Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: About 3 weeks ago, she started with right sore breast that has lumps there; Next day after receiving 2nd dose, she started with large area that was swollen, and itchy at; vaccination site rash; Vaccination site erythema; Next day after receiving 2nd dose, she started with large area that was swollen, and itchy at; Under her arms, she can barely touch; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BREAST PAIN (About 3 weeks ago, she started with right sore breast that has lumps there), PAIN IN EXTREMITY (Under her arms, she can barely touch), VACCINATION SITE PRURITUS (Next day after receiving 2nd dose, she started with large area that was swollen, and itchy at), VACCINATION SITE SWELLING (Next day after receiving 2nd dose, she started with large area that was swollen, and itchy at) and VACCINATION SITE RASH (vaccination site rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALPRAZOLAM (XANAX), METHIMAZOLE, METOPROLOL and HCTZ for an unknown indication.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Under her arms, she can barely touch). On 03-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Next day after receiving 2nd dose, she started with large area that was swollen, and itchy at). On 24-Mar-2021, the patient experienced VACCINATION SITE RASH (vaccination site rash) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). On an unknown date, the patient experienced BREAST PAIN (About 3 weeks ago, she started with right sore breast that has lumps there) and VACCINATION SITE SWELLING (Next day after receiving 2nd dose, she started with large area that was swollen, and itchy at). At the time of the report, BREAST PAIN (About 3 weeks ago, she started with right sore breast that has lumps there), PAIN IN EXTREMITY (Under her arms, she can barely touch), VACCINATION SITE PRURITUS (Next day after receiving 2nd dose, she started with large area that was swollen, and itchy at), VACCINATION SITE SWELLING (Next day after receiving 2nd dose, she started with large area that was swollen, and itchy at), VACCINATION SITE RASH (vaccination site rash) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.            Other relevant concomitant medications included Statin and Allergy Medication.  Treatment medication included antibiotics.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable     This case was linked to MOD-2021-131317, MOD-2021-131317 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: FUP attached