Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood triglycerides, Blood triglycerides increased, Gait disturbance, Impaired healing, Loss of personal independence in daily activities
Clinical narrative: Activities of daily living impaired; Walking difficulty; Mobility decreased; Triglyceride increased; Vaccination site injury; Pain upon movement; Rotator cuff tear; Postoperative pain; Postoperative complication; Psoriatic arthritis aggravated; Wound healing disturbance of; This is a solicited report from a contactable consumer (patient) based on information received by Pfizer from AbbVie (Mfr. Control No.: 21K-163-3818353-00). A 68-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: Unknown) intramuscularly on 22Apr2021 (at the age of 68-years-old) as a single dose for COVID-19 immunization and started to receive adalimumab (HUMIRA; solution for injection in pre-filled pen; strength: 40mg) subcutaneously from Apr2018 to 2021 at 40 mg, cyclic, 1 in 2 wk and subcutaneously from 14Mar2021 to 2021 at 40 mg, cyclic, 1 in 2 wk and adalimumab (HUMIRA; solution for injection in pre-filled pen; strength: 40mg) subcutaneously from 2021 and ongoing at 40 mg, cyclic, CF Pen (40 mg,1 in 2 wk), both taken for psoriatic arthritis and moderate to severe chronic plaque psoriasis. Medical history included shortness of breath from 2020 to an unspecified date and unspecified if ongoing, foot surgery (for big toe) in Jan2021, swelling/pitting edema in feet from an unspecified date to an unspecified date and unspecified if ongoing, slight arthritic pain in knees/shoulder/feet/neck from an unspecified date to an unspecified date and unspecified if ongoing and feet problem, had foot surgery from an unspecified date to an unspecified date and unspecified if ongoing (several years ago) and psoriatic arthritis from an unspecified date to an unspecified date and unspecified if ongoing and moderate to severe chronic plaque psoriasis from an unspecified date to an unspecified date and unspecified if ongoing. It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial.   Concomitant medications were reported as statins. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: Unknown) intramuscularly on 01Apr2021 (at the age of 68-years-old) as a single dose for COVID-19 immunization. In May2021, the patient experienced vaccination site injury; in 2021, the patient experienced postoperative pain, postoperative complication, psoriatic arthritis aggravated, wound healing disturbance of, pain upon movement and rotator cuff tear and on an unspecified date the patient experienced activities of daily living impaired, walking difficulty, mobility decreased and triglyceride increased. It was reported that in 2020, the patient had psoriasis patch and had a hard time to gauge on arthritic pain. He also had shortness of breath, could not hold his breath as long as and had to do quick during shower or washing face. In Jan2021 he had left foot surgery for his big toe. He had a second surgery on the same foot in Jun2021 and had physical therapy. In 2021 he reported he had pain while walking, he had physical difficulties due to surgery and thought his arthritis was worsened, was concerned of surgical wound healing, had shoulder pain. His physician told him that the condition was shoulder injury related to vaccine administration and the physician also thought that he had torn his rotator cuff with much pain. The condition his physician told was SIRVA (as reported) and pain started in May 2021 after his last COVID-19 vaccine but was doing better as of 15Sep2021. On unknown date the patient could not get out and do any gardening also carrying because of foot, also had walking difficulty so could not walk for a long time and had elevated triglycerides. The action taken in response to the events for adalimumab #1 was unknown and for adalimumab #2 was dose not changed. The clinical outcomes of the events wound healing disturbance of and vaccination site injury was recovering/resolving while the clinical outcomes of the events postoperative pain, triglyceride increased and pain upon movement were not recovered/not resolved while the clinical outcomes of the events postoperative complication, activities of daily living impaired, walking difficulty, mobility decreased, psoriatic arthritis aggravated and rotator cuff tear were unknown.  The reporter considered there was a reasonable possibility (probable) that the event vaccination site injury was related to BNT162b2.  