Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Aspartate aminotransferase increased, Basophil count, Blood albumin, Blood bilirubin, Blood calcium
Clinical narrative: Ovarian vein thrombosis; Microscopic colitis; Diverticulitis; Gestational diabetes mellitus; Elevated rheumatoid factor; Anticoagulation management encounter; Dehydration; Vaccine reaction; Chronic abdominal pain; Dizziness; GAD (generalized anxiety disorder); Generalized pain; Hypertriglyceridemia; Irritable bowel syndrome with diarrhea; Irritable bowel syndrome with diarrhea; Malaise and fatigue; Malaise and fatigue; Moderate episode of recurrent major depressive disorder; Severe anxiety; nausea; loss of appetite; vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 24May2021 13:15 (Lot number: EW0177) at the age of 35 years as dose 2, single for covid-19 immunisation. Vaccination facility type Workplace Clinic. Relevant medical history included: "appendectomy", start date: Nov2009, stop date: Nov2009, notes: Appendectomy Nov2009; "Sinus surgery x 2" (unspecified if ongoing), notes: Sinus surgery x 2, Sinus surgery 2014/2015; "anxiety" (unspecified if ongoing); "gestational diabetes" (unspecified if ongoing); "House dust mite allergy" (unspecified if ongoing).  Family medical history included Maternal grand mother heart attack x 2, hyperlipidemia. Concomitant medication(s) included: CELEXA [CELECOXIB] taken for anxiety (ongoing); ATORVASTATIN; BUSPIRONE; CITALOPRAM; CLINDAMYCIN; CLONAZEPAM; IPRATROPIUM; IVERMECTIN; LEVONORGESTREL; OMEPRAZOLE; ONDANSETRON; SELZENTRY; QNASL taken for dust allergy (ongoing), ongoing Atrovent nasal spray for dust mite allergy.  Vaccination history included: Bnt162b2 (Dose 1:Time: 4:00 Pm, Right arm, Intramuscular, Lot # EW0162), administration date: 20Apr2021, when the patient was 35 years old, for COVID-19 Immunization, reaction(s): "stomach ache/ Abdominal pain", "nausea/nauseous", "body aches all over/Body Aches/Pain", "Ovarian Vein Thrombosis", "Colitis", "Vomiting", "Diarrhea", "Fatigue/ tired/ felt exhausted", "Brain Fog", "Insomnia", "Panic Attacks", "Depression", "14% weight loss/lost 14% of her body weight", "high rheumatoid factor", "high inflammatory markers", "high cytokines", "Fear", "Blood clot", "Intestinal pain", "felt unwell", "arm soreness", "dizzy", "loss of appetite", "Chills". The following information was reported: OVARIAN VEIN THROMBOSIS (prolonged hospitalization, medically significant) with onset 02Jun2021, described as "Ovarian vein thrombosis"; COLITIS MICROSCOPIC (medically significant), described as "Microscopic colitis"; DIVERTICULITIS (medically significant), described as "Diverticulitis"; GESTATIONAL DIABETES (medically significant), described as "Gestational diabetes mellitus"; RHEUMATOID FACTOR, described as "Elevated rheumatoid factor"; ANTICOAGULATION DRUG LEVEL, described as "Anticoagulation management encounter"; DEHYDRATION, described as "Dehydration"; HYPERSENSITIVITY, described as "Vaccine reaction"; ABDOMINAL PAIN, described as "Chronic abdominal pain"; DIZZINESS, described as "Dizziness"; GENERALISED ANXIETY