Shingrix Vaccine’s Risk of Guillain-Barré Syndrome Results in New FDA Warning
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.
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Side effects of the shingles vaccine Zostavax may result in the development of a painful and persistent strain of shingles
Learn More About this Lawsuit SEE IF YOU QUALIFY FOR COMPENSATIONShingrix (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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19 Comments
malissaOctober 30, 2023 at 1:27 pm
my wife received her Shingrix vaccine on 08/07/2023 and was in the hospital 5 days later with her arm Swallen up to 3 softball size lumps where they gave her shot at it kept swelling and hot to touch took her to her dr and was transported to er right away had three surgery back-to-back within 3 days and the dr said it was from the Shingrix vaccine. gave her septic shock was in hospitable 15 day on[Show More]my wife received her Shingrix vaccine on 08/07/2023 and was in the hospital 5 days later with her arm Swallen up to 3 softball size lumps where they gave her shot at it kept swelling and hot to touch took her to her dr and was transported to er right away had three surgery back-to-back within 3 days and the dr said it was from the Shingrix vaccine. gave her septic shock was in hospitable 15 day on strong antibiotic and all the drs even infection control; dr said it was due to the Shingrix vaccine please help
KalAugust 22, 2022 at 12:50 am
I had my first Shindrix injection 2 weeks ago. Felt tired the next day, but that was expected. However, the day after that, I woke up with my right leg completely paralyzed. It lasted a whole day. Over the course of the next two weeks, various side effects came and went. My heart rate dropped to 52-53 beats per minute, my tongue was swollen for a few days, my lower back and thighs nerves endings[Show More]I had my first Shindrix injection 2 weeks ago. Felt tired the next day, but that was expected. However, the day after that, I woke up with my right leg completely paralyzed. It lasted a whole day. Over the course of the next two weeks, various side effects came and went. My heart rate dropped to 52-53 beats per minute, my tongue was swollen for a few days, my lower back and thighs nerves endings were very painful (like they were pinched). I was exhausted all the time, could barely lift my arms or squeeze my hands. My skin is so sensitive right now that wearing clothes feels like sandpaper. I have been sleeping 12 to 15 hours a day everyday. Currently, in my city, the medical system is in crisis. ERs are bursting and wait times are 15-20 hours, hospital beds are full, it’s difficult to see a doctor… so I spent two weeks wondering at what point I should try and get medical help. Each morning brings a new side effect, and I keep hoping GBS or nerve inflammation isn’t how I loose my health an my quality of life. Or course, no second dose for me. I am going nowhere near another shot of Shindrix.
WendellAugust 18, 2022 at 10:40 pm
I received the 1rst Shingrix shot in 2018, with in seven days i was in the hospital because my legs where weak and I kept falling it took them over amonth to figure out what was wrong and i was diagnosed with GBS. took i was in a wheelchair for a while. I a attorney in 2019 and they said shingrix wasn't on this "List" and i had no recourse. in 2021 i found out people where in litigation over t[Show More]I received the 1rst Shingrix shot in 2018, with in seven days i was in the hospital because my legs where weak and I kept falling it took them over amonth to figure out what was wrong and i was diagnosed with GBS. took i was in a wheelchair for a while. I a attorney in 2019 and they said shingrix wasn't on this "List" and i had no recourse. in 2021 i found out people where in litigation over the Shingrix virus. and when i calitations. so wtf i guess there is not justice for veterans . it was the va that gave me the vaccineled a different attorney they said it was past the statute of lim
steveAugust 11, 2022 at 9:48 am
I am a registered nurse , i got the Shingrix vaccine and ended up in the hospital with Meningo encephalitis. I lost the ability to walk and speak when I was rushed to a hospital ,I had an MRI of my brain, A CT of my brain, a spinal tap, I was pumped full of antibiotics, before determining this was reaction to the Vaccine. I have seen multiple articles where this is a known reaction, yet I see no l[Show More]I am a registered nurse , i got the Shingrix vaccine and ended up in the hospital with Meningo encephalitis. I lost the ability to walk and speak when I was rushed to a hospital ,I had an MRI of my brain, A CT of my brain, a spinal tap, I was pumped full of antibiotics, before determining this was reaction to the Vaccine. I have seen multiple articles where this is a known reaction, yet I see no lawsuit. Zostavax has mutiple lawsuits for same reaction, what is the difference?
CarolJuly 9, 2022 at 12:40 pm
On July 13, 2018, approximately 7:10 pm at Publix Pharmacy, I received my first round of Shingrix. At 2:30 am, July 14, 2018 ( just over 7 hours later), I got up to go to the bathroom. After using the bathroom, I stood up but was unable to move my feet. I literally could not pick my feet up. Minutes later, I had uncomfortable pins and needle-like tingling in my lower legs, ankles and hands. I sou[Show More]On July 13, 2018, approximately 7:10 pm at Publix Pharmacy, I received my first round of Shingrix. At 2:30 am, July 14, 2018 ( just over 7 hours later), I got up to go to the bathroom. After using the bathroom, I stood up but was unable to move my feet. I literally could not pick my feet up. Minutes later, I had uncomfortable pins and needle-like tingling in my lower legs, ankles and hands. I sought medical help from neurologists, cardiologist, Orthopedic surgeon and Family Internist from mid-July after this incident into mid-September. At each visit I told every physician that these issues started approximately 7 hours after getting the Shingrix vaccine. They all insisted this was probably not related. I continuously searched online to see if this was one of the reported side effects of Shingrix and found nothing to that effect. I eventually filled out the online VAERS and listed the illness I suffered after taking the first dosage (Needless to say, I never went back for the second dose). I received a letter from the Department of Health and Human Services dated October 23, 2018. Their letter merely assigned a VAERS ID stating that “reporting an event to VAERS does not constitute filing a claim with the VICP nor does it constitute filing for compensation with the CICP. “ When I saw that the FDA had now begun issuing a warning of potential adverse effects similar to that of Guillian-Barre, I somehow felt validated/vindicated.
