Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Diabetes mellitus, Pruritus
Clinical narrative: arm itch; blood sugar has been elevated; This spontaneous case was reported by a patient and describes the occurrence of DIABETES MELLITUS (blood sugar has been elevated) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), CANAGLIFLOZIN HEMIHYDRATE, METFORMIN HYDROCHLORIDE (INVOKANA DUO) and GLIMEPIRIDE for Diabetes.    On 08-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 09-Sep-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced DIABETES MELLITUS (blood sugar has been elevated) (seriousness criterion medically significant). On an unknown date, the patient experienced PRURITUS (arm itch). At the time of the report, DIABETES MELLITUS (blood sugar has been elevated) and PRURITUS (arm itch) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2022, Blood glucose: 181 in the morning, 191 at lunch, and 330 at bed time..         It was reported that on 9SEP2022 patients blood sugar was 181 in the morning, 191 at lunch, and 330 at bed time. She monitors her sugars very regularly and this is significantly elevated for her.  No Concomitant medication was reported.  Company comment: This is a spontaneous case concerning a 78-year-old, female patient with relevant concurrent medical condition of diabetes mellitus. The patient has vaccination history of receiving 4 previous doses of mRNA-1273. The patient experienced the unexpected serious (medically significant) event of diabetes mellitus (blood sugar has been elevated), and the unexpected non-serious event of pruritus (arm itch). The event diabetes mellitus (blood sugar has been elevated) occurred approximately 1 day after the fifth dose of mRNA-1273.222 vaccine administration. The event pruritus (arm itch) occurrence unknown with respect the fifth dose of mRNA-1273.222 vaccine administration. Allegedly the events were described as, the day after receiving the fifth dose of mRNA-1273.222 vaccine the patient's blood sugar have been elevated with blood sugar monitoring of 181 (no unit) in the morning, 191 (no unit) at lunch, and 330 (no unit) at bedtime. It was reported that the patient monitors her blood sugar regularly and these were significant elevations. It was reported that the patient had a little bit of itchy arm. No further clinical information was available for medical review. The patient's concurrent medical condition of diabetes mellitus remain confounder for the event diabetes mellitus (blood sugar has been elevated). The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 78-year-old, female patient with relevant concurrent medical condition of diabetes mellitus. The patient has vaccination history of receiving 4 previous doses of mRNA-1273. The patient experienced the unexpected serious (medically significant) event of diabetes mellitus (blood sugar has been elevated), and the unexpected non-serious event of pruritus (arm itch). The event diabetes mellitus (blood sugar has been elevated) occurred approximately 1 day after the fifth dose of mRNA-1273.222 vaccine administration. The event pruritus (arm itch) occurrence unknown with respect the fifth dose of mRNA-1273.222 vaccine administration. Allegedly the events were described as, the day after receiving the fifth dose of mRNA-1273.222 vaccine the patient's blood sugar have been elevated with blood sugar monitoring of 181 (no unit) in the morning, 191 (no unit) at lunch, and 330 (no unit) at bedtime. It was reported that the patient monitors her blood sugar regularly and these were significant elevations. It was reported that the patient had a little bit of itchy arm. No further clinical information was available for medical review. The patient's concurrent medical condition of diabetes mellitus remain confounder for the event diabetes mellitus (blood sugar has been elevated). The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.