Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Gait disturbance, Intervertebral disc degeneration, Rheumatoid arthritis
Clinical narrative: Rheumatoid Arthritis Flare Up On Knees, Back, And Shoulders; Degenerative disc disease; Difficulty in walking; Trouble walking flare up; Fatigue; This is a solicited report based on the information received by Pfizer from Regulatory Authority (Mfr. Control No.: 21K-163-4108585-00) from a contactable consumer (patient).  A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 (booster) intramuscular in 2021 (at age of 73 years old; Batch/Lot number was not reported) as single dose for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for moderate to severe rheumatoid arthritis. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 via intramuscular on 20Jan2021 (at age of 72 years old) for COVID-19 immunization, second dose of bnt162b2 via intramuscular on 12Feb2021 for COVID-19 immunization and experienced weakness, fatigue, flu like symptoms and dry heaves. The patient experienced degenerative disc disease, difficulty in walking, trouble walking flare up, rheumatoid arthritis flare up on knees, back, and shoulders, fatigue in 2021. The action taken in response to the events for bnt162b2 was not applicable, for adalimumab was dose not changed. The outcome of events fatigue and clinical flare reaction was unknown, not recovered for events degenerative disc disease, difficulty in walking, rheumatoid arthritis flare up. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of degenerative disc disease on spinose, trouble walking flare up and rheumatoid arthritis flare up on knees, back, and shoulders with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of booster vaccination had fatigue, second COVID vaccination and had weakness, second COVID vaccination and fatigue, second COVID vaccination and had flu like symptoms and second COVID vaccination and had dry heaves with Humira (Adalimumab) was no reasonable possibility.  The reporter's assessment of the causal relationship of the events 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 available information in the case, the causal association between the events, rheumatoid arthritis, intervertebral disc degeneration, gait disturbance, condition aggravated, fatigue and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.