Guillain–Barré Syndrome Warning to be Added to Johnson & Johnson COVID-19 Vaccine

Rare cases of an autoimmune disorder known as Guillain–Barré syndrome appear to be linked to the Johnson & Johnson COVID-19 vaccine, according to updated warnings issued this week by the FDA. However, the overall risk with the one-dose vaccine are small, and health officials indicate it should not discourage people from getting the shot.

The FDA updated label warnings this week for the COVID-19 vaccine manufactured by Janssen, a subsidiary of Johnson & Johnson. An updated fact sheet will be provided for doctors and patients, indicating there may be a potential increased risk of Guillain–Barré syndrome, but that health experts have not established a causal relationship, meaning they cannot be sure the vaccine actually causes the condition.

Guillain–Barré syndrome is a neurological autoimmune disorder that causes damage to the body’s nerve cells. This can cause muscle weakness, paralysis, and in rare cases, death.

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According to the warning, the vaccine is associated with a three to five-fold increased risk of the disorder, and symptoms of the syndrome occur during a 42-day period after receiving the vaccine. Most of the cases have been reported about two weeks after getting the shot and appears most prevalent in men over the age of 50.

The new label warning states:

Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain–Barré syndrome during the 42 days following vaccination.

Officials with the U.S. Centers for Disease Control and Prevention (CDC) say about 100 cases related to the vaccine have been reported, with 95 of those cases requiring hospitalization. There was one death reported. However, most people fully recover from the disorder, and the number of cases represents a miniscule fraction of the 12 million doses of the vaccine administered in the U.S. to date.

No signs of Guillain–Barré syndrome risks have been found with either the Pfizer or Moderna vaccines, whose 321 million doses to date account for most of the COVID-19 vaccinations given in the U.S.

The disorder is often linked to vaccines, but the exact cause is unknown. Earlier this year, the FDA placed a similar warning on the Shingrix vaccine, which is given to prevent shingles.

The warning comes amid a resurgence of cases of COVID-19 nationwide, following months of declining infection rates and deaths due to the wide distribution of the three approved vaccines. Those increasing rates appear to be occurring almost entirely among the unvaccinated, and is being driven by the spread of the Delta variant of the virus, which is believed to have its origins in India, which is being hit hard by the pandemic.

Since last year, when the outbreak was first detected, the U.S. has seen 33.8 million cases of COVID-19 and more than 606,000 deaths.

The potential link between the Janssen vaccine and Guillain–Barré syndrome is expected to be discussed at an upcoming meeting of the CDC’s Advisory Committee on Immunization Practices.

3 Comments

  • MikeApril 8, 2022 at 6:31 pm

    I took the JnJ shot last June 21st 2021 By July 7 I was paralyzed for my waist down and neck up. Spent 8 weeks in either the hospital or rehab hospital. Then finally came homely to go back to the hospital with a blood clot in my lung... That shot ruined my life. Not to mention how painful this experience has been, ITs been 10 months now and my legs are still numb and face is still patricianly pa[Show More]I took the JnJ shot last June 21st 2021 By July 7 I was paralyzed for my waist down and neck up. Spent 8 weeks in either the hospital or rehab hospital. Then finally came homely to go back to the hospital with a blood clot in my lung... That shot ruined my life. Not to mention how painful this experience has been, ITs been 10 months now and my legs are still numb and face is still patricianly paralyzed , not to mention my eye sight is now crap. Stay away from the JnJ !!!

  • MichelleAugust 6, 2021 at 2:54 pm

    I had the JJ covid shot on April 12th, ended up in the ER on April 14th with severe heart racing, raised blood pressure, light headedness. They said it was just GERD, over the next few weeks it turned into sharp shooting pains deep within my arms and legs to where my doctor ordered and ultrasound that turned up no clots. From there it worsened to my right arm feeling like it weighed a ton and I [Show More]I had the JJ covid shot on April 12th, ended up in the ER on April 14th with severe heart racing, raised blood pressure, light headedness. They said it was just GERD, over the next few weeks it turned into sharp shooting pains deep within my arms and legs to where my doctor ordered and ultrasound that turned up no clots. From there it worsened to my right arm feeling like it weighed a ton and I would have to lift it with my other arm to roll over at night. I have suffered severe pain and numbness in my arms ever since. My legs are very weak and I suffer severe burning sensation in my skin that comes and goes throughout the day and night. Gone to the doctor 4 times and they do not have a diagnosis except myalgia and menopause, then the news came out about GBS but I cannot get into a neurologist until October! I'm living a life of hell right now. Do not get the JJ covid shot it is not worth it.

  • SAugust 1, 2021 at 3:59 pm

    I experienced distressing and significant pain, nerve tingling, crawling sensations, twitching and jumping everywhere from lower back to toes one minth after 2nd dose if Pfizer. Drs have no answers. Only thing that has helped allieviate is many accupuncture treatments. 63 year old female.

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