Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatomegaly, Hyperplasia adrenal, Inappropriate schedule of product administration, Investigation, Laboratory test
Clinical narrative: Infection and inflammatory response in her foot in late Summer/ Early Fall in her middle 3rd toe on her left foot; First Dose: 27Mar2021; Second Dose: 13Apr2021; has always struggled with blood sugar, and since all of this it has always been that much harder to control blood sugar and it has been very high for quite some time; Lichen sclerosus (which existed before the vaccine/after vaccine had a horrible flare up that was off the charts); gastroparesis (existed before vaccine, much worse after vaccine due to inflammatory response) due to her diabetes; Lichen sclerosus (existed before the vaccine/after vaccine had a horrible flare up)/gastroparesis (existed before vaccine, much worse after vaccine) due to her diabetes; Enlarged Liver; Lichen planus; Hyperplasia of both adrenal gland/so sick and depressed felt like she was constantly on edge/elevated stress; Panniculitis which is inflammation of the tissue around her abdomen; Inflammation in tendons and ligaments is much worse/escalation in body aches, pains, inflammatory responses, new autoimmune issues/Inflammation Left Hip hip has been so bad/arthritis; Inflammation in tendons and ligaments is much worse/escalation in body aches, pains, inflammatory responses, new autoimmune issues/Inflammation Left Hip hip has been so bad/arthritis; Neuropathy in her legs, feet and hands, been progressively worsening, concerned is she not going to be able to walk one day; Woke up with trigger finger of her middle finger on the left hand; lifted something and heard a crunch and pop in right upper arm in the muscle and tore a muscle/Popeye muscle; Glaucoma worse; surgery shunt and valve; mass at the incision site on right breast/discovered it was fat necrosis/mass was benign; Questionable lab work that is pointing to systemic lupus erythematosus; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 13Apr2021 (Lot number: EN6204) administered in arm left at the age of 62 years as dose 2, single for COVID-19 immunization. Relevant medical history included: Obese, diabetic with notes: insulin resistant, Sjogren's syndrome, Basal Duct Metastatic Breast Cancer with start date: Oct2019 and notes: diagnosis of invasive ductal malignant stage 2 breast cancer, followed every 3 months by an oncologist, Glaucoma, Lichen sclerosus, Gastroparesis, and neuropathy in her legs, feet and hands, all ongoing; radiation treatment, systemic lupus erythematosus with notes: 25-30 years ago; injury to her left hip, fall and terrible bruising in her left hip joint in the bursa, all with notes: 25 years ago. There were no concomitant medications. Past drug history included: Cortisone for terrible bruising in her left hip joint in the bursa and injury to her left hip, both with notes: 25 years ago cortisone injections. Vaccination history included: BNT162B2 (Lot: ER2613, Expiry: Jul2021, Left Arm), administration date: 27Mar2021, when the patient was 62 years old, for COVID-19 immunization, reactions: Systemic lupus erythematosus, Panniculitis, Diabetic gastroparesis, Sjoegren's syndrome, Condition aggravated, Peripheral neuropathy aggravated, Hyperplasia adrenal, Trigger finger, Muscle rupture, Infected toe, Glaucoma aggravated, Fat necrosis of breast, Diabetes mellitus aggravated, Lichen sclerosus, Liver enlargement, and Lichen planus. The patient stated she reluctantly took the 2-part vaccine series in Mar2021 and Apr2021. She didn't want to take it, she was not well with a lot of things, and she had a lot of concerns about possible side effects, and she was obese, diabetic, is recovering from Basal Duct Metastatic Breast Cancer, Sjogren's Syndrome and she has a lot going on. Her mother who had great concern for her and for her diseases wanted her to take the vaccine. Over the last 10 months, patient has had an escalation in her illnesses. She has had an escalation in body aches, pains, inflammatory responses, new autoimmune issues, and one thing after another. She has been saying after all of these things have been escalating that the vaccine has really done something to her far and above over her normal crap she was dealing with before the vaccine. On Apr2021, she has been diagnosed with an enlarged liver, panniculitis which is inflammation of the tissue around her abdomen, and hyperplasia of both adrenal glands, lichen sclerosus (which existed before the vaccine, but it was not treated for years, and after the vaccine she had a horrible flare up that was off the charts), gastroparesis (which existed before the vaccine but is much worse after the vaccine due to the inflammatory response) due to her diabetes is so bad, inflammation in her tendons and ligaments is much worse, she has sores in her mouth and has been seen by dentists and an oral surgeon whom diagnosed the mouth sores as lichen planus. On an unspecified date in 2021, the patient has had questionable lab work that was pointing to systemic lupus erythematosus. She would be seeing a rheumatologist in April for SLE. She has had lab work over the years that pointed to SLE 25-30 years ago and now again her lab work was pointing that direction, she would know more when she sees the specialist in April. This has all been happening since the vaccine. She woke up with trigger finger of her middle finger on the left hand one morning. The doctor treated it with cortisone. She was seen by an orthopedic doctor for problems with her joints and she asked him about her finger, she told him she went to bed one night, and the next morning her middle finger on her left hand had trigger finger. She didn't understand all of the inflammatory stuff, but he gave her an injection with cortisone in the Fall of last year after she suffered a couple of months, and it took away pain from that. On Apr2021, the patient had a CT of her left hip, and it showed an inflammatory response. She had an injury to her left hip from a fall 25 years ago in her back yard that caused terrible bruising in her left hip joint in the bursa, but 25 years ago cortisone injections fixed that, but since she took the vaccine, her hip has been so bad. She asked the ortho doctor if he could do a CT or X-ray of the left hip and he informed her there was inflammation and arthritis and it is the bursa. The ortho doctor did not do those injections but she has not followed up to another doctor yet. Since auto immune is part of her everyday it can attack the connective tissue and muscles out of nowhere. On an unspecified date in 2021, she lifted something and heard a crunch and pop in her right upper arm in the muscle and she tore a muscle and when she saw the shoulder specialist, he called it a Popeye muscle after tore it out of nowhere. It is starting to resolve and heal, but out of blue she tore a muscle. Her body was under attack. She was hospitalized for an infection and inflammatory response in her foot in late Summer/Early Fall (2021) in her middle 3rd toe on her left foot. She had to have IV antibiotics and was hospitalized for 5-6 days and then she had to go back for a week for outpatient antibiotics.  