Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Influenza, Investigation, Pain, Pancreatic disorder
Clinical narrative: body hurt and was achy; Seeing a weight gain and doesn't need to gain weight which is probably worse for her joints; I got very sick with them; was told it effected her pancreas; she had the flu; Baker's Cyst; aggressive arthritis/Worsens and continues to worsen; Inappropriate schedule of vaccine administered; The fever she could feel in her limbs, felt like it was in her bones; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 45-year-old female patient received BNT162b2 (BNT162B2), on 21Apr2021 as dose 2, single (Lot number: EW0169) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: Asthma When 4-years-old.; "had her gallbladder out" (unspecified if ongoing), notes: When she was younger in her 20s she had her gallbladder out and had issues with her pancreas.; "had issues with her pancreas" (unspecified if ongoing), notes: When she was younger in her 20s she had her gallbladder out and had issues with her pancreas.; "Tested positive for COVID-19", start date: 01Feb2021 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (First Dose: Given: 28Jan2021, Batch/lot number: EN5318, Clarified product information is being provided from the vaccine card. , NDC/EXPIRY/Formulation, Dose: Not indicated on vaccine card. , Does not have product at time of call for either dose.), administration date: 28Jan2021, when the patient was 45-year-old, for COVID-19 immunization, reaction(s): "I was one of the ones giving injections but I got very sick with them", "I was one of the ones giving injections but I got very sick with them", "Tested positive three days later after the first dose of COVID-19 Vaccine", "Tested positive three days later after the first dose of COVID-19 Vaccine", "high fever", "swelling of hands, feet, and knees", "swelling of hands, feet, and knees", "come on in flashes and then go away". The following information was reported: PYREXIA (medically significant) with onset Apr2021, outcome "recovering", described as "The fever she could feel in her limbs, felt like it was in her bones"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Apr2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; SYNOVIAL CYST (medically significant) with onset Apr2022, outcome "unknown", described as "Baker's Cyst"; ARTHRITIS (medically significant) with onset 2022, outcome "not recovered", described as "aggressive arthritis/Worsens and continues to worsen"; PAIN (medically significant), outcome "unknown", described as "body hurt and was achy"; WEIGHT INCREASED (non-serious), outcome "unknown", described as "Seeing a weight gain and doesn't need to gain weight which is probably worse for her joints"; ILLNESS (non-serious), outcome "unknown", described as "I got very sick with them"; PANCREATIC DISORDER (non-serious), outcome "recovered", described as "was told it effected her pancreas"; INFLUENZA (non-serious), outcome "unknown", described as "she had the flu". The events "aggressive arthritis/worsens and continues to worsen", "the fever she could feel in her limbs, felt like it was in her bones", "baker's cyst", "body hurt and was achy" and "i got very sick with them" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) Negative, notes: Had blood tests that test for autoimmune because her HCP only sees something aggressive like that with autoimmune but it was negative; (unspecified date) aggressive arthritis, notes: Went to HCP and was told she was showing signs of aggressive arthritis that came through in a blood test, a panel; (02Jun2022) aggressive arthritis and cyst, notes: Was sent to to have a blood test on 02Jun2022 where the blood test showed her arthritis was aggressive and had developed a cyst that eventually grew to the size of a soft ball; (26Apr2021) Unknown result, notes: 26Apr2021 went in for knee, joint, and blood tests; Body temperature: (unspecified date) Unknown results; COVID-19: (unspecified date) Positive, notes: As soon as she got the vaccine she also tested positive for COVID-19; (01Feb2021) Positive, notes: Tested positive for COVID-19; External testing: (unspecified date) Negative; Rheumatoid factor: (02Jun2022) Negative, notes: Clarified RA latex test was on 02Jun2022 and was negative, RA factor was negative. Therapeutic measures were taken as a result of arthritis, pyrexia, synovial cyst, pain, illness.  