Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder, Therapeutic product effect incomplete, Vein discolouration
Clinical narrative: Humira leaves her susceptible to other infections plus the inability to fight them; effect that she gstill not getting the same ot from being on the Humira before; little tiny mark on her hand literally turned all of the veins in her arm black and she was taken to the hospital; Caller states they believe that the Humira is shutting down the immune system; she is in pain 24/7; she just broke out on her torso, front and back with psoriasis which is just getting worse as they go; his wife has been reduced to crutches, a back brace, a lot of pain, a sleep disorder now to where life has come to a stop for her.; patient is still not getting the same effect that she got from being on the Humira before; fever happened to her; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202200139664 (Pfizer).  A female patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 07Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA) (Batch/Lot number: unknown); hydrocodone (HYDROCODONE) (Batch/Lot number: unknown) at 3x/day (7.5 three times a day , 3x/day) for sleep disorder, pain. Relevant medical history included: "autoimmune disease" (unspecified if ongoing), notes: she has autoimmune disease; "psoriatic arthritis" (unspecified if ongoing), notes: what it does is apparently her brain thinks that all of her joints are broken or injured and it sends out inflammatory signals and so she has what is called psoriatic arthritis; "large scaly bloody patches" (unspecified if ongoing), notes: states that comes with outbreaks that sporadically turn into large scaly bloody patches that are difficult to get rid of. The patient's concomitant medications were not reported. The following information was reported: INFECTION SUSCEPTIBILITY INCREASED (hospitalization), outcome "unknown", described as "Humira leaves her susceptible to other infections plus the inability to fight them"; THERAPEUTIC PRODUCT EFFECT INCOMPLETE (hospitalization), outcome "unknown", described as "effect that she gstill not getting the same ot from being on the Humira before"; VEIN DISCOLOURATION (hospitalization), outcome "unknown", described as "little tiny mark on her hand literally turned all of the veins in her arm black and she was taken to the hospital"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Caller states they believe that the Humira is shutting down the immune system"; PAIN (non-serious), outcome "unknown", described as "she is in pain 24/7"; PYREXIA (non-serious), outcome "unknown", described as "fever happened to her"; PSORIASIS (non-serious), outcome "unknown", described as "she just broke out on her torso, front and back with psoriasis which is just getting worse as they go"; WALKING AID USER (non-serious), SLEEP DISORDER (non-serious), outcome "unknown" and all described as "his wife has been reduced to crutches, a back brace, a lot of pain, a sleep disorder now to where life has come to a stop for her.". The events "humira leaves her susceptible to other infections plus the inability to fight them", "effect that she gstill not getting the same ot from being on the humira before", "little tiny mark on her hand literally turned all of the veins in her arm black and she was taken to the hospital", "caller states they believe that the humira is shutting down the immune system", "she is in pain 24/7", "fever happened to her", "she just broke out on her torso, front and back with psoriasis which is just getting worse as they go", "his wife has been reduced to crutches, a back brace, a lot of pain, a sleep disorder now to where life has come to a stop for her." and "his wife has been reduced to crutches, a back brace, a lot of pain, a sleep disorder now to where life has come to a stop for her." were evaluated at the physician office visit. The action taken for adalimumab and hydrocodone was unknown. Therapeutic measures were taken as a result of immune system disorder, pain, sleep disorder. The lot number for bnt162b2 was not provided and will be requested during follow up.  Clinical Information: Caller states the patient was on a drug called Humira and states the other name for that wa adalimumab and patient was working a full time job and this was not a complete answer but the doctor put patient on a mild opioid and patient was able to work a full time job quite well and then the opioid epidemic issue hits and the doctors forced her to reduce patient opioids and the reduction resulted in her no longer being able to do the job anymore and patient opted to retire. Caller states then covid hit the scene and because of the patient's Humira or adalimumab, basically that shuts down patient immune system and basically going after patient TN4 cells which causes the inflammation in process.  States the Humira shuts down patient immune system and meanwhile the patient goes from working to non-working but patient was still completely functional and then patient goes off of the Humira. Caller states he himself is on disability and basically bedridden and he is following the news relentlessly and it says that the Pfizer Covid vaccine increased the T cells tremendously and that is what the patient's Humira is trying to defeat. Caller states once the patient got the Pfizer Covid vaccine patient did great and did go back on the Humira but the Humira is not working and patient was not getting any benefit from the Humira and then when patient went to get the booster of the Pfizer Covid vaccine at her doctor's office, there was a paragraph that really talked about immunocompromised people and the paragraph had a list of medications and Humira was one of them on the list and the patient asked the people that give the shots if she was on one of these medications listed should patient have the Pfizer Booster covid vaccine and states they told patient no to the shot; states the patient was still not getting the same effect that she got from being on the Humira before and states the original vaccine of the Pfizer covid vaccine that she had wearing off apparently. Caller asks if the Pfizer Covid booster vaccine when they say vaccine it a vaccine where some sort of modified version of the actual virus was being used to where the body builds up it's own immune system to it such as the polio vaccine for the first live version and then used a dead version on her and states the rheumatologist says as long as the patient is on Humira, to never take the live vaccine states he does not think the Pfizer Covid vaccine is live vaccine but needed to ask specifics on this if Pfizer is allowed to say if the vaccine based upon being given the version of the virus or is the Pfizer Covid vaccine a giant immune system booster and is the Pfizer Covid vaccine a giant immune system booster or is it a true vaccine using a version of the virus. Caller states he just thought he would give the background of now being faced with the patient's quality of life or life itself if you get covid it is personally against her states patient doctor says her getting the booster and then getting covid patient would get really sick and die if she does not get the booster dose so something has to be done to get her back to having some sort of quality of life. Caller states for the patient's opioids, she has simple Hydrocodone 7.5 three times a day and needs it for sleep and patient has to take it every 8 hours and to get her out of pain she has to lay down and she has been reduced on it and gets 2 hours of sleep and is up 2 hours and it wears patient completely out and she gets another two hours.  Caller states he has no lot numbers for the Humira or the Hydrocodone for the patient and states he has no Humira pens available to him to give that lot number for her states the patient was working a very grueling very long hour job as a flight attendant and that is when they reduced her opioid due to the opioid epidemic in 2017 and in three months, all it took was Humira working wonderfully and then three months later patient said she can't take it anymore. Caller states after she got the vaccine, she got back on Humira which was just not working. Caller specifies she got off the Humira when Covid hit to wait or the vaccine and once she got the vaccine. She got back on the Humira. Caller states that now it was 8 months after and she back on the Humira. Caller states his wife lost all quality of life when she was off the Humira waiting for the vaccine. Caller states that his wife's doctor recommends taking the booster to avoid getting seriously ill with Covid. Caller states when she went to sign the paperwork to get the booster, Humira was listed as a drug and the girls giving the shot stated she should not get the booster when taking Humira. Caller states his wife was faced with a decision.