Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood test, Diabetic ketoacidosis, Fatigue, Nausea
Clinical narrative: The patient reported going into the hospital after receiving the dose 4 days later because she went into diabetic ketoacidosis/she stated that they called it metabolic acidosis; Patient reported feeling tired; she was nauseas and she couldn't hold down food or fluid; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIABETIC KETOACIDOSIS (The patient reported going into the hospital after receiving the dose 4 days later because she went into diabetic ketoacidosis/she stated that they called it metabolic acidosis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 1 diabetes mellitus and Leg discomfort.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DIABETIC KETOACIDOSIS (The patient reported going into the hospital after receiving the dose 4 days later because she went into diabetic ketoacidosis/she stated that they called it metabolic acidosis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced FATIGUE (Patient reported feeling tired) and NAUSEA (she was nauseas and she couldn't hold down food or fluid). The patient was hospitalized on 17-Mar-2021 due to DIABETIC KETOACIDOSIS. On 22-Mar-2021, DIABETIC KETOACIDOSIS (The patient reported going into the hospital after receiving the dose 4 days later because she went into diabetic ketoacidosis/she stated that they called it metabolic acidosis) had resolved. At the time of the report, FATIGUE (Patient reported feeling tired) and NAUSEA (she was nauseas and she couldn't hold down food or fluid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: normal. On an unknown date, Blood test: abnormal.         No concomitant medications were reported. She said that she got the medication back when she had issues with her legs ( which was an issues prior to being vaccinated). She said that she took it because they helped her feel better. Patient stated that she hasn't spoken to her doctor at all.  This report refers to a case of a female patient of an unknown age who staff member injected her a little bit higher in her upper (Product administered at Inappropriate Site for mRNA-1273 (Lot #: 036A21A). Based on the current available information and temporal association between the use of the product and the start date of the other events (Diabetic ketoacidosis, Fatigue and Nausea), a causal relationship cannot be excluded. The event of product administered at Inappropriate is assessed as not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-073773 (E2B Linked Report).; Sender's Comments: This report refers to a case of a female patient of an unknown age who staff member injected her a little bit higher in her upper (Product administered at Inappropriate Site for mRNA-1273 (Lot #: 036A21A). Based on the current available information and temporal association between the use of the product and the start date of the other events (Diabetic ketoacidosis, Fatigue and Nausea), a causal relationship cannot be excluded. The event of product administered at Inappropriate is assessed as not applicable. US-MODERNATX, INC.-MOD-2021-073773:cross linked to Dose 2