Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: GUILLAIN-BARRE SYNDROME; This spontaneous report was received from a patient via news media article, via a company representative and concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) " about three months ago", dose and vaccination site were not reported, for prophylactic vaccination. Batch number was not reported. Company unable to conduct follow up to obtain batch number. No concomitant medications were reported.  On an unspecified date in JUN-2021, the patient experienced Guillain-Barre syndrome and was hospitalized (date unspecified). In JUN-2021, patient started feeling numbness and tingling in her hands and feet; "it was pretty fast moving up the legs to my hips where I was numb from the waist down and then your arms and your fingers". The patient went to different doctors and were told 'you are dehydrated' and  'you are fine'. Patient was told she had anxiety. Patient condition worsened, eventually affecting her ability to walk. She started falling and eventually ended up being paralyzed from the waist down. She went to the emergency room twice before she found out that she had Guillain-Barre syndrome.  After a spinal tap confirmed her diagnosis, she was hospitalized for 22 days, treated with unspecified medications and slowly regained feeling in her lower body. Patient underwent physical therapy "to learn how to walk again and how to sit". At the time of report, she was still using a walker to get around and still had numbness and tingling in her hands and feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from Guillain-Barre syndrome. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This spontaneous report from a patient via news media concerns a female of unknown age who was hospitalized and diagnosed with Guillain-Barre Syndrome (GBS) approximately 2 months after receiving the Janssen Covid-19 vaccine. Medical history and concomitant medications were not reported. Symptoms started with numbness and tingling in her hands and feet which moved quickly up the legs to her hips and she became numb from the waist down. She consulted different doctors but did not receive a diagnosis. Her condition worsened to point of affecting her ability to walk. She started falling and became paralyzed from the waist down. She went to the emergency room twice and received a spinal tap which confirmed her diagnosis of GBS. She was hospitalized for 22 days and received unspecified treatment.  She also underwent physical therapy to learn how to walk again and how to sit. At the time of report, she was still using a walker to get around and still had numbness and tingling in her hands and feet. Information is limited in this case (e.g. missing age, medical history, concomitant medications, diagnostic test results, corrective treatment). Therefore, the relationship of the event to vaccination is considered unclassifiable due to insufficient information.