Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin disorder, Weight decreased
Clinical narrative: cardiac enzymes were extremely elevated; Weight from 223 pounds to 211 pounds in 2 months; No appetite; Sleep pattern is bad/she cannot fall asleep until 0400 and then wakes right back up around 0800; Feels rough with fine bumps at times; Feels rough with fine bumps at times; Itches at times; Rash on outer aspect of arm; Tightness, uneasiness in chest; Palpitations, Fluttering in Chest; Palpitations, Fluttering in Chest; Easily Winded; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose on 16Mar2021 (Batch/Lot Number: EN6207; Expiration Date: 31Jul2021), then the second dose on 07Apr2021 (Batch/Lot Number: ER8730; Expiration Date: 31Jul2021), both via an unspecified route of administration, at the age of 67-years-old, administered in arm left as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from 2002 and ongoing, ongoing diabetes mellitus, penicillin allergy from an unknown date and unknown if ongoing, became really sick, really fast, uncertain if was Covid 19 from Feb2020 to an unknown date and chest discomfort from an unknown date and unknown if ongoing. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)), glyceryl trinitrate (NITROGLYCERIN), both taken for chest discomfort; dulaglutide (TRULICITY) taken for an unspecified indication, all from an unspecified start date and ongoing. The patient previously took morphine and codeine and experienced drug allergy. The patient was at her eye doctor on 02Apr2021 and decided afterwards to have her grandson take her to the Emergency Room (ER) for some tightening and uneasiness she had been having in her chest over the preceding days. She also felt some palpitations, they were fast, then slowed down; did not feel labored. She went to the ER and was there for 8 hours. They told her that her cardiac enzymes were extremely elevated.  After the cardiologist reviewed her results she was allowed to go home. She went to her regular cardiologist on 05Apr2021. That cardiologist went over her tests results and said that while it was not normal results for her he didn't find them too worrisome. He stated that just because her enzymes are elevated does not mean she is in trouble. He scheduled her for a Dobutamine Stress Test on 07Apr2021. She has been trying to get the results of this stress test from the doctor's office but has not been successful in doing so. Says that once she completed the Stress Test on 07Apr2021 she went to get her second dose of the Covid Vaccine. She was still having her symptoms when she got her second vaccine and they have continued since. She saw her endocrinologist who went over blood work with her. The endocrinologist told her that her blood glucose level was very good and her A1c was a 5.5.  The endocrinologist was concerned because usually the A1c is between 6 and 7. Patient was 5 foot 6- and one-half inches. Tightness, Uneasiness in chest:  Stated it is not pain, just an uneasy, uncomfortable, fluttering feeling. Palpitations, Fluttering in chest:  Not a labored feeling, goes fast, then slows down, not constant. Rash on outer aspect of arm: Extends from her wrist to about 2-3 inches below her elbow. Outside of arm, not on the inner part of her arm. Feels rough with fine bumps at times; then will feel smooth again. Itches at times. She uses calamine lotion, which does help to relieve the itching and smooth the skin. Stated it eventually does come back though. Easily Winded: She has had respiratory conditions all of her life. This winded feeling, she has been having is different than that she stated. She gets the fast heartbeat really quick, can almost hear it; becomes winded and sits down. The episodes last about 15 minutes. She has had no appetite; she has lost almost 15 pounds in 2 months. Her weight was 223 pounds 2 months ago and now weighs 211 pounds. She mentioned her sleep pattern is bad.  Some days she cannot fall asleep until 0400 and then wakes right back up around 0800. The patient underwent lab tests and procedures which included blood glucose: 100 on 22Apr2021, blood pressure measurement: 128/62 on 21Apr2021, body temperature: 97 degrees fahrenheit on 21Apr2021, haemoglobin: 5.5 on Apr2021, heart rate: 78 on 21Apr2021, myocardial necrosis marker: extremely elevated on 02Apr2021, oxygen saturation: 98 % on 21Apr2021. Therapeutic measures were taken as a result of rash on outer aspect of arm, Feels rough with fine bumps at times and Itches at times. The outcome of the events Itches at times, Feels rough with fine bumps at times, Rash on outer aspect of arm, Easily Winded was not recovered; Palpitations, Fluttering in Chest and Tightness, uneasiness in chest was recovering, while of the rest was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between the suspect drug and the events cannot be excluded.  This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.