Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Chronic inflammatory demyelinating polyradiculoneuropathy, Guillain-Barre syndrome, Laboratory test
Clinical narrative: They diagnosed him with CIBP like a chronic GBS syndrome; They diagnosed him with CIBP like a chronic GBS syndrome; Within 2 Months he lost 75 pounds.; tested positive for COVID Disease; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (They diagnosed him with CIBP like a chronic GBS syndrome) and GUILLAIN-BARRE SYNDROME (They diagnosed him with CIBP like a chronic GBS syndrome) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Blood pressure high (controlled with medications,), Diabetes and High cholesterol. Concomitant products included METFORMIN for Diabetes, ATORVASTATIN for High cholesterol.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (They diagnosed him with CIBP like a chronic GBS syndrome) (seriousness criteria hospitalization and medically significant) and GUILLAIN-BARRE SYNDROME (They diagnosed him with CIBP like a chronic GBS syndrome) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced WEIGHT DECREASED (Within 2 Months he lost 75 pounds.) and COVID-19 (tested positive for COVID Disease). At the time of the report, CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (They diagnosed him with CIBP like a chronic GBS syndrome) and GUILLAIN-BARRE SYNDROME (They diagnosed him with CIBP like a chronic GBS syndrome) had not resolved and WEIGHT DECREASED (Within 2 Months he lost 75 pounds.) and COVID-19 (tested positive for COVID Disease) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood test: abnormal. In April 2021, Protein total: off the chart.. In April 2021, Red blood cell count: off the chart.. In April 2021, Rheumatoid factor: Rheumatoid numbers were off the chart. In April 2021, White blood cell count: off the chart.. In 2021, Laboratory test: annual physical and lab works 2 months before vaccination, and all lab works were normal.. On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (They diagnosed him with CIBP like a chronic GBS syndrome) and GUILLAIN-BARRE SYNDROME (They diagnosed him with CIBP like a chronic GBS syndrome) to be related. No further causality assessments were provided for WEIGHT DECREASED (Within 2 Months he lost 75 pounds.) and COVID-19 (tested positive for COVID Disease).    The patient had no other vaccines within 4 months of the Moderna vaccination. Prior to vaccination and during vaccination time he was on High Blood Pressure medications.  After the first shot, patient started having Fatigue and Strength loss. and trouble standing up. He had to grab to something and push himself up, to stand up. At the time they did not realize that it was caused by the vaccine. A little while later, he could not walk upstairs. They still did not realize that it was the vaccine. They had to hire help to assist him at work. Around April 2021, he did not have muscle strength and realized it was caused by vaccine. He had Muscle pain in Calf and Tighes. The doctor took him off of Statin drugs. His situation got worst. The doctor did Blood Test in APR2021 and called the patient asking him to go to the Emergency Room right away. Almost all of his tests were abnormal. Patient had an annual physical and lab works 2 months before vaccination, and all lab works were normal. And 2 months later, all numbers on lab works were off the chart. They visited Neurologist, Rheumatologist and Oncologist, back and forth. The patient was taken to hospital and admitted him with critical condition. They diagnosed him with CIBP like a chronic GBS syndrome. They meditated him. It never reversed. He was still disabled and he could no longer work. As a result, he received IVIG blood transfusion 2 days a month. Patient was tested positive for COVID Disease after his diagnosis while spending only 1 day in rehab around 19JUL2022.   This case was linked to US-MODERNATX, INC.-MOD-2023-748820 (Linked Report).  Company Comment: This is a spontaneous case concerning a 65-year-old male patient with a history of Blood pressure high, Diabetes and High cholesterol, who experienced the serious (due to medically significant and hospitalization) unexpected, AESI events of chronic inflammatory demyelinating polyradiculoneuropathy and Guillain-barre syndrome, which occurred on an unknown date after a dose of mRNA-1273 vaccine. Patient received 3 doses of mRNA-1273 vaccine. After the first shot, patient started having fatigue, strength loss, and trouble standing up. He had to grab to something and push himself up, to stand up. A little while later, he could not walk upstairs. They had to hire help to assist him at work. On the following month after first vaccine, he did not have muscle strength. He had Muscle pain in Calf and Tighes. The doctor took him off Statin drugs. His situation got worst. The doctor did Blood Test and sent him to the Emergency Room. Almost all his tests were abnormal (Blood test, protein, rheumatoid factor). Patient had an annual physical and lab works 2 months before vaccination, which were normal. They visited Neurologist, Rheumatologist and Oncologist. The patient was taken to hospital and admitted him with critical condition. They diagnosed him with CIBP like a chronic GBS syndrome. They meditated him. It never reversed. He was still disabled, and he could no longer work. As a result, he received IVIG blood transfusion 2 days a month. The outcome of the events was reported as not recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748820:Wife case (tracking only)