Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram pelvis, Glycosylated haemoglobin increased, Hyperglycaemia, Insulin C-peptide
Clinical narrative: Transient hyperglycaemia; This literature-non-study case was reported in a literature article and describes the occurrence of HYPERGLYCAEMIA (Transient hyperglycaemia) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     Previously administered products included for Type 2 diabetes mellitus: Insulin in 2014 and glipizide in 2015. Past adverse reactions to the above products included No adverse event with Insulin and glipizide. Concurrent medical conditions included Type 2 diabetes mellitus since 2014, Hypertension, Hyperlipidemia and Weight loss (Over the previous year, he had also lost approximately 8 kg of weight for unexplained reasons.). Concomitant products included ATORVASTATIN for Hyperlipidemia, NIFEDIPINE and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HYDROCHLOORTHIAZIDE) for Hypertension, METFORMIN and DULAGLUTIDE for Type 2 diabetes mellitus.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERGLYCAEMIA (Transient hyperglycaemia) (seriousness criteria hospitalization and medically significant). The patient was treated with INSULIN GLARGINE for Type 2 diabetes mellitus, at a dose of 15 unit, qd; INSULIN GLARGINE for Type 2 diabetes mellitus, at a dose of 10 unit, qd and INSULIN ASPART for Type 2 diabetes mellitus, at a dose of 5 U with meals. At the time of the report, HYPERGLYCAEMIA (Transient hyperglycaemia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Anti-zinc transporter 8 antibody: was within the healthy range at <10 U/mL. On an unknown date, Antibody test: <5 IU/mL and normal at <1:4. On an unknown date, Blood glucose (Unknown-140 mg/dl): 400 mg/dl At the time of acute hyperglycemia episode and 398 mg/dl On admission to hospital after vaccination. On an unknown date, Body mass index: 23.5 kilogram per second per square metre. On an unknown date, Computerised tomogram pancreas: the pancreas did not reveal any pancreatic mass. On an unknown date, Computerised tomogram pelvis: the pelvis did not show a pelvic mass or infection.. On an unknown date, Glycosylated haemoglobin increased: 12.6 % a measure of the mean 90-day glucose level), which was increased from 6.5% as tested approximately 15 months and 22  months (February 2020 and August 2019) previously (healthy range <5.7%)., 10.5 % After 21 days, the patient's hemoglobin A1c decreased. and 6.2 % five months after that. On an unknown date, Insulin C-peptide (0.8-4.0 ng/mL): 0.9 ng/mL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HYPERGLYCAEMIA (Transient hyperglycaemia) to be related.  Company Comment: This literature-non-study case concerns a 76-year-old male patient, with well-controlled type 2 diabetes mellitus for 2 years, hypertension and hyperlipidemia, and excellent health behaviors, who experienced the unexpected and serious (due to hospitalization and medically significant) event of Hyperglycaemia, which occurred approximately 2 months after the second dose of mRNA-1273 vaccine. As reported, the patient presented to the clinic for follow-up care after having been discharged from the emergency department two months previously for an acute case of hyperglycemia. The patient went to the emergency department because his blood glucose levels were at approximately 400 mg/dL. In the emergency department, he had been given intravenous fluids, and when his blood glucose levels improved, he was advised to seek a follow-up evaluation. At the time of follow-up, the patient had a normal body mass index of 23.5 kg/m 2, and was taking metformin 1,000 mg twice daily for type 2 diabetes, which he had been taking for approximately seven years. Importantly, the patient reported that his blood glucose levels were normal at 100-140 mg/dL before having received the vaccinations and that the elevation in glucose started a few days after having received the second mRNA-1273 vaccine. Laboratory testing revealed elevated hemoglobin A1c at 12.6%, which was increased from 6.5% as tested approximately 15 months and 22 months previously (healthy range less than 5.7%). Computed tomography imaging of the pancreas and the pelvis were normal. The patient was prescribed dulaglutide 0.75 mg/mL weekly. The patient was admitted to an endocrinology clinic and evaluated for the possibility of type 1 diabetes. Glutamic acid decarboxylase antibodies were less than 5 IU/ml, islet cell antibody test was normal at less than 1:4, C-peptide was 0.9 ng/mL (reference range = 0.8-4.0 ng/mL), anti-zinc transporter 8 antibody was within the healthy range at less than 10 U/ml, and glucose was elevated at 398 mg/dL. The patient was then started on insulin glargine (15 U daily) and insulin aspart (5 U with meals) injections. The patient then went on to experience hypoglycemia with this regimen after 21 days. Therefore, preprandial insulin aspart was stopped, insulin glargine was decreased to 10 units daily, and dulaglutide was increased to 1.5 mg/mL weekly. After 21 days, the patient's hemoglobin A1c decreased to 10.5%, and five months after that to 6.2%, following which he was discharged from the endocrinology clinic. Physicians felt that there was a high likelihood that the patient's lack of glycemic control may have been secondary to vaccination. The patient was eventually tapered off all glycemic medications except for metformin. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Before vaccination, the patient went to the emergency department as his home glucose testing indicated elevated blood glucose levels. In the emergency department, he had been given an unspecified intravenous fluid. After his blood glucose levels improved, he was advised to seek a follow-up evaluation with his primary care provider. Patient daily took losartan hydrochlorothiazide (50-12.5 mg) for hypertension. He received insulin for a very short time and was transitioned to glipizide.   At the follow-up meeting in the family medicine clinic, the patient reported no recent changes in medication use, no changes in diet or exercise, no glucocorticoid use, and said that he had never tested positive for COVID-19. Seven days later, the patient was admitted to an endocrinology clinic and evaluated for the possibility of type 1 diabetes. Laboratory results did not indicate type 1 diabetes. The patient then went on to experience hypoglycemia with this regimen after 21 days. After 21 days, the patient's hemoglobin A1c decreased to 10.5%, and five months after that to 6.2%, following which he was discharged from the endocrinology clinic.   The patient was seen for a follow-up visit four months after discharge from the endocrinology clinic and reported having more energy and having gained back about 6 kg of weight. He reported continued regular exercise and consistent close monitoring of his blood glucose levels, which remained stable. The patient was eventually tapered off all glycemic medications except for metformin, and he was advised that he could receive a Moderna vaccine booster with close blood glucose monitoring; however, the patient was hesitant and stated that he would think about it.