Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: got a very large, painful red itching lump on their right; got a very large, painful red itching lump on their right; got a very large, painful red itching lump on their right; got a very large, painful red itching lump on their right; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (got a very large, painful red itching lump on their right), VACCINATION SITE PAIN (got a very large, painful red itching lump on their right), VACCINATION SITE PRURITUS (got a very large, painful red itching lump on their right) and VACCINATION SITE SWELLING (got a very large, painful red itching lump on their right) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     NO Medical History Information was reported.  Concomitant products included CYANOCOBALAMIN (VITAMIN B-12), TOPIRAMATE, PROPRANOLOL (PROPANOLOL [PROPRANOLOL]), VITAMIN D [VITAMIN D NOS] and ACICLOVIR for an unknown indication.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (got a very large, painful red itching lump on their right). On 09-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (got a very large, painful red itching lump on their right), VACCINATION SITE PAIN (got a very large, painful red itching lump on their right) and VACCINATION SITE SWELLING (got a very large, painful red itching lump on their right). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (got a very large, painful red itching lump on their right), VACCINATION SITE PAIN (got a very large, painful red itching lump on their right), VACCINATION SITE PRURITUS (got a very large, painful red itching lump on their right) and VACCINATION SITE SWELLING (got a very large, painful red itching lump on their right) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Feb-2021 and was forwarded to Moderna on 10-Feb-2021.    This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (got a very large, painful red itching lump on their right), VACCINATION SITE PAIN (got a very large, painful red itching lump on their right), VACCINATION SITE PRURITUS (got a very large, painful red itching lump on their right) and VACCINATION SITE SWELLING (got a very large, painful red itching lump on their right) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     NO Medical History Information was reported.  Concomitant products included CYANOCOBALAMIN (VITAMIN B-12), TOPIRAMATE, PROPRANOLOL (PROPANOLOL [PROPRANOLOL]), VITAMIN D [VITAMIN D NOS] and ACICLOVIR for an unknown indication.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (got a very large, painful red itching lump on their right). On 09-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (got a very large, painful red itching lump on their right), VACCINATION SITE PAIN (got a very large, painful red itching lump on their right) and VACCINATION SITE SWELLING (got a very large, painful red itching lump on their right). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (got a very large, painful red itching lump on their right), VACCINATION SITE PAIN (got a very large, painful red itching lump on their right), VACCINATION SITE PRURITUS (got a very large, painful red itching lump on their right) and VACCINATION SITE SWELLING (got a very large, painful red itching lump on their right) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.