Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Troponin I, Urine abnormality, Urine analysis, Urine ketone body
Clinical narrative: Albumin/Globulin ratio 2.2 (HIGH) (0.8 - 2.0); Mean corpuscular hemoglobin concentration: 32g/dl (LOW) (33 - 38); TCO2 (MEASURED): 22 mmol/L Flag: Low (23 - 27 mmol/L); Anion Gap: 19 mmol/L Flag: high (8 - 16 mmol/L); Specific gravity Urine (UA): 1.038, Flag: Abnormal (1.000-1.035); Protein Urine: 30mg/dl Flag: Abnormal (Negative mg/dl); Urobilinogen urine: 2EU/DL Flag: Abnormal (Negative EU/DL); Bacteria: Small Flag: Abnormal (None seen/hpf); Urine Clarity:  Slightly Cloudy, Flag: Abnormal (Clear); Blood pressure (BP): 146/100; Pulse: 113; lymphocytes: 4.1 k/ul (high) (1.2 - 3.4)/ 15Sep2021: Lymphocytes Abs: 4.0 1000/ul Flag: High (1.3 - 2.9 1000/ul); monocytes: 1.0 k/ul (high) (0.1 - 0.6)/ monocytes: 0.9 (high) (0.1 - 0.6); eosinophils 0.4 k/ul (high); tonic spasm of muscle; random muscle twitches; Significant tremors; Bilateral hand numbness; Right leg jumping involuntarily/ flailing to BLE; Myoclonic jerks; Right hand felt like electrical shock when squeezed/electrical shock feeling to right hand; convulsions/ seizure; Unable to walk at times; weakness to bilateral lower extremity (BLE); The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on (27Sep2021), this case now contains serious adverse reaction(s). Information processed together.  This is a spontaneous report from a contactable nurse (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in left arm (also reported as left deltoid) on 03Sep2021 at 12:00 (Batch/Lot Number: FC3183) (at the age of 40-years-old) as dose 1, single for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Vaccination facility type was hospital. Medical history included ovarian cyst, insomnia, helicobacter infection (currently treated and discovered after vaccination which patient had before). The patient has no known allergies. Concomitant medications included acetylsalicylic acid (ASPIRIN 81) 81 mg, daily with unknown dates then 325 mg from 01Sep2021 and ongoing for anticoagulant therapy; and trazodone 25 mg as needed with unknown dates, then 50 mg from 23Aug2021 to 01Sep2021 for insomnia. The patient did not receive other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient was tested for COVID post vaccination: Nasal Swab on 08Sep2021 with negative result. On 03Sep2021 at 12:00 PM, the patient experienced myoclonic jerks, right hand felt like electrical shock when squeezed, bilateral hand numbness and right leg jumping involuntarily. The patient also reported that she experienced Tonic spasms on 11Sep2021 at 1pm. Events started as random muscle twitches, then electrical shock feeling to right hand. Significant tremors began which prompted ER trip. Received Ativan. Patient was instructed to see neurologist for appointment coming 29Sep2021. Patient also reported that she experienced Unable to walk at times, weakness to bilateral lower extremity (BLE). Unable to lie flat, supine position causes convulsion and flailing to BLE. Seriousness criteria: Hospitalization, Prolongation of hospitalization. The events resulted in a visit to the Emergency room, doctor or other healthcare