Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Injection site bruising, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Injection site bruising; Injection site hives; Injection site swelling; Injection site itching; COVID-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 virus test positive), INJECTION SITE BRUISING (Injection site bruising), INJECTION SITE URTICARIA (Injection site hives), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE PRURITUS (Injection site itching) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In February 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, citrate free solution for injection in pre-filled pen. In January 2022, the patient experienced COVID-19 (COVID-19 virus test positive). On an unknown date, the patient experienced INJECTION SITE BRUISING (Injection site bruising), INJECTION SITE URTICARIA (Injection site hives), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE PRURITUS (Injection site itching). At the time of the report, COVID-19 (COVID-19 virus test positive), INJECTION SITE BRUISING (Injection site bruising), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE PRURITUS (Injection site itching) outcome was unknown and INJECTION SITE URTICARIA (Injection site hives) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication was reported.  There was no reported medical history.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event of COVID POSITIVE with HUMIRA(ADALIMUMAB) was reported as no reasonable possibility (not related), and for events Injection site hives, injection site swelling, injection site bruising and injection site pruritus was reported as reasonable possibility (probable).  No treatment information was reported.  Company Comment: This is a Spontaneous case concerning a 44-years-old female patient, medicated with Adalimumab, who experienced the non-serious unexpected AESI of COVID-19, in an unknown date after the administration of the 3rd dose of the mRNA-1273 vaccine in an unknown schedule of vaccination. Also, other non-serious adverse events were reported in this case. Relevant test was performed: COVID-19 virus test. The concomitant use of Adalimumab suggests a condition that will be a contributor for the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event assessed as non-serious.; Sender's Comments: This is a Spontaneous case concerning a 44-years-old female patient, medicated with Adalimumab, who experienced the non-serious unexpected AESI of COVID-19, in an unknown date after the administration of the 3rd dose of the mRNA-1273 vaccine in an unknown schedule of vaccination. Also, other non-serious adverse events were reported in this case. Relevant test was performed: COVID-19 virus test. The concomitant use of Adalimumab suggests a condition that will be a contributor for the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event assessed as non-serious.