Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Depressed mood, Vaccination site pain
Clinical narrative: Feeling sad/depressed mood/ slightly depressed due to life circumstances/worry and sadness; COVID-19 three times; Vaccination site pain/sore arm after Moderna; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (Feeling sad/depressed mood/ slightly depressed due to life circumstances/worry and sadness), COVID-19 (COVID-19 three times) and VACCINATION SITE PAIN (Vaccination site pain/sore arm after Moderna) in a 67-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.    The patient's past medical history included Rheumatoid arthritis.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Oct-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) at an unspecified dose. On an unknown date, the patient experienced DEPRESSED MOOD (Feeling sad/depressed mood/ slightly depressed due to life circumstances/worry and sadness), COVID-19 (COVID-19 three times) and VACCINATION SITE PAIN (Vaccination site pain/sore arm after Moderna). At the time of the report, DEPRESSED MOOD (Feeling sad/depressed mood/ slightly depressed due to life circumstances/worry and sadness), COVID-19 (COVID-19 three times) and VACCINATION SITE PAIN (Vaccination site pain/sore arm after Moderna) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Patient got suspect Humira in solution for injection in pre-filled pen.  No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.  Company comment: This spontaneous case concerns a 67 year old female with prior medication of adalimumab (Humira) indicated for rheumatoid arthritis who experienced the unexpected non-serious adverse event of special interest COVID-19, which occurred at an unknown interval after receiving the third dose of mRNA1273. The patient reported she had COVID-19 three times however the dates of the diagnosis were not specified in the case. Further details regarding the clinical course,  diagnostic or imaging test done and treatment were not provided. The patient's elderly age along with her impaired immunity due to rheumatoid arthritis as indicated by adalimumab (Humira) use may be considered as risk factors for COVID-19. The ongoing pandemic of COVID-19 remains as a confounder in this case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67 year old female with prior medication of adalimumab (Humira) indicated for rheumatoid arthritis who experienced the unexpected non-serious adverse event of special interest COVID-19, which occurred at an unknown interval after receiving the third dose of mRNA1273. The patient reported she had COVID-19 three times however the dates of the diagnosis were not specified in the case. Further details regarding the clinical course,  diagnostic or imaging test done and treatment were not provided. The patient's elderly age along with her impaired immunity due to rheumatoid arthritis as indicated by adalimumab (Humira) use may be considered as risk factors for COVID-19. The ongoing pandemic of COVID-19 remains as a confounder in this case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.