Sex: F
Vaccine: COVID19
Symptoms: Impaired gastric emptying, Unevaluable event
Clinical narrative: Gastroparesis; STRUGGLING TO KEEP WAIT ON; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED GASTRIC EMPTYING (Gastroparesis) in an adult 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concomitant products included mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   On an unknown date, the patient received third 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 IMPAIRED GASTRIC EMPTYING (Gastroparesis) (seriousness criterion medically significant) and UNEVALUABLE EVENT (STRUGGLING TO KEEP WAIT ON). At the time of the report, IMPAIRED GASTRIC EMPTYING (Gastroparesis) and UNEVALUABLE EVENT (STRUGGLING TO KEEP WAIT ON) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.  Physician advised to wait on booster for covid  vaccine. Patient had steroid shots in knee. It was unknown if patient was enrolled in a covid-19 vaccine trial. Treatment medications were not reported.  The reporter's causality for the event(s) of gastroparesis and struggling to keep wait on with rinvoq(upadacitinib) was a reasonable possibility.  Company Comment: This spontaneous case concerns an adult, female patient with history of co-suspect administration of Rinvoq (upadacitinib) for Moderate-to-severe Rheumatoid Arthritis, who experienced the unexpected, serious (medically significant) event of impaired gastric emptying and an unexpected, non-serious event. The events occurred unknown number of days after receiving the third (booster) dose of the mRNA-1273 vaccine. Of note, the vaccination date and event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient experienced gastroparesis and the physician advised to 'wait on booster for covid vaccine'. It was also reported that the patient had steroid shots in the knee. No further details were provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult, female patient with history of co-suspect administration of Rinvoq (upadacitinib) for Moderate-to-severe Rheumatoid Arthritis, who experienced the unexpected, serious (medically significant) event of impaired gastric emptying and an unexpected, non-serious event. The events occurred unknown number of days after receiving the third (booster) dose of the mRNA-1273 vaccine. Of note, the vaccination date and event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient experienced gastroparesis and the physician advised to 'wait on booster for covid vaccine'. It was also reported that the patient had steroid shots in the knee. No further details were provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.