Sex: M
Vaccine: COVID19
Symptoms: Body mass index, Body temperature, Decreased appetite, Diabetes mellitus, Glycosylated haemoglobin
Clinical narrative: RAPID AND SEVERE WORSENING OF DIABETES AFTER THE J&J COVID VACCINE ADMINISTRATION; SEVERE HYPERGLYCEMIA; ANOREXIA; FLU LIKE SYMPTOMS\FELT WARM WITHOUT FEVER; INSOMNIA; ANXIOUS; MILD HYPONATREMIA; HYPOCHLOREMIA; WEAK; This spontaneous report was received from literature. This report concerned a 55 year old male. The patient's weight was 53.6 kilograms, and height was not reported.  The patient's past medical history included developed ventricular tachycardia at age 35, congestive heart failure at age 42. He was found to have normal coronary arteries during the heart transplant evaluation. He received an orthotopic heart transplant at age 49 (transplanted heart functioned well). Histology of the native heart showed non ischemic cardiomyopathy and myofibrillar myopathy due to c.571 G C mutation in the MYOT gene, and concurrent conditions included ventricular tachycardia, and controlled mild diabetes, and other pre-existing medical conditions included the patient had no known diabetic complications and patient had family (siblings) history of diabetes. The patient was previously treated with prednisone for transplant immunosuppression.   The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included metformin for controlled mild diabetes, mycophenolate mofetil for transplant immunosuppression, tacrolimus for transplant immunosuppression, acetylsalicylic acid, gabapentin, magnesium oxide, mexiletine, and rosuvastatin.  On an unspecified date, the patient visited the endocrine clinic urgently for severe hyperglycemia. Four weeks before presentation, the patient had received the vaccine. A few days later, he developed flu-like symptoms, he felt warm without fever, weak, sleepy, and anorexic and he had to sleep most of the day. These symptoms lasted for a few days then abated. Most of the same symptoms recurred a few days later, in addition he developed insomnia even though he was tired, polyuria, and thirst, and lost 9 lbs. The patient's fasting glucose readings had ranged between 130-150 mg/dL (normal 65-99) before he received the vaccine. The fasting glucose rose to 200 mg/dL one day after the vaccine administration and gradually rose to 400 over the next few weeks. On the morning of the presentation, a routine blood test showed fasting glucose of 422 mg/dL. The patient was asked to go to the endocrine clinic immediately for advice. The patient had developed ventricular tachycardia at age 35 and congestive heart failure at age 42. He was found to have normal coronary arteries during the heart transplant evaluation. He received an orthotopic heart transplant at age 49, six years before the current presentation. Histology of the native heart showed nonischemic cardiomyopathy. His immunosuppression regimen initially consisted of prednisone, mycophenolate, and tacrolimus but prednisone was tapered off several months later. The transplanted heart functioned well. The patient had normal hemoglobin A1c (5.2, normal C mutation in the MYOT gene. The patient's medications at the current presentation included aspirin 81 mg daily, gabapentin 300 mg twice daily, mexiletine 150 mg twice daily, rosuvastatin 5 mg tablet three times weekly, magnesium oxide 400 mg twice daily, metformin 500 mg twice daily, mycophenolate 250 mg twice daily, and tacrolimus 3 mg twice daily. At the endocrine clinic, the patient appeared anxious and thin but was in no acute distress. The patient denied abdominal pain. The patient's temperature was 36.5 °C (97.7 °F), blood pressure 114/80 mmHg, heart rate 104 beats/minute, weight 53.6 kg, and body mass index (BMI) 19.67 kg/m². He had moist mucosa. Auscultation revealed tachycardia and clear