Clinical course: Caller mentions "she is an HCP but right now she is calling as a patient. "Yes, I was one of the ones giving injections but I got very sick with them. Before COVID and vaccines and all that had come along she was working at the nursing home. Had her CNA and was working for two different home health departments. Was doing home to home and wound care in (City name and State name withheld). Never had any problems, nothing at all. When COVID-19 came along she was doing Withheld County Injections. 28Jan2021 she received her first dose of Pfizer BioNTech COVID-19 Vaccine. As soon as she got the vaccine she also tested positive for COVID-19. Doesnt know if she got COVID-19 from being exposed to people in the line or because of the vaccine itself. On onset of the vaccine she had fever, high fever. Started with swelling of hands, feet, and knees. Would come on in flashes and then go away and would create fever in her body and limbs. As she got over it and it went away she kept on working. When working on the floor with patients she started noticing heat in her feet, hands, elbows, joints in general. Soon after she started experiencing the swelling she noticed knots on top of joints on the top of her foot, top of hands, knuckles, bottom part of knee would bulge and just dismissed it. Apr2021 came through with the second vaccine dose. Got COVID-19 about three more times after that. Developed a natural immunity to COVID-19. Same side effects continued. Went to HCP and was told she was showing signs of aggressive arthritis that came through in a blood test, a panel. Did a panel for autoimmune to make sure she was not having any kind of autoimmune response. Determined she just had a sudden onset of aggressive arthritis. Started treatment with Celebrex but couldnt get rid of fever. Two months after Apr2021 she quit her job. The fever she could feel in her limbs, felt like it was in her bones. Been through series of steroid injections, Celebrex, Indomethacin for the bones and recently stopped taking everything. Now her HCP wants to do a partial replacement of her knee joint. It went from never having an issue in her life to problems that have not stopped ever since she had the vaccines. Seems to progressively gotten worse. Not working a job and is on Medicaid. Want it to go away and it is not, she is progressively deteriorating. Doesnt see how this can just all of a sudden start and not stop. From 2021 into 2022 she has just felt it progressively get worse and dealt with it. Now she is trying to stop taking things. The swelling is to where the joints are no longer there and turned into an aggressive form of arthritis. There is nothing in the joints on both sides. Doesnt know about her feet or hands. While treating one knee the arthritis is going to another knee. Her HCP keeps running her blood but nothing showing up except for aggressive arthritis. Was supposed to go 23Jan2023 for an injection but didnt, she didnt want injections. HCP saw her for Bakers cyst but the progression went on from 2021 to 2022. Had a very large Bakers cyst the size of softball behind her knee cap. Surgery would have been too invasive and she had to wait for it to rupture and now she has another one on the right side. Quit indomethacin for the heat in bones because her HCP said he couldnt deal with her anymore. So she just started doing injections in the knee. Tested positive for COVID-19: Tested positive three days later after the first dose of COVID-19 Vaccine. Got her second dose of COVID-19 Vaccine and was diagnosed with COVID-19 a second time 25Apr2021 and was just as sick. Dates of other COVID-19 positive events unknown. Went into hospital twice and was told it effected her pancreas. Clarified hospitalizations happened with first and second time she had COVID-19. Clarified went to the emergency room and was not admitted to the hospital. Swelling of hands, feet, and knees: Was told her bones were running a fever, arthritic fever, before she was showing signs of arthritis. Clarified swelling started after her first dose of COVID-19 Vaccine. When she had COVID-19 it started with a heat in her body, like in her bones, and after that it gradually started to where she is now. Her body hurt and was achy and thought maybe she had the flu. Doesnt have the exact dates. Is still effected. High Fever: Started after the first dose almost immediately and went home visibly sick. Red, sweating, and fever. Clarified it started three days after her 28Jan2021 dose of COVID-19 vaccine. Had the fever in all her joints and it never went away but has improved. Aggressive arthritis: Diagnosed during the summer of 2022. Worsens and continues to worsen. Was sent to have a blood test on 02Jun2022 where the blood test showed her arthritis was aggressive and had developed a cyst that eventually grew to the size of a soft ball. Her Bakers Cyst started around Apr2022 and by June or July she went to see her HCP because the swelling was so huge. 12Feb2021 she went to the hospital for the second time she had COVID and had it back to back. Was not admitted to the hospital. 