Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Migraine
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of CEREBROVASCULAR ACCIDENT (quasi-stroke), BLOOD PRESSURE DECREASED (Blood pressure went to 64/40), DYSSTASIA (couldn't stand up and called it a hot reactor), MIGRAINE (had migraines) and COVID-19 (COVID-19) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Blood pressure increased, Blood cholesterol abnormal (under control), Slipped disc, Hepatitis B ((years later he had tested negative for it)), Migraine (always under control) and Surgery (they pricked him with a needle). Concurrent medical conditions included Hypertension, Back arthritis and Atrial fibrillation. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and WARFARIN SODIUM (COUMADIN) for an unknown indication. In 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (quasi-stroke) (seriousness criteria hospitalization and medically significant), BLOOD PRESSURE DECREASED (Blood pressure went to 64/40) (seriousness criterion hospitalization), DYSSTASIA (couldn't stand up and called it a hot reactor) (seriousness criterion hospitalization), MIGRAINE (had migraines) (seriousness criterion hospitalization) and COVID-19 (COVID-19) (seriousness criterion hospitalization). At the time of the report, CEREBROVASCULAR ACCIDENT (quasi-stroke), BLOOD PRESSURE DECREASED (Blood pressure went to 64/40), DYSSTASIA (couldn't stand up and called it a hot reactor), MIGRAINE (had migraines) and COVID-19 (COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 64/40. On an unknown date, Electrocardiogram: (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was taking sleeping pills at bedtime. He was on blood pressure medications to keep him under control. Patient was given saline fluids. 2 weeks after this reactions he got COVID-19. 6 weeks after reaction he had a quasi- stroke. Company comment; This spontaneous case concerns a 79-year-old male patient, with body mass index of 30, with relevant medical history of hypertension, cholesterol "disorder" (under control), atrial fibrillation, slipped disc, back arthritis, and migraine, with concomitant medications Coumadin and Rosuvastatin calcium, who experienced the unexpected serious (medically significant and hospitalization) AESI Cerebrovascular accident, and unexpected serious (hospitalization) COVID-19 (AESI), Blood pressure decreased, Dysstasia, and Migraines after receiving the second booster dose of mRNA-1273 vaccine. Onset latency could not be determined as date of vaccination and onset dates of events were not provided. Patient reported that 6 weeks after vaccination, his blood pressure went down to 64/40, and could not stand up. He was hospitalized, electrocardiogram was done with negative result. Two weeks later, patient got COVID-19. Clinical course and treatment details were not reported. The outcome of events was unknown. Elderly age, patient's body mass index, and medical history could be considered as risk factors for this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical judgement. Sender's Comments: This spontaneous case concerns a 79-year-old male patient, with body mass index of 30, with relevant medical history of hypertension, cholesterol "disorder" (under control), atrial fibrillation, slipped disc, back arthritis, and migraine, with concomitant medications Coumadin and Rosuvastatin calcium, who experienced the unexpected serious (medically significant and hospitalization) AESI Cerebrovascular accident, and unexpected serious (hospitalization) COVID-19 (AESI), Blood pressure decreased, Dysstasia, and Migraines after receiving the second booster dose of mRNA-1273 vaccine. Onset latency could not be determined as date of vaccination and onset dates of events were not provided. Patient reported that 6 weeks after vaccination, his blood pressure went down to 64/40, and could not stand up. He was hospitalized, electrocardiogram was done with negative result. Two weeks later, patient got COVID-19. Clinical course and treatment details were not reported. The outcome of events was unknown. Elderly age, patient's body mass index, and medical history could be considered as risk factors for this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical judgement.