The reporter's assessment of the causal relationship of the events postoperative pain, postoperative complication, psoriatic arthritis aggravated, wound healing disturbance of, pain upon movement, rotator cuff tear, activities of daily living impaired, walking difficulty, mobility decreased and triglyceride increased with the suspect product 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.   Causality for HUMIRA 40MG/0.8ML(ADALIMUMAB) The reporter's causality for the event(s) of SECOND FOOT SURGERY, FOOT SURGERY FOR BIG TOE, LEFT FOOT TWO SURGERY AND STILL HAD FOOT PAIN, PHYSICAL DIFFICULTIES DUE TO SURGERY/THOUGHT PSORIATIC ARTHRITIS WAS WORSE onset in 2021, COULD NOT GET OUT AND DO ANY GARDENING/CARRYING BECAUSE OF FOOT unknown onset, SOME PROBLEMS WALKING/UNABLE TO WALK FOR A LONG PERIOD OF TIME, COULD NOT GET OUT AND DO ANY GARDENING/CARRYING BECAUSE OF FOOT unknown onset, SHORTNESS OF BREATH/COULD NOT HOLD BREATH AS LONG AS PATIENT USED TO/HAD TO DO IT QUICK WHEN HAVING A SHOWER OR WASHING FACE, PHYSICAL DIFFICULTIES DUE TO SURGERY/THOUGHT PSORIATIC ARTHRITIS WAS WORSE onset in 2021, CONCERNED OF SURGICAL WOUND HEALING, ELEVATED TRIGLYCERIDES, PAIN WHILE WALKING, POSSIBLE HAD TORNED ROTATOR CUFF AND HAD PAIN and SHOULDER PAIN AND PHYSICIAN TOLD THAT THE CONDITION WAS SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION was not provided.  AbbVie's opinion is that there is no reasonable possibility that the events of SECOND FOOT SURGERY, FOOT SURGERY FOR BIG TOE, LEFT FOOT TWO SURGERY AND STILL HAD FOOT PAIN, PHYSICAL DIFFICULTIES DUE TO SURGERY/THOUGHT PSORIATIC ARTHRITIS WAS WORSE onset in 2021, COULD NOT GET OUT AND DO ANY GARDENING/CARRYING BECAUSE OF FOOT unknown onset, SOME PROBLEMS WALKING/UNABLE TO WALK FOR A LONG PERIOD OF TIME, COULD NOT GET OUT AND DO ANY GARDENING/CARRYING BECAUSE OF FOOT unknown onset, PHYSICAL DIFFICULTIES DUE TO SURGERY/THOUGHT PSORIATIC ARTHRITIS WAS WORSE onset in 2021, ELEVATED TRIGLYCERIDES, PAIN WHILE WALKING, POSSIBLE HAD TORNED ROTATOR CUFF AND HAD PAIN and SHOULDER PAIN AND PHYSICIAN TOLD THAT THE CONDITION WAS SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION are related to HUMIRA 40MG/0.8ML(ADALIMUMAB)'s opinion is that the event of SHORTNESS OF BREATH/COULD NOT HOLD BREATH AS LONG AS PATIENT USED TO/HAD TO DO IT QUICK WHEN HAVING A SHOWER OR WASHING FACE is not assessable. AbbVie's opinion is that there is a reasonable possibility that the event of CONCERNED OF SURGICAL WOUND HEALING is related to HUMIRA 40MG/0.8ML(ADALIMUMAB).  Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of SECOND FOOT SURGERY, FOOT SURGERY FOR BIG TOE and SHOULDER PAIN AND PHYSICIAN TOLD THAT THE CONDITION WAS SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter  causality for the event(s) of LEFT FOOT TWO SURGERY AND STILL HAD FOOT PAIN, PHYSICAL DIFFICULTIES DUE TO SURGERY/THOUGHT PSORIATIC ARTHRITIS WAS WORSE onset in 2021, COULD NOT GET OUT AND DO ANY GARDENING/CARRYING BECAUSE OF FOOT unknown onset, SOME PROBLEMS WALKING/UNABLE TO WALK FOR A LONG PERIOD OF TIME, COULD NOT GET OUT AND DO ANY GARDENING/CARRYING BECAUSE OF FOOT unknown onset, SHORTNESS OF BREATH/COULD NOT HOLD BREATH AS LONG AS PATIENT USED TO/HAD TO DO IT QUICK WHEN HAVING A SHOWER OR WASHING FACE, PHYSICAL DIFFICULTIES DUE TO SURGERY/THOUGHT PSORIATIC ARTHRITIS WAS WORSE onset in 2021, CONCERNED OF SURGICAL WOUND HEALING, ELEVATED TRIGLYCERIDES, PAIN WHILE WALKING and POSSIBLE HAD TORNED ROTATOR CUFF AND HAD PAIN was not provided.  AbbVie's opinion is that there is no reasonable possibility that the events of SECOND FOOT SURGERY, FOOT SURGERY FOR BIG TOE, LEFT FOOT TWO SURGERY AND STILL HAD FOOT PAIN, PHYSICAL DIFFICULTIES DUE TO SURGERY/THOUGHT PSORIATIC ARTHRITIS WAS WORSE onset in 2021, COULD NOT GET OUT AND DO ANY GARDENING/CARRYING BECAUSE OF FOOT unknown onset, SOME PROBLEMS WALKING/UNABLE TO WALK FOR A LONG PERIOD OF TIME, COULD NOT GET OUT AND DO ANY GARDENING/CARRYING BECAUSE OF FOOT unknown onset, PHYSICAL DIFFICULTIES DUE TO SURGERY/THOUGHT PSORIATIC ARTHRITIS WAS WORSE onset in 2021, CONCERNED OF SURGICAL WOUND HEALING, ELEVATED TRIGLYCERIDES, PAIN WHILE WALKING, POSSIBLE HAD TORNED ROTATOR CUFF AND HAD PAIN and SHOULDER PAIN AND PHYSICIAN TOLD THAT THE CONDITION WAS SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION are related to HUMIRA(ADALIMUMAB). AbbVie's opinion is that the event of SHORTNESS OF BREATH/COULD NOT HOLD BREATH AS LONG AS PATIENT USED TO/HAD TO DO IT QUICK WHEN HAVING A SHOWER OR WASHING FACE is not assessable.  No follow-up attempts are possible. Information about batch number cannot be obtained.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Procedural pain, Post procedural complication, Loss of personal independence in daily activities  and BNT162B2.  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.