Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dry mouth, Fatigue, Headache, Heart rate, Malaise
Clinical narrative: palpitations; syncope; Hypothyroidism; fast heartbeat beat, 150 bpm; blood pressure is up and down; hot flashes; chills; weakness; unable to do her job; Shaking all over; allergic reactions; I'm sick; feeling dizzy; ringing in my ear; an urgency to urinate; dry mouth; headache; feel unwell; exhausted; shortness of breath; lightheaded; Heartburn; Hypercholesterolemia; Migraine; Osteopenia; Raynaud's phenomenon; Thyroid nodule; Positive antinuclear antibody; Tachycardia; pain; Chest Pain; Itching; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via intramuscular route, administered in Arm Right on 08Mar2021 (Lot Number was ENG199) as single dose for covid-19 immunisation. Medical history included thyroid disorder, caesarean section, shoulder operation. Concomitant medications included levothyroxine (LEVOTHYROXINE) 50ug tablet taken daily from 08Feb2021 via oral route; rosuvastatin (ROSUVASTATIN) 5mg tablet every night via oral route; cholecalciferol (CHOLECALCIFEROL) tablet 25ug, 1x/day via oral route; metoprolol succinate (METOPROLOL SUCCINATE) tablet 50mg, 1x/day via oral route from 17Mar2021.  On 15Apr2021 the patient experienced palpitations and on an unspecified date had syncope, hypothyroidism , fast heartbeat, 150 bpm, blood pressure is up and down, hot flashes, chills, weakness , unable to do her job, shaking all over, allergic reactions , I'm sick, feeling dizzy, ringing in my ear, an urgency to urinate, dry mouth, headache, feel unwell, exhausted, shortness of breath, lightheaded. heartburn, Hypercholesterolemia, Migraine, Osteopenia, Raynaud's phenomenon, thyroid nodule, positive antinuclear antibody, tachycardia, pain, chest pain, and itching. The patient underwent lab tests and procedures which included alanine aminotransferase: 23 on 09Mar2021 (12 - 78 U/L), anion gap: 7 mmol/l on 09Mar2021 (2- 12mmol/L) , anion gap: 7 mmol/l on 15Mar2021 (2 - 12 mmol/L) , arrhythmia supraventricular: 99 on 09Mar2021, arrhythmia supraventricular: 86 on 10Mar2021, arrhythmia supraventricular: 101 on 13Mar2021 , arrhythmia supraventricular: 120 bpm on 15Mar2021 , aspartate aminotransferase: 22 on 09Mar2021 (15 - 37 U/L) , basophil count: 0.1 on 09Mar2021 (0.0 - 0.2 x10(3)/ul ), basophil count: 1.0 % on 09Mar2021, bilirubin urine: negative on 09Mar2021 Negative , bilirubin urine: negative on 15Mar2021 Negative , blood albumin: 3.7 g/dl on 09Mar2021 (3.4 - 5.0 g/dL) , blood alkaline phosphatase: 71 on 09Mar2021 (45 - 117 U/L) , blood calcium: 8.7 mg/dl on 09Mar2021 (0.55 - 1.30 mg/dL). Event outcome for Palpitations was not recovered and for all other events outcome was unknown.  Follow-up (24Mar2021): This is a follow-up Spontaneous report from a contactable consumer, events were added (fast heartbeat, shaking all over). Follow-up (24Mar2021): This is a follow-up Spontaneous report from a contactable consumer (patient) reported that, added Patient characteristics and events were added. When probed for adverse reactions, Consumer stated, That's allergic reactions and right now had 3 or more reactions every 2 days and also spiked in blood pressure, she have been to primary care physician and nobody can help her. Consumer stated experiencing adverse reactions and she don't know allergic reactions or not but it does look like allergic reactions. Due date of second shot of vaccination was on Monday, and she not capable to do anything now.  