Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Skin irritation, Spinal fracture, Splenic lesion, Splenomegaly, Thyroxine
Clinical narrative: head tremors; Hand tremor; chronic wedge compression fracture of the T12 vertebral body; strange feeling in the back of my throat; did not feel well; vertigo; fatigue; severe nausea; headache; hard time staying asleep; brain fog; hard time concentrating; dream state almost all the time; hard time remenbering things; hiccups; restless leg syndrome; my scalp is getting small sores; sore jaw; i m grinding my teeth at night; sore mouth; clenching my jaw; reflux; sweet taste in mouth; chronic diarrhea; vitamin D deficiency; serrated polyp with surface mucosal injury; focal active colitis; weight loss; hypodense splenic lesion; subcentimeter nodules; spleen is midly enlarged; lower lumbar degenerative disc disease; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (5570). The reporter is the patient.  A 41 -old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 20Jan2021 (Lot number: EL3249) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: Adenomyosis, start date: 04Nov2014, stop date: 17Sep2015, notes: total hysterectomy 17Sep2015; Follicular neoplasm of thyroid, start date: 03Jul2019, stop date: 06Sep2019, notes: Thyroidectomy 06Sep2019; "cough" (unspecified if ongoing); Ex-Smoker (unspecified if ongoing); Chest coldness (unspecified if ongoing); Diarrhoea (unspecified if ongoing); Tremors head (unspecified if ongoing). Concomitant medications included: PRAMIPEXOLE taken for tremor, start date: 24Mar2021, stop date: 17Apr2021; BENZATROPINE taken for tremor, start date: 06Aug2021, stop date: 22Aug2021; CARBIDOPA + LEVODOPA taken for tremor, start date: 20Sep2021, stop date: 10Oct2021; AMANTADINE taken for tremor, start date: 04Nov2021 (ongoing). Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation, reaction(s): "metal taste". The following information was reported: HEAD TITUBATION (medically significant), outcome unknown, described as head tremors; TREMOR (medically significant), outcome unknown, described as Hand tremor; SPINAL FRACTURE (medically significant), outcome unknown, described as chronic wedge compression fracture of the T12 vertebral body; OROPHARYNGEAL DISCOMFORT (non-serious), outcome unknown, described as strange feeling in the back go my throat; MALAISE (non-serious), outcome unknown, described as did not feel well; VERTIGO (non-serious), outcome unknown, described as vertigo; FATIGUE (non-serious), outcome unknown, described as fatigue; NAUSEA (non-serious), outcome unknown, described as severe nausea; HEADACHE (non-serious), outcome unknown, described as headache; INSOMNIA (non-serious), outcome unknown, described as hard time staying asleep; FEELING ABNORMAL (non-serious), outcome unknown, described as brain fog; DISTURBANCE IN ATTENTION (non-serious), outcome unknown, described as hard time concentrating; DREAMY STATE (non-serious), outcome unknown, described as dream state almost all the time; AMNESIA (non-serious), outcome unknown, described as hard time remembering things; HICCUPS (non-serious), outcome unknown, described as hiccups; RESTLESS LEGS SYNDROME (non-serious), outcome unknown, described as restless leg syndrome; SKIN IRRITATION (non-serious), outcome unknown, described as my scalp is getting small sores; PAIN IN JAW (non-serious), outcome unknown, described as sore jaw; BRUXISM (non-serious), outcome unknown, described as i m grinding my teeth at night; ORAL PAIN (non-serious), outcome unknown, described as sore mouth; JAW DISORDER (non-serious), outcome unknown, described as clenching my ja; REFLUX GASTRITIS (non-serious), outcome unknown, described as reflux DYSGEUSIA (non-serious), outcome unknow, described as sweet taste in mouth; DIARRHOEA (non-serious), outcome unknown, described as chronic diarrhoea; VITAMIN D DEFICIENCY (non-serious), outcome unknown, described as vitamin D deficiency; POLYP (non-serious), outcome unknown, described as serrated polyp with surface mucosal injury; COLITIS (non-serious), outcome unknown, described as focal active colitis; WEIGHT DECREASED (non-serious), outcome unknown, described as weight loss; SPLENIC LESION (non-serious), outcome unknown, described as hypodense splenic lesion; NODULE (non-serious), outcome unknown, described as subcentimeter nodules; SPLENOMEGALY (non-serious), outcome