Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: lower half of right upper  arm was warm; lower half of my  right upper arm was very red; lower half of right upper  arm was tight (swollen); Right arm was tender,sore; upper arm was itching; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (lower half of right upper  arm was warm), VACCINATION SITE PRURITUS (upper arm was itching), VACCINATION SITE ERYTHEMA (lower half of my  right upper arm was very red), VACCINATION SITE SWELLING (lower half of right upper  arm was tight (swollen)) and VACCINATION SITE PAIN (Right arm was tender,sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030LZOA and 02J20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 01-Jan-2021 to 08-Jan-2021. Concurrent medical conditions included Hypertension since 1997, Hypothyroidism since 1995, Hyperlipidemia since 1995, Gastroesophageal reflux disease since 2015, Depression since 2002, Wheezing since 1980 and Obesity (Most recent body mass index was 32) since 2010. Concomitant products included LORATADINE for Allergy, SERTRALINE for Depression, OMEPRAZOLE for Gastroesophageal reflux disease, ESTROGENS CONJUGATED (PREMARIN) for Hormone replacement therapy, SIMVASTATIN (ZOCOR) and EZETIMIBE (ZETIA) for Hyperlipidemia, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR) and METOPROLOL for Hypertension, LEVOTHYROXINE SODIUM (SYNTHYROID) for Hypothyroidism, CELECOXIB (CELEBREX) for Osteoarthritis, ACYCLOVIR [ACICLOVIR] for Prevention, VITAMIN C [ASCORBIC ACID], VITAMIN E NOS (VITAMIN E [VITAMIN E NOS]), MULTIVITAMINS [VITAMINS NOS] and FOLIC ACID for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (upper arm was itching) and VACCINATION SITE PAIN (Right arm was tender,sore). On 28-Jan-2021, the patient experienced VACCINATION SITE WARMTH (lower half of right upper  arm was warm), VACCINATION SITE ERYTHEMA (lower half of my  right upper arm was very red) and VACCINATION SITE SWELLING (lower half of right upper  arm was tight (swollen)). On 30-Jan-2021, VACCINATION SITE WARMTH (lower half of right upper  arm was warm), VACCINATION SITE PRURITUS (upper arm was itching) and VACCINATION SITE PAIN (Right arm was tender,sore) had resolved. On 31-Jan-2021, VACCINATION SITE ERYTHEMA (lower half of my  right upper arm was very red) had resolved. At the time of the report, VACCINATION SITE SWELLING (lower half of right upper  arm was tight (swollen)) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, SARS-CoV-2 antibody test: positive (Positive) source of sample was nasopharyngeal,  Type of test : RT-PCR.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient experienced mild shortness of breath with least bit of activity (from 1 Jan 2021 to 6 Jan 2021).  Treatment activities for event was done cetirizine 10 mg and cold compress over the injection site.  Patient was prescribed with an antibiotic and was asked to start the antibiotic if it worsened over the week. It was reported that patient had not used any antibiotic.  Action taken with mRNA-1273 in response to the event was not applicable.  Based on current available information and the temporal association between product use and the stat date of the events a causal relationship cannot be excluded.