Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Diabetes mellitus inadequate control
Clinical narrative: blood sugar started raising significantly/no control over her blood sugar; This spontaneous case was reported by a patient and describes the occurrence of DIABETES MELLITUS INADEQUATE CONTROL (blood sugar started raising significantly/no control over her blood sugar) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051b22a, 014f21a, 008b21-2a and 012a21a) for COVID-19 vaccination.  Concurrent medical conditions included Drug allergy (Demerol) and Diabetic. Concomitant products included GLYBURIDE for an unknown indication.  On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced DIABETES MELLITUS INADEQUATE CONTROL (blood sugar started raising significantly/no control over her blood sugar) (seriousness criterion medically significant). The patient was treated with INSULIN at an unspecified dose and frequency. At the time of the report, DIABETES MELLITUS INADEQUATE CONTROL (blood sugar started raising significantly/no control over her blood sugar) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, Blood glucose: Increased and extremely high, still in the 200 and 300s.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had not ever tested positive for COVID-19 and not had any acute illness at the time of vaccination and up to 1 month before and did not received any vaccine one month prior to moderna covid-19 vaccine.  The event caused the patient to seek medical care, patient just went to her doctor. The patient had sugar incidents related to food intake but never a reaction like that to a vaccine. The symptoms were the same, patient was still 95 percent of the time in the 200s or 300s of her blood sugar including while being in new medication. Patient stated the day after received the 2nd booster dose patient's blood sugar started raising significantly. Patient was diabetic and 3 weeks after receiving the 2nd booster patient still had no control over blood sugar. Patient's doctors tried insulin and new medication and patient  was going throw a very strict diet but the blood sugar was still in the 200 and 300s. Patient stated that had damaged to patient's body by not having blood sugars regulated. Patient further stated that patient had done some research. And that said yes, vaccines and boosters could raise blood sugar, So patient tried to find out if there's any data anywhere that said a lot of people were experienced that  and was normal. That would go away or else the patient though patient might been one of the people that had a reaction to the vaccine and patient's life now forever changed. Patient also reported that information that was read on the Internet said that if anyone experienced high blood sugar after a few days, to contact doctor for medical advice to make dosage adjustments.  Patient had a continuous glucose monitor on her arm of her blood sugar, patient stated that blood sugar started to get higher and higher, and the third day after receiving the 2nd booster that was extremely high, from that point on no matter patient ate, and had an alert that the sugar was in the 200s.  Company Comment: This spontaneous case concerns a 53-year-old female patient, with relevant medical history of Diabetes, who experienced unexpected, serious (medically significant) event of Diabetes mellitus inadequate control 1 day after vaccination with a fourth dose of mRNA-1273. The patient reported that after getting her second booster, her blood sugar started raising significantly despite using insulin and being on a very strict diet. The outcome of the events was reported as not resolved. The relevant medical history of Diabetes a contributory factor to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 53-year-old female patient, with relevant medical history of Diabetes, who experienced unexpected, serious (medically significant) event of Diabetes mellitus inadequate control 1 day after vaccination with a fourth dose of mRNA-1273. The patient reported that after getting her second booster, her blood sugar started raising significantly despite using insulin and being on a very strict diet. The outcome of the events was reported as not resolved. The relevant medical history of Diabetes a contributory factor to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.