Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Joint swelling, Pain, Post procedural complication, Staphylococcal infection
Clinical narrative: Bacterial infection due to unspecified staphylococcus; Joint infection; Difficulty in standing; Postoperative complication; Difficulty in walking; Pain; Swelling; Knee pain; Swelling of R knee; Folliculitis; This is a solicited report based on the information received from a contactable consumer by Pfizer (Mfr. Control No.: 21K-163-3877815-00).   A 49-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), dose 1 intramuscular on 14Apr2021 as dose 1, single (at the age of 49 years) for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2015 (Batch/Lot number was not reported) to 17Jun2021, at 40 mg (40 mg,1 in 2 wk) for hidradenitis, rheumatoid arthritis. The patient had a relevant medical history of Diabetes. Patient had Shellfish allergy manifested by itchy throat and swelling. Non tobacco user. No alcohol use. Concomitant medication(s) included olmesartan (OLMESARTAN) taken for blood pressure abnormal. On an unspecified date in Apr2021, the patient experienced folliculitis. On 18Apr2021, the patient experienced on and off right knee pain and right knee swelling. On an unspecified date in May2021, the patient experienced bacteria culture got positive staph infection to right knee joint. On 14May2021, the patient experienced right knee infection. On 19May2021, the patient experienced could not stand for more than two minutes after surgery/difficulty in standing for number of minutes and walking around, could not stand for more than two minutes after surgery, difficulty in standing for number of minutes and walking around, recurrent pain and recurrent swelling. On 30Jun2021, the bacteria culture got positive staph infection to right knee joint resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 18Apr2021, patient had pain and swelling to right knee. On 21Apr2021, patient went into the doctor and was diagnosed with staph infection to right knee joint. On 23Apr2021, patient had surgical intervention for knee. Patient had been recovering in the hospital with intravenous antibiotics. On 14May2021, patient started with right knee infection and patient had right knee infection surgery on 21May2021. Patient also mentioned that it was an unknown right knee infection. From 20May2021, patient shared that patient was hospitalized for a week and a half due to right knee infection. On May2021, patient was tested for bacteria culture and got positive for staphylococcus infection. While admitted his physician cleaned and flushed the infection on his right knee. On 30Jun2021, patient added that his infection was gone when patient had another bacteria culture follow up. Patient was also treated with antibiotics for eight weeks and was given hydrocodone for pain. On 23Jun2021, Patient also started physical therapy since patient had difficulty in standing for a number of minutes and walking around. Patient mentioned that patient missed his last Covid-19 vaccine dose because patient was hospitalized. Patient took unrecalled blood pressure medications His Humira was also placed on hold until patient fully recovered from the infection. Primary reporter did not have the lot number information, because the packaging was discarded. The patient underwent lab test which includes Bacteria Culture Test: Positive for Staphylococcus infection on an unspecified date in May2021; Bacteria Culture Test: Normal on 30Jun2021. The outcome of event Staphylococcal infection was recovered on 30Jun2021, for Joint infection was recovered on an unspecified date in 2021, for Difficulty in standing, Difficulty in walking, pain, Swelling was not recovered, for Folliculitis  was recovered o an unspecified date in Apr2021, for Knee pain recovering and for Swelling of R knee was unknown.  Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB): The reporter's causality for the event(s) of could not stand for more than two minutes after surgery/difficulty in standing for number of minutes and walking around, bacteria culture got positive staph infection to right knee joint, difficulty in standing for number of minutes and walking around, recurrent pain, recurrent swelling and folliculitis with Humira 40mg/0.4ml(Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of right knee infection, on and off right knee pain, could not stand for more than two minutes after surgery and right knee swelling was not provided. opinion is that there is no reasonable possibility that the events of could not stand for more than two minutes after surgery/difficulty in standing for number of minutes and walking around, on and off right knee pain, could not stand for more than two minutes after surgery, difficulty in standing for number of minutes and walking around, recurrent pain and recurrent swelling are related to HUMIRA 40MG/0.4ML(ADALIMUMAB).  Change History: On 09Jun2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information and narrative description. The events of "could not stand for more than two minutes after surgery", "right knee infection" and "could not stand for more than two minutes after surgery" were added. the event of "right knee pain" was amended to "on and off right knee pain". the event of "on and off right knee pain" is now considered serious.  On 01Jul2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information, treatment drug information, laboratory/diagnostic procedures, narrative description and medical history. The events of "difficulty in standing for number of minutes and walking around", "recurrent pain", "recurrent swelling" and "folliculitis" were added. the event of "could not stand for more than two minutes after surgery" was amended to "could not stand for more than two minutes after surgery/difficulty in standing for number of minutes and walking around". The event of "staph infection to right knee joint" was amended to "Bacteria culture got positive staph infection to right knee joint".  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided in the narrative, the reported events of Staph infection, arthritis infective, dysstasias,  arthralgia, joint swelling, gait disturbance, pain, swelling and  folliculitis  the suspected vaccine BNT162B2 cannot be completely excluded but also consider the possibility of known medical history of rheumatoid arthritis. However, the event of post procedural complications due to  is consider unrelated and mainly due to surgical procedure.  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.