DISORDER, described as "GAD (generalized anxiety disorder)"; PAIN, described as "Generalized pain"; HYPERTRIGLYCERIDAEMIA, described as "Hypertriglyceridemia"; IRRITABLE BOWEL SYNDROME, DIARRHOEA, and all described as "Irritable bowel syndrome with diarrhea"; MALAISE, FATIGUE, and all described as "Malaise and fatigue"; DEPRESSION, described as "Moderate episode of recurrent major depressive disorder"; ANXIETY, outcome "unknown", described as "Severe anxiety"; NAUSEA, outcome "recovering", described as "nausea"; DECREASED APPETITE, outcome "recovering", described as "loss of appetite"; VOMITING, outcome "recovering", described as "vomiting". Outcome of other events were unknown.  The patient prolonged hospitalization for ovarian vein thrombosis (hospitalization duration: 3 day(s)). The events "ovarian vein thrombosis" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: albumin globulin ratio: (20Aug2021) 1.9; (27Aug2021) 1.7; (22Sep2021) 1.9; (08Oct2021) 1.5; aspartate aminotransferase increased: (08Aug2021) 114; (20Aug2021) 95; (27Aug2021) 95; (22Sep2021) 95; ast to platelet ratio index: (08Aug2021) 22; (20Aug2021) 12; (27Aug2021) 14; (22Sep2021) 19; (08Oct2021) 22; basophil count: (08Aug2021) 0.9; (20Aug2021) 0.4; (20Aug2021) 0.03; (27Aug2021) 0.5; (27Aug2021) 0.04; (22Sep2021) 0.9; (22Sep2021) 0.06; (08Oct2021) 0.9; (08Oct2021) 0.04; (22Oct2021) 1.1; (22Oct2021) 0.06; blood albumin: (08Aug2021) 4.4; (20Aug2021) 4.2; (27Aug2021) 4.5; (22Sep2021) 4.6; (08Oct2021) 4.4; blood bilirubin: (20Aug2021) 0.8; (27Aug2021) 1.1; (22Sep2021) 0.8; (08Oct2021) 0.7; blood calcium: (08Aug2021) 9.3; (20Aug2021) 8.6; (27Aug2021) 9.4; (22Sep2021) 9.3; (08Oct2021) 9.3; blood chloride: (08Aug2021) 103; (20Aug2021) 109; (27Aug2021) 106; (22Sep2021) 106; (08Oct2021) 103; blood creatine phosphokinase: (02Jun2021) 30; blood creatinine: (08Aug2021) 0.6; (20Aug2021) 0.7; (27Aug2021) 0.7; (22Sep2021) 0.7; (08Oct2021) 0.6; (22Oct2021) 0.7; blood glucose: (08Aug2021) 91; (20Aug2021) h 111; (27Aug2021) 96; (22Sep2021) 87; blood immunoglobulin a: (28Jun2021) 0.20; (08Aug2021) 0.20; (13Aug2021) 0.30; (20Aug2021) 0.30; (27Aug2021) 0.30; (22Sep2021) 0.20; (08Oct2021) 0.20; (22Oct2021) 0.20; (08Aug2021) 0.01; (20Aug2021) 0.02; (27Aug2021) 0.02; (22Sep2021) 0.01; (08Oct2021) 0.01; (22Oct2021) 0.01; blood magnesium: (03Jun2021) 2.2; blood phosphorus: (08Aug2021) 54; (20Aug2021) 48; (27Aug2021) 50; (22Sep2021) 50; (08Oct2021) 54; blood pressure measurement: (07Jan2022) 100/67; blood sodium: (08Aug2021) 138; (20Aug2021) 141; (27Aug2021) 140; (22Sep2021) 140; (08Oct2021) 138; blood thyroid stimulating hormone: (13May2021) 1.84; blood urea: (08Aug2021) 9; (20Aug2021) 13; (27Aug2021) 11; (22Sep2021) 10; (08Oct2021) 9; body temperature: (07Jan2022) 36.9 Centigrade; carbon dioxide: (08Aug2021) 21; (20Aug2021) 23; (27Aug2021) 22; (22Sep2021) 24; (08Oct2021) 21; computerised tomogram: (02Jun2021) left gonadal vein thrombosis; (03Jun2021) small hemorrhagic cyst of right ovary; (08Jun2021) resolving thrombosis of left ovarian vein; c-reactive protein: (13May2021) 0.43; (02Jun2021) 0.36; (28Jun2021) 2; (10Jul2021) less than 0.30; (26Jul2021) 2; (04Aug2021) less than 0.30; eosinophil count: (08Aug2021) 0.4; (20Aug2021) 0.0; (20Aug2021) 0.00; (27Aug2021) 0.4; (27Aug2021) 0.03; (22Sep2021) 1.4; (22Sep2021) 0.09; (08Oct2021) 0.4; (08Oct2021) l 0.02; (22Oct2021) 1.3; (22Oct2021) 0.07; globulin: (08Aug2021) 3.0; (20Aug2021) 2.2; (27Aug2021) 2.7; (22Sep2021) 2.4; (08Oct2021) 3.0; glomerular filtration rate: (20Aug2021) 95; (27Aug2021) 95; (22Sep2021) 95; (08Oct2021) 114; glycosylated haemoglobin: (13May2021) 5.2; haematocrit: (28Jun2021) 39.6; (28Jun2021) 37.3; (10Jul2021) 41.9; (20Jul2021) 42.0, notes: POC Hct:43.0; (26Jul2021) 34.7; (04Aug2021) 38.5; (08Aug2021) 38.4; (10Aug2021) 40.8; (13Aug2021) 39.8; (20Aug2021) 36.0; (27Aug2021) 38.3; (22Sep2021) 38.2; (08Oct2021) 38.4; (22Oct2021) 39.6; haemoglobin: (13May2021) 13.9; (14May2021) l 10.8; (15May2021) 13.9; (02Jun2021) 13.8; (03Jun2021) 12.0; (08Jun2021) 14.4; (23Jun2021) 13.0; (28Jun2021) 12.7; (10Jul2021) 13.6; (20Jul2021) 14.4, notes: POC Hgb: 14.6; (26Jul2021) 11.8; (04Aug2021) 12.5; (08Aug2021) 12.7; (10Aug2021) 13.1; (20Aug2021) 11.6; (20Aug2021) 13.0; (27Aug2021) 12.6; (22Sep2021) 12.5; (22Sep2021) 13.9; (08Oct2021) 12.7; (22Oct2021) 12.9; heart rate: (07Jan2022) 16; hormone level abnormal: (08Aug2021) 17; (20Aug2021) 15; (27Aug2021) 20; (22Sep2021) 23; (08Oct2021) 17; immunology test: (04Jun2021) h 32.0; (28Jun2021) h 33.0; (26Jul2021) h 24.0; (04Aug2021) h 20.0; (20Aug2021) h 19.0; (27Aug2021) h 19.0; investigation: (08Aug2021) 14; (20Aug2021) 9; (27Aug2021) 12; (22Sep2021) 10; (08Oct2021) 14; (08Aug2021) 15; (20Aug2021) 19; (27Aug2021) 16; (22Sep2021) 14; (08Oct2021) 15; (13May2021) 103; (08Aug2021) 91; (20Aug2021) h 111; (27Aug2021) 96; (22Sep2021) 87; (08Oct2021) 91; (08Aug2021) 0.0; (20Aug2021) 0.0; (20Aug2021) 0.000; (27Aug2021) 0.0; (27Aug2021) 0.000; (22Sep2021) 0.0; (22Sep2021) 0.000; (08Oct2021) 0.0; (08Oct2021) 0.000; (22Oct2021) 0.0; (22Oct2021) 0.000; (08Aug2021) 4.6; (20Aug2021) 4.3; (27Aug2021) 4.3; (22Sep2021) 4.2; (08Oct2021) 4.6; (04Jun2021) h 32.00; (28Jun2021) h 33.0; (26Jul2021) h 24.0; (04Aug2021) h 20.00; (20Aug2021) h 19.0; (27Aug2021) h 19.0; (13May2021) negative; lymphocyte count: (08Aug2021) 32.4; (20Aug2021) 13.6; (27Aug2021) 16.6; (22Sep2021) 31.6; (08Oct2021) 32.4; (22Oct2021) 32.2; (08Aug2021) 1.45; (20Aug2021) l 0.95; (27Aug2021) 1.22; (22Sep2021) 2.03; (08Oct2021) 1.45; (22Oct2021) 1.68; mean cell haemoglobin: (13May2021) 29.9; (14May2021) 29.7; (15May2021) 29.2; (02Jun2021) 29.5; (03Jun2021) 29.9; (08Jun2021) 29.9; (23Jun2021) 30.0; (28Jun2021) 34.0; (28Jun2021) 30.2; (10Jul2021) 29.7; (20Jul2021) 30.8; (26Jul2021) 30.7; (04Aug2021) 30.1; (08Aug2021) 30.0; (10Aug2021) 29.8; (13Aug2021) 29.8; (20Aug2021) 30.0; (27Aug2021) 30.3; (22Sep2021) 30.0; (08Oct2021) 30.0; (22Oct2021) 29.8; mean cell haemoglobin concentration: (13May2021) 33.7; (14May2021) l 32.1; (15May2021) 33.1; (02Jun2021) 32.8; (03Jun2021) 32.6; (08Jun2021) 33.4; (23Jun2021) 33.7; (10Jul2021) 32.5; (20Jul2021) 34.3; (26Jul2021) 34.0; (04Aug2021) 32.5; (08Aug2021) 33.1; (10Aug2021) l 32.1; (20Aug2021) 