Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Transient ischaemic attack
Clinical narrative: Transient ischemic attack; HIgh blood sugars; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Transient ischemic attack) in a 56-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product SEMAGLUTIDE (OZEMPIC) solution for injection for Type 2 diabetes mellitus.    Concurrent medical conditions included Type 2 diabetes mellitus and Blood pressure high. Concomitant products included AMLODIPINE for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and SEMAGLUTIDE (OZEMPIC) (Subcutaneous) .5 milligram once a week. On 29-Jun-2022,  after starting mRNA-1273 (Spikevax), the patient experienced TRANSIENT ISCHAEMIC ATTACK (Transient ischemic attack) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (HIgh blood sugars). The patient was hospitalized from 29-Jun-2022 to 01-Jul-2022 due to TRANSIENT ISCHAEMIC ATTACK. On 01-Jul-2022, TRANSIENT ISCHAEMIC ATTACK (Transient ischemic attack) had resolved. At the time of the report, BLOOD GLUCOSE INCREASED (HIgh blood sugars) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose (67-140): 160-200 mg/dL.         Patient experienced high blood sugar for about two weeks.  It was reported that the patient received unspecified treatment including unspecified insulin while hospitalized.  Action taken with Ozempic was reported as drug discontinued temporarily.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a 56-year-old female patient, with relevant medical conditions of type 2 diabetes mellitus and blood pressure high, who experienced the unexpected and serious (due to hospitalization and medically significant) AESI of Transient ischaemic attack, which occurred on a date after an unspecified dose of mRNA-1273 vaccine, and resolved after 2 days. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. Co-suspect product included non-company product semaglutide for type 2 diabetes mellitus. Non-serious event of blood glucose increased was also reported, with values between 160 and 200 mg/dl. No information disclosed about other diagnostic tests performed or treatments received. Underlying type 2 diabetes mellitus and hypertension could be contributory factors for Transient ischaemic attack. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 56-year-old female patient, with relevant medical conditions of type 2 diabetes mellitus and blood pressure high, who experienced the unexpected and serious (due to hospitalization and medically significant) AESI of Transient ischaemic attack, which occurred on a date after an unspecified dose of mRNA-1273 vaccine, and resolved after 2 days. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. Co-suspect product included non-company product semaglutide for type 2 diabetes mellitus. Non-serious event of blood glucose increased was also reported, with values between 160 and 200 mg/dl. No information disclosed about other diagnostic tests performed or treatments received. Underlying type 2 diabetes mellitus and hypertension could be contributory factors for Transient ischaemic attack. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.