Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: GUILLAIN-BARRE SYNDROME; This spontaneous report received from a patient via a company representative via traditional media news concerned a 46 year old female, race and ethnicity not reported. The patient's height, and weight were not reported. The patient's past medical history included several underlying conditions (no further information provided). The patient has a teen-age child. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The patient suffered no immediate side effects. A week post vaccination in APR-2021, her feet started to hurt and then her legs. Days later, she woke up with intense neck pain. After an hour, her face felt funny. Patient went to bathroom and looked in the mirror. Her face was completely frozen and droopy. A trip to hospital (date unspecified) produced no answers. Five days later, she was walking back from the bathroom, she fell and was completely paralyzed from waist down. In mid-MAY, an MRI and spinal tap revealed diagnosis of Guillain-Barre syndrome (GBS). Months later (date unspecified), patient's many symptoms have improved. The patient needs a walker and can only eat pureed foods. Her doctors have told her that her symptoms may disappear 'next week' but condition can be permanent. Since past few days (dates unspecified), patient's muscle weakness worsened and she may require blood transfusion and plasma replacement therapy. It was reported that the patient had many underlying conditions but none were associated with GBS.  According to the patient, the neurologist believed events were due to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The event Guillain-Barre syndrome was not recovered. This report was serious (Disability Or Permanent Damage).; Sender's Comments: V0: This spontaneous report from a patient via traditional media concerns a 46 year-old female with "many" unspecified underlying conditions who was diagnosed with Guillain-Barre Syndrome (GBS) in the month following vaccination with Janssen Covid-19 vaccine. Concomitant medications were not reported. The patient initially did not experience any adverse events. One week post-vaccination, she experienced pain in her feet and then in her legs. An unspecified number of days later, she awoke with intense neck pain and then her face became "completely frozen and droopy" one hour later. She went to the hospital but did not receive answers. Five days later, she fell while walking and was "completely paralyzed" from the waist down. An MRI and spinal tap performed on unspecified dates diagnosed GBS. Months later, many of her symptoms have improved but she still requires a walker and can only eat pureed foods. In the past few days, her muscle weakness has worsened which may require blood transfusion and plasma replacement therapy. The patient reported that her neurologist believes the events are due to the vaccine. Considering the missing information (e.g. medical history, MRI & cerebrospinal fluid results, corrective treatment) and the temporal relationship, the events are assessed to have an indeterminate relationship with vaccination.