FDA labels Johnson & Johnson vaccine with new rare side effect

rare side effect, Guillain-Barré,
© Uladzimir Zuyeu

The FDA have labelled the Johnson & Johnson COVID vaccine as a possible cause of Guillain-Barré syndrome – an extremely rare side effect that can potentially cause nerve damage

Currently, there have been incidents of Guillain-Barré syndrome in 0.0008% of those vaccinated with Johnson & Johnson in the US. That works out at about 100 cases in 13 million people who took the vaccine, making this side effect extremely rare.

On 12 July, the US FDA added this note to the side effects section of the Johnson & Johnson vaccine: “Severe allergic reactions (including anaphylaxis), thrombosis with thrombocytopenia, Guillain-Barré syndrome, and capillary leak syndrome have been reported following administration of the Janssen COVID-19 Vaccine during mass vaccination outside of clinical trials.”

What is Guillain-Barré syndrome?

According to the NHS website: “The syndrome mainly affects the feet, hands and limbs, causing problems such as numbness, weakness and pain. It can be treated and most people will eventually make a full recovery, although it can occasionally be life-threatening and some people are left with long-term problems.”

Guillain-Barré syndrome is normally more common in adults and males, but the reports are coming from

What are the symptoms?

  • Numbness
  • Pins and needles
  • Muscle weakness
  • Pain
  • Problems with balance and co-ordination
  • Difficulty walking
  • Difficulty with facial movements, including speaking, chewing, or swallowing
  • Double vision or inability to move eyes
  • Difficulty with bladder control or bowel function.

If you experience any of the above symptoms, please seek medical attention. The FDA state that these effects could appear within the first 42 days of vaccination.

How could the vaccine cause Guillain-Barré syndrome?

The NHS, national health service in the UK, further explains that the syndrome has always been connected to vaccinations – long before the global pandemic. In 1976, a swine flu outbreak led to a vaccine that brought a small, increased risk of Guillain-Barré syndrome.

According to one study conducted over the 2009 swine flu outbreak, there were just two extra cases of the syndrome for every one million people vaccinated. The risk, both in the past and present, remains statistically extremely low.

The mRNA vaccines, like Moderna and Pfizer, are not impacted by this side effect – they use a different kind of biological mechanism to fight COVID-19.


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