H1N1 Swine Flu Vaccine Package Insert, Warnings

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H1N1 Swine Flu Vaccine Package Insert, Warnings
September 27, 2009 by ahrcanum

The U.S. Government has evaluated only these vaccines that are licensed by the U.S. Food and Drug Administration. They are-

Influenza A (H1N1) 2009 Monovalent Vaccine (CSL Limited)www.fda.gov...

Influenza A (H1N1) 2009 Monovalent Vaccine (Novartis Vaccines and Diagnostics Limited) www.fda.gov...

Influenza A (H1N1) 2009 Monovalent Vaccine (Sanofi Pasteur, Inc) www.fda.gov...

Influenza A (H1N1) 2009 Monovalent Vaccine (MedImmune LLC) www.fda.gov...

Lot release information will be updated weekly. Last update: 9/24/2009. www.fda.gov...

Manufacturer Total Number of Lots Released by FDA
MedImmune LLC 9
Novartis Vaccines and Diagnostics Limited 3
Sanofi Pasteur, Inc. 3

From the CSL package insert: Influenza A (H1N1) 2009 Monovalent Vaccine, Manufactured by CSL Limited, Suspension for Intramuscular Injection, Initial U.S. Approval: 2007 [sic- approved TWO YEARS AGO!)

From the CSL package insert-

Vaccination with Influenza A (H1N1) 2009 Monovalent Vaccine may not protect all individuals.

5.4 Limitations of Vaccine Effectiveness

Neurological disorders temporally associated with influenza vaccination, such as encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy, have been reported.

8.1 Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or AFLURIA. It is also not known whether these vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman only if clearly needed.

8.3 Nursing Mothers

Neither Influenza A (H1N1) 2009 Monovalent Vaccine nor AFLURIA has been evaluated in nursing mothers. It is not known whether Influenza A (H1N1) 2009 Monovalent Vaccine or AFLURIA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Influenza A (H1N1) 2009 Monovalent Vaccine is administered to a nursing woman.

8.4 Pediatric Use

Neither Influenza A (H1N1) 2009 Monovalent Vaccine nor AFLURIA has been evaluated in children. Safety and effectiveness in the pediatric population have not been established.

Similar warnings from the Novartis insert-www.fda.gov...

8.3 Nursing Mothers-It is not known whether FLUVIRIN or Influenza A (H1N1) 2009 Monovalent Vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Influenza A (H1N1) 2009 Monovalent Vaccine is administered to a nursing woman

8.4 Pediatric UseSafety and effectiveness in pediatric subjects below the age of 4 years have not been established. [see ADVERSE REACTIONS (6) and CLINICAL STUDIES (14)]

Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or FLUVIRIN. It is also not known whether Influenza A (H1N1) 2009 Monovalent Vaccine or FLUVIRIN can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman only if clearly needed.

The government is starting an unprecedented system to track possible side effects as mass flu vaccinations begin next month. The idea is to detect any rare but real problems quickly, and explain the inevitable coincidences that are sure to cause some false alarms.

“Every day, bad things happen to people. When you vaccinate a lot of people in a short period of time, some of those things are going to happen to some people by chance alone,” said Dr. Daniel Salmon, a vaccine safety specialist at the Department of Health and Human Services.


[edit on 6-10-2009 by smilinggrandma]

“Every day, bad things happen to people. When you vaccinate a lot of people in a short period of time, some of those things are going to happen to some people by chance alone,” said Dr. Daniel Salmon, a vaccine safety specialist at the Department of Health and Human Services.

Sound like the govt is covering their rear ends again.

Great Information! Why are people rushing to get this jab?

MSM must be getting the job done.

I know lots of people who are screaming that they want there shot, but I also know lots of people who are refusing to get it. It's sad how you can't even hold them responsible for any side effects.

I'll take my chances with the virus.

If you read the package insert for *any* medicine, you are likely to find such language. Very few drug manufacturers want to claim that a medicine is "safe" for pregnant or lactating women. Basically, the only way to find out is to see whether pregnant women give birth to injured babies, which isn't a good way to do things.

When you have many people using any drug, some of them will get sick. There isn't a good way to tell whether the drug caused the sickness, unless a lot of people get sick. So, someone taking aspirin could have a heart attack. Did the aspirin cause the heart attack? Probably not. Aspirin has been around for over 100 years, so we have a good idea what it does. Even so, someone occasionally dies from taking an aspirin.

The newer the drug, the less experience we have with it, so the less able we are to say whether some particular illness or death was caused by the drug. As a result, drug companies put in absolutely anything that might conceivably be related to their drug, just to protect themselves. If they put it in their package insert, they can't be blamed for not informing the doctors or patients about the risks.

With this flu vaccine, there is no time to even test it. It's pretty much been tested on a few people, and (apparently) no one died. That doesn't make it safe, of course. However, listing all the possible side-effects and adverse reactions that might come about from using the vaccine doesn't make it dangerous, either. You've got to balance the dangers of the flu against the potential dangers of the vaccine. Ideally, you wait to see how many people wind up dying of the flu. It it's a lot, you might go for the vaccine. If it's hardly any, maybe you'll skip it.

Chances are that you won't see a whole lot of people dying from either, though. Most of the stuff about the flu and the vaccine is sensationalism, scaremongering without presenting all the facts. Don't believe the hype.

Originally posted by exile1981
I know lots of people who are screaming that they want there shot, but I also know lots of people who are refusing to get it. It's sad how you can't even hold them responsible for any side effects.

I'll take my chances with the virus.

Umm... if the gov't tells me to insert this liquid into me... I just have to say no...

I can't trust them at all, nonetheless let them start injecting this into me...

