Vaccine Safety Package Inserts - Ever Seen One?
By Cathy Jameson
Vaccine exemptions exist to protect an individual's health care needs. In response to the growing number of states working to revoke exemptions and to restrict our personal rights, we thought we'd share this post today. This post doesn't include everything there is to know about vaccines, but it is a simple reminder. It's a reminder that vaccines come with side effects and that they can result in injury and death. For those who wish to avoid injury and death, who cannot be vaccinated, or who choose to not be vaccinated, have been able to successfully opt out of vaccines with one of three exemptions. Please remind the politicians that these exemptions were created for a reason.
I wrote the post below in 2013, but it's certainly relevent today:
For the last few weeks most of my posts here have been about vaccines and vaccine safety. Some of you may be missing my usual hopefully-ever-after writing, but vaccines have been bugging me lately. When that happens, I don’t feel very hopeful or very happy.
No matter what I’m reading–a magazine, a mainstream newspaper, or a blog, I can’t escape mention of vaccines these days. Sure, I subscribe to a few places that typically highlight only vaccine news, but I’m reading about them in other places, and the news isn’t looking good.
I can’t shake the disappointment I feel after seeing these stories. Most of what I’ve read lauds vaccines claiming that they are safe despite their side effects, and that they’ll work if we give them a chance, and what’s the big deal, anyway? Oh, when they don’t work? Well, we’re sorry, let’s move on. I know I speak for many when I say that that kind of news reporting is depressing and unacceptable.
Can you imagine if vaccine news stories across the mainstream channels would actually reveal all there is to know about the vaccine--including the bad stuff? I’m talking about the side effects, the lingering pain and the secondary illnesses that turn into everyday struggles after receiving a vaccination. That information should be discussed more openly in the exam room and in the news but hardly seems to be. I know this because I’ve been there in that exam room before and never got that sort of information. People I speak to today about their vaccine encounters say the same thing. When I hear from them, as they reach out to me for help, it’s clear that the right things are still not being said: “When do I worry about this rash? The doctor didn’t tell me anything!” “What? I never knew you can still get the chickenpox after getting the chickenpox vaccine!” “What should I do about this fever? It’s so high, and it won’t go down!”
Side effects aren’t being mentioned in the articles I’ve viewed lately, and the moms I run into are still unaware of them, so it’s time to expose them for what they are. Side effects are dangerous. Side effects happen. They can, and will, a last long after a vaccine is administered.
Now, some people may be aware of side effects if they’ve done any kind of basic research. The CDC tells us that side effects can be mild, moderate or severe. Basic information might also come from a medical provider who takes the time to have a conversation about them. Information may also come from the VIS (Vaccine Information Sheet). This handout, usually a two-sided piece of paper, is required by law to be given to someone receiving certain vaccines.
Basic is good, but getting as much information as possible is better.
With as many things that can go wrong with vaccines, you’d think reading each of the package inserts would be required reading. Maybe then people would understand more about them like who it’s been tested on (or not tested on), how long it was studied, what it’s made of and what it’s been known to do to the body. But, since that document isn’t the one that is usually shared with patients, here’s a quick recap of the side effects that can happen post vaccination (note: this is not a complete list):
Swelling at injection site
Rash
Fatigue
Headache
Nausea
Chills
Sudden Infant Death Syndrome
Fever
Seizures
Autism
Guillaine-Barre Syndrome
Brain swelling
Shock
Anaphylaxis
Cardiac arrest
Ataxia
Drowsiness
Insomnia
Narcolepsy
Myalgia
Arthralgia
Urticarial
Edema
Upper respiratory tract infection
Diarrhea
Paralysis
Infertility
Death
Besides having to disclose that side effects happen, I wonder, though, if in listing them that those promoting vaccines believe that side effects could be viewed as a good thing. Side effects mean that the body is reacting. It shows that the body recognizes that something’s been injected or inhaled. The body’s trying to figure out what to do with these toxins that make up the vaccine. It may show that the immune system is responding. As the body responds, some might say that the side effects are part of the vaccination process.
A response from the immune system means that the immune system works, right? We want our immune system to work. What does that mean, though, when the vaccine kicks the immune system into overdrive which may lead to complications which then leads to death? The vaccine did something. It may not have guaranteed immunity or helped prevent a disease, but instead it elicited a different response: death. What’s at fault: the vaccine? the toxic ingredients? the body’s ill response?
