Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: they look like a beehive stung them; reaction is becoming systemic, because the patient now has a terrible itching everywhere, and they look like a beehive stung them; COVID arm; looks like bleeding under the skin; big area that was red and as big as the front part of her arm with a wider irregular shape, about a half inch crescent, dark subcutaneous reaction; as a severe allergic reaction; A spontaneous report was received from a consumer concerning a 79-year-old female who received the second dose of Moderna's COVID-19 (mRNA-1273) vaccine and experienced the following:  covid arm (Vaccination site reaction), looks like bleeding under the skin (Vaccination site bruising), big area that was red and as big as the front part of her arm (Vaccination site erythema), the patient now has a terrible itching everywhere (Generalised pruritus), and they look like a beehive stung them (Generalized urticaria), and the reaction is becoming systemic, a severe allergic reaction (Allergy to vaccine).  The patient's medical history was not provided. Concomitant product use included high blood pressure medication (not specified),  curcumin, and acetylsalicyclic acid.  On 07 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided).    On 04 FEB 2021, approximately five days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 032L20A) intramuscularly in the left deltoid for the prophylaxis of COVID-19 infection.    On 08 Feb 2021, the patient experienced the events covid arm; mother of all covid arms; looked like hell, really bad; looked like bleeding under the skin; big area that was red and as big as the front part of arm with a wider irregular shape, about a half inch crescent, dark subcutaneous reaction; looked like bleeding under the skin; very tremendous reaction, but it does not hurt.   On 11-Feb-2011, the red subcutaneous reaction deepened and started to migrate almost immediately, and slowly migrated 5-6 inches to the bottom of the arm near the elbow. The reporter stated the reaction seemed to be getting better; it was not getting any worse, but was worried it may turn into cellulitis or gangrene. On an unknown date, the patient consulted with a dermatologist for the "Covid arm" and the reporter stated that the reaction was becoming systemic because the patient now had terrible itching everywhere, and they looked like a beehive stung them.  The reporter described it as a severe allergic reaction to the second vaccine dose with onset of this reaction 4-5 days after the second dose. Treatment for the events included some cream with steroids to treat the pruritus, as well as diphenhydramine.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.