Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Chills, Diabetes mellitus inadequate control, Headache, Lymphadenopathy
Clinical narrative: Type 1 diabetic and was having trouble controlling my blood sugars; Swollen lymph node in my armpit, which was tender; Swelling in armpit and left side of breast; Swollen lymph node in my armpit, which was tender; Fever; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS INADEQUATE CONTROL (Type 1 diabetic and was having trouble controlling my blood sugars) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Type I diabetes mellitus.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). On 23-Feb-2021, the patient experienced DIABETES MELLITUS INADEQUATE CONTROL (Type 1 diabetic and was having trouble controlling my blood sugars) (seriousness criterion medically significant), TENDERNESS (Swollen lymph node in my armpit, which was tender), BREAST SWELLING (Swelling in armpit and left side of breast) and LYMPHADENOPATHY (Swollen lymph node in my armpit, which was tender). The patient was treated with PARACETAMOL (TYLENOL) in February 2021 for Fever, at an unspecified dose and frequency. On 22-Feb-2021, HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) had resolved. On 02-Mar-2021, TENDERNESS (Swollen lymph node in my armpit, which was tender) had resolved. At the time of the report, DIABETES MELLITUS INADEQUATE CONTROL (Type 1 diabetic and was having trouble controlling my blood sugars) and LYMPHADENOPATHY (Swollen lymph node in my armpit, which was tender) had not resolved and BREAST SWELLING (Swelling in armpit and left side of breast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment included the patient adjusting her insulin multiple times to control her blood sugar.  Company comment: This case concerns a 50-year-old female with a serious unexpected event of diabetes mellitus inadequate control, and non-serious unexpected tenderness and breast swelling, and expected headache, pyrexia, chills and lymphadenopathy. Event latency 4 days after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 50-year-old female with a serious unexpected event of diabetes mellitus inadequate control, and nonserious unexpected tenderness and breast swelling, and expected headache, pyrexia, chills and lymphadenopathy. Event latency 4 days after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.