Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Condition aggravated, Drug ineffective, Drug interaction, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; HUMIRA EFFECTIVENESS NOT LASTING TWO WEEKS SINCE RECEIVED SECOND COVID VACCINE; Blood sugar increased; 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): 22K-163-4227694-00.  A 42 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Oct2021 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single and intramuscular, administration date Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; prednisone (PREDNISONE), administration date 2021 (Batch/Lot number: unknown) as dose 1,daily for rheumatoid arthritis. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA taken for rheumatoid arthritis, start date: Jun2021 (ongoing). The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 07Jan2022, outcome "recovered" (Jan2022), described as "Rheumatoid arthritis flare up"; BLOOD GLUCOSE INCREASED (non-serious) with onset 2021, outcome "recovered", described as "Blood sugar increased"; DRUG INTERACTION (non-serious) with onset Oct2021, outcome "unknown", described as "HUMIRA EFFECTIVENESS NOT LASTING TWO WEEKS SINCE RECEIVED SECOND COVID VACCINE". The patient underwent the following laboratory tests and procedures: blood glucose: increased. The action taken for prednisone was unknown. Therapeutic measures were taken as a result of blood glucose increased. Clinical course: In 2021, the patient experienced Increase in blood sugar due to prednisone and Rheumatoid arthritis flare. In Oct 2021, the patient experienced Humira effectiveness not lasting two weeks since received second covid Vaccine. In 2021, the Increase in blood sugar due to prednisone and Rheumatoid arthritis flare resolved. On 07Jan2022, the patient experienced RA flare. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient was treated with INSULIN.   PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN): Reporter causality for Blood sugar increased, Rheumatoid arthritis flare up and Drug interaction was Not Reported. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of Increase in blood sugar due to prednisone and RA flare with HUMIRA (ADALIMUMAB) was a reasonable possibility. Causality for prednisone Reporter Causality Blood sugar increased Probable and Rheumatoid arthritis flare up was Not Reported  The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, a causal association between reported events, rheumatoid arthritis, blood glucose increased, drug interaction and the suspect 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.