Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthropathy.    Concurrent medical conditions included Ankylosing spondylitis.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-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) 40 milligram. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive, diagnosed with COVID-19.         No concomitant medications were reported.   On an unknown date, the patient experienced COVID-19. It was unknown if patient was enrolled in a COVID-19 vaccine trial.   No treatment medication was provided.  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 spontaneous case concerns an adult, female patient with medical history of Ankylosing Spondylitis and history of co-suspect administration of Humira (adalimumab) for other Psoriatic arthropathy, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the event onset date was not provided, hence, the onset latency could not be assessed. It was reported that the patient tested positive for COVID-19. No symptoms were reported and treatment information was not provided. However, the event was resolving at the time of the report. The history of co-suspect administration of Humira, a tumor necrosis factor-alpha blocker that can lower the ability of the immune system to fight infections, remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult, female patient with medical history of Ankylosing Spondylitis and history of co-suspect administration of Humira (adalimumab) for other Psoriatic arthropathy, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the event onset date was not provided, hence, the onset latency could not be assessed. It was reported that the patient tested positive for COVID-19. No symptoms were reported and treatment information was not provided. However, the event was resolving at the time of the report. The history of co-suspect administration of Humira, a tumor necrosis factor-alpha blocker that can lower the ability of the immune system to fight infections, remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.