Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Diabetes mellitus inadequate control, Dyspnoea, Dysstasia, Incoherent
Clinical narrative: Keeps getting paralyzed on his right side/has no function on his right side at random times; total collapse in his sugar levels and his being having trouble controlling his sugars ever since/he cannot get it under control/he was at 68 and suddenly, his sugar level plummeted to the 40s; Can't stand up; Legs turn into jelly; his feet are tingly, as well as his hands; Very sleepy; Very sluggish; incoherent; shortness of breath; cheeks and mouth tingly; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Keeps getting paralyzed on his right side/has no function on his right side at random times) and DIABETES MELLITUS INADEQUATE CONTROL (total collapse in his sugar levels and his being having trouble controlling his sugars ever since/he cannot get it under control/he was at 68 and suddenly, his sugar level plummeted to the 40s) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 011M2DA and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN ASPART (NOVOLOG) and LISINOPRIL for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, the patient experienced PARALYSIS (Keeps getting paralyzed on his right side/has no function on his right side at random times) (seriousness criterion medically significant), DYSSTASIA (Can't stand up), PARAESTHESIA (his feet are tingly, as well as his hands), SOMNOLENCE (Very sleepy), SLUGGISHNESS (Very sluggish), INCOHERENT (incoherent) and DYSPNOEA (shortness of breath). 30-Sep-2021, the patient experienced DIABETES MELLITUS INADEQUATE CONTROL (total collapse in his sugar levels and his being having trouble controlling his sugars ever since/he cannot get it under control/he was at 68 and suddenly, his sugar level plummeted to the 40s) (seriousness criterion medically significant), MUSCULAR WEAKNESS (Legs turn into jelly) and PARAESTHESIA ORAL (cheeks and mouth tingly). At the time of the report, PARALYSIS (Keeps getting paralyzed on his right side/has no function on his right side at random times), DIABETES MELLITUS INADEQUATE CONTROL (total collapse in his sugar levels and his being having trouble controlling his sugars ever since/he cannot get it under control/he was at 68 and suddenly, his sugar level plummeted to the 40s), DYSSTASIA (Can't stand up), MUSCULAR WEAKNESS (Legs turn into jelly), PARAESTHESIA (his feet are tingly, as well as his hands), SOMNOLENCE (Very sleepy), SLUGGISHNESS (Very sluggish), INCOHERENT (incoherent), DYSPNOEA (shortness of breath) and PARAESTHESIA ORAL (cheeks and mouth tingly) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Oct-2021, Blood glucose: 68 (Low) 68 and 40s (Low) sugar level plummeted to the 40s.         On the night of vaccination patient had total collapse in sugar levels and had troubling in controlling them. Even with Dexcom and Insulin pump he could not get it under control. He did not take any medications for his symptoms as he was on insulin  and very careful about possible drug-interactions.  Treatment information was not provided.  Company comment This case concerns a 37-year-old, male patient with relevant medical history Type I diabetes mellitus, who experienced the serious unexpected events of PARALYSIS, DIABETES MELLITUS INADEQUATE CONTROL; non-serious expected events of DYSSTASIA, PARAESTHESIA, PARAESTHESIA ORAL, SOMNOLENCE, SLUGGISHNESS, INCOHERENT, DYSPNOEA, and MUSCULAR WEAKNESS was also reported. The events occurred the same day after the booster dose of Spikevax. The medical history of type I diabetes mellitus remains a confounder. The rechallenge was assessed as not applicable as the AEs occurred after the booster dose and we are not expecting another dose. The benefit -risk relationship of mRNA-1273  (Spikevax) is not affected by this report.   This case was linked to MOD-2021-346598, MOD-2021-347110 (Patient Link).; Sender's Comments: This case concerns a 37-year-old, male patient with relevant medical history Type I diabetes mellitus, who experienced the serious unexpected events of PARALYSIS, DIABETES MELLITUS INADEQUATE CONTROL; non-serious expected events of DYSSTASIA, PARAESTHESIA, PARAESTHESIA ORAL, SOMNOLENCE, SLUGGISHNESS, INCOHERENT, DYSPNOEA, and MUSCULAR WEAKNESS was also reported. The events occurred the same day after the booster dose of Spikevax. The medical history of type I diabetes mellitus remains a confounder. The rechallenge was assessed as not applicable as the AEs occurred after the booster dose and we are not expecting another dose. The benefit -risk relationship of mRNA-1273  (Spikevax) is not affected by this report.