Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Pain, Somnolence, Therapeutic product effect incomplete, Vomiting
Clinical narrative: Aches/pains; Slept all day; Drug effect incomplete; Fatigue; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches/pains), SOMNOLENCE (Slept all day), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete), FATIGUE (Fatigue) and VOMITING (Vomiting) in an elderly 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. Previously administered products included for Product used for unknown indication: REMICADE (She was doing okay and not doing as when on Remicade.). Past adverse reactions to the above products included No adverse event with REMICADE. Concomitant products included METHOTREXATE and PREDNISONE for an unknown indication.   On an unknown date, the patient received 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 PAIN (Aches/pains), SOMNOLENCE (Slept all day), PRODUCT EFFECT INCOMPLETE (Drug effect incomplete), FATIGUE (Fatigue) and VOMITING (Vomiting). At the time of the report, PAIN (Aches/pains), SOMNOLENCE (Slept all day), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete), FATIGUE (Fatigue) and VOMITING (Vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that RINVOQ not working as well as Remicade. Prednisone was being tapered off. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment information was provided by the reporter.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.  Company comment-This spontaneous case concerns an adult female patient of unspecified age with relevant medical history of Rheumatoid Arthritis reported, who experienced the non-serious unexpected event product effect incomplete that occurred on an unknown date in the context of mRNA-1273 vaccination. It was reported that RINVOQ WAS NOT WORKING AS WELL AS REMICADE, No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical.; Sender's Comments: This spontaneous case concerns an adult female patient of unspecified age with relevant medical history of Rheumatoid Arthritis reported, who experienced the non-serious unexpected event Therapeutic product effect incomplete that occurred on an unknown date in the context of mRNA-1273 vaccination. It was reported that RINVOQ WAS NOT WORKING AS WELL AS REMICADE, No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical.