Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itch at site of injection/rash sh from injection site downward; Triangular shaped redness/rash from injection site downward, approximately 3"x4"x2.5"; Injection site was sore, felt warm and developed  golf ball size lump; Developed golf size ball lump; Injection site was sore, felt warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Developed golf size ball lump), VACCINATION SITE WARMTH (Injection site was sore, felt warm), VACCINATION SITE PRURITUS (Itch at site of injection/rash sh from injection site downward), VACCINATION SITE PAIN (Injection site was sore, felt warm and developed  golf ball size lump) and VACCINATION SITE ERYTHEMA (Triangular shaped redness/rash from injection site downward, approximately 3"x4"x2.5") in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A27A) for COVID-19 vaccination.   The patient's past medical history included Stent insertion NOS on 24-Sep-2019. Concurrent medical conditions included Allergy to animal (Allergic to Pet Dander), Perfume sensitivity, Hair dye sensitivity, Food allergy (Allergic to clams), Diabetes (A1C increased from 6.5 in Dec. 2020 to 8.4 in May 2021) since 2009, Blood pressure high and Allergy to animal (scallops and oysters). Concomitant products included ROSUVASTATIN CALCIUM from 24-Sep-2019 to an unknown date for Cholesterosis, METFORMIN HCL for Diabetes, MECLIZINE HCL for Dizziness, ESTRADIOL (ESTRACE) for Hormone replacement therapy, PROPRANOLOL HCL for Hypertension, RAMIPRIL, TRIAMCINOLONE ACETONIDE (NASACORT), FAMOTIDINE, MAGNESIUM, ACETYLSALICYLIC ACID (ASPIRIN 81), LACTOBACILLUS NOS (CULTURELLE), MACROGOL 3350 (MIRALAX) and CENTRUM FOR WOMEN for an unknown indication.  On 02-Mar-2021 at 6:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021 at 4:00 PM, the patient experienced VACCINATION SITE MASS (Developed golf size ball lump), VACCINATION SITE WARMTH (Injection site was sore, felt warm) and VACCINATION SITE PAIN (Injection site was sore, felt warm and developed  golf ball size lump). On 03-Mar-2021 at 9:00 AM, the patient experienced VACCINATION SITE ERYTHEMA (Triangular shaped redness/rash from injection site downward, approximately 3"x4"x2.5"). On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itch at site of injection/rash sh from injection site downward). On 05-Mar-2021, VACCINATION SITE MASS (Developed golf size ball lump), VACCINATION SITE WARMTH (Injection site was sore, felt warm) and VACCINATION SITE PAIN (Injection site was sore, felt warm and developed  golf ball size lump) had resolved. On 08-Mar-2021, VACCINATION SITE ERYTHEMA (Triangular shaped redness/rash from injection site downward, approximately 3"x4"x2.5") had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itch at site of injection/rash sh from injection site downward) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, Glycosylated haemoglobin: 6.5 6.5. In May 2021, Glycosylated haemoglobin: 8.4 8.4.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Treatment information was not provided.  The concomitant medications included hair, skin and nails supplement.   This case was linked to MOD21-066388 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up received on 13-MAY-2021 contains information regarding mail address of the reporter. On 18-May-2021: Follow-up received on 18-May-2021 contains information regarding reporter details, the patient demographics, medical history, concomitant medicines, additional events vaccination site pain,vaccination site warmth, and vaccination site mass.