Sex: F
Vaccine: COVID19, UNK
Symptoms: Immunisation reaction, Osteoarthritis, Tuberculosis
Clinical narrative: possible case of Tuberculosis; bone on bone in knees; reaction to covid-19 pfizer vaccination with Humira; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4426107-00 (Abbvie).  A 71-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1154443) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TUBERCULOSIS (medically significant), outcome "unknown", described as "possible case of Tuberculosis"; OSTEOARTHRITIS (medically significant), outcome "not recovered", described as "bone on bone in knees"; IMMUNISATION REACTION (medically significant), outcome "recovering", described as "reaction to covid-19 pfizer vaccination with Humira". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of osteoarthritis included injections in knees for lubrication.   Causality for adalimumab (HUMIRA): The reporter's causality for the event (a) of possible case of tuberculosis, bone on bone in knees and reaction to covid 19 pfizer vaccination with Humira (Adalimumab) was no reasonable possibility. Abbvie's opinion is that the event of possible case of tuberculosis is not assessable. Abbvie's opinion is that there is no reasonable possibility that the events of bone on bone in knees and reaction to covid 19 pfizer vaccination are related to Humira (Adalimumab).  The causality between adalimumab (HUMIRA) and Tuberculosis was Not Related per reporter, was Not assessable per manufacturer; The causality between adalimumab (HUMIRA) and Knee osteoarthritis was Not Related per reporter, was No reasonable possibility per manufacturer; The causality between adalimumab (HUMIRA) and Vaccination adverse reaction was Not Related per reporter, was No reasonable possibility per manufacturer.  The reporter's assessment of the causal relationship of "possible case of tuberculosis" and "bone on bone 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. The reporter considered "reaction to covid-19 pfizer vaccination with humira" related to BNT162b2.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.