Sex: F
Vaccine: COVID19-2
Symptoms: Blood pressure measurement, Cerebrovascular accident, Cystitis, Hypertension
Clinical narrative: This spontaneous case was reported by a non-health professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (Have to have neurological tests after a stroke) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Type 1 diabetes mellitus. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Have to have neurological tests after a stroke) (seriousness criterion medically significant), CYSTITIS (I have since repeated cystitis) and HYPERTENSION (I have high pressure). At the time of the report, CEREBROVASCULAR ACCIDENT (Have to have neurological tests after a stroke), CYSTITIS (I have since repeated cystitis) and HYPERTENSION (I have high pressure) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: High. No concomitant medications were reported. The patient received Moderna and experienced side effects. The patient and her family had a lot of side effects, personally she was type one diabetic and unmanageable. She had since repeated cystitis which was dangerous given her state of health and must always be on antibiotics. She also never had a heart problem and since then she had high pressure and had neurological tests after a stroke. The treatment medication was reported as some unknown antibiotics. This is a spontaneous case concerning a female patient of approximately 42 years-old with a current condition of type 1 diabetes mellitus (with difficult management), who received a dose of mRNA-1273.222  vaccine and experienced the unexpected serious (medically significant) AESI of Cerebrovascular accident. Latency between vaccination and event could not be assessed since vaccination nor event onset date were provided. The patient also experienced the non-serious unexpected event of hypertension at an unknown date after vaccination. Outcome of the event was unknown. The patient required neurological tests with undisclosed results. Current condition of type 1 diabetes mellitus (with difficult management) is a risk factor for the event cerebrovascular accident. Chronic hypertension is also a risk factor for the event, although it is unclear if the patient had this condition before the event or it was a recent diagnosis. The benefit-risk relationship of mRNA-1273.222  vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a female patient of approximately 42 years-old with a current condition of type 1 diabetes mellitus (with difficult management), who received a dose of mRNA-1273.222  vaccine and experienced the unexpected serious (medically significant) AESI of Cerebrovascular accident. Latency between vaccination and event could not be assessed since vaccination nor event onset date were provided. The patient also experienced the non-serious unexpected event of hypertension at an unknown date after vaccination. Outcome of the event was unknown. The patient required neurological tests with undisclosed results. Current condition of type 1 diabetes mellitus (with difficult management) is a risk factor for the event cerebrovascular accident. Chronic hypertension is also a risk factor for the event, although it is unclear if the patient had this condition before the event or it was a recent diagnosis. The benefit-risk relationship of mRNA-1273.222  vaccine is not affected by this report.