Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bell's palsy, Blood test, Computerised tomogram, Guillain-Barre syndrome
Clinical narrative: GUILLAIN BARRE SYNDROME; LEFT AND RIGHT  SIDE OF THE FACE - BELL'S PALSY; TWITCHES; NERVE PAIN IN BILATERAL FEET AND HAND; TINGLING OF FEET AND HANDS; LOWER AND MIDDLE BACK PAIN; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight was 175 pounds, and height was 61 centimeters. The patient's was a non smoker, non drinker, allergies included bee allergy (she carries an Epipen), environmental and dust mite allergy. There was no history of drug abuse or illicit drug use. The patient did not have any current medical conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029) on 31-MAR-2021 for prophylactic vaccination. Concomitant medications included ergocalciferol, lactobacillus acidophilus, and vitamins nos.  On 16-APR-2021 the patient started experiencing a constant ache in her lower back near the sacrum, with a 4/10 on a the pain scale. At night the pain worsened and also included a stabbing middle back pain, with a 9-10/10 on the pain scale. She couldn't sleep, couldn't stand or sit. There was no relief even after taking Tylenol and ibuprofen.  On 21-APR-2021, she developed Bell's Palsy on the left side of her face. She was drinking water and it fell out of the side of her mouth. She went to the hospital for evaluation and the doctors suspected that she had been bitten by a tick. Blood work was done to assess for a tick bite as well as a computerised tomogram (CT) scan of the head to rule out a stroke. Both results came back normal and additional blood work was sent to a larger facility for further tick bite testing. She was discharged home from the Emergency Room (ER) with prescriptions for prednisone for 1 week, 10 day course of penicillin, and tramadol every 4-6 hours for the pain as needed.  On 22-APR-2021 or 23-APR-2021 she attended the hospital again. This time the right side of her face was affected with Bell's palsy in addition to the left side. Blood work was performed which came back normal. The doctors believed the symptoms were related to a tick bite. She received an injection for the back pain which she believed was tramadol but did not provide any relief. She was discharged home with a prescription for hydrocodone to be taken for pain as needed. She received the same follow-up advice and was advised to continue with the steroid, antibiotic and pain medications.  The left sided Bell's palsy resolved on 25-APR-2021 or 26-APR-2021. On 24-APR-2021 or 25-APR-2021 the patient visited hospital due to back pain, the severity of which had prevented her from sleeping for days. She arrived at 3:00 am and was discharged by 9:00 am. She received Intravenous morphine and a ketamine infusion for 1 hour. This provided instant relief and she was able to sleep. Blood work was done and was normal. Upon discharge she was advised to stop the tramadol and she instead received a prescription for oxycodone. She was advised to take the oxycodone if the hydrocodone didn't work. The patient stated that at this time, she felt great and hopeful that entire day until the back pain retuned at night.  On 26-APR-2021 she retuned to hospital due to the severity of the back pain. Middle and lower back pain had returned at a 9-10/10 pain level. She received an injection of tramadol which didn't provide relief. She was discharged home and the ER doctor suggested physiotherapy. She as seen by her primary care provided the same day, a nurse practitioner (NP). The NP prescribed 10 morphine pills. At this point the Bell's palsy was resolving.  On 28-APR-2021 or 29-APR-2021, she visited the hospital again for back pain and received a shot of morphine and was then discharged home. The ER physician recommended a neurologist.  On 29-APR-2021, the patient noticed that her hand writing was messier and she had a hard time writing. She began dragging her right foot when walking and on 30-APR-2021 she was unable to step onto a curb and couldn't drag either leg when getting into the car. She lost sensation and movement in both legs from the knee down. Initially her right leg was worse than the left but eventually they were the same. On 01-MAY-202 she fell because her left leg "gave out". The same day she underwent a magnetic resonance imaging (MRI) scan on her head/back.  Right sided Bell's palsy resolved on 01-MAY-2021 or 02-MAY-2021.  On 03-MAY-2021 the patient spoke to her NP and discussed her concerns that her symptoms may be Guillain-Barre syndrome. She was advised to go to the ER. She was admitted to hospital and she received an intravenous injection for pain.  A neurologist tested her reflexes; she was told her reflexes were absent from the knees down in both legs. This was tested on either the 03-MAY-2021 or 04-MAY-2021 and worsened on 04-MAY-2021. A lumbar puncture (Spinal tap) was performed on 04-MAY-2021 which confirmed Guillain-Barre syndrome (GBS) and a 5 day course of treatment (unspecified) was started.  On 04-MAY-2021 she experienced the worst back pain, during hospitalisation she received intravenous hydromorphone hydrochoride (Dilaudid) every 6 hours and intravenous hydrocodone every 4 hours. she had some relief after the first day and gained some mobility back but had the same back pain. During the 5 days of treatment, she noticed relief. By the time she was discharged, on 09-MAY-2021, she was able to walk again with the help of a cane. She received physiotherapy whilst in hospital and has continued with treatments since discharge. The stabbing pain in the middle of the back resolved during the 5 days of treatment, approximately 06-MAY-2021 but she stated that her lower back is still achy but physiotherapy has helped. Her lower back pain comes and goes at 2-3/10 pain level and she currently takes ibuprofen as needed for prevention before periods of activity.  The reported developing nerve pain on an unspecified date, in both feet describing the feeling like "when you sit on your foot for too long then the feeling returns initially". The pain started during the 5 days of treatment once feeling and mobility returned to her legs. The pain has improved over time but both feet remain tingly with the left foot feeling worse. Her movement is still impaired but she can still get around the house despite feeling shaky when using the stairs. She also experienced nerve pain in her hands during the treatment which she believes may have started sooner when her hand writing appeared messy. Her hands have improved and the nerve pain "comes and goes in stages" The pain has resolved but her hands feel tingly and a "little asleep". She also noticed her thumb and finger grip is weaker. The patient also experienced twitches in bilateral hands and legs, her face and "all over". Onset date was unspecified. The twitches "come and go" and occur 1 to 20 times per day.  The patient stopped using a cane on 09-JUN-2021. The patient did not have a plan for follow-up with a neurologist. She did not see the neurologist in July. The neurologist in the hospital said that follow-up is not needed unless issues arise. The pain doctor that the patient was seeing wanted to keep an eye on the back pain in case it was not related to GBS, or if the GBS had exacerbated a previous condition. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left and right side of the face - bell's palsy on 02-MAY-2021, was recovering from Guillain-Barre syndrome; nerve pain in bilateral feet and hand, tingling of feet and hands, and lower and middle back pain, and the outcome of twitches was not reported.  This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:  This spontaneous report from a patient concerns a 46-year-old female who developed Guillain-Barre Syndrome (GBS) which was diagnosed 34 days after receiving the Janssen COVID-19 vaccine. Symptom of lower back pain began 16 days post-vaccine which became severe and intractable over 13 days; she then developed bilateral Bell's palsy 21 days post-vaccine and lost sensation and movement below her knees 30 days post-vaccine, prompting hospitalization 34 days post-vaccine.  Reflexes were absent from the knees down and spinal tap confirmed GBS.  She underwent an unspecified course of treatment, received pain medication and physiotherapy, and was discharged on the 7th hospital day. She also developed nerve pain, tingling of the hands and feet, and muscle twitches.  Bell's palsy resolved and she is recovering from the remaining events.  Information regarding other potential etiologies was insufficient, and the occurrence of the events could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.