Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Headache, Rheumatoid arthritis, Vaccination site pain, Vaccination site rash
Clinical narrative: rheumatoid arthritis flare up; Blood in urine; Headache; had rash at site and sore arm/had covid 19 vaccination felt achy; had rash at site and sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (rheumatoid arthritis flare up) in a 35-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.    The patient's past medical history included Pregnancy and Live birth (the baby was born) in 2020. Concurrent medical conditions included Rheumatoid arthritis.   On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jul-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) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (rheumatoid arthritis flare up) (seriousness criterion medically significant), BLOOD URINE PRESENT (Blood in urine), HEADACHE (Headache), VACCINATION SITE PAIN (had rash at site and sore arm/had covid 19 vaccination felt achy) and VACCINATION SITE RASH (had rash at site and sore arm). At the time of the report, RHEUMATOID ARTHRITIS (rheumatoid arthritis flare up) and BLOOD URINE PRESENT (Blood in urine) had not resolved and HEADACHE (Headache), VACCINATION SITE PAIN (had rash at site and sore arm/had covid 19 vaccination felt achy) and VACCINATION SITE RASH (had rash at site and sore arm) outcome was unknown.            No concomitant medications were reported.  The lab data provided as blood urine present.  The fetus was exposed to maternal use of HUMIRA in utero. In 2020, the baby was born. No maternal medical problems or complications during delivery or the postpartum period were reported. No neonatal complications, congenital anomalies or birth defects were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter causality for the events of maternal exposure during pregnancy, had covid 19 vaccination felt achy, headache, had rash at site and sore arm unknown onset, had covid 19 vaccination felt achy, headache, had rash at site and sore arm unknown onset, had covid 19 vaccination felt achy, headache, had rash at site and sore arm unknown onset, had covid 19 vaccination felt achy, headache, had rash at site and sore arm unknown onset and blood in urine with Humira(adalimumab) was no reasonable possibility. The reporter causality for the events of live birth was not provided. the reporter's causality for the events of rheumatoid arthritis flares up with Humira(adalimumab) was a reasonable possibility.  No treatment medications were reported.  Company Comment: This spontaneous case concerns a female patient aged 35 years with relevant medical history of Rheumatoid arthritis on Humira reported, who experienced the unexpected serious (medically significant) of Rheumatoid arthritis(Rheumatoid arthritis flare up) that occurred on an unknown date in the context of mRNA-1273 vaccination. Patient had received initial two doses of mRNA-1273 at an interval of 1 month. 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.   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. Sender's Comments: This spontaneous case concerns a female patient aged 35 years with relevant medical history of Rheumatoid arthritis on Humira reported, who experienced the unexpected serious (medically significant) of Rheumatoid arthritis(Rheumatoid arthritis flare up) that occurred on an unknown date in the context of mRNA-1273 vaccination. Patient had received initial two doses of mRNA-1273 at an interval of 1 month. 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.