Follow-up (15Apr2021): This is a follow-up Spontaneous report from a contactable consumer (patient) reported that, she got the first dose on 08Mar2021 and got sick since then. she had been in the emergency room three times and had three visits with doctors, and they cannot help her, had allergic reactions, not anaphylaxis, hot flashes right after the vaccine. And then palpitations, change in blood pressure, feeling dizzy and feeling shaky that last a couple hours. Got chills and then felt sick. she going to see her primary care physician again.  Follow-up (15Apr2021): This is a follow-up Spontaneous report from a contactable consumer. This consumer reported for a patient that: consumer confirmed the information about the emergency was already reported and there is no new information to report he just wanted to add the contact information for the patient.  Follow-up (16Apr2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: It starts suddenly (not every day), but usually after breakfast. I either feel first something strange (like a dizziness, ringing in my ear, etc) in my head, and then I feel (and can see on my personal wellness tracker) my heart is racing up. It might go down fast enough and then come back or not. After the spike in heart rate, I also have "dry flushes" through my body, a bowel movement, an urgency to urinate, dry mouth, and feel very shaky (should walk very careful to a restroom). I might feel very dizzy or feel a strong headache, it depends. In the beginning, I was shaking and shivering sitting, but not during the return of the events on Monday. Heart rate goes down in 5 minutes to half an hour (though it's down to an elevated plato, not to my normal rate), but I feel unwell and cannot do much for a few hours. Then it's like a switch, and I am back to normal, but quite exhausted. I have no clue what it is, but it feels like a hormone is released in my body, but this is just a guess. This report is for documentation purposes only. The patient should not follow medication instructions within. For accurate instructions regarding medications, the patient should instead consult their physician or after visit summary, Sinus tachy rhythm. Nonspecific ST change. QRS narrow. No ectopy. EKG interpretation and visualization done by me, (name) MD, the ED attending in the absence of a cardiologist,I saw and evaluated this patient. I agree with the reported history, physical exam, and plan of action that has been implemented by the pa/np who evaluated the patient- (name withheld), md Saw this patient recently. She is been here multiple times concerned about a reaction to the Covid vaccine. She states she has been having palpitations. She was admitted, evaluated by cardiology and instructed to follow-up outpatient to receive a Holter monitor which she has not done. Here she is very adamant that we call Pfizer and let them know about her reaction. We have advised her we will not be able to call Pfizer but because she is unable to follow-up outpatient for the Holter monitor she will be admitted at this time. Patient is a 61 y.o. female with h/o below came to the ED for persistent palpitations after getting Pfizer vaccine on 08Mar2021. She developed palpitations shortly after getting the vaccine with hot flushes, She was admitted, cardiology Consulted and she had an echo which was normal. CTA was neg for PE. She is to have OP f/u for stress test and event monitor which she states its scheduled in Apr2021. She saw her PCP on thurs and she was prescribed metoprolol and steroids. She states she took Metoprolol x 1 dose only and never started steroids. She was back in the ED on Sat, but was discharged home. In the mean time she is still getting palpitations, she states they "cycle" getting worse every 48 hours. She reports her HR was in the 170s today and she came back to the ED for evaluation. She denies CP, dizziness, n/v/d. Cardiology