Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Pyrexia, Vaccination site erythema
Clinical narrative: Fatigue; Joint pain; Fever; Chills; The site was itchy; Large raised red bump at injection site/subsided 85% a small golfball size; Large raised red bump at injection site; COVID Arm" at the site of the injection with the local inflammation / reaction becoming the approximate size of a soft ball; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Large raised red bump at injection site/subsided 85% a small golfball size), VACCINATION SITE REACTION (COVID Arm" at the site of the injection with the local inflammation / reaction becoming the approximate size of a soft ball), VACCINATION SITE ERYTHEMA (Large raised red bump at injection site), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU (Body site: Left arm) on 18-Oct-2021. Concurrent medical conditions included Drug allergy (Allery to Keflex) and Blood pressure high. Concomitant products included CALLUNA VULGARIS (HEATHER [CALLUNA VULGARIS]) for Birth control, LISINOPRIL for Blood pressure high.    On 01-Nov-2021 at 4:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced VACCINATION SITE REACTION (COVID Arm" at the site of the injection with the local inflammation / reaction becoming the approximate size of a soft ball). On 02-Nov-2021, the patient experienced VACCINATION SITE MASS (Large raised red bump at injection site/subsided 85% a small golfball size) and VACCINATION SITE ERYTHEMA (Large raised red bump at injection site). On an unknown date, the patient experienced FATIGUE (Fatigue), ARTHRALGIA (Joint pain), PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE PRURITUS (The site was itchy). The patient was treated with HYDROCORTISONE for Adverse event, at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency; LORATADINE (CLARITINE) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Large raised red bump at injection site/subsided 85% a small golfball size) and VACCINATION SITE ERYTHEMA (Large raised red bump at injection site) had not resolved, VACCINATION SITE REACTION (COVID Arm" at the site of the injection with the local inflammation / reaction becoming the approximate size of a soft ball) had resolved and FATIGUE (Fatigue), ARTHRALGIA (Joint pain), PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE PRURITUS (The site was itchy) was resolving.            It was reported that Covid arm was most likely caused by suspect and there were no other potential causes. Patient did not experienced similar events in the past.  The reaction at the injection site continued to grow and spread up to the 72 hr maximum. Patient started treatment with Benadryl, Advil, hydrocortisone cream. Symptoms were stable and had additional spread of the reaction. On day 7, patient visited doctor who also recommended adding Claritin to the treatment and doctor confirmed that it was not a case of cellulitis. Patient continued treatment until day 9. Symptoms had subsided by 85% but a small golf ball size bump that's red and raised still persists.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Folloup document received on 10-NOV-2021 contains no new information On 10-Nov-2021: Follow-up document received on 10-NOV-2021,reporter, patient information, dose details,  allergies, chronic condition, historical vaccine, concomitant medicines, facility information and events were updated