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Shingrix Vaccine’s Risk of Guillain-Barré Syndrome Results in New FDA Warning

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Federal drug regulators have announced new warnings about the potential risk of Guillain-Barre Syndrome after a shingles vaccine, indicating side effects of Shingrix may cause the rare and serious disorder, which leaves users with muscle weakness and even paralysis.

In a drug safety communication issued this week, the FDA indicates new label warnings will be added about the potential link between Shingrix and Guillain-Barre Syndrome.

While the agency indicates there appears to be an association, the data has not yet established that the shingles vaccine causes the disorder.

Shingrix (recombinant zoster vaccine; RZV) was the second vaccine approved in the U.S. for prevention of shingles among adults, which involves two doses for inoculation. GlaxoSmithKline introduced the Shingrix vaccine in October 2017, and it has largely replaced the earlier shingles vaccine approved by the FDA in 2006, Zostavax, which involved the use of a live virus that has been linked to reports of severe shingles outbreaks and auto-immune problems.

Although Shingrix has been marketed as a safer alternative, side effects have been linked to reports of injection site reactions and other less severe problems. However, the drug maker is now being required to add new information about the potential Guillain-Barre Syndrome risk with the Shingrix vaccine, which may cause the body’s immune system to attack the nerves.

The FDA indicates the Warnings and Precautions section of the Shingrix Prescribing Information will now contain the following statement:

“In a postmarketing observational study, an increased risk of GBS (Guillain-Barre Syndrome) was observed during the 42 days following vaccination with Shingrix.”

The warning comes after a postmarketing safety surveillance of the Shingrix vaccine was conducted by the U.S. Centers for Disease Control and Prevention (CDC), which found a higher incidence rate of GBS among individuals 65 years of age or older who received the vaccine. The data came from the Vaccine Safety Datalink (VSD) and Shingrix vaccine recipients were compared to those who received the Zostavax vaccine.

The CDC estimated there are three excess cases of GBS per million doses administered to adults age 65 and older, which occurred during the first 42 days after they received the shot. The FDA said that while the data shows an association, it does not prove a causal effect, and has determined the benefits of the vaccine still outweigh the risks.

While the maker of Zostavax currently faces hundreds of shingles vaccine lawsuits filed in recent years, each involving allegations that Merck failed to adequately warn users about the potential side effects, the Shingrix manufacturer GlaxoSmithKline has not been part of the litigation. However, it appears that former user diagnosed with Guillain-Barre Syndrome may have a basis to file Shingrix lawsuits, if the drug maker knew or should have known about the risk earlier.

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10 comments

  1. Candace Reply

    I had the shiglix vaccine and diagnosed with GBS.hospitaLized for a week . How do I handle the covid vaccine?

  2. Chris Reply

    My mother (86yrs old) received the Shingrix vaccine 2/2020 – 2 weeks later was unable to walk. She passed away 3/9/2021 – GBS destroyed her and we all suspected the shingles vaccine. Where can I find out more information on a class action lawsuit?

  3. JOYCE Reply

    So the FDA and CDC allow this drug to be beta-tested on an unsuspecting public. I have seen this GBS reaction over 2 years ago and it is very serious for the patient. The drug should be removed from further ability to harm an un-warned public.

  4. donna Reply

    My sister had the shinGrix vaccine second shot mid March three days later had a full body rash and hives ten days later was in the hospital put on a ventilator totally paralyzed it’s been eight weeks she is still in the hospital paralyzed and ventilated this needs to be taken off the market it is more than severe muscle weakness as they portray on their new commercials we need a class action lawsuit immediately

  5. DONNA Reply

    My husband was diagnosed with GBS 1
    Month after getting the Shingles vaccine.

  6. Gary Reply

    They are really pushing these vaccines. I just got a letter from my doctor’s office recommending I come in and get the Shingrix vaccine and I emailed the back and said I don’t need it because I have never had chicken pox. I am sure of this because I was tested for markers several years ago. My doctor wrote back and said the CDC recommends the vaccine for anyone over 50. That is false! The CDC website says you should get it if you are unsure if you have had chicken pox. Why would I risk GBS or some other ailment taking a vaccine that is unnecessary, and it pains me that the CDC doesn’t make this more clear because obviously a lot of people are confused on this. It’s a big money maker vaccinating people whether they need it or not.

  7. MICHAEL Reply

    66 years old and had the 2nd dose of the Shringrex vaccine in Dec 2020 and contacted Guillain-Barre in January 2021. Hospitalized, PT, PTSD, monthly IVIG treatments and now slowly learning to walk again. No fun!

  8. Diane Reply

    My husband received the shingrix vaccine on 5/28/2021 and has been hospitalized since 5/31/2021 and diagnosed with GBS. Help!

  9. Daryl Reply

    After receiving the second dose I started having some pretty severe rashes breaking out. At the same time I started experiencing severe weakness and joint pain (mainly my wrists and hands but was very stiff all over. I didn’t even put 2 and 2 together until a local talk show host was complaining about rashes and other problems after he had the vaccine. It hit me like a ton of bricks that that caused my problem. I never had rash, weakness and joint pain issues like that before. The problem seems to be gone now but it took a few months to recover. Guess I was lucky not to be hospitalized or dead/paralyzed.

  10. Dennis Reply

    The Shingrix Vaccine is the worst thing to ever happen to my 92-year old dad. During the 2020 COVID year, he didn’t even see a doctor. He didn’t need one. Then in late Feb, he received the first Moderna vaccine from his VA doctor. In March he received the 2nd Moderna vaccine shot. Just 3 weeks later the VA doctor convinced him he needed the shingles vaccine. It was Shingrix. I knew within 15 minutes after we left there was something wrong. We went to Sam’s and parked and he always walked side-by-side with me. I got to the door and looked back and he had barely walked 50 feet. Then he started having trouble sleeping at night. He would walk out to get his newspaper or mail and be unable to talk because he couldn’t catch his breath. Then he started scratching his arms until they would bleed. The injection site had, and still has, small red itchy bumps. These also show up on his legs and hands. Then he bent over in his driveway and fell, requiring a trip to the ER. He never had balance problems. They ran tests and implanted a pacemaker. One month after the surgery we went to Sam’s again to get him some things. He was leaning on a cart. He suffered a heart attack in Sam’s. Next to the pharmacy, they have a HIGI station. His blood pressure was 232 over 135, pulse was 106. I have never even heard of blood pressure that high. I checked mine and verified it is an accurate machine. I took him to the ER again. They ran more tests and kept him 2 days and prescribed meds. No mention of GBS. He now has frequent angina attacks, even in the middle of the night. He dozes off 50 times a day, no kidding. Every time he sits down anywhere he is asleep in seconds. He has to carry nitro pills in his pocket. He can barely get out of the vehicle and walk 100 feet into a business without having to sit down. Shingrix has destroyed an otherwise healthy man in a matter of weeks. I HATE Shingrix. As far as I’m concerned, it’s poison. The VA office never even followed up with him to see how he was doing after the vaccine. That’s why the VAERS system is a failure and poisonous meds continue to afflict others instead of being withdrawn. I’m so thankful I saw your page here today. I had no idea about GBS. He called the VA today and the doctor will call him next Monday. I hope he will be evaluated by him physically next week. If not, we will go to another doctor. It keeps getting worse. He has trouble speaking in complete sentences. He forgets things we talked about a day earlier. And when his back and chest start hurting him, he becomes a different and scary person that I’ve never seen until Shingrix. It should be removed from the market and any doctor who takes a kickback for forcing it on a patient should burn in hell. That’s my experience and humble opinion.

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