consulted. CT head without contrast Indications: Dizziness, shortness of breath status post first Covid vaccine 5 days ago No comparison. Technique: Serial axial images of the brain obtained without contrast. Sagittal and coronal reconstructions also provided. Dose lowering technique(s) such as automated exposure control, iterative reconstruction, mA and/or KV adjustment for patient's size was utilized for this examination. Findings: Brain parenchyma normal for patient's age. There is no evidence of acute infarction, mass or haemorrhage. Posterior fossa and brainstem are normal. No skull fractures.  CTA chest with and without contrast Indications: Dizziness after first Covid vaccine 5 days ago, light-headedness, palpitations and high blood pressure Comparison: Chest x-ray 13Mar2021 at 1047 hours Pre- and post-contrast, axial and reconstructed coronal and MIP images obtained. 80 cc Omnipaque 300 IV. Dose lowering technique(s) such as automated exposure control, iterative reconstruction, mA and/or KV adjustment for patient's size was utilized for this examination. Thoracic aorta normal in appearance. Normal heart size. No pericardial or pleural effusion. No adrenal nodule. No axillary, mediastinal or hilar adenopathy. No PE. No pneumothorax, infiltrate or suspicious bony nodule. Impression:  1. Negative exam. Dictated on: 13Mar2021 2:09 pm Signed by: (name), M.D. 13Mar2021 2:11 PM Ct Angiogram Chest W WO Contrast. Result Date: 09Mar2021  CT Angio Chest With Contrast , History: Evaluate for pulmonary embolism. Comparison: 09Mar2021 Technique: Images obtained following the administration of IV contrast. Coronal and 3-D reconstructions generated. Dose lowering technique(s) such as automated exposure control, iterative reconstruction, and mA and/or KV adjustment for patient size was utilized for this exam. Contrast: 80mL Omnipaque 300 Findings: Thoracic inlet: Normal appearance. Mediastinum: No evidence of mediastinal or hilar adenopathy. Pleura and pericardium: No pleural or pericardial effusion present. Vascular: Negative for aortic aneurysm, aortic dissection, and acute pulmonary embolism. Lungs: No infiltrates or masses. Osseous/chest wall: No significant or acute abnormality. Impression: Negative for acute pulmonary embolism. Dictated on: 09Mar2021 5:37 PM Signed by: (name), M.D. 09Mar2021 5:38 pm Chest one view Indications: Lightheaded, palpitations, difficulty breathing status post Covid vaccine 5 days ago Comparison: CTA chest 09mar2021 Findings: The lungs are clear of acute infiltrate. Heart size is normal for a single view chest. The bones and soft tissues are normal for the patient's age Impression: Normal one-view chest x-ray. Dictated on: 13Mar2021 11:08 AM Signed by: (name), M.D. 13Mar2021 11:08 AM Procedure: XR chest 1 view indication: pain. Lightheaded, palpitations, syncope. Comparison: None. Findings: The heart is normal in size and contour. The trachea is midline. There is no effusion, pneumothorax or focal airspace consolidation. No acute osseous abnormality. Impression: 1. No acute radiographic abnormality demonstrated. Dictated on: 09Mar2021 4:01 PM Signed by: (name), MD 09Mar2021 4:02 PM, ECHO COMP Patient (Last, First, Middle): (name), Gender: Female Patient ID: # Account Number: # Date of Birth: (withheld) Age: 61 Procedure Date: 10Mar2021 Procedure Type: ECHO COMP Hospital(name) Height: 165.10 cm Weight: 72.58 kg BSA: 1.80 m2 Heart Rate: 82.00 bpm BP: 129.00 / 86.00 mmHg Sonographer: (name), RDCS Referring MD: (name), CRNP Cardiologist: (name), M.D. Indications:  Chest Pain Procedures: Complete Study (2-D, M-Mode, Color Doppler, Spectral Doppler)  Conclusions:  -Normal left ventricular size, thickness, systolic function, and wall motion.  -The visually estimated ejection fraction is between 60-64%.  -There is trace mitral valve regurgitation.  -There is no evidence of pericardial effusion.  -There is no evidence of pulmonary hypertension. Findings: Procedure Information The quality of the study was optimal. Left Ventricle Normal left ventricular size, thickness, systolic function, and wall motion. The visually estimated ejection fraction is between 60-64%. Normal left ventricular mass. Right Ventricle Normal right ventricular cavity size, wall thickness, and systolic function. The Tricuspid Annular Plane Systolic Excursion is 2.34 cm. The Right Ventricular Base is 2.58 cm. Atria Left atrium is normal in size. Right atrium is normal in size. The left atrium has a volume/index of 18.57. The right atrium has a volume/index of 12.20. Aortic Valve Normal aortic valve structure and function. There is no aortic valve stenosis. There is no aortic valve regurgitation. Mitral Valve Normal mitral valve structure and function. There is trace mitral valve regurgitation. Pulmonic Valve The pulmonic valve was not well visualized. There is trace pulmonic valve regurgitation. Tricuspid Valve Normal tricuspid valve structure and function. There is trace tricuspid valve regurgitation. There is no evidence of pulmonary hypertension. Great Vessels All visible segments of the aorta are normal in size. Venous The inferior vena cava is normal in size and collapses greater than 50% with inspiration. Pericardium/Pleural There is no evidence of pericardial effusion. There is no pleural effusion, is no pleural effusion.  Measurements M-Mode Linear Measurements Normals  -Women/Men Ao Root: 2.70cm 2.0-3.8 LA Diam: 2.80cm 2.7- 3.8/3.0-4.0 LAIDs Index: 1.56cm/m2 1.2-2.2 AOV Cusps: 1.50cm 1.5-2.6 2D Linear Measurements Normals - Women/Men IVSd: 0.76cm 0.6-0.9/0.6-1.0 LVIDd: 4.44cm 3.9-5.3/4.2-5.9 LVIDd Index: 2.47cm/m2 2.4-3.2/2.2-3.1 LVIDs: 2.93cm 2.0-3.6 LVPWd: 0.67cm 0.7-1.1 LV Mass: 95.97g 67-162/88-224 LV Mass Index: 53.32g/m2 43-95/49-115 LVOT Diam: 2.00cm 3.0+(-)1.3 RV Mid: 1.56cm RV Base: 2.58cm RV Length: 5.36cm 2D Volumes Normals - Women/Men LV SV: 56.6ml LV EDV: 89.6ml 56-104/67-155 LV ESV: 33ml 19-49/22-58 LA Vol: 33.8ml LA Vol Index: 18.57 RA ESV A/L: 12.20ml/m2 19-21 2D  Systolic Function Normals  -Women/Men EF Teich: 63.20% >55 FS: 34.00% 27-45/25-43 EF 4C: 63.50% >55 EF 2C: 62.50% >55 EF BiP: 63.10% >55 Mitral Valve MV Pk E: 56.60cm/s MV PK A: 70.80cm/s MV Decel Time: 266.00msec E/A: 0.80 ELateral: 8.45cm/s E Medial: 6.95cm/s E/E' Med: 8.10 E/E Lat: 6.70 PHT: 78.00msec MVA PHT: 2.82cm2 Decel Slope: 2.13m/s2 Aortic Valve AoV Pk Vel: 141.00cm/s AoV Mn Vel: 88.90cm/s AoV VTI: 27.60cm AoV Pk Grad: 8.00mmHg Aov Mn Grad: 4.00mmHg AVA Cont.VTI: 2.64cm2 Doppler Vel Index: 0.87 LVOT LVOT Pk Vel: 123.00cm/s LVOT Mn Vel: 77.20cm/s LVOT VTI: 23.20cm LVOT Pk Grad: 6.00mmHg LVOT Mn Grad: 3.00mmHg LVOT Diam: 2.00cm LVOT Area: 3.14cm2 Diastolic Function MV Pk E: 56.60cm/s MV Pk A: 70.80cm/s E/A: 0.80 E'Medial: 6.95cm/s E/E' Med: 8.10 E' Lateral: 8.45cm/s E/E' Lat: 6.70 IVC Diam Exp: 1.88cm Right Ventricle TAPSE: 2.34cm Tricuspid Valve TR Pk Vel: 162.00cm/s TR Pk Grad: 10.00mmHg RA Press: 3.00mmHg RVSP: 10.00mmHg IVC Diam Exp: 1.88cm  Patient is convinced that she has had an allergic reaction to COVID-19 vaccine. Is insisting to be evaluated for that. Patient was explained plan of care in this admission. That patient will be observed for 24 hours and potential discharge on beta-blocker with outpatient event monitor. Patient got quite upset. Patient is insisting to be worked up for Covid allergy. Patient had recently stopped crying at her PCPs office with her concerns for allergic reaction to Covid. She