Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Not feeling good; Headache; Itchy arm; It was all red at injection site/an eight-inch red area at injection site.; Left arm was v sore; Swelled arm; Having difficulty walking due to muscle fatigue; She can barely lift it; Muscle fatigue; Slept all day; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Having difficulty walking due to muscle fatigue), LIMB DISCOMFORT (She can barely lift it), MUSCLE FATIGUE (Muscle fatigue), SOMNOLENCE (Slept all day) and MALAISE (Not feeling good) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced GAIT DISTURBANCE (Having difficulty walking due to muscle fatigue), LIMB DISCOMFORT (She can barely lift it), MUSCLE FATIGUE (Muscle fatigue), SOMNOLENCE (Slept all day), VACCINATION SITE SWELLING (Swelled arm) and VACCINATION SITE PAIN (Left arm was v sore). On 25-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA (It was all red at injection site/an eight-inch red area at injection site.). On an unknown date, the patient experienced MALAISE (Not feeling good) and HEADACHE (Headache). At the time of the report, GAIT DISTURBANCE (Having difficulty walking due to muscle fatigue), LIMB DISCOMFORT (She can barely lift it), MUSCLE FATIGUE (Muscle fatigue), SOMNOLENCE (Slept all day), VACCINATION SITE SWELLING (Swelled arm) and VACCINATION SITE PAIN (Left arm was v sore) had resolved, MALAISE (Not feeling good) and HEADACHE (Headache) outcome was unknown and VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA (It was all red at injection site/an eight-inch red area at injection site.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient post receiving their first dose of vaccine 1st shot and on the next day their left arm was very sore and could barely lift it. The patient reported that they slept whole day, had muscle fatigue which lasted for a week due to which the patient was having difficulty in walking. The patient also experienced swelled arm which went away and on day 11, the patient had itchy arm and it was all red at injection site and was still not going away.  On 24-Jun-2021 the patient reported that the patient had an eight-inch red area at the injection site.  No Concomitant product use was reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow-up was received on 22-Apr-2021 and contains non significant information. On 24-Jun-2021: Follow-up was received on 24-Jun-2021. Updated the event verbatim of the event Vaccination site erythema.