Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Inappropriate schedule of product administration, Inflammation, Pain
Clinical narrative: Hurting a bit; Had extra inflammation; COVID-19; The patient had first Moderna dose on 12-Jun-2021 and second dose on 13-Dec-2021; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Hurting a bit), INFLAMMATION (Had extra inflammation), COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had first Moderna dose on 12-Jun-2021 and second dose on 13-Dec-2021) in a 59-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) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Dec-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) Citrate free. On 13-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had first Moderna dose on 12-Jun-2021 and second dose on 13-Dec-2021). On 07-Aug-2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PAIN (Hurting a bit) and INFLAMMATION (Had extra inflammation). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, PAIN (Hurting a bit), INFLAMMATION (Had extra inflammation) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had first Moderna dose on 12-Jun-2021 and second dose on 13-Dec-2021) outcome was unknown and COVID-19 (COVID-19) was resolving.            No concomitant medications were reported.  The patient had adalimumab (Humira) from solution for injection in pre-filled pen. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter causality for the events of hurting a bit, had an extra inflammation and COVID-19 was not provided.  Company Comment :  This spontaneous case concerns a 59 year-old female patient, with a relevant history of adalimumab use for rheumatoid arthritis, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred 421 days after the first dose of mRNA-1273 vaccine administration and 237 days after the second dose of mRNA-1273 vaccine administration. Dose 1 and Dose 2 were administered 184 days apart (Inappropriate schedule of vaccines administered). The ongoing COVID-19 pandemic and adalimumab use for rheumatoid arthritis could be confounders for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 59 year-old female patient, with a relevant history of adalimumab use for rheumatoid arthritis, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred 421 days after the first dose of mRNA-1273 vaccine administration and 237 days after the second dose of mRNA-1273 vaccine administration. Dose 1 and Dose 2 were administered 184 days apart (Inappropriate schedule of vaccines administered). The ongoing COVID-19 pandemic and adalimumab use for rheumatoid arthritis could be confounders for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.