Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Lack of drug effect; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS).   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 09-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (COVID-19) had resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.  No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Company Comment:  This spontaneous case concerns a 60-year-old female patient on concomitant Upadacitinib (Rinvoq) for Rheumatoid arthritis, who experienced the unexpected, non-serious  adverse event of special interest COVID-19, that occurred 7 months and 16 days  after receiving the second dose of mRNA-1273 vaccine.  SARS-CoV-2 test, and treatment were not reported. Outcome of the event was reported as resolved. Additionally, Drug ineffective was also noted. The 2-dose primary series of mRNA-1273 vaccine was given 30 days apart.  The concomitant Upadacitinib is an immunosuppressant that may slow down the immune system and lower the immune response to mRNA-1273 vaccine predisposing  to infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 60-year-old female patient on concomitant Upadacitinib (Rinvoq) for Rheumatoid arthritis, who experienced the unexpected, non-serious  adverse event of special interest COVID-19, that occurred 7 months and 16 days  after receiving the second dose of mRNA-1273 vaccine.  SARS-CoV-2 test, and treatment were not reported. Outcome of the event was reported as resolved. Additionally, Drug ineffective was also noted. The 2-dose primary series of mRNA-1273 vaccine was given 30 days apart.  The concomitant Upadacitinib is an immunosuppressant that may slow down the immune system and lower the immune response to mRNA-1273 vaccine predisposing  to infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.