Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Specific gravity urine, Urine ketone body, Weight, White blood cell count
Clinical narrative: Ketosis-Prone Diabetes Mellitus; Rapid Progression; admitted to the intensive care unit for diabetic ketoacidosis and prerenal acute kidney injury; This is a literature report for the following literature source(s)  A 69-year-old male with a past medical history of hypertension and prediabetes presented with worsening fatigue, polyuria, polydipsia, blurry vision, and 14 pounds of weight loss over three weeks. He also reported intermittent upper abdominal pain and episodic ambulatory lightheadedness for two weeks. He also reported a loss of taste and smell for two weeks with a diminished appetite. His home medications were irbesartan and chlorthalidone for hypertension; he also used to take aspirin intermittently. His family history was significant for some members with graves disease and celiac disease. He was a non-smoker with no alcohol or illicit drug use. On examination, he was afebrile with normal blood pressure, sinus tachycardia, and mild tachypnea. Physical exam was remarkable for mild upper abdominal tenderness and dry oral mucosa. Complete blood count was within normal limits; blood glucose was 750 mg/dl with serum sodium of 123 mmol/l (corrected sodium 133) and potassium 4.4 mmol/l; elevated anion gap of 29 with bicarbonate of 20 mmol/l; blood gas with pH 7.31; urine with glucosuria and 1+ ketonuria; and elevated creatinine (Table 1). He was admitted to the intensive care unit for diabetic ketoacidosis and prerenal acute kidney injury management and was placed on an insulin drip, intravenous normal saline, and potassium repletion [3]. Anion gap closed overnight and subsequently, and he was switched to basal-bolus insulin. His creatinine normalized with fluid repletion. His sodium level also improved with normal saline. Lab workup revealed hemoglobin A1c (HbA1c) of 13.7%, decreased c-peptide levels of 0.4 ng/ml (1.1-4.4) and elevated anti-GAD65 antibody level of 0.33 nmol/l (normal < 0.02). He never had autoimmune antibody checked prior to this admission as he was prediabetic with his last HbA1c 5.8% one year previously and was normal before. No infections were found with negative blood and urine cultures. He was transferred to the general floor on hospital day two after stabilization. His blood glucose was labile with daytime and nighttime excursions that required optimization of insulin dosing. On hospital day three, he reported persistent fatigue, which improved with the optimization of blood glucose by adjusting the dose of longacting glargine and short-acting lispro insulin. He was vaccinated with the messenger ribonucleic acid (mRNA) COVID-19 vaccine one year back, receiving his mRNA booster two months earlier. COVID-19 polymerase chain reaction (PCR) test was negative for this admission. He denied any history of COVID-19 infection in the past. His low-density lipoprotein (LDL) cholesterol was 104 mg/dl and triglycerides were 193 mg/dl. He was given diabetic education about new insulin-dependent diabetes mellitus and was discharged from the hospital with a basal-bolus insulin regimen optimized with a moderate-intensity statin. On a three-week endocrinology follow-up, his repeat HbA1c improved to 10.3%. He continues to be insulin dependent and regularly follows up with his physician.  No follow-up attempts are possible.; Sender's Comments: Based on the information provided in the literature article and close temporal relationship there is a reasonable possibility of causal association between the events Acute kidney injury, Disease progression, Ketosis-prone diabetes mellitus  with the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.