Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Insomnia, Pruritus, Swelling
Clinical narrative: symptoms started spreading from the injection site to the whole arm; Worried about the side effects; Red injection site; Itchy injection site; Swollen injection site; It is very itchy, symptoms started spreading from the injection site to the whole arm; she cannot sleep at night; some of the red spot in her right arm, symptoms started spreading from the injection site to the whole arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (some of the red spot in her right arm, symptoms started spreading from the injection site to the whole arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced ERYTHEMA (some of the red spot in her right arm, symptoms started spreading from the injection site to the whole arm) (seriousness criterion medically significant) and INSOMNIA (she cannot sleep at night). On an unknown date, the patient experienced PRURITUS (It is very itchy, symptoms started spreading from the injection site to the whole arm), SWELLING (symptoms started spreading from the injection site to the whole arm), FEELING ABNORMAL (Worried about the side effects), VACCINATION SITE ERYTHEMA (Red injection site), VACCINATION SITE PRURITUS (Itchy injection site) and VACCINATION SITE SWELLING (Swollen injection site). At the time of the report, ERYTHEMA (some of the red spot in her right arm, symptoms started spreading from the injection site to the whole arm), PRURITUS (It is very itchy, symptoms started spreading from the injection site to the whole arm), INSOMNIA (she cannot sleep at night), SWELLING (symptoms started spreading from the injection site to the whole arm), VACCINATION SITE ERYTHEMA (Red injection site), VACCINATION SITE PRURITUS (Itchy injection site) and VACCINATION SITE SWELLING (Swollen injection site) had not resolved and FEELING ABNORMAL (Worried about the side effects) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication information was provided  treatment products for the symptoms were Cortisone cream , prednisone tablet ice affected area.  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.   This case was linked to MOD-2021-141702 (Patient Link).; 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.