Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Infection, Nephrolithiasis, Pain, Sepsis
Clinical narrative: Sepsis; kidney stones; urinary tract infection; sore from working out; infections in pain; strength in knees; sinus infections; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, on 20May2021 as dose 2, single (Batch/Lot number: unknown) and on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEPSIS (medically significant), outcome "recovered"; NEPHROLITHIASIS (medically significant), outcome "recovering", described as "kidney stones"; URINARY TRACT INFECTION (non-serious), outcome "recovered"; PAIN (non-serious), outcome "recovering", described as "sore from working out"; INFECTION (non-serious), outcome "unknown", described as "infections in pain"; ARTHROPATHY (non-serious), outcome "recovering", described as "strength in knees"; SINUSITIS (non-serious), outcome "recovered", described as "sinus infections". The action taken for upadacitinib was dosage permanently withdrawn. Therapeutic measures were taken as a result of infection.  Clinical course: Report by a consumer of an adult female with events of septic and non-serious urinary tract infection, kidney stones, sore from working out, infections in pain, strength in knees and sinus infections with Rinvoq (Upadacitinib). On unknown dates, the patient experienced septic, urinary tract infection, kidney stones, sore from working out, infections in pain, strength in knees and sinus infections. On unknown dates, septic, urinary tract infection and sinus infections resolved. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. The patient went septic a while back. She paused Rinvoq medication for two weeks due to urinary tract infection. She had kidney stones and sinus infection. She was sore from working out. She had infections in pain and she took 500 milligram of Surpro. Her urinary tract infections much better now. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The patient was treated with Supro.  Causality for Rinvoq (Upadacitinib): The reporter's causality for the event(s) of septic, sore from working out and strength in knees with Rinvoq (Upadacitinib) was no reasonable possibility. The reporter's causality for the event(s) of urinary tract infection, kidney stones, infections in pain unknown onset, sinus infections and infections in pain unknown onset was not provided. Abbvie's opinion is that the events of septic, urinary tract infection, infections in pain unknown onset, sinus infections and infections in pain unknown onset are not assessable. Abbvie's opinion is that there is no reasonable possibility that the events of kidney stones, sore from working out and strength in knees are related to Rinvoq(Upadacitinib).  The reporter considered "sepsis", "kidney stones", "urinary tract infection", "sore from working out", "infections in pain" and "sinus infections" related to BNT162b2. The reporter's assessment of the causal relationship of "strength in knees" with the suspect product(s) BNT162b2 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 current available limited information in the case provided, the causal association between the events Sepsis, Nephrolithiasis, Urinary tract infection, Pain, Infection, Arthropathy and Sinusitis and the use of suspect product BNT162b2 cannot be fully excluded. Immunosuppressive nature of upadacitinib could be a confounding factor for the events.The case will be reassessed once further information is available 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 RAs, Ethics Committees, and Investigators, as appropriate.