Many factors will surely need to be investigated. Unfortunately, though, when side effects occur, that person’s family can’t find fault with the vaccine manufacturer or their doctor, which is why it’s important to understand fully not only what a vaccine can do and but what a vaccine will do. When considering vaccines, there is much to consider.
So, if this information about side effects is news for you, and it scares you, I’m sorry to be the bearer of bad news. If this information sounds old and like I’ve become the most annoying broken record ever to exist about vaccines and vaccine safety, it’s because this information needs to be said over and over again until more people are aware of it.
Why do people like me feel the need to keep repeating this? Because I care. I care about what is being said about vaccines and what is not being said about vaccines. Because the VIS barely scratches the surface. Because two pages is hardly enough space to truly inform someone about the supposed benefits as well as reveal the countless documented side effects every vaccine on the market carries. Because side effects and adverse events aren’t just a one-time thing. Because vaccine injury is real. Because it lasts longer than you can imagine. Because it will rob you of your abilities, your health, your time and your money as you try to reverse the affects.
Those who might be profiting from vaccinations may not being saying what needs to be said very clearly. But if we who’ve witnessed the side effects can say it clearer, better and louder, then so be it.
Know your rights.
Do your homework.
Ask your questions.
Weigh the pros and cons.
Look things up on your own.
Read the package insert.
Really read it.
Realize that side effects can be worse than the “disease-preventable” vaccine itself.
Remember, too, that when you vaccinate you can never UNvaccinate.
If more people knew about vaccine side effects and how devastating they can be, I’d expect we might see much less vaccine injury and death. I’d expect more people would do one of two things also: really begin to question vaccines or start to decline them. Neither of those are a bad thing.
Cathy Jameson is a Contributing Editor for Age of Autism.
My favorite is the DTaP shot that actually lists autism as a possibility.
Adverse events reported during post-approval use of Tripedia vaccine include idiopathic thrombocytopenic purpura, SIDS,
anaphylactic reaction, cellulitis, autism, convulsion/grand mal convulsion, encephalopathy, hypotonia, neuropathy, somnolence
and apnea. Events were included in this list because of the seriousness or frequency of reporting. Because these events are
reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequencies or to
establish a causal relationship to components of Tripedia vaccine.2
Page 11 right after the bullet points. AND it's on the FDA's website: http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM101580.pdf
Posted by: Debbie | February 23, 2015 at 01:17 AM
Was watching a bit of the Oscars and Jimmie Kimmel for some reason is on the red carpet and made some sort of statement “as that would be so anti-vaccine...” that was enough of that hyped show for me... Kimmel is paid to say what he says... I am sure his show will see a pharma check in the mail.
Holly Riley below has a great idea...
“...I think we need to produce a TV commercial for vaccines. I'm serious-bear with me on this. Just like the Viagra and other Pharma commercials, it could have some idillic scenery”
A “well baby / 9 vaccine visit” commercial would be about 9 minutes long to list all the things that can go very, very wrong.
The news media does all the ...flu shot commercials “for free” each season... as they interview their local health departments and announce free flu shot clinics wherever you live.
With no actual vaccine commercial, pharma does not have to provide the few dozen side effects of the flu shot or any other vaccines that may be mentioned in a newscast.
Posted by: go Rand | February 22, 2015 at 09:01 PM
The NYS Board of Health recommendation:
"Immunizations in the Postpartum Period
The period after delivery and before discharge from the hospital is an ideal time to administer both live and inactivated vaccines. It ensures that both the woman and her child will be protected from preventable diseases after leaving the birthing facility, when they are especially vulnerable. Women who plan to breastfeed can and should receive vaccinations as no evidence exists of any risk to a mother or her infant if she is vaccinated while breastfeeding. Breastfeeding is not a contraindication to any vaccination, with the exception of vaccinia vaccine. 4
The following vaccinations are recommended for women at risk for these diseases or for those who do not have a history of immunity:
• Influenza - Women should receive an annual dose of influenza vaccine, either TIV or LAIV, if they have not already been immunized during their pregnancy. Influenza vaccine should be given before leaving the hospital.
• Rubella (MMR) - Women born on or after January 1, 1957, without evidence of immunity to rubella should be vaccinated with one dose of the MMR vaccine before leaving the hospital. Single antigen rubella vaccine should not be used.
