Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-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 ADALIMUMAB (HUMIRA) (Subcutaneous) CF. In 2021, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  In 2021, the patient experienced COVID. MODERNA COVID-19 VACCINE (COVID-19 VACCINE MRNA (MRNA 1273)) was also considered suspect.  No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of COVID was not 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 a 68-year-old, female patient with history of co-suspect administration of Humira (adalimumab) for Moderate-to-severe Rheumatoid Arthritis, 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 reported as unspecified date in 2021, hence, the onset latency could not be assessed. It was reported that the patient experienced COVID-19. No symptoms were reported and treatment information was not provided. The event had not resolved 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 patient's advanced age (high risk for infections) also 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 a 68-year-old, female patient with history of co-suspect administration of Humira (adalimumab) for Moderate-to-severe Rheumatoid Arthritis, 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 reported as unspecified date in 2021, hence, the onset latency could not be assessed. It was reported that the patient experienced COVID-19. No symptoms were reported and treatment information was not provided. The event had not resolved 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 patient's advanced age (high risk for infections) also remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.