Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Very sore in arm; Arm where shot was given was swollen; Swollen lymph node; Arm where shot was given was red; Arm where shot was given was burning; Arm where shot was given was itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very sore in arm), VACCINATION SITE WARMTH (Arm where shot was given was burning), VACCINATION SITE PRURITUS (Arm where shot was given was itchy), VACCINATION SITE SWELLING (Arm where shot was given was swollen) and VACCINATION SITE ERYTHEMA (Arm where shot was given was red) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 013620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mastectomy in 2013. Concurrent medical conditions included Diabetes, Asthma, Hypertension, Latex allergy, Drug allergy (Steroid), Sulfonamide allergy, Ligament disorder NOS (Physical therapy to treat ligament in right shoulder and work with both arms.) and Thyroid disorder NOS. Concomitant products included CANDESARTAN CILEXETIL (ATACAND), AMLODIPINE BESILATE (NORVASC), HYDROCHLOROTHIAZIDE, LEVOTHYROXINE and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Arm where shot was given was burning), VACCINATION SITE PRURITUS (Arm where shot was given was itchy) and VACCINATION SITE ERYTHEMA (Arm where shot was given was red). On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Very sore in arm), VACCINATION SITE SWELLING (Arm where shot was given was swollen) and LYMPHADENOPATHY (Swollen lymph node). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Mar-2021, PAIN IN EXTREMITY (Very sore in arm), VACCINATION SITE WARMTH (Arm where shot was given was burning), VACCINATION SITE PRURITUS (Arm where shot was given was itchy), VACCINATION SITE SWELLING (Arm where shot was given was swollen) and VACCINATION SITE ERYTHEMA (Arm where shot was given was red) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph node) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Additional information received included patient demographic details race, ethnicity, height and weight; current medical condition of the patient including sulfa allergy, steroids allergy, latex allergy, diabetes, asthma and hypertension; concomitant medication details including Atacand, Norvasc, hydrocholithiazide, levothyroxine and Advair; suspect vaccine first dose details; adverse event details included vaccination site itching; update to adverse events included stop date and change in outcome from unknown to recovered for events vaccination site red, burning and swelling; treatment medication Benadryl details.