The nurse practitioner said this had to be more of an inflammatory response to something, so they requested a rheumatology consult but that happened after discharge. She also has glaucoma, and she has had multiple laser surgeries over the years and in this last 8, 9, 10 months it has only gotten worse since the vaccine (2021). She had issues with higher eye pressure before but once she took the vaccine the pressure in her right eye has been uncontrollable and she has seen doctors and tried many eye drops with no answer with the pressure as high as 38-42. 4 weeks ago, she had had a major surgery in her right eye, they had to go in and put in a shunt and valve to get the pressure down so wouldn't lose her sight. She asked the eye doctor in January if it was inflammatory glaucoma, and he was not sure at that time but certainly for whatever unknown reason nothing was helping it. Now after her surgery and she was recovering, the pressures were climbing again, and she may have to do another laser surgery with a heavy-duty machine. The doctor was waiting on a new machine, or they may possibly have to go in and put in a larger shunt and drain more fluid down. The doctor has no answer, but it has exponentially worsened, none of the drops have helped. There have been so many different eye drops Glauctabs, Dorzolamide, Alphagan, Pilocarpine as a last resort and there were 3-4 in between. Since the vaccine she used Dorzolamide and Pilocarpine. She stopped pilocarpine because she suffered from environmental acephalgic migraines, and the pilocarpine just increased the headaches and it caused bad redness and burning in the eye. She was not going to take something that would add to that. The surgeon stopped the Pilocarpine quickly so her only option was the surgery, because nothing had helped her eye pressure. She has neuropathy in her legs, feet and hands. It was bad before, like bad, prior to taking the vaccine, but it has been progressively worsening, and now it was so exponentially worse, she was concerned was she not going to be able to walk one day. With her diagnosis in Oct2019 of invasive ductal malignant stage 2 breast cancer, she had radiation treatment and she is followed every 3 months by an oncologist. In the Fall of 2021, she noticed she had a mass at the incision site on her right breast. They did a mammogram and biopsy, and discovered it was fat necrosis and probably caused by radiation or an inflammatory process. Thankfully the mass was benign, but it has been 2 years after radiation, so she wondered if it was from the inflammatory process since her body was going through something very inflammatory. During her hospitalization for her left foot, a nurse practitioner who saw her thinks it had something to do with an inflammatory response and low and behold, she saw a TV show where they had a doctor and he was discussing problems with the Pfizer Covid Vaccine and studies were being done about the RNA and DNA and the things that were being found in the labs that RNA and DNA have issues and problems and one thing they didn't see was whether DNA would be integrated into people's own chromosomes, and that might happen and what it could possibly mean. It would be a worry because it could cause autoimmune and inflammation. She took this vaccine and things were getting worse for her. She sees an endocrinologist and she has always struggled with her blood sugar, and since all of this it has always been that much harder to control her blood sugar and it has been very high for quite some time (reported as from Apr2021). She asked her endocrinologist about it when she was hospitalized with her foot. She was so sick and depressed and felt like she was constantly on edge and because of the adrenal glands enlarged, her doctor told her about cortisol and stress producing hormones were elevated so they did a saliva and urine test and because on some blood work showing cortisol levels were elevated, they did a series of tests in and out of the hospital to see if another condition but they were glad to report she didn't feel she had it. The elevated stress made her blood sugar levels difficult to control, she was insulin resistant to begin with. The patient underwent the following laboratory tests and procedures: biopsy: (2021) discovered it was fat necrosis; cortisol: (Apr2021) elevated; blood sugar: (Apr2021) very high for quite some time; blood work: (Apr2021) cortisol levels were elevated; CT of left hip: (Apr2021) showed an inflammatory response, notes: there was inflammation and arthritis and it is the bursa; series of tests: (Apr2021) she didn't feel she had it; lab work: (unspecified date) pointed to sle 25-30 years ago, notes: lab work over the years; (unspecified date) pointing to systemic lupus erythematosus, notes: questionable lab work; mammogram: (2021) discovered it was fat necrosis; saliva: (Apr2021) she didn't feel she had it; urine test: (Apr2021) she didn't feel she had it. The outcome of the events trigger finger and "infection and inflammatory response in her foot in late Summer/Early Fall in her middle 3rd toe on her left foot" was recovered on an unspecified date in 2021. The outcome of the event "lifted something and heard a crunch and pop in right upper arm in the muscle and tore a muscle/Popeye muscle" was recovering. The outcome of the events "mass at the incision site on right breast/discovered it was fat necrosis/mass was benign" and "First Dose: 27Mar2021; Second Dose: 13Apr2021" were unknown. The outcome of the remaining events was not recovered.