Age: 38.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient had second dose on 27 apr 2021 and patient had COVID on 03rd Dec 2021.; Patient had second dose on 27 apr 2021 and patient had COVID on 03rd Dec 2021.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient had second dose on 27 apr 2021 and patient had COVID on 03rd Dec 2021.) and VACCINATION FAILURE (Patient had second dose on 27 apr 2021 and patient had COVID on 03rd Dec 2021.) in a 38-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 Ulcerative colitis and Psoriatic arthritis.     No other relevant medical history was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 03-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Patient had second dose on 27 apr 2021 and patient had COVID on 03rd Dec 2021.). On an unknown date, the patient experienced VACCINATION FAILURE (Patient had second dose on 27 apr 2021 and patient had COVID on 03rd Dec 2021.). At the time of the report, COVID-19 (Patient had second dose on 27 apr 2021 and patient had COVID on 03rd Dec 2021.) was resolving and VACCINATION FAILURE (Patient had second dose on 27 apr 2021 and patient had COVID on 03rd Dec 2021.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Dec-2021, SARS-CoV-2 test: (Positive) Positive.         Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This is a spontaneous case reported by a consumer. A 38-year-old female patient in treatment with ADALIMUMAB (HUMIRA) for Ulcerative colitis and Psoriatic arthritis, completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days between doses and seven months later she received third dose. 3 days after last dose she experienced non serious event of COVID-19 (AESI). No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A 38-year-old female patient in treatment with ADALIMUMAB (HUMIRA) for Ulcerative colitis and Psoriatic arthritis, completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days between doses and seven months later she received third dose. 3 days after last dose she experienced non serious event of COVID-19 (AESI). No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.