Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Diabetes mellitus inadequate control, Disorientation, Dizziness, Fall
Clinical narrative: concerned about her blood sugar not being controlled, even with the medication/After vaccination her sugar was in the 400's.; Fell down twice/ The evening of vaccination day, heard her hit the floor/fell down twice; she was loosing orientation; she was dizzy/felt lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS INADEQUATE CONTROL (concerned about her blood sugar not being controlled, even with the medication/After vaccination her sugar was in the 400's.) in a 65-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient never had any COVID-19 vaccine.  Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN LISPRO (HUMALOG) for Type 1 diabetes mellitus.    On 07-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Jul-2022, the patient experienced DIABETES MELLITUS INADEQUATE CONTROL (concerned about her blood sugar not being controlled, even with the medication/After vaccination her sugar was in the 400's.) (seriousness criterion medically significant), FALL (Fell down twice/ The evening of vaccination day, heard her hit the floor/fell down twice), DISORIENTATION (she was loosing orientation) and DIZZINESS (she was dizzy/felt lightheaded). The patient was treated with INSULIN LISPRO (HUMALOG) for Diabetes mellitus aggravated, at a dose of extra dose (dose increased). At the time of the report, DIABETES MELLITUS INADEQUATE CONTROL (concerned about her blood sugar not being controlled, even with the medication/After vaccination her sugar was in the 400's.) outcome was unknown and FALL (Fell down twice/ The evening of vaccination day, heard her hit the floor/fell down twice), DISORIENTATION (she was loosing orientation) and DIZZINESS (she was dizzy/felt lightheaded) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, Blood glucose: 400's.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The reporter stated the evening of vaccination day, he heard patient hit the floor, rescued her and it happened a second time also. All the events lasted only 1 day. On an unknown date in Jul-2022, the patient was taking extra medication (Humalog Insulin) to keep the sugar lower, but it did not keep normal. Reporter further stated that he was concerned about patient's blood sugar not being controlled, even with the medication.  Reporter stated the patient had called the doctor and the doctor stated that it was normal for the sugar to go up, it was just like getting a flu. Treating physician suggested to keep adjusting insulin level to keep the sugar around 200's or lower.  Company comment-This spontaneous case concerns a female patient aged 65 years with relevant medical history of Type 1 diabetes mellitus reported, who experienced the unexpected serious (medically significant) event of Diabetes mellitus inadequate control the same day after receiving first dose of mRNA-1273 vaccine. Patient had a little splurge up, was dizzy and fell down twice along with disorientation in the evening after vaccination. It lasted for a day. She is having uncontrolled blood sugars even with extra medication Humalog Insulin. After vaccination her blood sugars was in 400's (unit not specified). Consulted a doctor, was advised to adjust insulin and to keep blood sugars below200. Outcome of the event was unknown at the time of report. Relevant medical history could be confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient aged 65 years with relevant medical history of Type 1 diabetes mellitus reported, who experienced the unexpected serious (medically significant) event of Diabetes mellitus inadequate control the same day after receiving first dose of mRNA-1273 vaccine. Patient had a little splurge up, was dizzy and fell down twice along with disorientation in the evening after vaccination. It lasted for a day. She is having uncontrolled blood sugars even with extra medication Humalog Insulin. After vaccination her blood sugars was in 400's (unit not specified). Consulted a doctor, was advised to adjust insulin and to keep blood sugars below200. Outcome of the event was unknown at the time of report. Relevant medical history could be confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.