Sex: F
Vaccine: COVID19, UNK
Symptoms: Infection, Musculoskeletal disorder, Pain in extremity, Post procedural complication, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis; Foot surgery; Eye operation; Fatigue; Energy decreased; Upper extremity dysfunction; Postoperative complication; Difficulty in walking; Filmy visionDifficulty focusing eyes; Foot pain; Pain in hand; Infection; Lower extremity dysfunction; This is a solicited report from a contactable consumer (patient) based on information received by Pfizer from a company (Mfr. Control No.:21K-163-3829982-00).  A 66-year-old (pending clarification) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 intramuscular on 18Aug2021 (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) to an unspecified date, at unspecified dose for moderate to severe rheumatoid arthritis. On 28Jul2021, patient received first dose COVID-19 vaccine manufactured by Pfizer for Covid-19 Immunisation intramuscularly. The patient medical history was not reported. Concomitant medications included sulfasalazine; vitamins nos. The patient experienced rheumatoid arthritis on an unspecified date with outcome of unknow, foot surgery on an unspecified date with outcome of recovering , eye operation on an unspecified date with outcome of unknown , fatigue on an unspecified date with outcome of not recovered , energy decreased on an unspecified date with outcome of unknown , upper extremity dysfunction on an unspecified date with outcome of not recovered , lower extremity dysfunction in 2021 with outcome of not recovered , postoperative complication on an unspecified date with outcome of not recovered , difficulty in walking on an unspecified date with outcome of not recovered, filmy vision/ difficulty focusing eyes on an unspecified date with outcome of not recovered , foot pain on an unspecified date with outcome of recovering , pain in hand on an unspecified date with outcome of not recovered , infection in 2021 with outcome of unknown.  The action taken in response to the events for adalimumab was unknown.    Clinical course: Solicited report by a consumer of a 66-year-old female with events of big left toe amputated from rheumatoid arthritis/no big toe on it cause toes to bunch up, right foot surgery and eye surgery and on-serious tired all the time/feeling fatigued, no energy anymore, left hand had lot of trouble things up/could barely put fingers together pick up a pill and could only use hands about 20 percent of the left hand. Problems with left foot/four toes of left foot really bad, eyes were getting worse after first surgery, that there was a film over eyes. Hard to walk, hard to focus on an object/screen, foot pain. Pain in hands/hands were getting bad and not look any better and infection with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced big lift toe amputated from rheumatoid arthritis/no big toe on it and causes toes to bunch up, right foot surgery, eye surgery, tired all the time /feeling fatigued, no energy anymore, left hand had lot of trouble picking things up/could barely put use hands about 20 percent of the left hand, eyes were getting worse after first surgery, that there was film over eyes, hard to talk, hard to focus an object or screen, foot pin and pain in hands/hands were getting really bad and not look any better. In 2021, the patient experienced problems with left foot/four foot/four toes of left foot really bad infection. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was considered suspect. The patient had to go off Humira for her right foot surgery, and she said she could absolutely tell a difference with her pain. In Mar2021, they took the pins out, rebuilt her whole right foot and her big toe was fused, and her foot was so much better. She was so happy with her right foot it was like it was back to normal and so she was walking more on that side. She had problems with her left foot in 2021, she did not have a big toe, it was amputated. Since there was no big toe on it, it caused her toes to bunch up, and makes it really hard to walk. Physician looked at her hands and they did not look any better but they did not look any worse, she could use her hands about twenty percent of her left hand, she could barely put her fingers together pick up a pill and had a lot of trouble in picked things up. She reported her eyes were getting worse after her first surgery, that there was a film over her eyes. It was hard to focus on an object or screen. She did not have a big toe of left foot, and the other four toes were really bad. She stopped her Humira and methotrexate. Physician put her on a low dose of steroids for a few weeks, she took them all and she was finished and she actually felt better. The last time she stopped then it took a while for the Humira to take effect she was so fatigued. In 2021, had surgery for correct her left toes from rheumatoid arthritis. She got a infection, had not started back yet. Causality for surgery was reported as reasonable possibility and outcome was reported as recovering. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On 28Jul2021, patient received first dose COVID-19 vaccine manufactured by Pfizer. On 18Aug2021, patient received second dose COVID-19 vaccine manufactured by Pfizer. The patient was treated with Prednisone and Methotrexate.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of big left toe amputated from  rheumatoid arthritis/no big toe on it cause toes to bunch up, right foot  surgery and eye surgery and  on-serious tired all the time/feeling fatigued no energy anymore, left hand had lot of trouble things up/could barely put fingers together pick up a pill and could only use hands about 20 percent of the left hand, eyes were getting worse after first surgery, that there was film over eyes unknown onset, hard to focus on an object, hard to focus on screen and pain in hands/hands were getting really bad and not look any better with Humira (Adalimumab) was no reasonable possibility. The reporter's casualty for the event(s) of eye surgery, no energy anymore, problems with left foot/four toes of foot really bad, hard to walk. Foot pain and infection was not provided. Company's opinion is that there is no reasonable possibility that the events of big left toe amputated from rheumatoid arthritis /no big toe on it causes toes to bunch up, right foot surgery, eye surgery, tired all the time/feeling fatigued, no energy anymore, left hand had lot of trouble picking things up/could barely put fingers together pick up a pill and could only use hands about 20 percent of the foot hand. Problems with left  foot/foot toes of left foot really bad, eyes were  getting worse after first surgery, that there was a film over eyes unknown onset, hard to focus on an object or screen, foot pain and pain in hands/hands were getting really bad and not look any better are related Humira (Adalimumab). Company's opinion is that the event of infection not assessable.  The reporter considered that no reasonable possibility for event Pain in hand with PFIZER BIONTECH COVID-19, for other events the causality was not reported.   The reporter's assessment of the causal relationship of the events other than Pain in hand 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 in the narrative, a causal association between the suspect drug (bnt162b2) and the events Rheumatoid Arthritis, foot deformity, eye disorder, fatigue, asthenia, musculoskeletal disorder, post procedural complication, gait disturbance, blurred vision, foot pain and infection cannot be completely excluded. However, the causal association between the suspect drug (bnt162b2) and pain in hand is unrelated.  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.