Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itching and redness about the size of a quater of Injection site; redness about the size of a quater around the injection site; Tested positive for covid; Swollen, red, and painful injection site; Painful injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching and redness about the size of a quater of Injection site), VACCINATION SITE ERYTHEMA (redness about the size of a quater around the injection site), VACCINATION SITE SWELLING (Swollen, red, and painful injection site), VACCINATION SITE PAIN (Painful injection site) and COVID-19 (Tested positive for covid) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003J21-2A) for COVID-19 vaccination. No Medical History information was reported.On 15-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2022, the patient experienced VACCINATION SITE SWELLING (Swollen, red, and painful injection site) and VACCINATION SITE PAIN (Painful injection site). On 22-Jan-2022, the patient experienced VACCINATION SITE PRURITUS (Itching and redness about the size of a quater of Injection site), VACCINATION SITE ERYTHEMA (redness about the size of a quater around the injection site) and COVID-19 (Tested positive for covid). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 18-Jan-2022, VACCINATION SITE SWELLING (Swollen, red, and painful injection site) and VACCINATION SITE PAIN (Painful injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itching and redness about the size of a quater of Injection site), VACCINATION SITE ERYTHEMA (redness about the size of a quater around the injection site) and COVID-19 (Tested positive for covid) had not resolved.DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 22-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.Patient had COVID related symptoms includes Nausea, fatigue, body aches,chest tightness,mild fever and a bad headache.Patient was using a CPAP (Continuous positive airway pressure) while awake and been forced deep breaths to stave off pneumonia.Patient not experienced any shortness of breath. The patient not had any previous diagnosis of myocarditis,percarditis or COVID before 22-Jan-2022.The concomitant medication was not reported. Company Comment:This case concerns a 33-year-old female patient, with no medical history reported, who experienced the unexpected AESI event of COVID-19 and the expected events of Vaccination site pruritus, Vaccination site erythema, Vaccination site swelling and Vaccination site pain. The events occurred approximately 1 day after receiving the first dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was not resolved. The rechallenge is not applicable as the events occurred after the first dose and no information about second dose is available. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 33-year-old female patient, with no medical history reported, who experienced the unexpected AESI event of COVID-19 and the expected events of Vaccination site pruritus, Vaccination site erythema, Vaccination site swelling and Vaccination site pain. The events occurred approximately 1 day after receiving the first dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was not resolved. The rechallenge is not applicable as the events occurred after the first dose and no information about second dose is available. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.