Sex: M
Vaccine: COVID19, COVID19
Symptoms: HIV infection, Headache, Influenza like illness, Insomnia, Lumbar puncture
Clinical narrative: LYME'S-INDUCED GUILLAIN-BARRE SYNDROME; SHORT-TERM MEMORY LOSS; BURNING SENSATION WITH PAIN IN LEGS AND HIPS; INSOMNIA; LOW BACK PAIN; MASSIVE GUM INFECTION; FACIAL PARALYSIS; WOOD TICK BITE; HEADACHE; INTENSE FLU; This spontaneous report was received from a patient and concerned a 61 year old male. Initial information was processed with additional information obtained from the patient via telephone follow up on 05-AUG-2021. The patient's weight was 159 pounds and height was 70 inches. The patient's concurrent conditions included: non-smoker, wine drinker, marijuana user, and no known allergies. Other relevant history included no auto-immune diseases, no recent vaccinations, infectious illnesses, or hospitalizations, no family history of malignancies, neurologic or autoimmune diseases, no recent visit to forest or travel, and active lifestyle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 7/9/2021) dose was not reported, administered on 07-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the patient experienced intense flu-like feeling with body aches, nausea, headache and chills.  On 15-APR-2021, the patient had wood tick bite, "removed the tick and went on with the day." On 24-APR-2021, abruptly, the right side of his face was swollen and fingers were numb on both hands, as well as swollen gums on the bottom right inside the mouth. On 25-APR- 2021, the right side of his face was still swollen, also his fingers and toes on both sides were numb. On 26-APR-2021, the patient experienced facial paralysis. He could "swallow okay but not chew".  On 27-APR-2021, he had a dentist appointment, and the X-ray showed a massive right side infection in the gums. The patent was prescribed Amoxicillin K-Clav 500/125 mg and took it twice a day for ten days. The swelling did get better in his face/gums on the right side by 29-APR-2021, and then on 30-APR-2021, the facial numbness was gone, but he still had full facial paralysis, and his toes and fingers were still numb. On 30-APR-2021, the patient's hips and legs started burning, it would come and go mostly at night, so he couldn't sleep because of it. He also had bilateral weakness, pain in the lower back, and he still had a headache. On 03-MAY-2021, he went to the Emergency Room, and was treated  "like I had a stroke at first and then they thought it was all from a tick bite/Lyme's disease, but they were unaware of how to proceed since everything with the vaccine is so new, so they prescribed me Doxycycline."  By 06-MAY-2021, the patient had no energy, was always tired and couldn't sleep well, and it was hard for him to work or do anything at home.   On 07-MAY-2021, he went to his doctor to go over the results of the tests done at the Emergency Room. He was negative for Lyme's disease, but was told to continue Doxycycline for 21 days, and his last dose was on 26-MAY-2021. On 01-JUN-2021, he went to see a neurologist and was tested for Guillain-Barre Syndrome GBS). The neurologist was 99% sure it was GBS and ordered an MRI with "blue dye",  a spinal tap, bloodwork and an unspecified "nerve test"; result not provided. Neurologist prescribed Gabapentin for the hip burning and pain, which helped patient to sleep. There were "abnormal proteins in the bloodwork results".  Additional laboratory data included CT scan, ECG, and urinalysis; results not provided for all tests. His HIV status was negative and COVID-19 test was also negative.  On 09-JUN-2021, patient had numbness and pain on the left side of his ribs and neck and had nerve test done. Immunoglobulin infusions were ordered through the PICC line from 13-JUN-2021 to 17-JUN-2021.  On 18-JUN-2021, the neurologist told the patient that he had Lyme's induced Guillain-Barre syndrome.   At the time of report, the patient still had right-sided facial paralysis, both hands and feet were still numb, no more pain, a "weaker energy level than normal". He also added that for the last month, "it feels like my nervous system is almost short circuiting, like a shock feeling or a spasm all over my body, in all the areas affected." He had some difficulty with bowel movements but it resolved. Also he had blurry vision and no problems with breathing/chewing/swallowing. The whole time his balance was off, he had had a few falls, the last one was " just two days ago." He added that he had been experiencing short-term memory loss for "couple months for sure". He had been sleeping better.  The patient was referred to the clinic, he would like a second opinion about his diagnoses and these medical/health issues. Lyme disease was inconclusive, but was initially negative. The patient was not hospitalized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from facial paralysis, and the outcome of headache, massive gum infection, insomnia, Lyme's-induced Guillain-Barre syndrome, low back pain, short-term memory loss, burning sensation with pain in legs and hips and intense flu was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous case from a patient concerns a 61-year-old male who was diagnosed with Lyme's-induced Guillain-Barre syndrome (GBS) 73 days after receiving Janssen Covid-19 vaccine. Concurrent conditions included non-smoker, wine drinker, marijuana user, and no known allergies, auto-immune diseases, recent vaccinations, infectious illnesses, hospitalizations, or recent visit to forest or travel; he has an active lifestyle. No concomitant medications were reported. On post-vaccination day (PVD) 1, he experienced flu-like symptoms of bodyaches, nausea, headache, and chills.  PVD8, he noted a tick bite and removed the tick. PVD17, the right side of his face, mouth, and gums became abruptly swollen and his fingers were numb bilaterally. PVD18, toes were numb bilaterally. PVD19, facial paralysis with inability to chew began. PVD20, a dentist diagnosed right sided gum infection and prescribed amoxicillin-clavulanate. PVD23, facial swelling improved, but facial paralysis & extremity numbness persisted, and burning in hips and legs, back pain, and bilateral weakness started. PVD26, he went to the Emergency Room where he was prescribed doxycycline for 21 days for Lyme's disease; Lyme's test (post-amoxicillin clavulanate) was negative. PVD55, the patient consulted a neurologist; MRI, spinal tap, unspecified blood tests, a "nerve" test, CT scan, ECG, & urinalysis were performed but results not provided. HIV & Covid-19 tests were negative. Corrective treatments included gabapentin and immunoglobulin infusions on PVD68-72. On PVD73, the neurologist informed him that he had Lyme's induced GBS. As of the time of this report, the patient still had right-sided facial paralysis, bilateral extremity numbness, & decreased energy. Based on the available information which includes a neurologist's diagnosis after multiple tests, the relationship of the GBS to vaccine is assessed to be inconsistent.