Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: One doctor mentioned maybe it could be Guillen barre syndrome, but it was nothing definitive, not a definitive diagnosis; lower right arm cramped and in pain; All 5 of his digits in the right hand were numb. The 2 digits from the ulnar nerve are worse than the others. They are stiff, have less feeling, more numb/now in his lower right leg and knee.; The 2 digits from the ulnar nerve are worse than the others. They are stiff, have less feeling, and more numb.; lower right arm cramped and in pain; really bad carpal tunnel problem; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (One doctor mentioned maybe it could be Guillen barre syndrome, but it was nothing definitive, not a definitive diagnosis) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dialysis. Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (One doctor mentioned maybe it could be Guillen barre syndrome, but it was nothing definitive, not a definitive diagnosis) (seriousness criterion medically significant), MUSCLE SPASMS (lower right arm cramped and in pain), HYPOAESTHESIA (All 5 of his digits in the right hand were numb. The 2 digits from the ulnar nerve are worse than the others. They are stiff, have less feeling, more numb/now in his lower right leg and knee.), MUSCULOSKELETAL STIFFNESS (The 2 digits from the ulnar nerve are worse than the others. They are stiff, have less feeling, and more numb.), PAIN IN EXTREMITY (lower right arm cramped and in pain) and CARPAL TUNNEL SYNDROME (really bad carpal tunnel problem). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) at an unspecified dose and frequency. At the time of the report, GUILLAIN-BARRE SYNDROME (One doctor mentioned maybe it could be Guillen barre syndrome, but it was nothing definitive, not a definitive diagnosis), MUSCLE SPASMS (lower right arm cramped and in pain), HYPOAESTHESIA (All 5 of his digits in the right hand were numb. The 2 digits from the ulnar nerve are worse than the others. They are stiff, have less feeling, more numb/now in his lower right leg and knee.), MUSCULOSKELETAL STIFFNESS (The 2 digits from the ulnar nerve are worse than the others. They are stiff, have less feeling, and more numb.), PAIN IN EXTREMITY (lower right arm cramped and in pain) and CARPAL TUNNEL SYNDROME (really bad carpal tunnel problem) outcome was unknown.            It was reported that Patient mentions he is on dialysis, because his kidney function is not good. Because of this, he receive his booster dose.He did not have an immediate reaction, but 48-56 hours later, the symptoms he was feeling came back but with more intensity. The symptoms are now in his lower right leg and knee.  MRIs done, an EMG, which did not show anything significant.  One doctor mentioned maybe it could be Guillen barre syndrome, but it was nothing definitive, not a definitive diagnosis.  Company comment: This case concerns a 73 year-old male patient with a history of diabetes mellitus, on dialysis, who experienced the unexpected     adverse event special interest of Guillain-Barre syndrome, possibly. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable as no additional dosing will be administered. The medical history of diabetes mellitus and dialysis remain confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-383455.; Sender's Comments: This case concerns a 73 year-old male patient with a history of diabetes mellitus, on dialysis, who experienced the unexpected     adverse event special interest of Guillain-Barre syndrome, possibly. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable as no additional dosing will be administered. The medical history of diabetes mellitus and dialysis remain confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.