Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Lack of drug effect; patient experienced COVID-19 POSITIVE; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (patient experienced COVID-19 POSITIVE) and DRUG INEFFECTIVE (Lack of drug effect) in a 61-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.    Concurrent medical conditions included Rheumatoid arthritis.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-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 ADALIMUMAB (HUMIRA) (Subcutaneous) 1 in 1 Once. On 26-Oct-2021, the patient experienced COVID-19 (patient experienced COVID-19 POSITIVE). On an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (patient experienced COVID-19 POSITIVE) had not resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Symptoms Stuffy nose,  Scratchy throat, Runny nose and Body aches manifested under COVID-19.  No concomitant medications were reported.  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 treatment information was reported.  Company Comment:  This spontaneous case concerns a 61-year-old female patient on Adalimumab (Humira) for Rheumatoid arthritis, who experienced the unexpected, non-serious  adverse event of special interest COVID-19 , that occurred 8 months and 21 days after receiving the second dose of mRNA-1273 vaccine.  Patient presented with stuffy nose, scratchy throat, runny nose, and body aches along with a positive SARS-CoV-2 test. No treatment was reported. Additionally, Drug ineffective was noted. The interval between the first and second dose of mRNA-1273 vaccine was 28 days and within the recommended dosing schedule.  Adalimumab 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.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 61-year-old female patient on Adalimumab (Humira) for Rheumatoid arthritis, who experienced the unexpected, non-serious  adverse event of special interest COVID-19 , that occurred 8 months and 21 days after receiving the second dose of mRNA-1273 vaccine.  Patient presented with stuffy nose, scratchy throat, runny nose, and body aches along with a positive SARS-CoV-2 test. No treatment was reported. Additionally, Drug ineffective was noted. The interval between the first and second dose of mRNA-1273 vaccine was 28 days and within the recommended dosing schedule.  Adalimumab 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.