Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Fatigue, Feeling abnormal, Feeling hot, Pyrexia
Clinical narrative: it could be a beginning of diabetic neuropathy; STRESS; sugar went up without changing food intake, it reached 500; shaking in her hands; fatigue; fever; on Saturday she couldn't stand up/On monday she couldn't stand up; started to experience hotness; On Fri she started to feel bad/On Sunday she felt bad/feeling weight; dizziness; body burning inside; she couldn't move her shoulders when she already had tendinitis in the shoulders,she noticed inflammation/shoulders cramps/cramps in the extremities that comes and goes/ felt pressure in the neck; This spontaneous case was reported by a patient and describes the occurrence of DIABETES MELLITUS (sugar went up without changing food intake, it reached 500) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006h21a, 031l20a and 011a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (before vaccination) in April 2020. Concurrent medical conditions included Drug allergy (Insulin Humulin), Drug allergy (Humalog), Food allergy (spicy food), Type 1 diabetes mellitus (since 22 years ago) and Shoulder tendinitis. Concomitant products included INSULIN LISPRO (ADMELOG) for an unknown indication.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced BURNING SENSATION (body burning inside), DIZZINESS (dizziness) and ROTATOR CUFF SYNDROME (she couldn't move her shoulders when she already had tendinitis in the shoulders,she noticed inflammation/shoulders cramps/cramps in the extremities that comes and goes/ felt pressure in the neck). On 22-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (On Fri she started to feel bad/On Sunday she felt bad/feeling weight). On 23-Jul-2022, the patient experienced DYSSTASIA (on Saturday she couldn't stand up/On monday she couldn't stand up), FEELING HOT (started to experience hotness), FATIGUE (fatigue) and PYREXIA (fever). On 25-Jul-2022, the patient experienced DIABETES MELLITUS (sugar went up without changing food intake, it reached 500) (seriousness criterion medically significant) and TREMOR (shaking in her hands). On an unknown date, the patient experienced DIABETIC NEUROPATHY (it could be a beginning of diabetic neuropathy) and STRESS (STRESS). The patient was treated with ACETAMINOPHEN at a dose of 500 milligram twice a day. At the time of the report, DIABETES MELLITUS (sugar went up without changing food intake, it reached 500) was resolving, FEELING ABNORMAL (On Fri she started to feel bad/On Sunday she felt bad/feeling weight), DYSSTASIA (on Saturday she couldn't stand up/On monday she couldn't stand up), FEELING HOT (started to experience hotness), TREMOR (shaking in her hands), DIABETIC NEUROPATHY (it could be a beginning of diabetic neuropathy), BURNING SENSATION (body burning inside), DIZZINESS (dizziness), FATIGUE (fatigue) and PYREXIA (fever) had not resolved and STRESS (STRESS) and ROTATOR CUFF SYNDROME (she couldn't move her shoulders when she already had tendinitis in the shoulders,she noticed inflammation/shoulders cramps/cramps in the extremities that comes and goes/ felt pressure in the neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2020, SARS-CoV-2 test: (Positive) Positive. On 25-Jul-2022, Blood glucose: 500. On 26-Jul-2022, Blood glucose: 100.         Concomitant medicine included Insulin Vastral. Before 1st dose patient stated she had still antibodies of having COVID before vaccination. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Patient did not have any symptoms with the first and second dose of the vaccine. On 22-Jul-2022, patient received first booster dose. On 23-Jul-2022, patient stayed in the bed. On 25-Jul-2022, sugar reached 500, stress could have that effect on patient, on 26-Jul-2022, patient noticed it was more controlled it was 100. It was reported that patient did not experience similar event in the past, it was worst than having COVID when she noticed her pressure went up. It was reported that on Sunday (24-Jul-2022) patient felt better than on Saturday(23-Jul-2022). The patient received treatment with Power nerve pills, took one on the day of reporting for nerve damage for diabetic patients. Patient was about to take Ibuprofen.  Company Comment: This is spontaneous case concerns a 48-year-old female patient with a relevant 22-year history of Type 1 diabetes mellitus, who experienced the unexpected serious (medically significant) event of Diabetes mellitus (Diabetes mellitus aggravated) which occurred 3 days after the third dose of mRNA-1273 vaccine in covid-19 vaccination series. Patient also experienced non-serious events of Diabetic neuropathy, Dizziness and Fatigue. 1 day after the booster dose patient couldn't stand up, she started to experience hotness, fever, fatigue, and stayed in bed. Next day she couldn't move her shoulders, she already had tendinitis in the shoulders, she noticed inflammation, she couldn't stand up and felt pressure in the neck and shoulder cramps and shaking in her hands. Patient has Diabetes type 1 and thought it could be a beginning of diabetic neuropathy. Patient is experiencing dizziness and feeling weight, fever, body burning inside. 3 days after the booster dose patients blood sugar reached 500, she thought stress could have that effect, next day blood sugars reached to 100. The patient received treatment with Power nerve pills. The outcome of the event Diabetes mellitus was reported as resolving. Patients medical history of Type 1 diabetes mellitus could be confounding for the event Diabetes mellitus. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is spontaneous case concerns a 48-year-old female patient with a relevant 22-year history of Type 1 diabetes mellitus, who experienced the unexpected serious (medically significant) event of Diabetes mellitus (Diabetes mellitus aggravated) which occurred 3 days after the third dose of mRNA-1273 vaccine in covid-19 vaccination series. Patient also experienced non-serious events of Diabetic neuropathy, Dizziness and Fatigue. 1 day after the booster dose patient couldn't stand up, she started to experience hotness, fever, fatigue, and stayed in bed. Next day she couldn't move her shoulders, she already had tendinitis in the shoulders, she noticed inflammation, she couldn't stand up and felt pressure in the neck and shoulder cramps and shaking in her hands. Patient has Diabetes type 1 and thought it could be a beginning of diabetic neuropathy. Patient is experiencing dizziness and feeling weight, fever, body burning inside. 3 days after the booster dose patients blood sugar reached 500, she thought stress could have that effect, next day blood sugars reached to 100. The patient received treatment with Power nerve pills. The outcome of the event Diabetes mellitus was reported as resolving. Patients medical history of Type 1 diabetes mellitus could be confounding for the event Diabetes mellitus. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.