Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Injection site pruritus, Lung disorder, Rheumatoid arthritis
Clinical narrative: 1st dose on 15-MAR-2021 and 2nd dose on 21-APR-2021; Rheumatoid arthritis flare ups; spots on lungs; Injection site itching; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare ups) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Back pain and Back surgery since 2016. Concurrent medical conditions included Rheumatoid arthritis.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose once a day. On 24-Jun-2021, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose once a day. On 21-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 15-MAR-2021 and 2nd dose on 21-APR-2021). In 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare ups) (seriousness criterion medically significant), LUNG DISORDER (spots on lungs) and INJECTION SITE PRURITUS (Injection site itching). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare ups) had not resolved and LUNG DISORDER (spots on lungs), INJECTION SITE PRURITUS (Injection site itching) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 15-MAR-2021 and 2nd dose on 21-APR-2021) outcome was unknown.            No concomitant medications were reported.   event cough subsumed under lung disorder  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In 2021 patient had a cough for about a month. She went off to Rinvoq for a while because of spots on her lungs. She was on therapy for about two months before the spots on the lungs and she was coughing constantly. She started Rinvoq therapy back and it helps especially in the jaw area and feet.  Rinvoq helped with the back pain. She had itching at injection site after COVID-19 vaccine. The reporter's causality for the event(s) of spots on lungs, injection site itching, cough and rheumatoid arthritis flare ups was not provided.   No treatment details were reported.   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 a female patient aged 72 years with relevant medical history of Rheumatoid arthritis on RINVOQ reported, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis(Rheumatoid arthritis flare up) that occurred on an unknown date( in 2021) in the context of mRNA-1273 vaccination. Patient had received initial two doses of mRNA-1273 at an interval of 37 days so Inappropriate schedule of product administration was noted. No further information on clinical course, lab investigations and treatment received was available in the report. Outcome of the event was not resolved at the time of report. Relevant medical history remains a confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement; Sender's Comments: This spontaneous case concerns a female patient aged 72 years with relevant medical history of Rheumatoid arthritis on RINVOQ reported, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis(Rheumatoid arthritis flare up) that occurred on an unknown date( in 2021) in the context of mRNA-1273 vaccination. Patient had received initial two doses of mRNA-1273 at an interval of 37 days so Inappropriate schedule of product administration was noted. No further information on clinical course, lab investigations and treatment received was available in the report. Outcome of the event was not resolved at the time of report. Relevant medical history remains a confounder to the event The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement