Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: diagnosed with GBS Guillain-Barré/completely paralyzed/She could not walk/Her feet turned into neuropathy/experience imbalance in her walking/joints are a lot more difficult/now experiencing severe pain ever since the shot with her feet.; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (diagnosed with GBS Guillain-Barré/completely paralyzed/She could not walk/Her feet turned into neuropathy/experience imbalance in her walking/joints are a lot more difficult/now experiencing severe pain ever since the shot with her feet.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034B21A and 006B21A) for COVID-19 vaccination.     The patient's past medical history included Disability. Concurrent medical conditions included Depression.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced GUILLAIN-BARRE SYNDROME (diagnosed with GBS Guillain-Barré/completely paralyzed/She could not walk/Her feet turned into neuropathy/experience imbalance in her walking/joints are a lot more difficult/now experiencing severe pain ever since the shot with her feet.) (seriousness criteria hospitalization, medically significant and life threatening). The patient was treated with GABAPENTIN for Neuropathy, at a dose of 1 dosage form; LUMATEPERONE TOSYLATE (CAPLYTA) at a dose of 1 dosage form and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) at a dose of 1 dosage form. At the time of the report, GUILLAIN-BARRE SYNDROME (diagnosed with GBS Guillain-Barré/completely paralyzed/She could not walk/Her feet turned into neuropathy/experience imbalance in her walking/joints are a lot more difficult/now experiencing severe pain ever since the shot with her feet.) had resolved with sequelae.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   After her second shot, three days later 18April2021 she experience imbalance in her walking. She could not walk. By Tuesday, she was completely paralyzed. She could not walk at all. On 20-April-2021 patient was taken to the ER and placed in intensive care for 2 weeks. Which was reported as so severe and thought that patient may dead. She was later diagnosed with GBS Guillain-Barré which traveled from bottom of her feet to the respiratory system. She had to go to rehab facility to learn to walk again and get her strength back. This took 2 months of rehab for her to walk again. It was most frightening experience she ever had. She did home healthcare for 4 weeks. She is now experiencing severe pain ever since the shot with her feet. Her feet turned into neuropathy. The eurologist gave her Gabapentin (did not help) and aqua therapy (somewhat helped). Neuropathy is still there. Her joints are a lot more difficult.   She was completely healthy before the vaccine. Everyday she is in pain in her feet.  Treatment: Aquatherapy,  Company Comment : This spontaneous case concerns a 61-year-old female, with no relevant medical history, who experienced the serious (life threatening, hospitalization, medically significant) unexpected AESI of Guillain-Barre Syndrome. Patient received 2 doses of mRNA 1273 COVID-19 Vaccine with 31 days interval between 2 doses. Three days after the second dose of mRNA 1273 COVID-19 vaccine, patient experienced imbalance while walking, and then had complete paralysis and could not walk. Five days after the vaccine, patient was sent to the Emergency room and was diagnosed with Guillain-Barre Syndrome which has affected her lower extremities up to her respiratory system. She stayed in the intensive care unit for 2 weeks. No information regarding diagnostics was provided. Patient had rehabilitation for 2 months to gain strength and be able to walk again and home health care for 4 weeks. Patient is still experiencing pain in her feet and some neuropathy. Patient was given Gabapentin, Caplyta and Protonix as treatment medications and Aquatherapy for rehabilitation. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 61-year-old female, with no relevant medical history, who experienced the serious (life threatening, hospitalization, medically significant) unexpected AESI of Guillain-Barre Syndrome. Patient received 2 doses of mRNA 1273 COVID-19 Vaccine with 31 days interval between 2 doses. Three days after the second dose of mRNA 1273 COVID-19 vaccine, patient experienced imbalance while walking, and then had complete paralysis and could not walk. Five days after the vaccine, patient was sent to the Emergency room and was diagnosed with Guillain-Barre Syndrome which has affected her lower extremities up to her respiratory system. She stayed in the intensive care unit for 2 weeks. No information regarding diagnostics was provided. Patient had rehabilitation for 2 months to gain strength and be able to walk again and home health care for 4 weeks. Patient is still experiencing pain in her feet and some neuropathy. Patient was given Gabapentin, Caplyta and Protonix as treatment medications and Aquatherapy for rehabilitation. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.