lungs. The patient had no lower extremity edema. Point-of-care glucose was 382 mg/dL and A1c 13.0. The same blood specimen which showed glucose of 422 mg/dL also showed mild hyponatremia and hypochloremia but normal creatinine, bicarbonate, and anion gap. Additional tests were added to the existing blood specimen collected earlier that day. Amylase and lipase levels were normal; insulin and C-peptide levels were in the low normal range, which showed ß cell function deficiency in the face of severe hyperglycemia. ß cell autoantibodies including those against glutamic acid decarboxylase-65, ICA-512, and insulin were tested but the results were not immediately available. The patient was deemed stable enough to be managed as an outpatient. Insulin glargine 10 units daily and insulin lispro 5 units before each meal were started and metformin was held. In two days, Insulin glargine dose was raised to 15 units daily and insulin lispro to 7 units. A week later, he was seen at the endocrine clinic again. He felt much better and regained 1-2 lbs. ß cell autoantibodies were all negative. Fasting glucose levels were 137-150 mg/dL and daytime glucose 273 to 330 mg/dL. Insulin glargine dose was raised to 18 units daily and insulin lispro to 10 units. On the last follow-up 16 days after the urgent endocrine clinic visit, his glycemia was well controlled with insulin glargine 30 units daily and insulin lispro 10 units before each meal. The patient felt that he had been back to his baseline health before receiving the vaccine. Laboratory data (dates unspecified) included: Amylase (NR: 31 - 124) 56 U/L, Anion gap (NR: 8 - 19) 12 mmol/L, 13 mmol/L, Anti-glutamic acid decarboxylase antibody (NR: 0.0 - 5.0) less than 5.0 IU/mL, Anti-insulin antibody (NR: 0.0 - 0.4) less than 0.4 U/mL, Anti-islet cell antibody (NR: 0.0 - 7.4) less than 5.4 U/mL, Auscultation (NR: not provided) revealed tachycardia and clear lungs, Autoantibody test (NR: not provided) negative, Bicarbonate (NR: 20 - 30) 27 mmol/L, 24 mmol/L, Blood glucose (NR: not provided) 382 mg/dL, Blood pressure (NR: not provided) 114/80 mmHg, Blood urea nitrogen (NR: 7 - 22) 17 mg/dL, 29 mg/dL, Body mass index (NR: not provided) 19.67 kg/m2, Body temperature (NR: not provided) 36.5 C, Calcium (NR: 8.6 - 10.4) 9.3 mg/dL, 9.5 mg/dL, Chloride (NR: 96 - 106) 95 mmol/L, 102 mmol/L, Creatinine (NR: 0.60 - 1.30) 0.97 mg/dL, 0.89 mg/dL, Fasting blood glucose 130-150 mg/dL, 200 mg/dL, 400 mg/dL, 422 mg/dL, Fasting blood glucose (NR: not provided) 137-150 mg/dL, 113-145 mg/dL, Glucose (NR: not provided) 273 to 330 mg/dL, Glucose (NR: 65 - 99) 422 mg/dL, 145 mg/dL, HbA1C (NR: 5.2 - 5.7) 6.6 %, 5.9-7.6 %, 6.5 %, 13.0 %, 6.7 %, 6.7 %, 6.1 %, 8.4 %, normal, Heart rate (NR: not provided) 104 beats/minute, Insulin (NR: 3 - 25) 6 uU/mL, Insulin C-peptide (NR: 1.1 - 4.3) 2.3 ng/mL, Lipase (NR: 9 - 63) 49 U/L, Magnesium (NR: 1.4 - 1.9) 1.6 mEq/L, 1.6 mEq/L, Postprandial hyperglycemia (NR: not provided) 200-300 mg/dL, Potassium (NR: 3.6 - 5.3) 4.6 mmol/L, 5.3 mmol/L, Sodium (NR: 135 - 146) 139 mmol/L, 134 mmol/L, Weight (NR: not provided) 53.6 kg, and (NR: not provided) regained 1-2 lb. Treatment medications (dates unspecified) included: insulin glargine, and insulin lispro. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild hyponatremia, and hypochloremia, was recovering from severe hyperglycemia, and the outcome of flu like symptoms\felt warm without fever, anorexia, rapid and severe worsening of diabetes after the j&j covid vaccine administration, weak, insomnia and anxious was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210754168-Covid-19 vaccine ad26.cov2.s - Rapid and severe worsening of diabetes after the J&J covid vaccine administration, severe hyperglycemia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).