, swelling larger than 5 cm or hard lump where the injection was given, feeling nervous.

Uncommon (these may occur with up to 1 in 100 doses of the vaccine): upper respiratory tract infection, feeling sleepy, cough, large swelling at the injected limb.

Rare (these may occur with up to 1 in 1,000 doses of the vaccine): bronchitis, rash, swollen glands in the neck, armpit or groin (lymphadenopathy), bleeding or bruising more easily than normal

(thrombocytopenia), in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination, temporarily stopping breathing

(apnoea), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema), swelling of the whole injected limb, blisters.

Very rare (these may happen with up to 1 in 10,000 doses of the vaccine): itching (dermatitis).

Experience with hepatitis B vaccine

In extremely rare cases the following side effects have been reported with hepatitis B vaccine: paralysis, numbness or weakness of the arms and legs (neuropathy), inflammation of some nerves, possibly with pins and needles or loss of feeling or normal movement (Guillain-Barré syndrome), swelling or infection of the brain (encephalopathy, encephalitis), infection around the brain (meningitis).

The causal relationship to the vaccine has not been established.

Bleeding or  bruising more easily than normal (thrombocytopenia) has been reported with hepatitis B

vaccines.

Rotarix https://www.medicines.org.uk/emc/files/pil.201.pdf

¨ Common (These may occur with up to 1 in 10 doses of the vaccine):

  • diarrhoea
  • irritability

¨ Uncommon (These may occur with up to 1 in 100 doses of the vaccine):

  • abdominal pain (see also below for signs of very rare side effects of intussusception)
  • flatulence
  • inflammation of the skin

Side effects that have been reported during marketed use of Rotarix include:

  • Very rare: hives (urticaria)
  • Very rare: intussusception (part of the intestine gets blocked or twisted). The signs may

include severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high

fever. Contact a doctor/health care professional right away if your child experiences one of these symptoms.

  • blood in stools
  • in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal

between breaths may occur for 2-3 days after vaccination.

  • children with a rare inherited illness called Severe Combined Immunodeficiency (SCID) may have an inflamed stomach or gut (gastroenteritis) and pass the vaccine virus in their stools. The signs of gastroenteritis may include feeling sick, being sick, stomach cramps or

diarrhoea

Prevnar 13 https://www.medicines.org.uk/emc/files/pil.453.pdf

(6 weeks to 5 years of age):

The most common side effects (these may occur with more than 1 in 10 doses of the vaccine) are:

  • Decreased appetite
  • Fever; irritability; pain, tenderness, redness, swelling or hardness at the vaccination-site; drowsiness; restless sleep
  • Redness, hardness, swelling at the vaccination-site of 2.5 cm -7.0 cm (after the booster dose and in older children [aged 2 to 5 years])

Common side effects (these may occur with up to 1 in 10 doses of the vaccine) are:

  • Vomiting; diarrhoea
  • Fever of more than 39°C; tenderness at the vaccination-site interfering with movement, redness,

hardness, swelling at the vaccination-site of 2.5 cm -7.0 cm (after the initial course of injections)

  • Rash

Uncommon side effects (these may occur with up to 1 in 100 doses of the vaccine) are:

  • Seizures (or fits), including those caused by a high temperature
  • Hives (urticaria or urticaria-like rash)
  • Redness, swelling, or hardness at the vaccination-site of more than 7 cm; crying

Rare side effects (these may occur with up to 1 in 1,000 doses of the vaccine) are:

  • Collapse or shock-like state (hypotonic-hyporesponsive episode)
  • Allergic (hypersensitivity) reaction, including swelling of the face and/or lips, difficulty in breathing

The following side effects include those reported for Prevenar 13 in children and adolescents (6 to 17 years of age):

The most common side effects (these may occur with more than 1 in 10 doses of the vaccine) are:

  • Decreased appetite
  • Irritability; pain, tenderness, redness, swelling or hardness at the vaccination-site; drowsiness; restless sleep; tenderness at the vaccination-site interfering with movement

Common side effects (these may occur with up to 1 in 10 doses of the vaccine) are:

  • Headaches
  • Vomiting; diarrhoea
  • Rash; hives (urticaria or urticaria-like rash)
  • Fever

Children and adolescents with either HIV infection, sickle cell disease or a blood-forming stem cell transplant had similar side effects however the frequencies of headaches, vomiting, diarrhoea, fever, fatigue, joint and muscle pain were very common.

The following additional side effects have been seen with Prevenar 13 in infants and children up to 5 years of age in postmarketing experience

  • Severe allergic reaction including shock (cardiovascular collapse); angioedema (swelling of lips, face or throat)
  • Hives (urticaria), redness and irritation (dermatitis) and itching (pruritus) at the vaccination-site; flushing
  • Enlarged lymph nodes or glands (lymphadenopathy) near the vaccination-site, such as under the arm or in the groin
  • A rash causing itchy red blotches (erythema multiforme)

Page 5 of 7

In babies born very prematurely (at or before 28 weeks of gestation), longer gaps than normal between breaths may occur for 2-3 days after vaccination.

The following side effects include those reported for Prevenar 13 in adults:

The most common side effects (these may occur with more than 1 in 10 doses of the vaccine) are:

  • Decreased appetite; headaches; diarrhoea; vomiting (for those 18 to 49 years of age)
  • Chills; tiredness; rash; pain, redness, swelling hardness or tenderness at the vaccination-site, interfering with arm movement (severe pain or tenderness at vaccination-site for those 18-39 years of age and severe limitation of arm movements for those 18 to 39 years of age)
  • Worsening or new pain in your joints, worsening or new pain in your muscles
  • Fever (for those 18 to 29 years of age)

Common side effects (these may occur with up to 1 in 10 doses of the vaccine) are:

  • Vomiting (for those 50 years and older); fever (for those 30 years and older)

Uncommon side effects (these may occur with up to 1 in 100 doses of the vaccine) are:

  • Nausea
  • Allergic (hypersensitivity) reaction, including swelling of the face and/or lips, difficulty in

breathing

  • Enlarged lymph nodes or glands (lymphadenopathy) near the vaccination-site, such as under the arm

Adults with HIV infection had similar side effects however the frequencies were very common for fever, vomiting and common for nausea.

Adults with a blood-forming stem cell transplant had similar side effects however the frequencies were very common for fever and vomiting.

Bexsero  https://www.medicines.org.uk/emc/files/pil.5168.pdf

Infants and children (up to 10 years of age)

Very common (these may affect more than 1 in 10 people)

- fever (≥38ºC)

- loss of appetite

- tenderness at the injection site (including severe injection site tenderness resulting in crying when injected limb is moved)

- painful joints

- skin rash (children aged 12 to 23 months) (uncommon after booster)

- sleepiness

- feeling irritable

- unusual crying

- vomiting (uncommon after booster)

- diarrhoea

- headache

Common (these may affect up to 1 in 10 people)

- skin rash (infants and children 2 to 10 years of age)

Uncommon (these may affect up to 1 in 100 people)

- high fever (≥40°C)

- seizures (including febrile seizures)

- dry skin

- paleness (rare after booster)

Rare (these may affect up to 1 in 1,000 people)

- Kawasaki disease which may include symptoms such as fever that lasts for more than five days, associated with a skin rash on the trunk of the body, and sometimes followed by a peeling of the skin on the hands and fingers, swollen glands in the neck, red eyes, lips, throat and tongue

- Itchy rash, skin rash

Adolescents (from 11 years of age) and adults

Very common (these may affect more than 1 in 10 people)

- pain at the injection site resulting in inability to perform normal daily activity

- painful muscles and joints

- nausea

- generally feeling unwell

- headache

Side effects that have been reported during marketed use include:

Allergic reactions that may include severe swelling of the lips, mouth, throat (which may cause

difficulty in swallowing), difficulty breathing with wheezing or coughing, rash, loss of consciousness and very low blood pressure.

