Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth, Vaccination site pain
Clinical narrative: Injection site reaction; Warm at injection site; Itchy at the injection site; Redness at injection site; Painful at injection site/tender at injection site; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INJECTION SITE REACTION (Injection site reaction), INJECTION SITE WARMTH (Warm at injection site), INJECTION SITE PRURITUS (Itchy at the injection site), INJECTION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Painful at injection site/tender at injection site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced INJECTION SITE REACTION (Injection site reaction), INJECTION SITE WARMTH (Warm at injection site), INJECTION SITE PRURITUS (Itchy at the injection site), INJECTION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Painful at injection site/tender at injection site). At the time of the report, INJECTION SITE REACTION (Injection site reaction), INJECTION SITE WARMTH (Warm at injection site), INJECTION SITE PRURITUS (Itchy at the injection site), INJECTION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Painful at injection site/tender at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   A spontaneous case was received from a Pharmacist on 20-JAN-2021 which refers to a Female  who developed the following events injection site reaction(PT: Vaccination site reaction ,itchy at injection site(PT: Vaccination site pruritus),redness at injection site(PT: Vaccination site erythema),warm at injection site(PT: Vaccination site warmth) and tender at injection site(PT: Vaccination site tenderness) The patients past medical history and concomitant medications list were not reported. No lab data were reported. The patient received their first of two planned doses of mRNA-1273 (Batch No 011J20A) on 28-DEC-2020, intramuscularly.  The outcome of all the events were reported as resolved. The action taken for Moderna COVID-19 Vaccine was Unknown.  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre- existing disease); there is no plausible mechanism to implicate the drug.  Concomitant product use was not provided by the reporter. No treatment information was provided.