Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination complication
Clinical narrative: COVID VACCINE ISSUE; diagnosed with covid; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL NERVE STIMULATOR IMPLANTATION (SPINAL CORD STIMULATOR IMPLANTED), COVID-19 (diagnosed with covid), WOUND INFECTION (wound infection), SPINAL NERVE STIMULATOR IMPLANTATION (SPINAL CORD STIMULATOR IMPLANTED/PLACED AGAIN) and VACCINATION COMPLICATION (COVID VACCINE ISSUE) in a 63-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.    Concurrent medical conditions included Peripheral neuropathy (patient got a spinal cord stimulator due to neuropathy).   In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In March 2022, the patient experienced SPINAL NERVE STIMULATOR IMPLANTATION (SPINAL CORD STIMULATOR IMPLANTED) (seriousness criterion medically significant). In July 2022, the patient experienced SPINAL NERVE STIMULATOR IMPLANTATION (SPINAL CORD STIMULATOR IMPLANTED/PLACED AGAIN) (seriousness criterion medically significant). On 24-Jul-2022, the patient experienced COVID-19 (diagnosed with covid) (seriousness criterion medically significant). On an unknown date, the patient experienced WOUND INFECTION (wound infection) (seriousness criterion medically significant) and VACCINATION COMPLICATION (COVID VACCINE ISSUE) (seriousness criterion medically significant). The patient was treated with IBUPROFEN at an unspecified dose and frequency. In 2022, SPINAL NERVE STIMULATOR IMPLANTATION (SPINAL CORD STIMULATOR IMPLANTED) had resolved. At the time of the report, COVID-19 (diagnosed with covid), WOUND INFECTION (wound infection), SPINAL NERVE STIMULATOR IMPLANTATION (SPINAL CORD STIMULATOR IMPLANTED/PLACED AGAIN) and VACCINATION COMPLICATION (COVID VACCINE ISSUE) outcome was unknown.            Concomitant medications included Vitamins and nose spray.  The patient got a spinal cord stimulator due to neuropathy. She developed a wound infection and had to have the stimulator removed in 2022. The patient had a spinal cord stimulator implanted in Mar 2022. In Jul 2022, spinal cord stimulator was placed again.  The reporter's causality for the events of spinal cord stimulator implanted, spinal cord stimulator implanted/placed again, covid vaccine issue, covid, wound infection with Rinvoq was not provided.  Agency's opinion was that there was no reasonable possibility that the events of spinal cord stimulator implanted, spinal cord stimulator implanted/placed again, covid vaccine issue, covid were related to Rinvoq (upadacitinib). Agency's opinion was that the event of wound infection was not assessable.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  CC: This spontaneous case concerns a 63 year-old female patient, with a relevant history of intake of upadacitinib for moderate to severe rheumatoid arthritis, who experienced the unexpected, serious (medically significant) Adverse Event of Special Interest of COVID-19, which occurred 173 days after the a dose (fourth dose in series) of mRNA-1273 vaccine administration. Vaccination complication was also reported. No treatment medication were reported. The ongoing COVID-19 pandemic and intake of upadacitinib (immunosuppressant) could be a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    This case was linked to MOD-2022-624415, MOD-2022-624564.; Sender's Comments: This spontaneous case concerns a 63 year-old female patient, with a relevant history of intake of upadacitinib for moderate to severe rheumatoid arthritis, who experienced the unexpected, serious (medically significant) Adverse Event of Special Interest of COVID-19, which occurred 173 days after the a dose (fourth dose in series) of mRNA-1273 vaccine administration. Vaccination complication was also reported. No treatment medication were reported. The ongoing COVID-19 pandemic and intake of upadacitinib (immunosuppressant) could be a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.