Collapse (sudden onset of muscle floppiness), less responsive than usual or lack of awareness, and paleness or bluish skin discoloration in young children.

Feeling faint or fainting.

Fever (adolescents from 11 years of age and adults).

Injection site reactions like extensive swelling of the vaccinated limb, blisters at or around the injection site and hard lump at the injection site (which may persist for more than one month).

Neck stiffness or uncomfortable sensitivity to light (photophobia), indicating meningeal irritation, has been sporadically reported shortly after vaccination; these symptoms have been of mild and transient nature. 

 

Comments

Linda1

One in a hundred is "uncommon"?

One in a thousand is "rare"?

Remember when one in a million was "rare"?

Hera

Hi Frederic,
It would appear that in first world countries, the data supports the exact opposite. We know that some children have and continue to die following the MMR vaccine ( by the way, the CDC addresses this and says that death of a sibling from a vaccine is not a medical reason to get a vaccine exemption) .
We know that breathing difficulties, following vaccination is a known side effect for premature babies,
Quote "in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal
between breaths may occur for 2-3 days after vaccination."
We know that SIDS is death from breathing cessation in babies.

According to the timing of SIDS data,in first world countries, SIDS deaths peak at 2 to 4 months.
https://www.stanfordchildrens.org/en/topic/default?id=sudden-infant-death-syndrome-sids-90-P02412
Quote from the article
"It happens most often between 2 and 4 months old. SIDS and other types of sleep-related infant deaths have similar risk factors."

So at two months, just after they are given a medical product known to produce breathing cessation problems, baby deaths from breath cessation ( SIDS ) start to peak.
I wondered if those with asthma,bronchitis, lung disorders, colds etc are also more risk for dying in this fashion, and decided to have a quick look at whether the data supported this.
Apparently, ( from the same site) they have no clue why babies are suddenly stopping breathing, but
again a quote from the site
"Some babies who die from SIDS have respiratory infections before death. SIDS happens more often during the colder months, when respiratory illnesses are more common."
Given that no one is actively tracking reliable data on vaccine injury, and that the CDC is apparently "too busy" to actually investigate cases of vaccine injury( they just like to "follow trends" ) and it appears the U.K is just as uninterested, the available data on this and other vaccines, seems to suggest that death or maiming from vaccines in first world countries is a much higher risk, than death or maiming from disease.

The law of unintended consequences...

Aimee Doyle

@Bob -

I think that the $8 billion jury award of punitive damages in Nicholas Murray's case reflects the growing anger against big Pharma. However, it's extremely unlikely those damages will actually be awarded. It's highly likely that amount will be reduced by the court because it will be seen as "unreasonably high." And Johnson and Johnson will definitely appeal.

Interesting that the punitive damage phase of the trial was conducted separately from the original personal injury trial, with a different jury. Murray's case actually began in 2013. In 2015, a Philadelphia jury awarded Murray $1.75 million in compensatory damages, but this amount was later reduced to $680,000.

Bob Moffit

There's "known risks" of vaccines .. and .. there's "known risks" of pharma drugs prescribed as "treatment" of those known risks of vaccines. Consider the following article:

https://www.cnbc.com/2019/10/08/jj-must-pay-8-billion-in-case-over-male-breast-growth-linked-to-risperdal.html

This article reports that JOHNSON & JOHNSON was fined 8 BILLION DOLLARS in "punative damages" to a young man prescribed Risperdal at the age of 9 on the Autism Spectrum that eventually grew female breasts which are untreatable. Apparently J&J had warned of this potential risk.

