Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 / Unspecified disorder of knee joint/ Knee Issues; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 / Unspecified disorder of knee joint/ Knee Issues) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Rheumatoid arthritis aggravated and Allergy.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced COVID-19 (COVID-19 / Unspecified disorder of knee joint/ Knee Issues). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 / Unspecified disorder of knee joint/ Knee Issues) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       RINVOQ Co-suspect reported with (1138391,1138391,1154507,1160069) batch numbers. Event COVID-19 infection occurred 2 weeks after the patient received a 1st dose of mRNA-1273 vaccine in Feb 2021. A positive COVID-19 test was obtained on 10 Mar 2021. RINVOQ, indicated for moderate to severe rheumatoid arthritis, was temporarily discontinued for a week as the patient was scheduled to receive her 1st COVID-19 vaccination with mRNA-1273 vaccine. RINVOQ was resumed 2 weeks after her positive COVID-19 test. On an unknown date, patient had sniffles and post-nasal drip. On unknown date, patient received cortisone shots in her knee.   Company Comment: This spontaneous case concerns a 62-year-old, female patient with concurrent conditions of allergies & moderate to severe rheumatoid arthritis (RA), currently treated with RINVOQ, who experienced an unexpected, non-serious AESI COVID-19 in association with a 1st dose of mRNA-1273 vaccine. Patient has completed a 2-dose primary series of mRNA-1273 vaccine and has received a 3rd dose of mRNA-1273 vaccine 6 months after her 2nd vaccination. Event COVID-19 reportedly occurred 2 weeks post-vaccination with her 1st dose of mRNA-1273 vaccine. A positive COVID-19 test was obtained 1 month after her 1st vaccination. On an unknown date, patient had sniffles and post-nasal drip. RINVOQ was temporarily discontinued for a week due to her COVID-19 vaccination and was resumed 2 weeks after receiving a positive COVID-19 test. On an unknown date, cortisone shots were given as a treatment for her unspecified knee issues. Event COVID-19 has resolved. Patients with moderate to severe RA most likely have immune dysfunction due to immunosuppressant therapy. RINVOQ and cortisone could predispose a patient to infections. Upper respiratory tract infection is a commonly reported adverse effect of RINVOQ. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns a 62-year-old, female patient with concurrent conditions of allergies & moderate to severe rheumatoid arthritis (RA), currently treated with RINVOQ, who experienced an unexpected, non-serious AESI COVID-19 in association with a 1st dose of mRNA-1273 vaccine. Patient has completed a 2-dose primary series of mRNA-1273 vaccine and has received a 3rd dose of mRNA-1273 vaccine 6 months after her 2nd vaccination. Event COVID-19 reportedly occurred 2 weeks post-vaccination with her 1st dose of mRNA-1273 vaccine. A positive COVID-19 test was obtained 1 month after her 1st vaccination. On an unknown date, patient had sniffles and post-nasal drip. RINVOQ was temporarily discontinued for a week due to her COVID-19 vaccination and was resumed 2 weeks after receiving a positive COVID-19 test. On an unknown date, cortisone shots were given as a treatment for her unspecified knee issues. Event COVID-19 has resolved. Patients with moderate to severe RA most likely have immune dysfunction due to immunosuppressant therapy. RINVOQ and cortisone could predispose a patient to infections. Upper respiratory tract infection is a commonly reported adverse effect of RINVOQ. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement.