Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: covid arm/not very sore; red circle about 4-5 inches in diameter, warm, itchy, and not very sore.; red circle about 4-5 inches in diameter, itchy; red circle about 4-5 inches in diameter; mild fever; nausea; arms flailing and she was not able to control the movement/She could not stop her arms from moving.; I did fall back asleep but it happened again that night; I was in bed, sleeping; I thought I was having a seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (I thought I was having a seizure) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, GABAPENTIN, HYDROCHLOROTHIAZIDE, PROPRANOLOL and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, the patient experienced SEIZURE (I thought I was having a seizure) (seriousness criterion medically significant), DYSKINESIA (arms flailing and she was not able to control the movement/She could not stop her arms from moving.), INSOMNIA (I did fall back asleep but it happened again that night), SOMNOLENCE (I was in bed, sleeping), PYREXIA (mild fever) and NAUSEA (nausea). On 30-Dec-2021, the patient experienced VACCINATION SITE PAIN (covid arm/not very sore), VACCINATION SITE WARMTH (red circle about 4-5 inches in diameter, warm, itchy, and not very sore.), VACCINATION SITE PRURITUS (red circle about 4-5 inches in diameter, itchy) and VACCINATION SITE ERYTHEMA (red circle about 4-5 inches in diameter). On 30-Dec-2021, SEIZURE (I thought I was having a seizure), DYSKINESIA (arms flailing and she was not able to control the movement/She could not stop her arms from moving.) and INSOMNIA (I did fall back asleep but it happened again that night) had resolved. On 01-Jan-2022, PYREXIA (mild fever) had resolved. On 02-Jan-2022, SOMNOLENCE (I was in bed, sleeping) and NAUSEA (nausea) had resolved. On 04-Jan-2022, VACCINATION SITE PAIN (covid arm/not very sore), VACCINATION SITE WARMTH (red circle about 4-5 inches in diameter, warm, itchy, and not very sore.), VACCINATION SITE PRURITUS (red circle about 4-5 inches in diameter, itchy) and VACCINATION SITE ERYTHEMA (red circle about 4-5 inches in diameter) had resolved.            Patient took Analapril for unknown indication. Patient experienced COVID arm with all her doses of the Moderna vaccine. She said that it started the day after receiving the vaccine each time and lasted for about 4-5 days. She described it as a red circle about 4-5 inches in diameter, warm, itchy, and not very sore. on the night of 29-DEC-2021, after receiving the booster dose, she woke up in the middle of the night with her arms flailing and she was not able to control the movement. She thought that she was having a seizure. She could not stop her arms from moving. She felt like her insides were quivering. She said that the movement felt like it lasted a long time, but maybe in reality only lasted a few minutes. She did not know exactly how long these movements lasted for. She stated that she was able to fall back asleep, but this episode happened once more during the night. She felt like she was vibrating. The following morning, on 30-DEC-2021, it happened a third time. However, this time it was for a very brief time. After the third episode, things became normal again and she did not experience any abnormal movement. She says that she also experienced a mild fever that lasted for about 3 days. She said that she was in bed, sleeping with fever and nausea for about 4 days   This case was linked to MOD-2022-451878 (Patient Link).  This spontaneous case concerns a 68 year old female with no  medical history reported, who experienced  Serious ( medically significant ) , unexpected , AESI event of Seizure which occurred on the same day post vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid19 vaccine ) . This was accompanied by other non-serious unexpected events of dyskinesia , insomnia , somnolence and expected events of fever and nausea. One day post vaccination with the 3rd dose of mRNA-1273 vaccine  , she experienced  non-serious expected events of vaccination site pain , vaccination site pruritus and vaccination site erythema. The re-challenge for this case is positive for the vaccination site pain , vaccination site pruritus , vaccination site erythema, vaccination site warmth .  because it was reported that all these events  occurred  and recurred upon vaccination from the 1st to the 3rd dose of vaccination for this  patient.  The benefit -risk relationship of mRNA -1273 ( Moderna Covid19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a 68 year old female wih no  medical history reported, who experienced  Serious ( medically significant ) , unexpected , AESI event of Seizure which occurred on the same day post vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . This was accompanied by other non-serious unexpected events of dyskinesia , insomnia , somnolence and expected events of fever and nausea. One day post vaccination with the 3rd dose of mRNA-1273 vaccine  , she experienced  non-serious expected events of vaccination site pain , vaccination site pruritus and vaccination site erythema. The re-challenge for this case is positive for the vaccination site pain , vaccination site pruritus , vaccination site erythema, vaccination site warmth .  because it was reported that all these events  occurred  and recurred upon vaccination from the 1st to the 3rd dose of vaccination for this  patient.  The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.