Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Illness
Clinical narrative: sick; A little cough when patient laid down; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) and COUGH (A little cough when patient laid down) in a 61-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) prolonged-release tablet for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (sick) (seriousness criterion medically significant) and COUGH (A little cough when patient laid down) (seriousness criterion medically significant). At the time of the report, ILLNESS (sick) had not resolved and COUGH (A little cough when patient laid down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. On unknown dates, the patient had experienced four spine surgeries including fuse and custom spine and had more degeneration, shots in spine had problem walking and did not do anything, sick, nerve damage from complication surgery, back pain, inflammation, and cough. on 06 Aug 2021, the patient experienced stroke after second covid-19 vaccine. COVID-19 VACCINE MODERNA (ELASOMERAN) was also considered suspect The patient had four surgeries including fuse and custom spine and had more degeneration. Patient had trigger shots in spine had problem walking and this did not do anything. On 06 Aug 2021, Patient had a stroke after the second COVID-19, 1st vaccine was sick. She was sick and it did not end had a little cough when Patient laid down. Patient had a surgery for a spinal fusion. Patient was off RINVOQ for a week due to having surgery. She had a complication from surgery, nerve damage. She had back surgery and was in extreme pain and Patient had a lot of inflammation. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were provided  Company comment: This is a spontaneous case concerning a 61 year-old, female patient with a history of Rheumatoid arthritis and concomitant use of upadacitinib (reported as co-suspect drug), who experienced the serious (due to medically important condition) unexpected, events of illness and cough, after the first dose of mRNA-1273 vaccine, exact onset and vaccination date not provided, thus temporal association cannot be assessed. The mentioned medical history remains as a confounder for the event illness and the concomitant use of upadacitinib for the event cough. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event´s seriousness assessed as reported.   This case was linked to MOD-2021-586352 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2022: Live Significant follow up- New event added, Change History Field updated. On 11-Apr-2022: Non Significant Follow Up appended. On 13-May-2022: Live Significant follow up- Change History Field updated On 08-Jun-2022: Live:Significant follow up: suspect, event and narrative updated; Sender's Comments: This is a spontaneous case concerning a 61 year-old, female patient with a history of Rheumatoid arthritis and concomitant use of upadacitinib (reported as co-suspect drug), who experienced the serious (due to medically important condition) unexpected, events of illness and cough, after the first dose of mRNA-1273 vaccine, exact onset and vaccination date not provided, thus temporal association cannot be assessed. The mentioned medical history remains as a confounder for the event illness and the concomitant use of upadacitinib for the event cough. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event´s seriousness assessed as reported.