32.2; (27Aug2021) 32.9; (22Sep2021) 32.7; (08Oct2021) 33.1; (22Oct2021) 32.6; mean cell volume: (13May2021) 88.6; (14May2021) 92.3; (15May2021) 88.2; (02Jun2021) 90.0; (03Jun2021) 91.8; (08Jun2021) 89.4; (23Jun2021) 89.1; (28Jun2021) 88.8; (10Jul2021) 91.5; (20Jul2021) 89.7; (26Jul2021) 90; (04Aug2021) 92.8; (08Aug2021) 90.6; (10Aug2021) 92.7; (13Aug2021) 91.3; (20Aug2021) 93.0; (27Aug2021) 92.1; (22Sep2021) 91.6; (08Oct2021) 90.6; (22Oct2021) 91.5; mean platelet volume: (13May2021) 10.3; (14May2021) 10.4; (15May2021) 10.4; (02Jun2021) 10.5; (03Jun2021) 10.5; (08Jun2021) 10.6; (23Jun2021) 10.3; (10Jul2021) 10.4; (20Jul2021) 11.0; (04Aug2021) 11.5; (10Aug2021) 11.4; monocyte count: (08Aug2021) 7.6; (20Aug2021) 3.4; (20Aug2021) 0.24; (27Aug2021) 4.2; (27Aug2021) 0.31; (22Sep2021) 5.5; (22Sep2021) 0.35; (08Oct2021) 7.6; (08Oct2021) 0.34; (22Oct2021) 5.2; (22Oct2021) 0.27; neutrophil count: (13May2021) 69.8; (14May2021) 48.8; (15May2021) 67.9; (02Jun2021) 80.7; (03Jun2021) 61.0; (08Jun2021) 73.3; (23Jun2021) 61.2; (28Jun2021) 61.6; (10Jul2021) 76.9; (20Jul2021) 78.9; (26Jul2021) 76; (04Aug2021) 73.4; (08Aug2021) 58.5; (08Aug2021) 2.62; (10Aug2021) 78.9; (13Aug2021) 80.0; (20Aug2021) 82.3; (20Aug2021) 5.74; (27Aug2021) 78.0; (27Aug2021) 5.74; (22Sep2021) 60.4; (22Sep2021) 3.88; (08Oct2021) 58.5; (08Oct2021) 2.62; (22Oct2021) 60.0; (22Oct2021) 3.13; platelet count: (13May2021) 342; (14May2021) 266; (15May2021) 333; (02Jun2021) h 390; (03Jun2021) 321; (08Jun2021) h 419; (23Jun2021) 310; (28Jun2021) 321; (10Jul2021) 361; (20Jul2021) 349; (26Jul2021) 277; (04Aug2021) 290; (08Aug2021) 237; (10Aug2021) 32.7; (13Aug2021) 312; (20Aug2021) 254; (27Aug2021) 250; (22Sep2021) 256; (08Oct2021) 237; (22Oct2021) 286; po2: (07Jan2022) 96 %; protein total decreased: (08Aug2021) 7.4; (20Aug2021) 6.4; (27Aug2021) 7.2; (22Sep2021) 7.0; (08Oct2021) 7.4; red blood cell count: (13May2021) 4.65; (14May2021) l 3.64; (15May2021) 4.76; (02Jun2021) 4.68; (03Jun2021) 4.01; (04Jun2021) 4.68; (28Jun2021) 4.20; (10Jul2021) 4.82; (20Jul2021) 4.33; (26Jul2021) 4.40; (08Aug2021) 4.24; (10Aug2021) 4.58; (20Aug2021) l 3.87; (27Aug2021) 4.16; (27Aug2021) 3.84; (22Sep2021) 4.17; (22Sep2021) 4.15; (08Oct2021) 4.24; (22Oct2021) 4.33; red cell distribution width increased: (13May2021) 12.2; (14May2021) 12.8; (15May2021) 12.7; (02Jun2021) 12.3; (03Jun2021) 12.4; (08Jun2021) 12.3; (23Jun2021) 12.2; (10Jul2021) 10.4; (20Jul2021) 11.0; (26Jul2021) 12.1; (04Aug2021) 11.5; (08Aug2021) 11.8; (10Aug2021) 11.4; (20Aug2021) 12.6; (27Aug2021) 12.4; (22Sep2021) 12.0; (08Oct2021) 11.8; (22Oct2021) l 11.5; respiratory rate: (07Jan2022) 16; thyroxine: (13May2021) 1.36; tri-iodothyronine: (13May2021) 2.5; ultrasound doppler: (03Jun2021) no dvt; white blood cell count: (13May2021) 7.86; (14May2021) 5.50; (15May2021) 7.42; (02Jun2021) 8.17; (03Jun2021) 7.62; (08Jun2021) 8.61; (23Jun2021) 7.64; (28Jun2021) 5.19; (10Jul2021) 8.94; (20Jul2021) h 12.11; (26Jul2021) 8.4; (04Aug2021) 7.44; (08Aug2021) 4.48; (10Aug2021) 6:27; (20Aug2021) 6.98; (27Aug2021) 7.36; (22Sep2021) 6.42; (08Oct2021) 4.48; (22Oct2021) 5.22. Therapeutic measures