unknown, described as spleen is madly enlarged; INTERVERTEBRAL DISC DEGENERATION (non-serious), outcome unknown, described as lower lumbar degenerative disc disease; NO ADVERSE EVENT (non-serious), outcome unknown, described as She has had many negative test and labs for other things all negative. The patient underwent the following laboratory tests and procedures: alanine aminotransferase normal (3-45): (21Jun2021) 16, notes: 16 u/l; albumin globulin ratio (0.8-2.2): (unspecified date) 1.7; albumin globulin ratio (6.4-8.9): (unspecified date) 7.0 g/dl; amylase: (26Mar2021) 28 uL anion gap (2-16): (21Jun2021) 9; aspartate aminotransferase (10-40): (unspecified date) 11 uL aspartate aminotransferase (13-39): (unspecified date) 12 ug/kg; basophil count (0.00-0.36 10 3): (30Jul2021) 0.20 10 3 uL basophil count (0.0-3.0): (21Jun2021) 0.5 percent (22Aug2021) 1.4 percent biopsy: (unspecified date) fragments of small intestinal and gastric mucosa w; biopsy colon: (unspecified date) colonic mucosa with no significant pathologic find, notes: No evidence of microscopic colitis; biopsy stomach: (unspecified date) antral and body-type gastric mucosa with no sign, notes: The findings are nonspecific. Conditions to consider include SAIDs injury, post-infectious states, autoimmune disorders, and celiac sprue. Serologic studies may be helpful, if clinically indicated; blood albumin (3.6-5.0): (21Jun2021) 4.4 g/dl; blood alkaline phosphatase (37-98): (21Jun2021) 56 ug/L; blood bilirubin (0.2-1.2): (21Jun2021) 0.6 mg/dl; blood bilirubin (0.03-0.18): (unspecified date) 0.10 mg/dl; blood bilirubin (0.2-1.2): (unspecified date) 0.6; (21Jun2021) 0.5; (22Aug2021) 0.52, notes: BILIRUBIN, DIRECT; blood calcium (8.0-10.50): (21Jun2021) 9.36 mg/dl; blood chloride (96-110): (21Jun2021) 105 mEq/l; blood creatinine (0.6-1.40): (unspecified date) 0.84 mg/dl; (13Apr2021) 0.84 mg/dl; blood creatinine (0.60-1.40): (21Jun2021) 0.84 mg/dl; blood folate: (26Mar2021) 16.17 mg/ml; blood folate: (26Mar2021) 16.17 pg/mL; blood glucose (70-105): (unspecified date) 86 mg/dl; blood glucose (65-99): (unspecified date) 91 mg/dl; (21Jun2021) 91 mg/dl; blood immunoglobulin a: (13Apr2021) 159; blood immunoglobulin a increased: (21Jun2021) 159.9 mg/dl; (30Jul2021) unknown results; blood lactic acid: (22Aug2021) 1.3 mmol/L; (22Aug2021) 1.3 mmol/L; blood magnesium: (13Apr2021) 20 mg/dl; (25Apr2021) 20 mg/dl; (22Aug2021) 1.8 mg/dl; blood parathyroid hormone: (26Mar2021) 21.5 mg/ml; blood parathyroid hormone: (13Apr2021) 21.5 pg/mg blood phosphorus (37-98): (unspecified date) 56 uL (22Aug2021) 49 uL blood potassium (3.5-4.9): (21Jun2021) 4.2 mEq/l; blood sodium (135-145): (21Jun2021) 141 mEq/l; blood thyroid stimulating hormone: (26Mar2021) 3.99 IU/ml; (22Aug2021) 0.73 IU/ml; blood urea (6-23): (21Jun2021) 12 mg/dl; blood urea (7.0-20.0): (unspecified date) 16.8; carbon dioxide (20.0-32.0): (21Jun2021) 27.0 mmol/L; chest x-ray: (30Jul2021) there is no pneumothorax; computerised tomogram abdomen: (unspecified date) lung bases: included extent of the lung bases are, notes: Hepatobiliary: The liver has a normal size with a smooth surface. The portal veins are patent. There is no biliary+ dilatation and the gallbladder is unremarkable with no calcified stones. Pancreas: The pancreas is normal. Spleen: There is a 1.3 cm hypodense splenic lesion (series 2 image #30), new from the study performed 2007. adrenals The adrenal glands are normal.Kidneys, Ureters, & Bladder: Both kidneys have a normal size and there is no hydro nephrosis. Both ureters have à normal calibre. The urinary bladder is unremarkable. Gastrointestinal: The stomach and small bowel are normal with no obstruction or inflammation. The appendix is normal. The large bowel is normal. Reproductive Organs: Postsurgical changes from the patient's prior hysterectomy. There is a right-sided corpus luteum. The left ovary is present. Lymphatic System: There is mesenteric stranding within the mid mesentery with small subcentimeter nodules. Approximately 1.2 cm periaortic lymph node seen on series 2 image #74. Vasculature: Normal calibre abdominal aorta. The main abdominal aortic branch vessels including the celiac, mesenteric, and renal arteries appear patent with no evidence of a stenosis. There is no evidence for mesenteric venous thrombosis. Peritoneum: Trace amount of free fluid within the pelvis. Abdominal Wall & Musculoskeletal: