Age: 56.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis and Psoriatic arthritis.    Concurrent medical conditions included Psoriasis and Psoriatic arthritis.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 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 an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 spontaneous case concerns an adult, male patient with history of co-suspect administration of Humira (adalimumab) for Moderate-to-severe Chronic Plaque Psoriasis and Psoriatic Arthritis, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred unknown number of days after receiving Humira and unknown number of days after receiving the third dose of the mRNA-1273 vaccine. Of note, the administration date of Humira was not reported and the vaccination date of the third dose of the mRNA-1273 vaccine was reported as unspecified date in Sep2021 while the event onset date was not provided, 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. 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, male patient with history of co-suspect administration of Humira (adalimumab) for Moderate-to-severe Chronic Plaque Psoriasis and Psoriatic Arthritis, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred unknown number of days after receiving Humira and unknown number of days after receiving the third dose of the mRNA-1273 vaccine. Of note, the administration date of Humira was not reported and the vaccination date of the third dose of the mRNA-1273 vaccine was reported as unspecified date in Sep2021 while the event onset date was not provided, 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. 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.