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A case report revealed details about a person who developed Guillain-Barré syndrome (GBS) 10 days after receiving a COVID-19 vaccine in a clinical trial in Boston.

The patient, a 60-year-old woman with a history of migraines, received the Johnson & Johnson one-dose vaccine and recovered from GBS after intravenous immunoglobulin (IVIG) treatment, reported Anthony Amato, MD, of Harvard Medical School in Boston, and co-authors, in .

It's unlikely the vaccine caused GBS, Amato said.

"About 10 to 20 per million people get Guillain-Barré every year," he told MedPage Today. "Approximately one billion people worldwide are expected to be vaccinated against COVID-19. There could be thousands of cases of Guillain-Barré syndrome that will occur only by coincidence."

GBS is an acquired demyelinating polyneuropathy with an axonal variant, often beginning in the lower extremities and ascending over time, with loss of reflexes. Some cases start a few days or weeks after respiratory or gastrointestinal viral infection. Treatment often is IVIG or plasmapheresis. Diagnosis may include electromyography and nerve conduction studies; cerebral spinal fluid (CSF) may contain elevated protein but minimal or no cells.

Links between viral infection and Guillain-Barré are well recognized, but whether vaccinations increase GBS risk is less certain, noted Dennis Bourdette, MD, of Oregon Health and Science University in Portland, and Joep Killestein, MD, PhD, of Amsterdam UMC in The Netherlands, in an .

"Despite this uncertainty, the association of GBS with one vaccine contributed to the collapse of a national immunization program," they said, referring to the , vaccine in 1976.

"Subsequent epidemiological studies suggested that the H1N1 influenza vaccine may have increased the number of cases of GBS by ~1 per one million on a background incidence of 10-20 cases per million," Bourdette and Killestein wrote. If an H1N1 pandemic had occurred, fear of GBS may have influenced acceptance of the vaccine, they added.

"Today, we have a pandemic and we do not want fears arising among the public over the possibility that COVID-19 vaccines are causing GBS," they said.

Reports of two trial participants who developed GBS within weeks of receiving a COVID-19 vaccine injection -- one in the active arm and one in the placebo -- were in the Johnson & Johnson submitted to the FDA for emergency use authorization. The Neurology case report discussed the participant in the active arm.

The patient was in usual health when she received the vaccine in December 2020. Reverse-transcriptase–polymerase-chain-reaction (RT-PCR) assay for SARS-CoV-2 and antibody testing were negative at screening, and she had no respiratory or gastrointestinal illness at the start of the trial.

Ten days after vaccination, she developed painful aches in her back and legs. Four days after symptom onset, PCR assay for SARS-CoV-2 was negative.

The next day, she awoke with a headache, nausea, vomiting, and diplopia and she went to the hospital. Examination showed left eye esotropia on midline gaze and bilateral ocular abduction deficits, with intact strength, sensation, and reflexes.

Over the next 3 days, she developed lower extremity weakness and numbness, areflexia in her legs, and facial weakness. MRI of the lumbar spine showed enhancement of the cauda equina; brain MRI was normal. Lumbar puncture showed an increased opening pressure (29 cm H₂O), elevated CSF protein (140 mg/dL), nine nucleated cells, and normal glucose (63 mg/dL).

Nerve conduction studies 2 days after admission showed normal compound muscle action potentials and sensory nerve action potentials. Peroneal and posterior tibialis F-waves and H-reflexes were absent. Needle electromyography showed neurogenic recruitment in leg muscles. Antiganglioside antibodies were negative.

RT-PCR for SARS-CoV-2 was repeated twice during admission; both tests were negative. The patient received IVIG 2 g/kg over 2 days starting on the second day of admission. Her strength improved slowly and she was discharged to rehabilitation 10 days after admission.

As COVID-19 vaccinations continue, numerous adverse events will be reported and most won't have evidence of causality, Bourdette and Killestein noted. Neurologists should report cases of GBS and other autoimmune diseases occurring within 6-8 weeks after a COVID-19 vaccination even if causation is not suspected, they added.

"Temporal associations do not imply causality. There's no strong evidence to date that COVID vaccines cause Guillain-Barré," Amato said. "You would have to do large epidemiologic studies and surveillance studies to determine if there's an increased risk. And the benefits of the vaccine far, far, far outweigh the risk."

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