professional office/clinic. The patient considered the Pfizer product had a causal effect to the adverse event. MD saw the patient on 14Sep2021 for further evaluation and treatment. The chief complaint was Seizure. Vitals on arrival included Temperature: blank, Blood pressure (BP): 146/100; Pulse: 113; Respiration 18; oxygen saturation (SaO2) 100%; Diagnostics included Electrocardiogram (ECG). Relevant tests on 13Sep2021 included the following: [COMPLETE BLOOD COUNT]: White blood cell count (WBC): 11.0 k/ul (4.0 - 12.5); Red blood cell count (RBC): 4.63 m/ul (4.20 - 5.40); Hemoglobin: 13.8g/dl (12.0 - 16.0); Hematocrit 42.0% (37.0 - 47.0); Mean cell volume (MCV): 91 fl (81 - 99); Mean corpuscular hemoglobin (MCH): 29.8 pg/dl (27.0 -32.0); Mean corpuscular hemoglobin concentration; (MCHC): 33g/dl (33 - 38); Red cell distribution width (RDW) 13.3 % (11.6 - 13.7); Platelet count: 279 k/ul (150 - 400); %neutrophils (%NEUT): 49.9% (40.0 - 74.0); %lymphocytes(%LYMPH): 36.9% (14.0 - 46.0); %monocytes (%MONO): 8.8% (4.0 - 13.0); %eosinophils (%EOS): 4.0% (0.0 - 7.0); %basophils (%BASO): 0.4% (0.0 - 3.0); #neutrophils: 5.5 k/ul (1.4 - 9.8); #lymphocytes: 4.1 k/ul (high) (1.2 - 3.4); #monocytes: 1.0 k/ul (high) (0.1 - 0.6); #eosinophils 0.4 k/ul (high) (0.0 - 0.3); #basophils 0.0 k/ul (0.0 - 0.1).// Lab test: Resulted on 15Sep2021: [URINALYSIS] [Component: Value (Standard Range)]: Color: Yellow (Colorless, Straw, Yellow); Clarity:  Slightly Cloudy, Flag: Abnormal (Clear); Specific gravity Urine (UA): 1.038, Flag: Abnormal (1.000-1.035); Glucose UA: Negative mg/dl (Negative mg/dl); Protein Urine: 30mg/dl Flag: Abnormal (Negative mg/dl); Bilirubin urine: Negative (Negative); Urobilinogen urine: 2EU/DL Flag: Abnormal (Negative EU/DL); PH Urine: 5 (5- 8); Hemoglobin urine: Negative (Negative); Ketone urine: Negative mg/dl (Negative mg/dl); Nitrite urine: Negative (Negative); Leukocyte esterase urine: Negative (Negative); Microscopic needed: YES; WBC urine: 0-5 hpf (None, 0-5/hpf); Blood urine:  1-50 (None seen, 0-1, 1-5/hpf); Epithelial urine: 3-5 (None seen 0-1,2-3, 3-5); Bacteria: Small Flag: Abnormal (None seen/hpf); Urine collection source: Urine clean catch.// Test: Resulted on 15Sep2021 [COMPLETED BLOOD COUNT] [Component: Value (standard range)] White blood cell count: 10.3 1000/ul (4.0 - 11.0 1000/uL); Red blood cell count: 4.42 mill/uL (3.80 - 5.30 mill/uL); Hemoglobin: 13.2 g/dL (12.0 - 16.0 g/dL); Hematocrit: 39.9 % (37.0 - 47.0 %); Mean corpuscular volume: 90 fL (80 - 100 fL); Mean corpuscular hemoglobin concentration: 33.1 g/dL (31.0 - 37.0 g/dL); Red cell distribution width: 13.3 % (12.1 -14.9%); Platelet count: 289 K/uL (150 - 375 K/uL); Mean platelet volume: 10.2fL (6.5-12.0 fL); Neutrophils Abs: 5.1 1000/UL (1.5 - 10.0 1000/UL); Lymphocytes Abs: 4.0 1000/ul Flag: High (1.3 - 2.9 1000/ul); Monocytes Abs: 0.8 1000/ul (0.1 - 1.0 1000/ul); Eosinophils Abs: (0.3 1000/ul) (0.0 - 0.7 1000/UL); Basophils Abs: 0.1 1000/UL (0.0 - 0.1 1000/UL); neutrophils %: 50 % (44 - 81 %); Lymphocytes %: 39 % (21 - 47 %); Monocytes %: 8 % (2 - 11 %); Eosinophils %: 3 % (0 - 7 %); Basophils %: 1 % (0 - 1 %); Nucleated red blood cells (NRBCs): 0.0 /100 WBCs  (0.0 - 0.0 /100 WBCs); Immature Granulocytes: 0.4 % (0.0 - 0.6 %); Immature Grans (Abs) 0.04 1000/ul (0.00 - 0.09 1000/ul).