Sex: M
Vaccine: COVID19
Symptoms: Vaccination site papule, Wound, Wound complication, Wound drainage
Clinical narrative: Cone shape wound has change to a puss mess on his arm/drains everyday; cone shape and concave point near injection site; Knot at injection site and bright red rash 3 inches in diameter; Injection site bright red rash 3 inches in diameter; open flesh sore that will not go away; it bleeds; very frustrated because he tried 4-5 antibiotics; he's tried 4-5 different antibiotics to help his open flesh sore that will not go away; wound is painful; 8 drain holes the size of toothpicks in his wound; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 13-May-2021. The most recent information was received on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAPULE (cone shape and concave point near injection site), VACCINATION SITE MASS (Knot at injection site and bright red rash 3 inches in diameter), VACCINATION SITE ERYTHEMA (Injection site bright red rash 3 inches in diameter) and WOUND DRAINAGE (Cone shape wound has change to a puss mess on his arm/drains everyday) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced VACCINATION SITE MASS (Knot at injection site and bright red rash 3 inches in diameter) (seriousness criterion hospitalization) and VACCINATION SITE ERYTHEMA (Injection site bright red rash 3 inches in diameter) (seriousness criterion hospitalization). On 01-May-2021, the patient experienced VACCINATION SITE PAPULE (cone shape and concave point near injection site) (seriousness criterion hospitalization). On 11-May-2021, the patient experienced WOUND DRAINAGE (Cone shape wound has change to a puss mess on his arm/drains everyday) (seriousness criterion hospitalization). On 13-May-2021, the patient experienced WOUND COMPLICATION (wound is painful) and WOUND COMPLICATION (8 drain holes the size of toothpicks in his wound). On an unknown date, the patient experienced WOUND (open flesh sore that will not go away), VACCINATION SITE HAEMORRHAGE (it bleeds), FEELING ABNORMAL (very frustrated because he tried 4-5 antibiotics) and TREATMENT FAILURE (he's tried 4-5 different antibiotics to help his open flesh sore that will not go away). At the time of the report, VACCINATION SITE PAPULE (cone shape and concave point near injection site), VACCINATION SITE MASS (Knot at injection site and bright red rash 3 inches in diameter), VACCINATION SITE ERYTHEMA (Injection site bright red rash 3 inches in diameter), WOUND DRAINAGE (Cone shape wound has change to a puss mess on his arm/drains everyday), WOUND COMPLICATION (wound is painful) and WOUND COMPLICATION (8 drain holes the size of toothpicks in his wound) had not resolved and WOUND (open flesh sore that will not go away), VACCINATION SITE HAEMORRHAGE (it bleeds), FEELING ABNORMAL (very frustrated because he tried 4-5 antibiotics) and TREATMENT FAILURE (he's tried 4-5 different antibiotics to help his open flesh sore that will not go away) outcome was unknown.            Treatment included Sulfamethoxazole, Cephalexin, Clindamycin. Concomitant product use was not reported. Follow up received on 18-May-2021 was significant and included adverse event update. It was reported that the patient was very frustrated because he  tried 4-5 different antibiotics to help his open flesh sore that would not go away and would bleed and drain everyday since his second dose of the moderna vaccine.  Company Comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up was significant and included addition of 2 new events and minor narrative update.; Sender'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.