Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site urticaria, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Raised hive on left arm; The raised rash was warm to the touch, slightly itchy; The raised rash was warm to the touch, slightly itchy; A 2 inches x 2 inches raised patch rose at the injection site; The raised rash was warm to the touch, slightly itchy; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE SWELLING (A 2 inches x 2 inches raised patch rose at the injection site), VACCINATION SITE RASH (The raised rash was warm to the touch, slightly itchy), INJECTION SITE URTICARIA (Raised hive on left arm), VACCINATION SITE PRURITUS (The raised rash was warm to the touch, slightly itchy) and VACCINATION SITE WARMTH (The raised rash was warm to the touch, slightly itchy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025J20A) for COVID-19 vaccination.     Patient had never been diagnosed with or tested positive for COVID -19.  Patient does not have any acute illness at the time of vaccination and up to one month before.  Concurrent medical conditions included Penicillin allergy, Iodine allergy (Radioactive Iodine) and Migraine headache since 01-Jan-1960.   On 13-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021 at 9:20 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced VACCINATION SITE SWELLING (A 2 inches x 2 inches raised patch rose at the injection site), VACCINATION SITE RASH (The raised rash was warm to the touch, slightly itchy), VACCINATION SITE PRURITUS (The raised rash was warm to the touch, slightly itchy) and VACCINATION SITE WARMTH (The raised rash was warm to the touch, slightly itchy). On 16-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE URTICARIA (Raised hive on left arm). In February 2021, VACCINATION SITE SWELLING (A 2 inches x 2 inches raised patch rose at the injection site), VACCINATION SITE RASH (The raised rash was warm to the touch, slightly itchy), VACCINATION SITE PRURITUS (The raised rash was warm to the touch, slightly itchy) and VACCINATION SITE WARMTH (The raised rash was warm to the touch, slightly itchy) had resolved. At the time of the report, INJECTION SITE URTICARIA (Raised hive on left arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered INJECTION SITE URTICARIA (Raised hive on left arm) to be related. No further causality assessments were provided for VACCINATION SITE SWELLING (A 2 inches x 2 inches raised patch rose at the injection site), VACCINATION SITE RASH (The raised rash was warm to the touch, slightly itchy), VACCINATION SITE PRURITUS (The raised rash was warm to the touch, slightly itchy) and VACCINATION SITE WARMTH (The raised rash was warm to the touch, slightly itchy).    Patient saw an allergist, was tested for 20 allergens (pollens, mold, pets, etc), but no allergies were discovered. Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at time of vaccination  or at the time of the adverse event were reported as none. After all injections, injection arm was moved in a "chicken wing" type motion to ensure vaccine does not remain at injection site for approximately 15 minutes continuously then more sporadically. It was reported that approximately 5 days after inoculation in left arm, a 2 inches x 2 inches raised patch rose at the injection site. The raised rash was warm to the touch, slightly itchy, and lasted approximately 5 days. The event did not cause patient to seek medical care. The reporter did not report any other potential causes. The patient did not experienced a similar event in the past. It was reported as no treatment was required.   This case was linked to MOD-2022-555542, MOD-2022-555525 (Patient Link).