26Apr2021 went in for knee, joint, and blood tests. Also went in 28Apr2022 for swelling of her joints. 13May2022 went in for swelling. Her HCP started giving her Indocin for inner joint and bone heat, Celebrex, Medrol dose pack, and prednisone but she cant keep taking all of that. Bakers Cyst: Has it now and needs to get it checked because she cant stand it. Clarified she assumes she has it because the joint is so bad and she now has to have the other side checked. Had injections to the top part of the cyst. Clarified the Bakers Cyst in one knee ruptured and had to wait for it to rupture because the surgery is too invasive. First Bakers Cyst ruptured by Aug2022 when she went to an orthopedic specialist and now has to go to a rheumatologist. Doesnt know if the Bakers Cyst has resolved and was just keeping it steady with injections. Went in for more injections in October and then didnt go to her appointment 23Jan2023 for another injection. Is hearing her bones crack and needs to go in for her other knee to have both knees seen at the same time. Recently stopped taking medications: Stopped taking her medications Jan2023. No Celebrex, Prednisone, no pills, no injections. It is quite painful. Went off all of it, takes nothing. Afraid she will hurt her bones. Seeing a weight gain and doesnt need to gain weight which is probably worse for her joints. When she took the COVID-19 vaccine and then the second dose she took was a double whammy and she never experienced it before. Clarified the injections to her knee as Corticosteroids starting in Aug2022. Her pancreas is no longer being effected. HCP had no reason as to why COVID-19 was effecting her organ. HCP told her COVID-19 is effecting certain peoples organs who have something weak in her organ. When she was younger in her 20s she had her gallbladder out and had issues with her pancreas. Clarified she has no patient information or details regarding other people with effected organs. Fever came in flare ups. Like a flare. When it happens she gets hot like feverish. Celebrex: 200mg oral capsule, 1 capsule by mouth, started: 22Apr2022. Reading from a patient portal does not have medication at this time. nIndocin: Clarified to indomethacin. Further clarified product to Indocin SR 75mg. Product is almost like a poison. Started: 03Jun2022. Took it when the other medications werent working. Then it started to not working she started the injections. No longer has product, manufacturer, NDC/LOT/EXPIRY, formulation unknown. Used it to get the heat off the joints and to keep heat off. There was another medication her HCP said she would have to take it so much during the day until she threw up then once she threw up it would reduce the heat. Never took the medication. Name of medication unknown. Prednisone: No longer has the product. Was on 20mg but started with 10mg and her HCP upped it 10mg. Manufacturer, NDC/LOT/EXPIRY, Formulation: Unknown. Started off with a Medrol pack, 4mg. Had to then climb up real high and then work down with the dosing. No longer has the Medrol pack. Issued on 08Feb2021. Manufacturer/NDC/LOT/EXPIRY, Formulation: Unknown. Celebrex: Dispensed: Enough for one a day for a month then got another month but didnt refill it. HCP said she could do one or the other but there was too much in her system so she started the injections but is trying to get off injections. Testing: Had blood tests that test for autoimmune because her HCP only sees something aggressive like that with autoimmune but it was negative. Had an RA latex test that was negative. External testing was negative. Clarified RA latex test was on 02Jun2022 and was negative, RA factor was negative. Doesnt understand why she has it but blood wise she doesnt have it. Another HCP did one and it was negative. Didnt start until after immunizations and now has advanced rheumatoid arthritis but her blood tests doesnt show it.".; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events Arthiritis, pyrexia, synovial cyst, pain and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : US-PFIZER INC-202300047499 same patient/drug, different dose number/event;US-PFIZER INC-202300048100 same patient/drug, different dose number/event;