RobertFebruary 7, 2022 at 11:15 am
Prior to receiving the Shingrix vaccine two years ago I was perfectly healthy. Within approximately six weeks of receiving the vaccine I began having strange symptoms (the feeling as though a large insect was moving around deep within my right inner ear, pain and electrical sensations in my right temporal region, etc.). Eventually, I was experiencing painful burning sensations in various are[Show More]Prior to receiving the Shingrix vaccine two years ago I was perfectly healthy. Within approximately six weeks of receiving the vaccine I began having strange symptoms (the feeling as though a large insect was moving around deep within my right inner ear, pain and electrical sensations in my right temporal region, etc.). Eventually, I was experiencing painful burning sensations in various areas of my head, and randomly throughout my body (which continue to this day). I was diagnosed as having nerve damage most likely as a result of an over immune reaction to Shingrix. I continue to have these symptoms presently, and I've been on gabapentin for almost two years to help cope with these symptoms (which also includes paresthesia in random parts of my body as well).
JoanFebruary 6, 2022 at 12:23 am
Got both shingrix vaccines in 2020 and my health has been devastated since. First dose left me bedridden for nearly a week; 2nd dose was similar experience but less severe. I naively believed the side effects would be temporary. I was literally sorely mistaken. Nearly 2 years have passed and I suffer from continual headaches, muscle aches and weakness, severe joint pain and stiffness, blurred visi[Show More]Got both shingrix vaccines in 2020 and my health has been devastated since. First dose left me bedridden for nearly a week; 2nd dose was similar experience but less severe. I naively believed the side effects would be temporary. I was literally sorely mistaken. Nearly 2 years have passed and I suffer from continual headaches, muscle aches and weakness, severe joint pain and stiffness, blurred vision and nerve pain. The manufacturer needs to be sued big-time IMMEDIATELY and must be held accountable!
BrianNovember 19, 2021 at 12:14 pm
Sept 2019 I received vaccine (shingrex) the next morning I was sick filling then was found passed out in my truck. I dident like the hospital I was tacked to so I refused going in. I lauded down and slept for a couple hours then woke up all most paralyzed. My back was extremely painful. I called friends for help. That’s all I remember, until I woke in ICU. I was told I had seizures. Also I couldn’[Show More]Sept 2019 I received vaccine (shingrex) the next morning I was sick filling then was found passed out in my truck. I dident like the hospital I was tacked to so I refused going in. I lauded down and slept for a couple hours then woke up all most paralyzed. My back was extremely painful. I called friends for help. That’s all I remember, until I woke in ICU. I was told I had seizures. Also I couldn’t move my legs. Seizures are permanent now. I have emailed and call gsk cdc and vaccine injury lawyers. Seems no one is interested. Hospital said I had pneumonia. Ha ! CDC said it’s wasn’t related to the vaccine.
JanetOctober 5, 2021 at 5:15 pm
My husband received the second dose of Shri Grix and within weeks started loosing strength, began shuffling when walking, falling. By July he gone. When he died he couldn’t move anything except his eyes. He was in three different hospitals. He took every treatment they could give him. I believe a total of 7 IVIGs, cleaning his blood plasma two times, and another treatment. They never should h[Show More]My husband received the second dose of Shri Grix and within weeks started loosing strength, began shuffling when walking, falling. By July he gone. When he died he couldn’t move anything except his eyes. He was in three different hospitals. He took every treatment they could give him. I believe a total of 7 IVIGs, cleaning his blood plasma two times, and another treatment. They never should have given it to him because he was a cancer survivor who had chemo and radiation which causes weakened immune system. Someone please help me find a way to make them accountable. I gave all his medical records from every hospital and records showing when he received the shots. No one should die like he did, no one! All hospitals say it presented as GBS
DennisAugust 20, 2021 at 5:35 am
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 minut[Show More]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.
DarylJuly 23, 2021 at 10:39 pm
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 caus[Show More]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.
DianeJuly 22, 2021 at 5:09 pm
My husband received the shingrix vaccine on 5/28/2021 and has been hospitalized since 5/31/2021 and diagnosed with GBS. Help!
MICHAELJuly 13, 2021 at 7:17 pm
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!
GaryJuly 13, 2021 at 1:16 am
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 web[Show More]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.
DONNAMay 30, 2021 at 7:07 pm
My husband was diagnosed with GBS 1 Month after getting the Shingles vaccine.
donnaMay 22, 2021 at 4:45 pm
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 law[Show More]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
JOYCEMay 20, 2021 at 7:02 pm
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.
ChrisMay 18, 2021 at 1:04 am
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?
CandaceApril 12, 2021 at 2:30 pm
I had the shiglix vaccine and diagnosed with GBS.hospitaLized for a week . How do I handle the covid vaccine?