Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Electrocardiogram, Feeling abnormal, Feeling hot, Heart rate, Hypoaesthesia
Clinical narrative: She said they took her blood pressure and it read 180/100.; She felt so odd; She said she noticed that the numbness in her left toes crept up a bit to her ankle on one leg.; Lightheaded/ dizzy; Left arm soreness at injection site; Felt a warm sensation; She said there were numbing and tingling sensations/  gets tingling feeling in feet; A few days later, she felt lightheaded and had motion sickness.; Pulse rate was at 114.; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FA6780, Expiry date: not reported), via intramuscular route of administration in left arm on 13Aug2021 12:00 (at age of 67-years-old) as dose 1, single for covid-19 immunization; rosuvastatin (ROSUVASTATIN), oral from 18Aug2021 (Batch/Lot number was not reported) to an unspecified date, at 10 mg, daily for high cholesterol. Medical history included cardiac disorder from an unknown date and unknown if ongoing Family had heart troubles and they wanted to make sure she was ok and she was. Other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional vaccines administered on same date of the bnt162b2 suspect were none. The patient had not received any other vaccine within 4 weeks. On 13Aug2021, she said she noticed that the numbness in her left toes crept up a bit to her ankle on one leg, lightheaded/ dizzy (onset time: 14:00 -15:00), left arm soreness at injection site (onset time: 17:00- 18:00). On 18Aug2021 at 16:00, the patient said they took her blood pressure and it read 180/100 (serious, medically significant). On the same day, she felt so odd. On an unspecified date in Aug2021, a few days later, she felt lightheaded and had motion sickness, pulse rate was at 114, felt a warm sensation, she said there were numbing and tingling sensations/ gets tingling feeling in feet. The reporter stated that the patient experienced some symptoms after receiving 1st dose of the bnt162b2 vaccine on 13Aug2021. After receiving first dose, the patient felt lightheaded and then an hour or two later, her right foot on small toes started to feel odd and the patient felt a numbing and tingling sensation on them. A few days later, the patient felt lightheaded and had motion sickness. Five days after 1st dose, she felt odd and went to doctor and had blood pressure checked, and it was 180/100. Doctor's tried to bring it down with a medication, but in the end, it read 180/98 and her pulse rate was 114. She felt dizzy. She was sent to the ER and was just given fluid IV and sent home. She also mentioned it took 2 weeks to get her blood pressure back to normal and also said numbness in left toes crept up a bit to the ankle in one leg. She is taking Rosuvastatin, a cholesterol medication, but stopped before receiving first dose. She also said it has already on Friday, will be 5 weeks since her first dose. Patient clarified information above. The patient had not started the Rosuvastatin yet when she started first shot. It was prescribed, but the patient did not want to start it and wanted to be sure it would not cause any problems with the vaccine. The patient did not start it until 1 week after receiving the first dose of the vaccine. Now, the patient had stopped taking it again. It seemed like numbness and tingling was creeping up leg and yesterday, it went all the way up left leg. The patient called and they told her to stop taking it in case it was that. She was not sure it was related or not. They thought lightheadedness may be anxiety about getting shot. She noticed it within that 5 days period. Once she got her blood pressure back to normal state, it dissipated. Right foot small toes felt numb and tingly. This started an hour or two after she got home. She also felt a warm sensation when she put her foot on the cold floor. The warmth went away but the strange feeling was still there today. The other foot has started doing the same thing and actually yesterday was the worst it ever was. On the left side, it went all the way up leg where it felt tingly and it dissipated and just left her feeling the sensation in toes. She just gets tingling feeling in feet and at night time it gets better. She does not have a history of high blood pressure. It was on the 5th day that her blood pressure was 180.100. That is when it was checked. It took 2 weeks. They did not medicate her, but within 2 weeks, now her blood pressure is back to normal. They gave her a little Clonidine and an Aspiring and it did not take it down. She does not have the dose of the Clonidine or the lot or the expiration. It was very mild amount. It did not say on her paper. It just said 1 Clonidine was given. She thinks they only gave her a half of one. She does not know the normal dose. She does not have a lot or expiration for the Clonidine because she received it at the doctor's office. They gave her the bottle of Aspirin. It was the Low dose aspirin, 81mg. Unknown lot and expiration. She does not know if they were sealed and intact. They gave her the bottle and it was 81 mg low dose. Count size 32 tablets. he does not know if it was sealed. They were in a big hurry to give it to her. A few hours later and by the night her injection site arm was the sorest, and by the next day it was gone. She was overdue to get second one and Friday, they were going to get second one, which was the 5th week. She thought you are supposed to get it no longer than 6 weeks. She said the previous agent told her that the CDC said you should get second dose within 6 weeks of first dose. She is supposed to go this Friday and had all these concerns, so she wanted to know if it was safe to do so. That is why she called and talked to previous agent. Visit to emergency room for blood pressure and increased heart on 18Aug2021. Gave IV fluids and released with no further treatment. They did several tests which did not show up anything that was of concern. She does not know specific tests or results. There was nothing concerning. There were 14 different lab tests and imaging test, Chest XRay, ECG and all those things. They let her go without any treatment. Reason for visit: hypertension, dizziness and abnormal ECG. They did an EKG and it was normal and did not tell her anything of concern. Diagnosis did not list anything about the EKG. It just said lightheadedness and high blood pressure disorder. Visit to physician Office on 18Aug2021 due to high blood pressure and high heart rate. Given Clonidine and low dose aspirin. Dose of Clonidine unknown. The patient said that did not lower her blood pressure, so she was sent to the ER as mentioned above. Number of days was the hospital stay was none. Relevant tests were none or unknown. Five days after 1st dose of Pfizer COVID vaccine, patient felt odd and went to doctor and had blood pressure checked, and it was 180/100. Doctor's tried to bring it down with a medication, but in the end, it read 180/98 and her pulse rate was 114. The medication given was Clonidine and Aspirin, low dose 81mg. She does not know the dose of the Clonidine and said it was a mild dose and she thinks they only gave her half. She does not have the dose, manufacturer, lot or expiration for the Clonidine as it was given in the doctor's office. The Aspirin was given from a bottle that they gave her of 81 mg, count size 32. Product strength and count size dispensed: Unknown for Clonidine. The aspirin was 81mg and the count size was 32 tablets. She does not know if they were sealed and intact as they gave them to her in a hurry. The patient underwent lab tests and procedures which included blood pressure measurement: normal  on Aug2021 She said it took 2 weeks before her blood pressure became normal again , blood pressure measurement: 180/98 on 18Aug2021, blood pressure measurement: 180/100 on 18Aug2021, chest x-ray: unknown results on 18Aug2021, computerised tomogram: fine on 18Aug2021 CT scan of her head , electrocardiogram: unknown results on 18Aug2021, electrocardiogram: abnormal on 18Aug2021, electrocardiogram: unknown results on 18Aug2021, electrocardiogram: normal on 18Aug2021, heart rate: 114 on 18Aug2021, imaging procedure: unknown results on 18Aug2021, investigation: unknown reaction on 18Aug2021, ultrasound scan: ok on 18Aug2021 Carotid neck arteries and they were ok. The action taken in response to the event(s) for rosuvastatin was unknown. Therapeutic measures were taken as a result of the events she said they took her blood pressure and it read 180/100, lightheaded/ dizzy, pulse rate was at 114. Outcome of the events felt a warm sensation, pulse rate was at 114, she felt so odd, a few days later, she felt lightheaded and had motion sickness was unknown while the outcome of the events she said there were numbing and tingling sensations/ gets tingling feeling in feet, she said she noticed that the numbness in her left toes crept up a bit to her ankle on one leg was not recovered. The event lightheaded/ dizzy was recovering while the event she said they took her blood pressure and it read 180/100 recovered in 2021 and the event recovered left arm soreness at injection site on 14Aug2021.