Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Antibody test, General physical condition, General physical condition abnormal, Laboratory test, Laboratory test abnormal
Clinical narrative: Rheumatoid arthritis aggravated; Lab test abnormal; General physical condition abnormal; Liver function test increased; Mild Fever; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4157395-00.  A 48 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 48 years as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (ongoing) (Lot number: 1150509) for rheumatoid arthritis. The patient's relevant medical history was not reported. Concomitant medication(s) included: METHOTREXATE. It was unknown if patient was enrolled in a covid-19 vaccine trial. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis aggravated"; LABORATORY TEST ABNORMAL (non-serious), outcome "recovered", described as "Lab test abnormal"; GENERAL PHYSICAL CONDITION ABNORMAL (non-serious), outcome "recovered", described as "General physical condition abnormal"; LIVER FUNCTION TEST INCREASED (non-serious), outcome "unknown", described as "Liver function test increased"; PYREXIA (non-serious), outcome "recovered", described as "Mild Fever". The patient underwent the following laboratory tests and procedures: antibody test: did not have enough antibodies after 2nd covid sho, notes: Did not have enough antibodies after 2nd covid shot; general physical condition: abnormal; laboratory test: rheumatoid arthritis condition worsened, notes: Rheumatoid arthritis condition worsened; abnormal; liver function test: liver number went up, notes: Liver number went up; the liver numbers also went up, notes: The liver numbers also went up; increased. The action taken for upadacitinib was dosage not changed. Therapeutic measures were taken as a result of rheumatoid arthritis, liver function test increased.  Causality for Rinvoq (upadacitinib): The reporter reported that the causality for Rinvoq (upadacitinib).The causality assessment for the events was did not had enough antibodies after 2nd Covid shot, physical issues and mild fever from vaccination with Rinvoq (Upadacitinib) was no reasonable possibility.The reporter's causality for the events of liver number went up and rheumatoid arthritis worsened was not reported.   Causality for Pfizer Biontech Covid-19 Vaccine (Tozinameran):  The causality assessment for the events Lab test abnormal was Possible. Causality assessment for the events General physical condition abnormal, Liver function test increased, Rheumatoid arthritis aggravated was not reported.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between all the reported  events  Rheumatoid arthritis, Laboratory test abnormal , General physical condition abnormal , Liver function test increased  , pyrexia and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate