Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Gait disturbance, Muscular dystrophy, Paraesthesia oral, Syncope
Clinical narrative: Slight stroke; Everything in the body shut down/ hit the floor if there hadn't been a chair there; Whole body went limp; Tongue was hanging; All muscles went down; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Slight stroke) and SYNCOPE (Everything in the body shut down/ hit the floor if there hadn't been a chair there) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Slight stroke) (seriousness criterion medically significant), SYNCOPE (Everything in the body shut down/ hit the floor if there hadn't been a chair there) (seriousness criterion medically significant), GAIT DISTURBANCE (Whole body went limp), PARAESTHESIA ORAL (Tongue was hanging) and MUSCULAR DYSTROPHY (All muscles went down). At the time of the report, CEREBROVASCULAR ACCIDENT (Slight stroke), SYNCOPE (Everything in the body shut down/ hit the floor if there hadn't been a chair there), GAIT DISTURBANCE (Whole body went limp), PARAESTHESIA ORAL (Tongue was hanging) and MUSCULAR DYSTROPHY (All muscles went down) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant medications included high blood pressure pills and blood thinner medications  Lab data included EKG and BP with unknown results.  This case concerns a 63-year-old, male patient with previous relevant medical history of hypertension and high cholesterol, who experienced the unexpected events of cerebrovascular accident, syncope, gait disturbance, paraesthesia oral and muscular dystrophy. The events occurred 30 days day after the second dose of mRNA-1273. The rechallenge was not applicable due the patient did not experienced side effects after the first dose. The reporter assessed the events as possible. The medical history of hypertension, high cholesterol and use of concomitant medication remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.  On 22-Apr-21 patient was in the ER  for four hours, he was not treated with any medications and was discharged with no medications.; Sender's Comments: This case concerns a 63-year-old, male patient with previous relevant medical history of hypertension and high cholesterol, who experienced the unexpected events of cerebrovascular accident, syncope, gait disturbance, paraesthesia oral and muscular dystrophy. The events occurred 30 days day after the second dose of mRNA-1273. The rechallenge was not applicable due the patient did not experienced side effects after the first dose. The reporter assessed the events as possible. The medical history of hypertension, high cholesterol and use of concomitant medication remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.