Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, Vaccination site erythema
Clinical narrative: migraine like headache; entire arm swollen; burning inside; itchy; redness below injection site about 3 inches to either side; muscle spasms at injection site; Fever; Large left rash on arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle spasms at injection site), MIGRAINE (migraine like headache), PERIPHERAL SWELLING (entire arm swollen), BURNING SENSATION (burning inside) and PRURITUS (itchy) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fever. Concurrent medical conditions included Hypothyroidism since 1980, Atrial fibrillation since 13-Jun-2019 and Congestive heart failure since 07-Jul-2019. Concomitant products included RIVAROXABAN (XARELTO) for Anticoagulant therapy, LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN, MONTELUKAST, DENOSUMAB (PROLIA), METOPROLOL, POTASSIUM CHLORIDE, FUROSEMIDE, DIGOXIN, TRAZODONE, TIZANIDINE, OMEPRAZOLE, AZELASTINE, FISH OIL, GLUCOSAMINE, CALCIUM CARBONATE, COLECALCIFEROL (CALTRATE + D [CALCIUM CARBONATE;COLECALCIFEROL]), VITAMIN D3, LORATADINE (CLARITIN [LORATADINE]), VITAMIN B12 NOS, ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS) and MAGNESIUM 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 14-Feb-2021, the patient experienced RASH (Large left rash on arm) and PYREXIA (Fever). On 27-Feb-2021, the patient experienced MUSCLE SPASMS (muscle spasms at injection site). On an unknown date, the patient experienced MIGRAINE (migraine like headache), PERIPHERAL SWELLING (entire arm swollen), BURNING SENSATION (burning inside), PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (redness below injection site about 3 inches to either side). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of for 2 days. On 16-Feb-2021, PYREXIA (Fever) had resolved. On 19-Feb-2021, RASH (Large left rash on arm) had resolved. At the time of the report, MUSCLE SPASMS (muscle spasms at injection site) had not resolved and MIGRAINE (migraine like headache), PERIPHERAL SWELLING (entire arm swollen), BURNING SENSATION (burning inside), PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (redness below injection site about 3 inches to either side) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 100.6 (High) 100.6-High.         The patient reported that exactly two weeks after receiving the second Moderna Vaccine, she started having muscle spasms at the injection site. It seemed to happen 10-12 times per day/ night, but each event would last only about 30 seconds. When it happened at night, it would awaken her. Sometimes during the day, it would be so intense that the injection site on arm would jump. In the process, the patient got shot on the front side of arm, not in the usual side muscle.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Updated reporter contact details, patient demographics, race and ethnic group, medical history added, Concomitant medicine added and events added.