Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test negative, Sensory loss, Vitamin B12 deficiency
Clinical narrative: GUILLAIN-BARRE SYNDROME; LOSS OF FEELING IN LEGS; TROUBLE BREATHING; NUMBNESS; TINGLING IN FINGER  AND HANDS; VITAMIN-B12 DEFICIENCY; NOT FEELING WELL; CHILLS; SORE ARM; "LITTLE REACTION"; This spontaneous report received from a consumer concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroid. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for hypothyroid.  On 19-MAR-2021, the patient had "little reaction" in first few hours after vaccination including chills and sore arm. On 01-APR-2021 (13 days post-vaccination), the patient was not feeling well and made an appointment with primary care physician.  On 03-APR-2021 (15 days post-vaccination), she woke-up feeling numbness in right hand and tingling in her fingers and hands and called a doctor and saw the doctor same day in office. While driving to the appointment, the symptoms progressed to numbness in left hand and both legs. The primary care physician examined the patient and recommended immediate evaluation in emergency room (ER). In the ER, tests were performed including CT scan. ER diagnosed was B12 deficiency, was treated for that and the patient was discharged. Symptoms got worse while in ER, and on way to home, the patient had something to drink and couldn't swallow it and she began losing feeling in her arm. On 04-APR-2021 (16 days post-vaccination), the patient woke up in the morning yelling that she couldn't "feel herself pee" and endorsed having trouble breathing and went back to the ER that day. She was assisted into a bed because she could not walk and her "Oxygen tanked to 85%. She was given oxygen. Two more MRIs and a CT scan were done to rule out anything. A spinal tap was done and the patient was admitted later that night and was assessed as "stable." The patient had no tick exposure and there was no concern for Lyme disease. On 5-APR-2021 (17 days post-vaccination), her husband came to know that, the patient had since been intubated and lost feeling in her legs. A neurologist explained that it was Guillain-Barre Syndrome and that they had ruled "everything else out and it was 99.9% sure derivative of the vaccine." At this point, the patient could only communicate with her eyes and was completely paralyzed otherwise. The patient was treated with intravenous immunoglobulin for 4 days and plan was to plasmapheresis (the husband thought so it was plasmapheresis). For next week, there was plan for tracheostomy and feeding tube placement. The patient had no recent illness, no recent colds, no history of COVID (including 2 negative tests in ER).  At the time of the report, the patient was in medical intensive care unit (fighting for her life, according to the husband). The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from Guillain-Barre Syndrome, numbness, tingling in finger and hands, trouble breathing, and loss of feeling in legs, and the outcome of vitamin-B12 deficiency, not feeling well, chills, sore arm and "little reaction" was not reported. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0: A 49-year-old woman with a history of hypothyroidism was hospitalized with Guillain-Barre Syndrome 16 days after vaccine. Symptoms began with right hand numbness 13 days after vaccine, then rapidly spread to all four extremities, and the patient was intubated within 48 hours of symptom onset. She was treated with intravenous immunoglobulin for 4 days without improvement. "Everything was ruled out on CT, MRI, and spinal tap" per the reporter (her husband) who stated the neurologist was "99.9% sure derivative of the vaccine."  The patient tested negative for Lyme disease, COVID, and "other causes." Contact has not yet been established with the treating team of physicians. This case has insufficient information to make a meaningful medical assessment.  Additional information has been requested, including information from the treating physicians.