Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Cataract, Condition aggravated
Clinical narrative: Bilateral cataracts; Lack of drug effect; osteoarthritis in her knee; in her knee, and it was twice the size it should be with swollen knee/swollen area on her left wrist that was hard as a rock; warm to touch; hardly get up after sitting down; depressed; not sleeping well; lost some weight; swollen area on her left wrist that was hard as a rock; did not feel well when weather was cloudy; low back pain; Flu like symptoms; Nausea; Mobility decreased; Joint range of motion decreased; Lower extremity mass; Tooth extraction/all teeth pulled; Painful hand; flare with hands and body/flare; Swelling of hands/both hands swollen; Wrist pain; Generalized aching/General body pain/aches/sitting for long times everything started hurting/hurt all over; This is a solicited report from a Study based on information received by Pfizer from Company (manufacturer control number: 20K-163-3447033-00).   A contactable consumer (patient) reported that a 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 intramuscular on 15Aug2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 Vaccination at age of 78 years old; adalimumab (HUMIRA, Solution for injection in pre-filled pen), from 05Dec2019 to an unspecified date, at 40 mg, 1 in 1 week, Citrate Free, then from an unspecified date to Feb2021, at 40 mg, 1 in 1 week, Citrate Free, then from 2021 to 2021, at Citrate Free; all via subcutaneous for moderate to severe rheumatoid arthritis and moderate to severe adult crohn's disease; paracetamol (TYLENOL), via an unspecified route of administration from an unspecified date to an unspecified date, at 1300 mg, once a day for pain. Medical history included abstains from alcohol, diabetes from 16Apr2020 to 01May2020, non-tobacco user, recurrent urinary tract infection, fatigue, urinary tract infection, cataract surgery. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Lot number: Unknown) intramuscular on 02Mar2021 at age of 78 years old for COVID-19 immunization, and experienced swelling of fingers, generalized aching, lack of drug effect, burning finger, feeling unwell, lost weight, sleep unwell, fatigue, heart disorder, condition aggravated, finger deformity, hand deformity, nausea, one finger was brusied, bilateral cataracts. The patient previously received the second dose of BNT162B2 (Lot number: Unknown) intramuscular on 23Mar2021 at age of 78 years old for COVID-19 immunization, and experienced generalized aching, hand deformity, finger deformity, red hands, knee pain, sensitivity to weather change, vomiting, low back pain, foot pain, diarrhea, shoulder pain, condition aggravated, bilateral cataracts, flu like symptoms, nausea, mobility decreased, heart disorder, depression, lost weight, feeling unwell, diabetes, lack of drug effect, she had swelling and redness in her hands and lump on her left knee, fingers were swollen, hurt and look bruised, she could not bend two fingers on left hand and thumb, body aches/achiness, flared with hands, achiness. The patient experienced tooth extraction/all teeth pulled on 30Aug2021 with outcome of recovered in 2021, bilateral cataracts on an unspecified date with outcome of unknown, swelling of hands/both hands swollen on 16Aug2021 with outcome of recovering, generalized aching/general body pain/aches/sitting for long times everything started hurting/hurt all over in 2021 with outcome of not recovered, wrist pain in Aug2021 with outcome of not recovered, painful hand on 16Aug2021 with outcome of recovering, flare with hands and body/flare on 16Aug2021 with outcome of not recovered, osteoarthritis in her knee on an unspecified date with outcome of unknown, in her knee, and it was twice the size it should be with swollen knee on an unspecified date with outcome of unknown, warm to touch on an unspecified date with outcome of unknown, hardly get up after sitting down on an unspecified date with outcome of unknown, depressed on an unspecified date with outcome of not recovered, not sleeping well on an unspecified date with outcome of not recovered, lost some weight on an unspecified date with outcome of unknown, swollen area on her left wrist that was hard as a rock on an unspecified date with outcome of unknown, did not feel well when weather was cloudy on an unspecified date with outcome of unknown, low back pain on an unspecified date with outcome of not recovered, flu like symptoms on an unspecified date with outcome of recovered, nausea on an unspecified date with outcome of recovered, mobility decreased on an unspecified date with outcome of unknown, joint range of motion decreased on an unspecified date with outcome of unknown, lower extremity mass on an unspecified date with outcome of unknown, lack of drug effect on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: fever on an unspecified date, body weight: lost on an unspecified date. The action taken in response to the events for bnt162b2 was not applicable, for adalimumab was unknown, for paracetamol was unknown. Therapeutic measures were taken as a result of the events generalized aching/general body pain/aches/sitting for long times everything started hurting/hurt all over, and tooth extraction/all teeth pulled. Causality for Humira (Adalimumab): The reporter's causality for the events of flare unknown onset, body aches, flu like symptoms, nausea, lack of effect, urinary tract infection and vomiting with adalimumab was a reasonable possibility. The reporter's causality for the events of cataracts on both eyes, hands were twisted, fingers were twisted,  flare with hands, could hardly get up after sitting down, heart condition, fatigue, osteoarthritis affected knees and hands, two fingers on left hand and thumb would not bend was straight as a board, lump on left knee, swollen area on left wrist that was hard as a rock unknown onset, flare onset 16Aug2021, both hands swollen, depressed and not sleeping well unknown onset, depressed and not sleeping well unknown onset, all teeth pulled, lost weight, did not feel well when weather was cloudy, swollen area on left wrist that was hard as a rock unknown onset, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02 mar 2021, diabetes, another urinary tract infection, body aches/sitting for long times  everything started hurting, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02Mar2021, hands and fingers were red, shoulder pain, diarrhea, foot pain, low back pain, left knee was extremely painful when it was cold onset in May2021, left knee was extremely painful when it was cold onset in May2021, wrist hurt, hurt all over and both hands painful was not provided. Withheld opinion is that there is no reasonable possibility that the events of flare unknown onset, cataracts on both eyes, hands were twisted, fingers were twisted, flare with hands, could hardly get up after sitting down, fatigue, osteoarthritis affected knees and hands, two fingers on left hand and thumb would not bend was straight as a board, lump on left knee, swollen area on left wrist that was hard as a rock unknown onset, flare onset 16Aug2021, both hands swollen, depressed and not sleeping well unknown onset, depressed and not sleeping well unknown onset, all teeth pulled, lost weight, did not feel well when weather was cloudy, swollen area on left wrist that was hard as a rock unknown onset, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02Mar2021, diabetes, lack of effect, body aches/sitting for long times everything started hurting, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02Mar2021, hands and fingers were red, shoulder pain, diarrhea, foot pain, low back pain, vomiting, left knee was extremely painful when it was cold onset in May2021, left knee was extremely painful when it was cold onset in May2021, wrist hurt, hurt all over and both hands painful are related to adalimumab. withheld opinion is that there is a reasonable possibility that the events of body aches, flu like symptoms, nausea, urinary tract infection and another urinary tract infection are related to adalimumab. Withheld opinion is that the event of heart condition is not assessable.  Causality for bnt162b2: The reporter's causality for the events of condition aggravated, swelling of hands, general body pain, painful hand with bnt162b2 was probable, for other events was not provided.  Causality for Tylenol (Paracetamol): The reporter's causality for the events of condition aggravated, swelling of hands was probable, for other events was not provided.  The reporter's assessment of the causal relationship of all the events (except for condition aggravated, swelling of hands, general body pain, painful hand) 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events tooth disorder,drug ineffective,cataract and the suspect drug "BNT162B2" cannot be completely excluded.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.