• Tdap - Women who have not previously received one dose of Tdap should receive Tdap before leaving the hospital. There is no minimum interval between receipt of Tdap and of the last Td booster. Immunizing the mother with Tdap will help protect the newborn during their first few months of life when they are most vulnerable to pertussis.
• Varicella - Women without evidence of immunity to varicella should be vaccinated with the first dose of varicella vaccine before leaving the hospital. The second dose should be given at the postpartum visit, six to eight weeks after delivery. As it is a live virus vaccine, women should be counseled to avoid pregnancy for four weeks after receiving the varicella vaccine.7
• HPV - Women ages nine through 26 years who have not completed a primary series should receive three doses of HPV vaccine at zero, two and six months. If the HPV series was started prior to pregnancy, the series can be completed postpartum without repeating the initial dose(s).5"
https://www.health.ny.gov/prevention/immunization/vaccinating_women_of_reproductive_age_guidelines.htm
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From the Gardasil insert (AAHS/AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate - so no true placebo):
"8.3 Nursing Mothers
Women 16 Through 45 Years of Age
It is not known whether GARDASIL is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GARDASIL is administered to a nursing woman. GARDASIL or AAHS control were given to a total of 1133 women (vaccine N = 582, AAHS control N = 551) during the relevant Phase III clinical studies. Overall, 27 and 13 infants of women who received GARDASIL or AAHS control, respectively (representing 4.6% and 2.4% of the total number of women who were breast-feeding during the period in which they received GARDASIL or AAHS control, respectively), experienced a serious adverse reaction. In a post-hoc analysis of clinical studies, a higher number of breast-feeding infants (n = 7) whose mothers received GARDASIL had acute respiratory illnesses within 30 days post vaccination of the mother as compared to infants (n = 2) whose mothers received AAHS control."
http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf
----------------------------
Varivax [chicken pox vaccine]:
8.3 Nursing Mothers
It is not known whether varicella vaccine virus is excreted in human milk. Therefore, because some viruses are excreted in human milk, caution should be exercised if VARIVAX is administered to a nursing woman. [See Warnings and Precautions (5.4).]
http://www.merck.com/product/usa/pi_circulars/v/varivax/varivax_pi.pdf
--------------------------------------------------
Adacel (Sanofi Pasteur Tdap)
"8.3 Nursing Mothers
It is not known whether Adacel vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Adacel vaccine is given to a nursing woman."
https://www.vaccineshoppe.com/image.cfm?doc_id=10437&image_type=product_pdf
-------------------------------------------------
Boostrix (GlaxoSmithKline Tdap)
339 8.3 Nursing Mothers 340 It is not known whether BOOSTRIX is excreted in human milk. Because many drugs are 341 excreted in human milk, caution should be exercised when BOOSTRIX is administered to a 342 nursing woman.
http://www.fda.gov/downloads/BiologicsBloodVaccines/UCM152842.pdf
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MMR
"Nursing Mothers
It is not known whether measles or mumps vaccine virus is secreted in human milk. Recent studies have shown that lactating postpartum women immunized with live attenuated rubella vaccine may secrete
the virus in breast milk and transmit it to breast-fed infants.{53} In the infants with serological evidence of rubella infection, none exhibited severe disease; however, one exhibited mild clinical illness typical of acquired rubella.{54,55} Caution should be exercised when M-M-R II is administered to a nursing woman."
"Routine administration of DTP (diphtheria, tetanus, pertussis) and/or OPV (oral poliovirus vaccine) concurrently with measles, mumps and rubella vaccines is not recommended because there are limited data relating to the simultaneous administration of these antigens. However, other schedules have been used. The ACIP has stated "Although DATA ARE LIMITED CONCERNING THE SIMULTANEOUS ADMINISTRATION OF THE ENTIRE RECOMMENDED VACCINE SERIES (i.e., DTaP [or DTwP], IPV [or OPV], Hib with or without Hepatitis B vaccine, and varicella vaccine), data from numerous studies have indicated no interference between routinely recommended childhood vaccines (either live, attenuated, or killed). These findings support the simultaneous use of all vaccines as recommended."{61}
http://www.merck.com/product/usa/pi_circulars/m/mmr_ii/mmr_ii_pi.pdf
Posted by: Linda1 | February 22, 2015 at 08:09 PM
on-line
Posted by: Irma | February 22, 2015 at 06:36 PM
A product monograph is usually available no-line for additional information,this could be reviewed ahead of time.It is important to be well prepared before getting to the doctor's office.