There is lower lumbar degenerative disc disease. Chronic wedge; c-reactive protein: (22Aug2021) <0.5 mg/dl; egfr status assay: (26Mar2021) 60 ml/min; (13Apr2021) unknown results; (22Aug2021) 760 ml/min; electrocardiogram: (unspecified date) heart rate-57, notes: RR Interval-1044 Atrial Rate-57 P-R Interval-172 P Duration-124 P.Horizontal Axis--8 P Front Axis-201 Q Onset-504QRSD Interval-96 QT Interval-437 QTGB-426 QTcF-430 QRS HorizontalAxis-37 QRS Axis 25 1-40 Horizontal Axis-61 1-40 Front Axis-17 T-40 Horizontal Axis-50 T-40 Front Axis 44 T Horizontal Axis-11 T Wave Axis-5 S-T Horizontal Axis-38 S-T Front Axis-20; eosinophil count (0.00-0.72 10 3): (22Aug2021) 0.20 10 3 uL; eosinophil count (0.0-6.0): (21Jun2021) 2.9 percent; (22Aug2021) 3.7 percent; glomerular filtration rate: (unspecified date) 91.44; (unspecified date) 77.44; haematocrit (36.0-45.0): (21Jun2021) 36- 45.0 percent; (22Aug2021) 40.2 percent; haemoglobin (12.0-15.0): (21Jun2021) 14.6 g/dl; hepatitis c antibody: (21Jun2021) non-reactive; (21Jun2021) non-reactive; laboratory test: (unspecified date) negative; lipase: (26Mar2021) 43 uL; (21Jun2021) 21 uL; lipase: (21Jun2021) 21 ug/L; lymphocyte count (0.56-4.92 10 3): (21Jun2021) 2.10 10 3 uL; (22Aug2021) 2.30 10 3 uL; lymphocyte count (14.0-41.0): (21Jun2021) 36.7 percent; (22Aug2021) 34.2 percent; magnetic resonance imaging head: (25Apr2021) no evidence of diffusion restriction; (13Apr2021) there is no evidence of an intraparenchymal mass,, notes: Diffusion imaging demonstrates no evidence of diffusion restriction. As such, there is no evidence of either an acute or subacute ischemic event, infarct, cerebritis or encephalitis.The GRE scan images reveal no acute, subacute or remote haemorrhage nor susceptibility related signal alteration within grey or white matter. The FLAIR images demonstrate no abnormal grey or white matter signal within the cerebral or the cerebellar hemispheres. There is no evidence of an intraparenchymal mass, mass effect or vasogenic enema. Normal signal intensities are noted on; mean cell haemoglobin concentration (31.0-37.0): (21Jun2021) 34.7 g/dl, notes: 31.0-37.0; (22Aug2021) 35.0 g/dl; mean cell volume (80-100): (21Jun2021) 88, notes: 80-100; (22Aug2021) 86; monocyte count (0.0-1.32 10 3): (21Jun2021) 0.40 uL (22Aug2021) 0.50 10 3 uL; monocyte count (0.0-11.0): (21Jun2021) 6.8 percent (22Aug2021) 7.1 percent; neutrophil count (1.96-9.72 10 3): (21Jun2021) 3.10 10 3 uL; (22Aug2021) 3.60 10 3 uL; neutrophil count (49.0-81.0): (21Jun2021) 53.1 percent; (22Aug2021) 53.6 percent; platelet count (31.0-37.0): (21Jun2021) 265 10 3 g/dl (22Aug2021) unknown result; polypectomy: (13Apr2021) colonic mucosa with serrated features and crypti, notes: negative for granulomas and architectural features of chronicity; protein total (6.0-8.0): (21Jun2021) 7.0 g/dl; red blood cell count (3.50-55510 6): (21Jun2021) 4.79 10 6 uL (22Aug2021) 4.66 10 3 uL; red cell distribution width increased (11.6-14.6): (21Jun2021) 13.5 percent (22Aug2021) 12.7 percent; thyroxine: (13Apr2021) 0.79 mg/dl; (26Mar2021) 0.79 mg/dl; tissue polypeptide antigen: (21Jun2021) negative/ numeric 0.3 elia; troponin i: (22Aug2021) 2 pg/mL; ultrasound abdomen: (13Apr2021) spleen is mildly enlarged., notes: The focal splenic lesion seen on recent CT has characteristics most in keeping with a benign haemangioma. No further follow-up or workup is necessary; vitamin b12: (26Mar2021) unknown result; (13Apr2021) 20 pg/mL; vitamin d: (21Jun2021) 18.8 mg/ml, notes: low; white blood cell count (4.0-12.010 3): (21Jun2021) 5.8 10 3 uL (22Aug2021) 6.8 10 3 uL x-ray: (26Mar2021) normal.  Clinical course: She received first dose of the vaccine. she immediately had a metal taste in my mouth which lasted about 5-10 minutes. she had no other reactions. she received the second dose on 20Jan2021 There was no metal taste with the second dose, but she did not a strange feeling in the back of my throat. It lasted about 20 minutes. There were several occasions between Jan and Mar where she just did not feel well. she suffered from vertigo, fatigue, severe nausea and headaches. This would last for about a day at a time. During the second week of Mar, she started noticing my head moving nonstop when she laid down at night. Within a week she was having head tremors during the day. The tremors progressed to the point that it looked like she was