Drug dealers are more reliable! :lol; (not condoning drugs)

I'll take my chances with the virus, over the expressed mere chance bad things will happen when vaccinating people. Geesh.

Influenza A (H1N1) 2009 Monovalent Vaccine
Manufactured by CSL Limited
Suspension for Intramuscular Injection
Initial U.S. Approval: 2007

Influenza A (H1N1) 2009 Monovalent Vaccine
Manufactured by Novartis Vaccines and Diagnostics Ltd.
Suspension for Intramuscular Injection
Safety data were collected in a total of 2768 adult and geriatric subjects (18 years of age and older) who have received FLUVIRIN in 29 clinical studies since 1982.

Influenza A (H1N1) 2009 Monovalent Vaccine
Manufactured by Sanofi Pasteur Inc.
Suspension for Intramuscular Injection
Initial US Approval: 1980

Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal
Manufactured by MedImmune, LLC
Intranasal Spray
Initial U.S. Approval: 2003

WTH?? 1980??? 1982??? 2003??? 2007???

Is anyone else realizing just how bad you have been lied to yet???

A "NOVEL" (as in new, never seen before) strain of virus, the 2009 H1N1 is the problem, but the answer has been around since 1980???

Are you waking up yet?

The worst is FluMist(R) intranasal from MedImmune. Inhalation of the LIVE H1N1 VIRUS also means you will expel it out of your nose only to infect more people with the virus. I saw somewhere on TV they have drive thru clinics. Patients can go on their merry way to Wal-Mart, the grocery store, to school, where ever to continue viral shedding into the general population.

We already have warned people here in ATS, those that will listen will benefit from the knowledge, those that don't then that is their choice.

I will never tell anybody no to get a vaccine, but as every thing is at your own risk.

If a medication or a vaccine like in this instance have more than three side effects that are dangerous to your health, is nothing but a poison.

Yes even with all those warnings the government wants to push that particular poison on the unborn and our children.

I wonder why.

I think I will just seat back and wait for the results of the mass vaccination that is going to take place in the next few weeks.

Good luck to those that will chose to become testing grounds for yet another big pharma wonder drug.

Still can not forget what the vaccination in the 70s did, so the new generations are the one that have no clue what is going on and the target here.

BTW you can not sue the government and neither big pharma like many did in the 70s.



[edit on 7-10-2009 by marg6043]

I believe the Flumist vaccine will spread H1N1 like wildfire, not only spread but mutate. We really need to be on the look out now, any information no matter how small we need to share. It's very important for people in the areas that have been given the Flumist vaccine to report in if there has been an increase in Swine Flu cases. We can no longer trust the media, so stay aware and share your findings.

I just heard on the radio news that priority for the H1N1 vaccine would be given to pregnant women and...(sorry I was so stunned to hear that I didn't catch the rest).

Honestly, I am sick to my stomach as I remember the OP:

Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or AFLURIA. It is also not known whether these vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman only if clearly needed.

This is total B.S. Caution is thrown to the wind when nobody can be held accountable financially.

Originally posted by redhatty
Influenza A (H1N1) 2009 Monovalent Vaccine
Manufactured by CSL Limited
Suspension for Intramuscular Injection
Initial U.S. Approval: 2007

Influenza A (H1N1) 2009 Monovalent Vaccine
Manufactured by Novartis Vaccines and Diagnostics Ltd.
Suspension for Intramuscular Injection
Safety data were collected in a total of 2768 adult and geriatric subjects (18 years of age and older) who have received FLUVIRIN in 29 clinical studies since 1982.

Influenza A (H1N1) 2009 Monovalent Vaccine
Manufactured by Sanofi Pasteur Inc.
Suspension for Intramuscular Injection
Initial US Approval: 1980

Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal
Manufactured by MedImmune, LLC
Intranasal Spray
Initial U.S. Approval: 2003

WTH?? 1980??? 1982??? 2003??? 2007???

Is anyone else realizing just how bad you have been lied to yet???

A "NOVEL" (as in new, never seen before) strain of virus, the 2009 H1N1 is the problem, but the answer has been around since 1980???

Are you waking up yet?

Talk aboout conspiracy! This post deserves it own thread.

Did you know that 28 pregnant women have died of the swine flu? Not the vaccine, but the flu. So that means 28 unborn children as well.

I'm sure they won't be giving the live virus to a pregnant woman, but the shot with the inactive virus.

[edit on 10/7/09 by GirlNextDoor]

reply to post by GirlNextDoor


Does the story of the death pregnant women tells if they were given tamiflu for the symptoms of the swine flu?

No, why because believe it or not tamiflu is the first anti viral that is given if you have the flu be seasonal or not if you have no taken the vaccine.

Have you read the side effects of tamiflu?

It can very well be the reason for the deaths if the death pregnant women took it.

Still seasonal flu also kills pregnant women every year due to under going health conditions or complications from the flu.

In other words the same group of pregnant women that die every year from the seasonal flu due to complications and health problems will also die from swine flu regardless of treatment.

Sad but that is the truth.

Prevention, prevention and more prevention.

Safety and effectiveness in the pediatric population have not been established.

I can't believe people are going to trust the government and have their kids take this vaccine.

Not my kid, no way..

Originally posted by exile1981
I know lots of people who are screaming that they want there shot, but I also know lots of people who are refusing to get it. It's sad how you can't even hold them responsible for any side effects.

I'll take my chances with the virus.

Ha ha name one person who wants this shot. My fiancée is a nurse and just about everyone at the hospital she works at has said they will not take it whether it means their jobs or not. It just happens to be one of the largest hospitals in the nation at a certain university.

If hundreds of thousands of people start dropping like flies then ya I'm sure we would take it but until that starts to happen then no way would we take the shot.