Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Feeling abnormal, Gait disturbance, Monoplegia
Clinical narrative: legs became paralyzed; Within an hour of discharge I was walking wobbling outside,; sometimes brain fog; more like a sinus condition in my head; effecting my sleeping; nauseous; still tired; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of MONOPLEGIA (legs became paralyzed) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced MONOPLEGIA (legs became paralyzed) (seriousness criteria hospitalization, disability and medically significant), GAIT DISTURBANCE (Within an hour of discharge I was walking wobbling outside,), FEELING ABNORMAL (sometimes brain fog), SINUS HEADACHE (more like a sinus condition in my head), SLEEP DISORDER (effecting my sleeping), NAUSEA (nauseous) and FATIGUE (still tired). The patient was treated with Physical therapy (to gain strength) for Gait disturbance. At the time of the report, MONOPLEGIA (legs became paralyzed), GAIT DISTURBANCE (Within an hour of discharge I was walking wobbling outside,), FEELING ABNORMAL (sometimes brain fog), SINUS HEADACHE (more like a sinus condition in my head), SLEEP DISORDER (effecting my sleeping), NAUSEA (nauseous) and FATIGUE (still tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Scan brain: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   The patient took his second dose of the Moderna COVID-19 vaccine (Right Dominant Upper Arm) on 25-Mar-2021. About 1.5 hours after his second dose while he was eating lunch, his legs became paralyzed. He went to urgent care and they took an EKG which found nothing. They suggested he spend the night in the hospital which he did.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. It is of note that date in RA report is not consistent with the narrative date of second dose (suspect dose), 25 March 2021, after which events took place. Age of subject can be a confounding factor in the event. No further information is expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. It is of note that date in RA report is not consistent with the narrative date of second dose (suspect dose), 25 March 2021, after which events took place. Age of subject can be a confounding factor in the event. No further information is expected.