It is getting tiresome reading multi-million dollar compensation awards to victims of pharmaceutical drugs …. OPIOIDS, ZANTAC, VIOXX, ON AND ON .. I think it safe to say these pharmaceutical drug companies would no longer exist as financial behemoths if they were not provided PRODUCT LIABILITY PROTECTION ON THEIR MOST LUCRATIVE .. DANGEROUS .. VACCINES.

As I have said before .. isn't it great to be a vaccine manufacturer in the good old USA? Not so much to be a victim of them.

David L

The 6-in-1 Infanrix Hexa and other combination vaccines (5 in 1, 6 in 1 etc) as well as multiple vaccines given at the same visit increase the likelihood of hospitalization or death for an adverse reaction. I have put together research on this topic in one paper here https://tgl.ink/pVkAyF
There have also been concerns over the Infanrix Hexa chemical analysis findings. https://www.ageofautism.com/2018/12/corvelva-vaccinegate-gsks-infanrix-hexa-exposed.html

Morag

Ach well John,you can only do the best you can with them and for them !
Suppot advice and guidance has it's limitations and boundaries!
See Book Memories of Glasgow By True North Books Ltd 1999 ISBN I 900463687
Page 21 In sickness and in health
Glasgow's campaign to eradicate the scorge of tuberculosis from the city in 1957 .
At the end of the campaign Dr William A Horn the Chief Medical Officer of Health said that the end of TB was in sight . Oh What ! Is that type of wishful thinking still living in cloud cookoo land?
Any vaccine mandates appearing will be getting well and truly safely "Planked" using the universally agreed totally proven "Safe and Effective " no language barriers evident either .
"Laughter suppositories protocols, universally accepted, no violence physical verbal or other required or acceptable or necessary !

The Plank 1967 Youtube
Ballad of Buster Scruggs - saloon scene youtube
Laughter is the best treatment plan for the silly wee sausages . Laughter is the best medicine for their utterly failed and fractured risk assessments ! They have no place left to hide from laughter !

John Stone

Morag

The trouble with Dame Sally is that she can’t stand people - they are dirty messy things which need to be controlled. Her other parting shot as Chief Medical Officer is to call for the ban of eating and drinking on public transport. Perhaps we live in a world now mad enough to listen to her, but I don’t know.

Hector Berlioz

Fred

You have just demonstrated the modern doctor’s inability to read small print when it comes to medications!

Morag

England might well end up with mandatory vaccines -Dame Sally Davis .
Her comments come after some health experts condemned Health Secretary Matt Hancock for saying he is considering mandatory vaccination .
https/www.thenorthernecho.co.uk>news>national>17959765.

That's enough to cause a commotion ,a rumpus and a riot in an empty parliamentarians ,Houses of Commons and Houses of Lords, empty canteens !

"If you think it's expensive to hire a professional to do the job ,wait until you hire an amateur"
Red Adair

Frederic Chopin

The risks from the diseases these vaccines prevent are greater and more common though. So there's that

Pete

Infanrix hexa is so horrible, it's not surprising that many people will conclude it's actually a bioweapon.

They even semi-admit about SIDS on the package insert "if your baby was born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination. These babies may require respiratory monitoring for 48-72h following the administration of the first two or three doses of Infanrix hexa."

Bob Moffit

Opening sentence: "Informed consent is every patient's right"

No longer true in good old USA .. "informed consent" no longer required for vaccinations.

All one has to do is read the extensive list of known adverse reactions to vaccines .. yes .. ALL vaccines .. and it would require patient's INFORMED CONSENT TO BE DENIED.

Who in their right mind would vaccinate their perfectly healthy child after reading that extensive list of KNOWN RISKS ASSOCIATED WITH VACCINES??????

Just about every product in the country comes with a "warning" on what not to do .. do not play with electric shaver in bathtub .. do not swallow colorful capsules of TIDE laundry product .. do not drink or otherwise inhale fumes of glue .. on and on .. yet .. parents are REQUIRED TO IGNORE the warnings on vaccines because ……?????

Is this a great country to be vaccine manufacturer or what?

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