Posted by: Irma | February 22, 2015 at 06:35 PM
"Safety and effectiveness of FLULAVAL QUADRIVALENT have not been established in pregnant women or nursing mothers."
"There is the 85 possibility that broad use of FLULAVAL QUADRIVALENT could reveal adverse reactions not 86 observed in clinical trials."
"There are no postmarketing data available for FLULAVAL QUADRIVALENT."
"There are insufficient data to assess the concomitant administration of FLULAVAL 227 QUADRIVALENT with other vaccines."
"FLULAVAL QUADRIVALENT has not been evaluated for carcinogenic or mutagenic 325 potential."
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM404086.pdf
Posted by: nhokkanen | February 22, 2015 at 06:24 PM
I think we need to produce a tv commercial for vaccines. I'm serious-bear with me on this. Just like the viagra and other pharma commercials, it could have some idillic scenery (with or without twin bathtubs) for us to gaze upon as the list of possible side effects goes on and on and on. In big print we could include the warning: After receiving live virus vaccines, you will shed the virus for up to 6 weeks-avoid contact with immune compromised individuals. And a warning that the vaccine manufacturer and your doctor are liability free if something goes wrong. And for a flu vax note that it's recommended for pregnant women but has never been studied for safety in that population. It could all come verbatim from the package inserts. And the flu shot commercial could have the scull and crossbones in the corner of the screen the whole time due to thimerosal.
Since vaccines are recommended by the CDC and pushed on us by the AMA and pediatricians, there is no need for tv commercials. But they would help achieve the desperately needed informed consent, because, by law, pharmaceuticals that are advertised in print or media have to list ALL of the info. (don't you love how in magazines, all of the negative stuff is in tiny print on the back side of the page? some products are so bad they need three pages for their ad).
Vaccines are products that cleaverly side-step the need for marketing (and liability), but I so would love to see a real tv ad produced for the MMR. Just for fun.
Posted by: Holly Riley | February 22, 2015 at 06:24 PM
I think the actors sorry I mean Doctors should give the warning in full in an ideal world.Without the actors sorry Doctors not giving that warning I don't know if many people would pay much attention to a package insert.
We certainly never knew about the package insert and if we had I think we would have still vaccinated, why shouldn't we ?we never had a reason not to, yet..
MMR RIP
Posted by: Angus Files | February 22, 2015 at 11:26 AM
Cathy, Thank you for this post.
You said "Can you imagine if vaccine news stories across the mainstream channels would actually reveal all there is to know about the vaccine--including the bad stuff?"
That rarely happens. Instead the CDC and Pharma messages on mainstream television and other media can only say that vaccine safety studies are complete and conclusive and that all vaccines and their ingredients are safe. No debate.
But here is one example of a report that says they are not. “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate.” See http://www.ncbi.nlm.nih.gov/pubmed/22336803 .
Unfortunately, very few journalists do their homework and then actually report the whole story. One of the journalists that actually does her homework then reports the story is Sharyl Attkisson. See http://sharylattkisson.com/medical-vaccine-links/ .
Posted by: Jim Thompson | February 22, 2015 at 08:39 AM
Cathy ... all you warn about regarding the vaccines themselves is worth knowing information.
I sometimes wonder what Donald Rumsfeld meant when he once said: "We don't know what we don't know".
Are all pediatrician staffs experienced and knowledgeable regarding their responsibilities to administer and maintain records of vaccines given to toddlers? Do they "shake well" before administering a vaccine that requires it?
Are they knowledgeable, vigilent and due diligent while following the "contra-indication" warnings on each vaccine?
Where on the toddler's body to administer multi-dose vaccines .. arms, legs, buttocks .. subcutaneously or intra-muscular?
Maintaining proper "records" to prevent a toddler from receiving by "mistake" a second .. unnecessary .. dose of the same vaccine?
Are pediatrician offices examined periodically to assure vaccines are being stored as required by the manufacturer .. no exposure to sun light .. proper temperature .. especially following power outages?
Proper maintainence and use of syringes?
I seems to me the possibility of "mistake and error" in the storage, administration and record keeping of vaccines .. in a busy pediatrician's office .. is no different than in a hospital .. where some have reported thousands die every year due to "neglect, error, mistake and carelessness" by overworked and undertrained staff.
Posted by: Bob Moffitt | February 22, 2015 at 07:09 AM