Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Restless legs syndrome, Seizure like phenomena, Tremor
Clinical narrative: Seizure like phenomena; Breath sounds abnormal; Dizziness; Dyskinesia; Eyelid function disorder; Fall; Hyperhidrosis; Hypopnoea; Hypotonia; Muscle twitching; Pallor; Presyncope; Restless legs syndrome; Tremor; This case was received via FDA VAERS on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of SEIZURE LIKE PHENOMENA (Seizure like phenomena) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vagal reaction (patient stated he has experienced vagal responses to injections in the past).    On 02-Mar-2021 at 5:46 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced SEIZURE LIKE PHENOMENA (Seizure like phenomena) (seriousness criterion medically significant). 02-Mar-2021, the patient experienced BREATH SOUNDS ABNORMAL (Breath sounds abnormal), DIZZINESS (Dizziness), DYSKINESIA (Dyskinesia), EYELID FUNCTION DISORDER (Eyelid function disorder), FALL (Fall), HYPERHIDROSIS (Hyperhidrosis), HYPOPNOEA (Hypopnoea), HYPOTONIA (Hypotonia), MUSCLE TWITCHING (Muscle twitching), PALLOR (Pallor), PRESYNCOPE (Presyncope), RESTLESS LEGS SYNDROME (Restless legs syndrome) and TREMOR (Tremor). At the time of the report, SEIZURE LIKE PHENOMENA (Seizure like phenomena), BREATH SOUNDS ABNORMAL (Breath sounds abnormal), DIZZINESS (Dizziness), DYSKINESIA (Dyskinesia), EYELID FUNCTION DISORDER (Eyelid function disorder), FALL (Fall), HYPERHIDROSIS (Hyperhidrosis), HYPOPNOEA (Hypopnoea), HYPOTONIA (Hypotonia), MUSCLE TWITCHING (Muscle twitching), PALLOR (Pallor), PRESYNCOPE (Presyncope), RESTLESS LEGS SYNDROME (Restless legs syndrome) and TREMOR (Tremor) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Blood pressure measurement: 120/72 (normal) 120/72 mmHg. On 02-Mar-2021, Heart rate: 64 (normal) 64 beats per minute. On 02-Mar-2021, Oxygen saturation: 99 (normal) 99%. On 02-Mar-2021, Respiratory rate: 20 (normal) 20 breaths per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The patient remained in the vaccination chair for 5 minutes after injection and he reported feeling well and moved to the observation chair without any problems [~10ft].  After being in the observation chair the patient stood up and took 4-5 steps toward the wall and sat down on the floor.  The patient stated he felt dizzy and then became limp and slumped to the right side, his eyes remained open with dilation of pupil fixed at 2mm with no blinking noted.  The patient's breathing pattern became shallow and snoring sounds were noted. The patient did not respond when spoken to nor did he respond to soft shaking of the shoulders.  The patient began to demonstrate large jerky body movements similar to seizure activity. The seizure like activity continued for 3-4 minutes before the patient was able to become aware of surroundings and answer orientation questions. The patient was diaphoretic, pale, shaking of hands and arms, restlessness of lower limbs with frequent repositioning/twitching of legs.  EMS (emergency medical services) arrived to find the patient regaining stability. The patient reported to EMS that he is familiar with this type of response and declined to be taken anywhere.  Treatment medications were not reported.  Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded. The Company believes the event of Restless leg syndrome is not supported in the source documents and should be delete.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded. The Company believes the event of Restless leg syndrome is not supported in the source documents and should be delete.