Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination site nodule
Clinical narrative: spasms are so severe that I cannot sleep; getting to the point of depression because this is taking over my entire body; Where she got the shot is still sore, like a knot; working from home because I cannot drive; first dose >35 days ago; soreness of her arm,hurts to the touch; spasms; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (spasms), INSOMNIA (spasms are so severe that I cannot sleep), DEPRESSION (getting to the point of depression because this is taking over my entire body) and MYALGIA (soreness of her arm,hurts to the touch) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced MUSCLE SPASMS (spasms) (seriousness criterion disability), MYALGIA (soreness of her arm,hurts to the touch) (seriousness criterion disability) and PRODUCT DOSE OMISSION ISSUE (first dose >35 days ago). On an unknown date, the patient experienced INSOMNIA (spasms are so severe that I cannot sleep) (seriousness criterion disability), DEPRESSION (getting to the point of depression because this is taking over my entire body) (seriousness criterion disability), VACCINATION SITE NODULE (Where she got the shot is still sore, like a knot) and MOBILITY DECREASED (working from home because I cannot drive). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg twice a day; TIZANIDINE on 26-May-2021 for Pain and Spasms, at a dose of 4 mg once a day; CELECOXIB on 14-Jun-2021 for Pain, at a dose of 400 mg twice a day; TRAZODONE from 05-May-2021 to 07-Jul-2021 for Insomnia, at a dose of 50 mg once a day; VENLAFAXINE on 24-May-2021 at a dose of 37.5 mg once a day and ZOLPIDEM on 07-Jul-2021 at a dose of 5 mg once a day. At the time of the report, MUSCLE SPASMS (spasms), INSOMNIA (spasms are so severe that I cannot sleep), DEPRESSION (getting to the point of depression because this is taking over my entire body), MYALGIA (soreness of her arm,hurts to the touch), VACCINATION SITE NODULE (Where she got the shot is still sore, like a knot), MOBILITY DECREASED (working from home because I cannot drive) and PRODUCT DOSE OMISSION ISSUE (first dose >35 days ago) outcome was unknown.        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.   Concomitant product was not reported.  She had tried different medications, different types of therapies, and went to different doctors. The patient had an appointment to get an ultrasound on 09-Jul-2021 and a nerve conjunction test in August 2021.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.