Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oral pain, Sjogren's syndrome
Clinical narrative: Sjogren's; MOUTH SORE THAT JUST CAME UP SOME HOW/THERE WAS ABOUT FIVE THAT CAME UP AT ONCE; HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of SJOGREN'S SYNDROME (Sjogren's) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 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) 1 dosage form. In 2021, the patient experienced HEADACHE (HEADACHE). In July 2021, the patient experienced ORAL PAIN (MOUTH SORE THAT JUST CAME UP SOME HOW/THERE WAS ABOUT FIVE THAT CAME UP AT ONCE). On an unknown date, the patient experienced SJOGREN'S SYNDROME (Sjogren's) (seriousness criterion medically significant). At the time of the report, SJOGREN'S SYNDROME (Sjogren's), ORAL PAIN (MOUTH SORE THAT JUST CAME UP SOME HOW/THERE WAS ABOUT FIVE THAT CAME UP AT ONCE) and HEADACHE (HEADACHE) outcome was unknown.            No concomitant medication information was reported. No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 is a spontaneous case concerning a 67-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of Sjogren's syndrome, after receiving the third dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown 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.; Sender's Comments: This is a spontaneous case concerning a 67-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of Sjogren's syndrome, after receiving the third dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown 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.