Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea, Vaccination site erythema
Clinical narrative: under the weather; has a knot which is a size a little smaller than a golf ball; headache; nausea; body aches; red, swollen, itchy, and painful injection site/injection site started itching and being red again about the size of a quarter.; red, swollen, itchy, and painful injection site/injection site started itching and being red again about the size of a quarter.; red, swollen, itchy, and painful injection site/injection site started itching and being red again about the size of a quarter. She also has a knot which is a size a little smaller than a golf ball; painful injection site; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (under the weather), VACCINATION SITE MASS (has a knot which is a size a little smaller than a golf ball), VACCINATION SITE PRURITUS (red, swollen, itchy, and painful injection site/injection site started itching and being red again about the size of a quarter.), VACCINATION SITE ERYTHEMA (red, swollen, itchy, and painful injection site/injection site started itching and being red again about the size of a quarter.) and VACCINATION SITE SWELLING (red, swollen, itchy, and painful injection site/injection site started itching and being red again about the size of a quarter. She also has a knot which is a size a little smaller than a golf ball) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003J21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2022, the patient experienced VACCINATION SITE PRURITUS (red, swollen, itchy, and painful injection site/injection site started itching and being red again about the size of a quarter.), VACCINATION SITE ERYTHEMA (red, swollen, itchy, and painful injection site/injection site started itching and being red again about the size of a quarter.), VACCINATION SITE SWELLING (red, swollen, itchy, and painful injection site/injection site started itching and being red again about the size of a quarter. She also has a knot which is a size a little smaller than a golf ball) and VACCINATION SITE PAIN (painful injection site). On 22-Jan-2022, the patient experienced MALAISE (under the weather), VACCINATION SITE MASS (has a knot which is a size a little smaller than a golf ball), HEADACHE (headache), NAUSEA (nausea) and MYALGIA (body aches). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (under the weather), VACCINATION SITE MASS (has a knot which is a size a little smaller than a golf ball), VACCINATION SITE PRURITUS (red, swollen, itchy, and painful injection site/injection site started itching and being red again about the size of a quarter.), VACCINATION SITE ERYTHEMA (red, swollen, itchy, and painful injection site/injection site started itching and being red again about the size of a quarter.), VACCINATION SITE SWELLING (red, swollen, itchy, and painful injection site/injection site started itching and being red again about the size of a quarter. She also has a knot which is a size a little smaller than a golf ball), VACCINATION SITE PAIN (painful injection site), HEADACHE (headache), NAUSEA (nausea) and MYALGIA (body aches) 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.   No concomitant drug details were reported.