Age: 75.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthritis, Cough, Fatigue, Nasopharyngitis, Vitamin D decreased
Clinical narrative: Cough; ARTHRITIS IN TOES; Cold; Fatigue/Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), ARTHRITIS (ARTHRITIS IN TOES), NASOPHARYNGITIS (Cold) and FATIGUE (Fatigue/Tiredness) in a 75-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) injection for Rheumatoid arthritis.    The patient's past medical history included Cataract operation (The patient had cataract surgery. The cataract surgery was successful.). Concurrent medical conditions included Rheumatoid arthritis.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-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) UNK, Solution for injection in pre-filled pen. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In 2021, the patient experienced FATIGUE (Fatigue/Tiredness). On an unknown date, the patient experienced COUGH (Cough), ARTHRITIS (ARTHRITIS IN TOES) and NASOPHARYNGITIS (Cold). At the time of the report, COUGH (Cough), ARTHRITIS (ARTHRITIS IN TOES) and NASOPHARYNGITIS (Cold) had not resolved and FATIGUE (Fatigue/Tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vitamin D decreased: Low vitamin d levels.         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.  No concomitant medication information was  provided. It was reported that  unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient was getting cold so her body had been achy and painful, her tired and coughing had subsided.  No treatment medication information was provided.  Company Comment: This is a spontaneous case concerning a 75-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, non-serious adverse event of special interest of Arthritis, after receiving the second dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The event had not resolved at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Significant Follow Up Appended (Live Follow-up) _ Event, Event information and narrative description updated.; Sender's Comments: This is a spontaneous case concerning a 75-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, non-serious adverse event of special interest of Arthritis, after receiving the second dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The event had not resolved at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.