// Lab test: Resulted on 16Sep2021: Component results by Clinical point of care (POC) [Test: Value (standard range & unit)] Glucose: 102mg/dl (70 - 110mg/dL); BUN: 8 mg/dL (6 - 30 mg/dL); Creatinine: 0.7 mg/dL (0.5 - 1.4 mg/dL); Sodium: 143 mmol/L (136 - 145 mmol/L); Potassium: 3.8 mmol/L (3.5 - 5.1 mmol/L); Chloride: 106 mmol/L (95 - 110 mmol/L); TCO2 (MEASURED): 22 mmol/L Flag: Low (23 - 27 mmol/L); Sodium: 143 mmol/L (136 - 145 mmol/L); Anion Gap: 19 mmol/L Flag: high (8 - 16 mmol/L); Hematocrit: 45 %PCV (36 - 54 %PCV); HEMOGLOBIN: 15 g/dL.// Lab test: Resulted on 21Sep2021: COMPREHENSIVE METABOLIC PANEL: [Test: value (low - high)] Sodium: 139mEq/L (136 - 145); Potassium: 4.8 (3.5 - 5.1); Chloride: 103 mEq/L (98 - 107); CO2: 31 mEq/L (21 - 31); Anion gap: 10 (5 - 15); Glucose: 83 mg/dL (70 - 105); Blood urea nitrogen (BUN): 10 mg/dL (7 - 17); Creatinine 0.70 mg/dL (0.60 - 1.20); BUN/Creatinine: 0.70 (6 - 25); Total protein 6.5 g/dL (6.4 - 8.9); Albumin 4.3 g/dL (3.5 - 5.7); Globulin: 2g/dL (2 - 4); Albumin/Globulin ratio 2.2 (HIGH) (0.8 - 2.0); Calcium: 9.8 mg/dL (8.6 - 10.3); Total Bilirubin: 0.3 mg/dL (0.3 - 1.0); Alkaline phosphatase: 50 IU/L (34 - 104); Aspartate transaminase (SGOT/AST): 14 IU/L (13 - 39); Alanine transaminase (SGPT/ALT): 18 IU/L (7 - 52); Non-Estimated Glomerular Filtration Rate (NON-AA-GFR) 99ml/min; Estimated Glomerular Filtration Rate (AA-GFR) 119 ml/min. // Test: Resulted on 21Sep2021 [COMPLETED BLOOD COUNT] [Test: value (low - high)] White blood cell count: 10.1k/ul (4.0 - 12.5); Red blood cell counts 4.61 m/ul (4.20 - 5.40); Hemoglobin: 13.7g/dl (12.0 - 16.0); Hematocrit 42.7% (37.0 - 47.0); Mean cell volume (MCV) 93 fl (81 - 99); Mean corpuscular hemoglobin (MCH): 29.7 pg/dl (27.0 - 32.0); Mean corpuscular hemoglobin concentration: 32g/dl (LOW) (33 - 38); Red cell distribution width (RDW) 13.3 % (11.6 - 13.7); Platelet count: 317 k/ul (150 - 400); %neutrophils (%neu): 56.0% (40.0 - 74.0); %lymphocytes(%leu) 31.5% (14.0 - 46.0); %monocytes (%mono) 8.7% (4.0 - 13.0); %eosinophils (%eos) 3.4% (0.0 - 7.0); %basophils (%baso) 0.4% (0.0 - 3.0); #neutrophils: 5.7 k/ul (1.4 - 9.8); #lymphocytes: 3.2 k/ul (1.2 - 3.4); #monocytes: 0.9 (high) (0.1 - 0.6); #eosinophils 0.3 (0.0 - 0.3) and #basophils 0.0 k/ul (high) (0.0 - 0.1). Other orders included the following: Medications: Ativan (Lorazepam) 1mg IV, Ativan (Lorazepam) 2mg IV, Benadryl (Diphenhydramine) 50mg IV. Procedures: None. The discharge diagnosis was tonic spasm of muscle. Discharge medication was Ativan (Lorazepam) 1mg. The disposition upon discharge was in good condition, stable condition, sent to home. The outcome of all events was not recovered, except for Eosinophil count increased which was recovered on 21Sep2021, and other abnormal lab values which was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Considering a temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported Tonic clonic movements,myoclonus, muscle twitching, seizure, electric shock sensation and tremor cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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