Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Generalized erythema; Developed a hardness the size of half a dollar, it is red and sore; Pain, tenderness and swelling in the arm of the injection, the right on/Developed a hardness the size of half a dollar, it is red and sore; Pain, tenderness and swelling in the arm of the injection, the right one; Developed a hardness the size of half a dollar, it is red and sore; Itching 2 or 3 days after the shot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching 2 or 3 days after the shot), ERYTHEMA (Generalized erythema), VACCINATION SITE INDURATION (Developed a hardness the size of half a dollar, it is red and sore), VACCINATION SITE PAIN (Pain, tenderness and swelling in the arm of the injection, the right on/Developed a hardness the size of half a dollar, it is red and sore) and VACCINATION SITE SWELLING (Pain, tenderness and swelling in the arm of the injection, the right one) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 032M20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mastectomy (Patient had a mastectomy in the left side in the past). Concurrent medical conditions included Chronic kidney disease stage 3 since 2014, Chronic obstructive pulmonary disease since 2019, Thyroid disorder, Runny nose since 1980 and Pollen allergy (Spring outdoor allergies pollen). Concomitant products included LEVOTHYROXINE for Thyroid disorder, LISINOPRIL, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), VITAMINS NOS and INFLUENZA VACCINE for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PRURITUS (Itching 2 or 3 days after the shot). On 24-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ERYTHEMA (Generalized erythema), VACCINATION SITE INDURATION (Developed a hardness the size of half a dollar, it is red and sore), VACCINATION SITE PAIN (Pain, tenderness and swelling in the arm of the injection, the right on/Developed a hardness the size of half a dollar, it is red and sore), VACCINATION SITE SWELLING (Pain, tenderness and swelling in the arm of the injection, the right one) and VACCINATION SITE ERYTHEMA (Developed a hardness the size of half a dollar, it is red and sore). On 03-Dec-2021, PRURITUS (Itching 2 or 3 days after the shot), ERYTHEMA (Generalized erythema), VACCINATION SITE INDURATION (Developed a hardness the size of half a dollar, it is red and sore), VACCINATION SITE PAIN (Pain, tenderness and swelling in the arm of the injection, the right on/Developed a hardness the size of half a dollar, it is red and sore), VACCINATION SITE SWELLING (Pain, tenderness and swelling in the arm of the injection, the right one) and VACCINATION SITE ERYTHEMA (Developed a hardness the size of half a dollar, it is red and sore) had resolved.            No treatment medication were reported.   This case was linked to MOD-2021-396109, MOD-2021-396130 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Follow up received included Patient demographic details, concurrent conditions, allergic conditions, concomitant information updated,  new events Erythema and Pruritus added, Events outcome Updated to Recovered, stop date added and reporter causality was updated to unknown from not provided.