were taken as a result of ovarian vein thrombosis, abdominal pain, colitis microscopic, rheumatoid factor, anticoagulation drug level, dehydration, hypersensitivity. In summary, she had received the Pfizer COVID vaccine in Apr2021 and May2021. Soon after, she developed abdominal pain and found to have a left gonadal thrombosis on 03Mar2021. She was ultimately started on Eliquis. She had a hypercoagulation evaluation that was negative and has been working with COVID spe-cialists based in withheld who has started her on a protocol to help her ongoing symptoms of nau-sea, loss of appetite and abdominal pain. Since starting this protocol, she reports feeling better and now able to eat better with less nausea and vomiting. She reports ongoing intermittent abdominal pain and has now had multiple scans since Jun show-ing no acute pathology. Her abd MRI in Aug revealed resolution of her left gonadal vein thrombus. She reports no lower leg swelling and denies any chest pain, shortness of breath or cough. All other systems reviewed and are negative.  Polytypic mature B cells are show a normal kappa to lambda ratio of 1.9:1. Unremarkable T cells are 85.3% of lymphocytes (CD4:CD8 ratio 1.21:1). NK cells are 5.3% of lym-phocytes. Diagnostic immunophenotypic features of involvement by a non-Hodgkin B or T cell lym-phoma are not identified. The final diagnosis is based upon flow cytometric analysis of the speci-men. Microscopic slides are examined for correlation. Gross Description: A: A specimen labeled with the patient's name and "peripheral blood" per container is received in 1-7mL EDTA tube and I-10mL heparin tube on 16Aug2021. Submitted entirely for flow cytometry. (mr/flow). Final Diagnosis: A: Right colon, biopsy: Colonic mucosa with focal active colitis. B: Left colon, biopsy: Colonic mucosa with focal active colitis. Comment: Both biopsies demonstrate focal active colitis of minimal inflammatory intensity, This is a nonspe-cific finding that can be seen in several conditions including infection, drug-induced gastrointestinal mucosal injury, and Crohn's disease despite the absence of granulomatous inflammation. No changes of ulcerative colitis are identified. There is no evidence of lymphocytic or collagenous coli-tis. No dysplasia or malignancy is identified. Clinical Information: Abdominal pain. Gross Description: A: Received in formalin, labeled with the patients name and "A. Right colon random biopsy", are nine, 0.2-0.7 cm, tan soft tissue fragments entirely submitted in A1-A2. B: Received in formalin, labeled with the patient's name and "B. Left colon random biopsy", are multiple, 0.1-0.7 cm, tan soft tissue fragments entirely submitted in B1-B2.jns VR). Current Treatment: Eliquis 5mg BID Physical Examination: Vitals: 07Jan2022 14:52 BP: 100/67;Pulse: 86 ;Resp: 16 ;Temp: 36.9 degree C ; SpO2: 96%; Ecog Performance Status, ECOG: 0; Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is normal weight. She is not ill-appearing, toxic-appearing or  diaphoretic. Hent: Head: Normocephalic and atraumatic. Eyes: General: No scleral icterus. Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, end reactive to light. Cardiovascular: Rate and Rhythm: Normal rate. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Abdominal: General: There is no distension. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Mental status is at baseline. Cranial Nerves: No cranial nerve deficit. Sensory: No sensory deficit. Motor: No weakness. Coordination: Coordination normal. Gait: Gait normal. Deep Tendon Reflexes: Reflexes normal. Psychiatric: Mood and Affect: Mood normal. Thought Content: Thought content normal. Judgment: Judgment normal. Laboratory Studies: 22Oct2021 LFTs normal. Imaging/Pertinent Studies: MRI pelvis 17Sep2021: Impression: 1. Improved left gonadal vein thrombus with near complete resolution. No new thrombus. 2. Normal ovaries. 3. Intrauterine device present in expected position.CT abd/pelvis Jun2021, Impression:1. No bowel obstruction or acute inflammatory process identified. 2. Suspicion of left gonadal vein thrombosis. Mixing artifact seems less likely given the homogeneous enhancement of other venous structures. 3. No free fluid or adenopathy. Assessment: Withheld has history of left gonadal vein thrombus that occurred in the context of getting the Pfizer COVID vaccine. We spent significant time reviewing the potential contribution of the vaccine to her recent blood clot but that this is not clear and difficult to prove. The clot certainly occurred within a period of weeks after her second vaccine. I discussed my limited expertise in COVID com-plications and defer any discussion about the association of her ongoing symptoms to the COVID vaccine. Given the spotty data about the association of blood clots with the vaccine could warrant a more prolonged period of anticoagulation. We discussed the risk of bleeding and very low risk of spontaneous bleeding on Eliquis which could be life threatening but very rare outside of an accident or trauma. With that in mind, I expressed my support to continue Eliquis for an extended period of time, maybe up to a year while she continues to sort out onoging symptoms post COVID vaccine.  Plan: continued follow up with her "COVID' providers; continue Eliquis 5mg BID for now, likely plan for a year but will continue to discuss the risks/benefits of continued anticoagulation. Home Medications:Current Outpatient Medications:atorvastatin 10 MG tablet: No dose, route, or frequency recorded;  busPlRone (BUSPAR): 15 mg, Oral, Daily; citalopram (CELEXA): 40 mg, Oral, Daily; clindamycin 1 % gel: 1 application, Topical Daily PRN; clonazePAM 0.5 MG tablet : 1 tablet, oral, Daily PRN; Eiquis: 5 mg, Oral, 2 times daily; ipratropium 0.03 % nasal spray: 2 sprays; ivermectin 3 MG tablet: 9mg po qAm / 3mg po qhs every 3 days, 0 Refill(s); levonorgestrel (Mirena) 52 mg (20 mcg/day) IUD: 1 each, Intrauterine, Every 6 months; omeprazole 20 MG DR capsule: No dose, route, or frequency recorded; ondansetron 4 MG disintegrating tablet: No dose, route, or frequency recorded; Qnasl 80 MCG/ACT nasal spray: 1 spray, Nasal, Daily PRN; Saline 0.9 % aerosol solution: 1 spray; Selzentry: 300 mg, Oral, Daily.