Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Sore at the injection site; Painful red knot at the site of injection; painful red knot at the site of injection; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Sore at the injection site), VACCINATION SITE SWELLING (Painful red knot at the site of injection) and VACCINATION SITE ERYTHEMA (painful red knot at the site of injection) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO Medical History Information was reported.     On 28-Dec-2020 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore at the injection site) and VACCINATION SITE SWELLING (Painful red knot at the site of injection). 04-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (painful red knot at the site of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CEFALEXIN (KEFLEX [CEFALEXIN]) on 09-Jan-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Sore at the injection site), VACCINATION SITE SWELLING (Painful red knot at the site of injection) and VACCINATION SITE ERYTHEMA (painful red knot at the site of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Jan-2021 and was forwarded to Moderna on 14-Jan-2021.    This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Sore at the injection site), VACCINATION SITE SWELLING (Painful red knot at the site of injection) and VACCINATION SITE ERYTHEMA (painful red knot at the site of injection) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO Medical History Information was reported.     On 28-Dec-2020 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore at the injection site) and VACCINATION SITE SWELLING (Painful red knot at the site of injection). 04-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (painful red knot at the site of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CEFALEXIN (KEFLEX [CEFALEXIN]) on 09-Jan-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Sore at the injection site), VACCINATION SITE SWELLING (Painful red knot at the site of injection) and VACCINATION SITE ERYTHEMA (painful red knot at the site of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.