was given a prescription of steroids per earlier notes. Patient acknowledges not actually taking steroids. Patient is not agreeable to being discharged when cleared by cardiologist. Explained her rest of the work-up would need to be done outpatient to which she gets annoyed. Patient then got her husband on the phone and the plan was discussed with patient's husband on the speaker phone. Also want Pfizer to be reached out to inform of patient's reaction. Have agreed with the couple to call Pfizer's hotline and to notify of patient's complaints Hospital Course:  61 yrs female admitted with palpitations and flushing since getting the Covid 19 Vaccine on 3/8.. She was prescribed metoprolol and a short course of steroids by her pcp for symptomatic relief which patient took 1 dose of metoprolol and did not start steroids. She came to the ED due to her symptoms, Her main concern was why did she react to the Vaccine., and wanted answers Cardiology was consulted, EKG shows ST no acute st changes, troponins neg, D dimer was elevated CTA was neg for PE. TSH was elevated, T4 WNL, 2D echo done LVEF 60-64%. HR now 90-107 bpm. Patient was started on metoprolol XL 25 mg daily, increased at DC to 50 mg daily . Patient was advised to report palpitations and flushing to Pfizer as a side effect/adverse reaction, take metoprolol as prescribed and f/u with Cardiology and PCP in 1 week. Patient and her husband still concerned about why she is having reaction to the vaccine and felt that the question remains unanswered Current Facility-Administered Medications: acetaminophen (TYLENOL) tablet 650 mg, 650 mg, oral, q4h PRN, 650 mg at 10Mar2021 0850 OR acetaminophen (TYLENOL) 325 mg/10.15 mL solution 650 mg, 650 mg, oral, q4h PRN OR acetaminophen (TYLENOL) suppository 650 mg, 650 mg, rectal, q4h PRN, (name), NP enoxaparin (LOVENOX) syringe 40 mg, 40 mg, subcutaneous, q24h, (name), NP, 40 mg at 09Mar2021 1807 levothyroxine (SYNTHROID) tablet 50 mcg, 50 mcg, oral, Daily, (name), NP, 50 mcg at 10Mar2021 0836 [COMPLETED] Insert peripheral IV,  Once AND lidocaine (XYLOCAINE) 10 mg/mL (1 %) injection 5 mg, 0.5 mL, subcutaneous, Once PRN and Maintain IV access, Until discontinued and Saline lock IV, Once and sodium chloride 0.9 % (flush) injection 1 mL, 1 mL, intravenous, q8h PRN, (name), NP magnesium sulfate IVPB 2 g, 2 g, intravenous, q1h PRN, (name), potassium chloride (KLOR-CON) ER tablet 40 mEq, 40 mEq, oral, PRN, 40 mEq at 10Mar2021 0006 OR potassium chloride 20 mEq/15 mL solution 40 mEq, 40 mEq, oral, PRN, (name), NP potassium chloride 10 mEq/100 mL IVPB 10 mEq, 10 mEq, intravenous, q1h PRN OR potassium chloride 10 mEq/100 mL IVPB 20 mEq, 20 mEq, intravenous, q1h PRN, (name), NP rosuvastatin (CRESTOR) tablet 5 mg, 5 mg, oral, QHS, (name), NP, 5 mg at 09Mar2021 2348 Issues Requiring Follow-Up F/u Cardiology 1 week F/u pcp 1 week Outpatient Follow-Up No future appointments. Review of Systems Constitutional: Negative for fatigue and fever. HENT: Negative. Eyes: Negative for visual disturbance. Respiratory: Negative for chest tightness and shortness of breath. Cardiovascular: Positive for palpitations. Negative for chest pain and leg swelling. Gastrointestinal: Negative for abdominal pain. Genitourinary: Negative for flank pain. Musculoskeletal: Negative for back pain. Neurological: Positive for dizziness. Negative for seizures, syncope, weakness and numbness. Psychiatric/Behavioral: Negative for confusion, Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic. Nose: Nose normal. Eyes: Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Musculoskeletal: General: Normal range of motion. Cervical back: Normal range of motion. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal