Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Computerised tomogram normal, Electrocardiogram normal, Fatigue, Feeling abnormal
Clinical narrative: forceful beat feeling in her chest/she was really uncomfortable in her chest, the force was the most uncomfortable at this point; seemed like UTI symptoms were coming back; felt really wiped out and worn down/tired; anxiety; racing/ pounding in chest; potassium was a little low; elevated blood pressure; arm a little bit sore; 99.1 degrees Fahrenheit fever; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685), via intramuscular on 28Dec2020 07:15 at single dose on deltoid left for COVID-19 immunisation.  Medical history included hepatitis C which cleared in 2016, hysterectomy was done in 2004 or 2005, cyst removed from breast long ago, ongoing arthritis in left knee, urinary tract infection was treated in Nov2020. The patient's concomitant medications were not reported. She received the first vaccine on 28Dec2020. She did fine that day. She came home and laid down and rested. Her temperature went up to 99.1 degrees Fahrenheit but was resolved that same day/night. Early in the morning on 29Dec2020, around 3:30 a.m., she woke up and had a racing/pounding feeling in her chest. She took her blood pressure and it was 158/86, heart rate (HR) was 83. She felt really funny. She hadn't been diagnosed with high blood pressure before, so this was high for her. She took her blood pressure again about an hour later and it was 165/95, HR 73. She took it again about an hour later and her blood pressure read 180/98, HR 77. Her heart rate stayed in the normal range, but the force felt really strong. She did go to the emergency room around 5:00 am on 29Dec2020. She told them what she was experiencing and that she had received the COVID-19 vaccine. About the time she got to the hospital, her blood pressure was starting to come down. An EKG was done and they drew bloodwork. Her potassium came back a little low-they didn't tell her how low or what her level was. She was given 2 potassium tablets which did help. She confirms she doesn't have any NDC, Lot number or expiration date for the potassium she was given. It was given to her at the hospital. She was also given a sheet to monitor her salt intake, which she already does that. She confirmed she was not admitted into the hospital, she was discharged from the Emergency Room. She felt pretty good. She didn't go to work that Wednesday, 30Dec2020, but she went to work on Thursday, 31Dec2020. On 01Jan2021, the same thing happened to her again. She had elevated blood pressure, forceful beat. She went back to the ER early in the morning, around 5:00 am, on 01Jan2021. Her pulse stayed within normal range, but she had such a forceful beat. She informed them that she was really uncomfortable in her chest, the force was the most uncomfortable at this point. They wanted to make sure she wasn't have a stroke or heart attack, so they did their normal procedures to rule this out. They did 2 EKG's, 2 sets of labs, Chest X-ray, CAT scan and everything came back normal. She had a discussion with the physician that saw her about what she was experiencing and the physician was asking her about having anxiety. Caller explains she has never really had problems with anxiety before, but she can't say she hasn't had it. Being around COVID patients and getting the shot, sometimes anxiety can be there. The physician wanted her to try a low dose of Hydrochlorothiazide 12.5mg. She was to only to take a half dose by mouth, if her top number (systolic blood pressure) was between 140-160. Caller clarifies when she means half of a dose, the dose equals 12.5mg. She was instructed to take this 12.5mg dose until she saw her PCP. So, she did this and called her PCP and wasn't able to get an appointment to speak with a provider until the following Wednesday, 06Jan2021. She did a tele visit with her provider and let her know what had happened and that the half of the pill will only bring her top number (systolic blood pressure) to 130's-140's. Caller states she was used to her top number (systolic) being maybe in the 120's, low 130's. Her doctor increased her dose to 25mg. She was prescribed to take 25mg, tablet, by mouth, once a day. She confirmed she still checks her blood pressure before she takes the medicine. Caller verifies she has 2 bottles, one being the 12.5mg dose and the second being the 25mg dose. With the 12.5mg bottle, she sees refills and the date 05Jan2022. Caller clarifies both bottles are dispensed in pharmacy vials with no NDC, Lot number or expiry date. About a month prior to all of this and receiving the COVID-19 vaccine, clarified as Nov2020, she was treated for a UTI. During that time, her blood pressure went up a little and kind of bounced around a little bit, but came back down. Then, she got the COVID-19 shot. She initially felt fine but later on by the time she got a chance to do the tele visit with her PCP, she was telling her about her previous UTI, and the provider put her on Cipro because it seemed like her UTI symptoms were coming back. Caller verifies she doesn't have any NDC, Lot number or expiration for the Cipro. She already took of all of that. She went to the ER for the third time on 08Jan2021 because she again felt the forceful beat feeling in her chest. She explained she felt really wiped out and worn down and she was tired. An EKG was done and they did labs. She confirms she doesn't have any results with her at this time. She was taken off of work for a couple of weeks. She is currently getting in contact with a Cardiologist to make sure everything is alright. The cardiologist wants her to have a stress test. The caller states so this is where she is now. She is taking blood pressure medicine and getting set up to do a stress test. Sore arm outcome: Caller confirms she recovered from the arm soreness within that same day. Her arm didn't stay sore long at all. Racing/pounding in chest: This had improved. It's not like it was. She still has it a little bit of it now, but she is going to see her cardiologist and do a stress test. The blood pressure medicine has helped some. Elevated blood pressure: Today her blood pressure top number got to 161 and she had to take medication but her blood pressure has improved. Outcome of elevated blood pressure, racing/ pounding in chest was resolving; outcome of forceful beat feeling in her chest, UTI, potassium was a little low, felt really wiped out and worn down/tired, anxiety was unknown; outcome of arm a little bit sore, 99.1 degrees Fahrenheit fever was resolved on 28Dec2020.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be 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.