Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Computerised tomogram, Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: GUILLAIN-BARRE SYNDROME; CHILLS; LEGS HURT; NO ENERGY; FEELING SICK; This spontaneous report received from a patient concerned a 50 year old male. The patient's weight was 210 pounds, and height was 73 inches. The patient's past medical history included seizures (last on e25 years ago), and covid-19 infection in DEC-2020. Concurrent conditions included non smoker, and occasional alcohol use. The patient had no known allergies, no history of drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, expiry: 08-JUL-2021) on 21-JUN-2021 in the left arm at noon for prophylactic vaccination. Concomitant medications included carbamazepine.  On 22-JUN-2021, he started feeling sick (like he had COVID-19), he also experienced chills, legs hurt and no energy. The symptoms only lasted one day and resolved on 23-JUN-2021.  On 01-JUL-2021 the patient experienced Guillain-Barre syndrome (GBS) beginning with pain in his legs and back which was managed with ibuprofen (Advil). On 05-JUL-2021, his leg locked and he couldn't move it so we went to urgent care. The doctors assumed it was a pinched nerve. On 06-JUL-2021 the patient underwent  a computerised tomogram (CT) scan of his back which was fine. On 07-JUL-2021 "his legs fell out from under him" when trying to climb the stairs so he went to the Emergency Room (ER) and was admitted. The day after, he lost all feeling in his face and it was painful. On 08-JUL-2021 a CT scan was performed on his head which was also clear so they underwent 3 lumbar punctures (spinal taps) and found GBS. The patient was then admitted to hospital from 08-JUL-2021 to 20-JUL-2021 where he received intravenous immunoglobulins therapy for 5 days which didn't work and then plasma exchange for 5 days. He started to feel better but then worsened and was readmitted to a rehabilitation hospital. At the time of reporting, his facial muscles were not working, except the bottom lip, he was paralyzed from the waist down, he had minimal movement in his foot, with tingling in his feet, and severe back pain which was treated with ibuprofen (Motrin) and morphine 24/7. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, legs hurt, no energy, and feeling sick on 23-JUN-2021, and had not recovered from GBS.  This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a consumer concerns a 50-year-old male patient of unspecified ethnicity who was hospitalized for Guillain-Barre syndrome (GBS) 17 days after receiving the Janssen Covid-19 vaccine.  Patient had prior COVID infection 7 months prior, seizures (last attack was 25 years prior), and BMI of 27.7. Symptoms reported was pain in his legs and back 7 days prior to admission.  An urgent care consult was made when the patient reported "leg locked and he couldn't move"; CT scan of back was "fine".  1 days prior to admission, the patient reported "legs fell out from under him" while climbing stairs prompted emergency room consult and subsequent admission.  The patient also reported "lost all feeling in his face and it was painful".  Head CT scan was "clear"; lumbar puncture done "found GBS".  The patient was treated with  intravenous immunoglobulins therapy and plasma exchange.  At the time of reporting, his facial muscles were not working, except the bottom lip, he was paralyzed from the waist down (minimal movement in his foot), tingling in his feet, and severe back pain which was treated with ibuprofen and morphine.  No other pertinent information reported.  Information is limited in this case, and the occurrence of could represent background incidence in the general population. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.