Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site inflammation, Vaccination site pain, Vaccination site swelling
Clinical narrative: Heat at the injection site; Slight bruise at the injection site; Feeling of inflammation; One small hive, fairly large, underneath the injection site; Swollen at the injection site; Soreness at the injection site/Tiny bit of aching at the injection site; Red with a slight wheel at the injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Heat at the injection site), VACCINATION SITE BRUISING (Slight bruise at the injection site), VACCINATION SITE INFLAMMATION (Feeling of inflammation), VACCINATION SITE URTICARIA (One small hive, fairly large, underneath the injection site) and VACCINATION SITE SWELLING (Swollen at the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Heat at the injection site), VACCINATION SITE BRUISING (Slight bruise at the injection site), VACCINATION SITE INFLAMMATION (Feeling of inflammation), VACCINATION SITE URTICARIA (One small hive, fairly large, underneath the injection site), VACCINATION SITE SWELLING (Swollen at the injection site), VACCINATION SITE PAIN (Soreness at the injection site/Tiny bit of aching at the injection site) and VACCINATION SITE ERYTHEMA (Red with a slight wheel at the injection site). On 10-Jan-2021, VACCINATION SITE WARMTH (Heat at the injection site), VACCINATION SITE BRUISING (Slight bruise at the injection site), VACCINATION SITE INFLAMMATION (Feeling of inflammation), VACCINATION SITE URTICARIA (One small hive, fairly large, underneath the injection site), VACCINATION SITE SWELLING (Swollen at the injection site), VACCINATION SITE PAIN (Soreness at the injection site/Tiny bit of aching at the injection site) and VACCINATION SITE ERYTHEMA (Red with a slight wheel at the injection site) had resolved.        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.   Treatment for the event included betamethasone topically and fexofenadine.  No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: NNI; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded. Injection site pain, injection site swelling and injection site redness are consistent with the known safety profile of the vaccine.