Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: Hives; Lump; Redness; Itch that is driving her crazy; Dose did not go into the deltoid muscle, it went into the tissue; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MASS (Lump), ERYTHEMA (Redness), PRURITUS (Itch that is driving her crazy), URTICARIA (Hives) and PRODUCT ADMINISTRATION ERROR (Dose did not go into the deltoid muscle, it went into the tissue) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066D21A, 029K20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Hives (numerous issues with hives thought the years- giant hives-- cause in determined - treated with steroids) since 10-Jan-1990, Breast cancer (multiple surgeries due to implant rejection-- 4 surgeries) since 12-Jan-2016, Osteoporosis (Prolia stopped due to severe bone and muscle pain 10/01/2020) since 15-Feb-2005 and Leukopenia (Remains chronic---- in depth invertigation finds no direct cause) since 10-Mar-2000. Concurrent medical conditions included Immunocompromised, Allergy (allergic to several antibiotics-face and neck rash - at time on the trunk and back) since 10-Jan-1980 and Allergy (allergic to sulpha-swelling redness pain) since 15-Jan-1990. Concomitant products included DENOSUMAB (PROLIA) from 15-Feb-2005 to 01-Oct-2020 for Osteoarthritis NOS, PANTOPRAZOLE from 15-Jan-2021 to an unknown date, HYDROXOCOBALAMIN ACETATE (VITAMIN B12 [HYDROXOCOBALAMIN ACETATE]) from 01-Jun-1995 to an unknown date, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) from 06-May-2006 to an unknown date and CALCIUM from 01-Jun-2006 to an unknown date for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 08-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTRATION ERROR (Dose did not go into the deltoid muscle, it went into the tissue). On 09-Sep-2021, the patient experienced MASS (Lump), ERYTHEMA (Redness) and PRURITUS (Itch that is driving her crazy). On an unknown date, the patient experienced URTICARIA (Hives). At the time of the report, MASS (Lump), ERYTHEMA (Redness), PRURITUS (Itch that is driving her crazy) and URTICARIA (Hives) outcome was unknown and PRODUCT ADMINISTRATION ERROR (Dose did not go into the deltoid muscle, it went into the tissue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   treatment medication includes steroids   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow-up received includes- Patient route of administration-Subcutaneous tissue On 16-Sep-2021: ADR Received on 16 Sep 2021,include Patient details, Medical History and concomitants mediations added