nodding yes all of the time. Along with the tremors she had such severe nausea that Zofran didn't even touch it. This was all day everyday especially after eating. During this time, she also became very fatigued. she also having a hard time staying asleep all night. she wakes up several times throughout the night. she can usually fall back asleep right away but not always. She has also been dealing with brain fog. she has a hard time concentrating on anything. she can't read a book. she can barely get through a tv show. she feels like she in a dream state almost all of the time. she has also been having a hard time remembering things. she had to retrace my whole day once to recall who she had had a certain conversation with. she remembered the conversation just not who she had it with. she has a hard time finding the word she wants to say and also forming my thoughts. In the second week of June, she developed a right hand/arm tremor. It is like my hand is trying to make a fist anytime it is at rest. If she is reaching out and holding onto something, my whole right forearm will tremor. These are pretty fast tremors and they have not improved since they started. They actually got worse within a month of starting. she heads tremors have settled down. They are more like hiccups now. They are still happening daily though. Since Mar2021 she has also started having restless leg syndrome. This has never been a problem for me before. she also has a few other strange things going on. My scalp is getting small sores and is also quite: sore and feels swollen in spots at times. she now has random times where my eyes will blink hard, and my nose will scrunch up. she also clenching my jaw quite frequently even though she is trying not to. This is causing me to have a sore jaw. she also thinks that I am grinding my teeth at night because she wakes up with a sore mouth. The nausea has improved although it is not gone completely. she also now has reflux and an almost constant sweet taste in my mouth. she went to a gastroenterologist in June because of the nausea and she was also having pretty chronic diarrhoea. They ordered many tests which all came back as pretty normal. she has been to the primary care physician's office several times since this all started. she has mostly seen a nurse practitioner who has consulted with one of the lead doctors. Her first thought was that maybe it was the anxiety/depression medicines she was taking. she had been taking Abilify for as far back as 2017 and had started Pristiq in Aug2020. She had me wean off the Abilify at the end of March and the Pristiq in the middle of April. This had no effect on my symptoms. she did have some severe side effects from stopping the Pristiq. Also, my depression got to a pretty high level, so she was put on Lexapro at the beginning of May. she was also put on Trazodone to try and help me sleep better. My depression is under control but unfortunately it didn't help with the sleep. she first saw a Neurologist in Jul2021. He ordered a data scan to rule out Parkinson disease. He said that she was a mystery and she made him use his brain. He didn't really know what to think of me. My follow up with his PA was also not very beneficial. She blamed my anxiety for the brain fog. She also though maybe she had sleep apnoea and that is why she so fatigued. she does not even snore. The most recent specialist that she saw on 03Nov2021 was a movement disordered specialist. Her diagnosis was that my tremors were caused by the Abilify even though the right-hand tremors didn't. start until over three months after she stopped taking it. She also thought maybe the brain fog was from my body being worried about possibly having Parkinson's and it could only focus on one thing at a time. she not worried about that and would actually be thrilled to have a real diagnosis of any kind. She put me on Amantadine three times daily. she still currently taking it with no improvements yet. This is the fourth different medication she has been put on for the tremors with none helping thus far. she has a follow up with the movement disorder specialist in Feb she feel like a shell of my former self. she works four days a week and have a family to take care of. Not to mention the tremors are very noticeable. she just would like to find out.  No follow-up attempts are possible. No further information is expected.