Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Had an allergic reaction to Moderna Covid-19 vaccine; Broke out in hives around eyes/broke out in hives on nose/broke out in hives behind her ears; Broke out in rash on her injection site right arm.; Broke out in Hives on her injection site right arm.; Achy; Tired; Swollen lymph nodes in my right arm pit; Sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke out in Hives on her injection site right arm.), ALLERGY TO VACCINE (Had an allergic reaction to Moderna Covid-19 vaccine), URTICARIA (Broke out in hives around eyes/broke out in hives on nose/broke out in hives behind her ears), VACCINATION SITE PAIN (Sore right injection site arm) and VACCINATION SITE RASH (Broke out in rash on her injection site right arm.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore right injection site arm). On 18-Aug-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes in my right arm pit). On 19-Aug-2021, the patient experienced MYALGIA (Achy) and FATIGUE (Tired). On 20-Aug-2021, the patient experienced URTICARIA (Broke out in Hives on her injection site right arm.) and VACCINATION SITE RASH (Broke out in rash on her injection site right arm.). On 24-Aug-2021, the patient experienced URTICARIA (Broke out in hives around eyes/broke out in hives on nose/broke out in hives behind her ears). On an unknown date, the patient experienced ALLERGY TO VACCINE (Had an allergic reaction to Moderna Covid-19 vaccine). On 20-Aug-2021, MYALGIA (Achy) and FATIGUE (Tired) had resolved. At the time of the report, URTICARIA (Broke out in Hives on her injection site right arm.), ALLERGY TO VACCINE (Had an allergic reaction to Moderna Covid-19 vaccine), URTICARIA (Broke out in hives around eyes/broke out in hives on nose/broke out in hives behind her ears), VACCINATION SITE PAIN (Sore right injection site arm), VACCINATION SITE RASH (Broke out in rash on her injection site right arm.) and LYMPHADENOPATHY (Swollen lymph nodes in my right arm pit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported.  Treatment medication not reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. Case downgraded to non-serious due to the lack of evidence of seriousness from a regulatory or clinical standpoint for the events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. Case downgraded to non-serious due to the lack of evidence of seriousness from a regulatory or clinical standpoint for the events.