Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site reaction, Vaccination site warmth
Clinical narrative: tiny scab; Right arm swollen; sore arm; Red rash (4" x 5") on Injection Site; Itchy Injection Site; Warm to touch Injection Site; lumpy Injection Site; Pain in the right arm; COVID Arm (Right arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch Injection Site), VACCINATION SITE MASS (lumpy Injection Site), PAIN IN EXTREMITY (Pain in the right arm), VACCINATION SITE REACTION (COVID Arm (Right arm)) and SCAB (tiny scab) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pre-diabetes (Improved by 07/2021 from 6.2-5.8 A1C) since August 2020, High cholesterol since August 2019, AFib since 2019, Diverticulosis (Hospitalized 11/2020 - no surgery. Antibiotics & Prednisone) since February 2021, GERD since 1995, Flu vaccination (DIZZINESS for a couple of days (stopped having flu vaccines after this)) in October 2018, Drug allergy (Allergic to drug COMPAZINE ("TEXTBOOK REACTION" - Drug given for vomiting during pregnancy - antidote given in ER)) in May 1975 and Drug allergy (Allergic to augmentin) in November 2020. Concomitant products included APIXABAN (ELIQUIS) and METOPROLOL for AFib, ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN [ATORVASTATIN CALCIUM TRIHYDRATE]) for Cholesterol, OMEPRAZOLE SODIUM (OMEPRAZOLE [OMEPRAZOLE SODIUM]) and PANTOPRAZOLE for GERD, MATURE MULTIVITAMINS, CALCIUM, CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID), VITAMIN D3 and PSYLLIUM HYDROPHILIC MUCILLOID (METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID]) for Gastroenterologist consultation.    On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch Injection Site), VACCINATION SITE MASS (lumpy Injection Site), PAIN IN EXTREMITY (Pain in the right arm), VACCINATION SITE REACTION (COVID Arm (Right arm)), VACCINATION SITE RASH (Red rash (4" x 5") on Injection Site) and VACCINATION SITE PRURITUS (Itchy Injection Site). On an unknown date, the patient experienced SCAB (tiny scab), PERIPHERAL SWELLING (Right arm swollen) and MYALGIA (sore arm). The patient was treated with ETHANOL (ALCOHOL RUBBING) from 02-Sep-2021 to 06-Sep-2021 at a dose of UNK, bid. On 05-Sep-2021, VACCINATION SITE MASS (lumpy Injection Site) and VACCINATION SITE RASH (Red rash (4" x 5") on Injection Site) had resolved. On 11-Sep-2021, SCAB (tiny scab) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warm to touch Injection Site), PAIN IN EXTREMITY (Pain in the right arm), VACCINATION SITE REACTION (COVID Arm (Right arm)), PERIPHERAL SWELLING (Right arm swollen), VACCINATION SITE PRURITUS (Itchy Injection Site) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included Warm Packs & Alcohol Rub for 2 days. On NOV-2020 the patient diagnosed with  heat rash and ER result was unknown and also COVID ARM diagnosis was made through conversations. The patient has  given Warm Packs treatment from 02-sep-2021  to 06-sep-2021 two times per day.   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Added new events, medical history and concomitant products On 18-Sep-2021: Significant follow up received on 18-SEP-2021. Consumer consent form attached. HCP contact details updated.