Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain in extremity, Paraesthesia
Clinical narrative: Injection site swelling, appears red and itchy with about 3 inches in size; Appears itchy; Small red spot at the injection site; Tingling sensation on her skin, legs and back; arm soreness; A spontaneous report was received from an other health care professional, concerning herself, a 31-years-old female patient, who received Moderna's COVID-19 Vaccine and developed tingling sensation on her skin, legs and back; arm soreness;  small red spot at the injection site and injection site swelling, appears red and itchy with about 3 inches in size.  The patient's medical history was not provided. Concomitant medications reported included ethinylestradiol, levonorgestrel; ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc; fish oil 1000 mg and sumatriptan as needed.   On 31-Dec-2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 039K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 31-Dec-2020, minutes after the administration of vaccine. the patient developed tingling sensation on her skin, legs and back that had lasted for 30 minutes and also developed arm soreness which had lasts for 2-3 days. Additionally, on 08-Jan-2021, a small red spot was evident at the injection site and on 09-Jan-2021 she also noticed that it was swelled up, appears red and itchy with about 3 inches in size. Treatment for the event included over the counter (OTC) diphenhydramine 25 mg, q4-6hrs (2 tablets last night). Patient also reported that she was planning to take just 1 tablet and apply OTC itch cream.  Action taken with mRNA-1273 in response to the events were not provided.   The events, tingling sensation on her skin, legs and back were considered resolved or on 31-Dec-2020. The event, arm soreness was considered resolved on 02-Jan-2021. The outcome of the events, small red spot at the injection site and injection site swelling, appears red and itchy with about 3 inches in size was not reported.; Reporter's Comments: This spontaneous report concerns 31-years-old female patient who experienced events of tingling sensation on her skin, legs and back; arm soreness; small red spot at the injection site and injection site swelling, appears red and itchy with about 3 inches in size. The events occurred on the same day after the administration of the first dose of the mRNA-1273 vaccine (Lot #: 039K20A, expiration date-unknown).  Treatment included diphenhydramine (OTC). Outcome is resolved for tingling sensation and unknown for other events. Based on the information provided, which includes a temporal association between the reported events and the administration of mRNA-1273 vaccine, a causal association cannot be excluded. The events of ; small red spot at the injection site and injection site swelling, appears red and itchy are consistent with the known safety profile of mRNA-1273 vaccine.