Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Limb discomfort, Mass
Clinical narrative: Sleepy; Raised red areas; Raised area; Could hardly lift the arm to change clothes; Warm arm; Fever; chills; Bump on injection site, nearly 3 inches in diameter; Redness at injection site; Arm soreness; Heat coming from bump; COVID arm; Stomach itching; Heat at the injection site; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Stomach itching), PAIN IN EXTREMITY (Arm soreness), MILIARIA (Heat coming from bump), VACCINATION SITE WARMTH (Heat at the injection site) and VACCINATION SITE REACTION (COVID arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: FLU (Injection site reactions to the flu vaccine including redness extending beyond the injection site.). Past adverse reactions to the above products included Injection site redness with FLU. Concurrent medical conditions included Allergy to insect sting and Allergy to insect sting.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Heat at the injection site) and FATIGUE (Fatigue). On 02-May-2021, the patient experienced PRURITUS (Stomach itching). On 07-May-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), MILIARIA (Heat coming from bump), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE SWELLING (Bump on injection site, nearly 3 inches in diameter) and VACCINATION SITE ERYTHEMA (Redness at injection site). On an unknown date, the patient experienced SOMNOLENCE (Sleepy), ERYTHEMA (Raised red areas), MASS (Raised area), LIMB DISCOMFORT (Could hardly lift the arm to change clothes), SKIN WARM (Warm arm), PYREXIA (Fever) and CHILLS (chills). On 02-May-2021, PRURITUS (Stomach itching), PAIN IN EXTREMITY (Arm soreness), VACCINATION SITE WARMTH (Heat at the injection site), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Redness at injection site) had resolved. At the time of the report, MILIARIA (Heat coming from bump), VACCINATION SITE REACTION (COVID arm), SOMNOLENCE (Sleepy), ERYTHEMA (Raised red areas), MASS (Raised area), LIMB DISCOMFORT (Could hardly lift the arm to change clothes), SKIN WARM (Warm arm), PYREXIA (Fever), CHILLS (chills) and VACCINATION SITE SWELLING (Bump on injection site, nearly 3 inches in diameter) 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.    .   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2021: Follow-up information  received on  13 Jun 2021 contains patient details include height and weight updated. Events(mass, fever, chills, arm discomfort and skin warm) updated. On 13-Jun-2021: Follow-up information  received on 13 Jun 2021contains non-significant information.