Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Pain in extremity, Tremor
Clinical narrative: her blood pressure went sky high (upper number is over 200, bottom number is 135); heart rate was 111; continuous tremors and shaking that went with this; her left 2nd and 3rd toes (counting from the big toe) were with shooting pain right after the shot but have gone away right now; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).   A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 70-years), administered in arm left on 30Jun2021 as dose 1, single for COVID-19 immunization. Medical history included ongoing high blood pressure and she clarified she was told she has Labile hypertension. She was not sure when she had high blood pressure, it was before 2016. 2016 was the first time she took medicine for it and went to the hospital. Her heart was beating so fast, ongoing hypothyroidism and she had it for about 20 years, ongoing osteoporosis and she got osteoporosis within 10 years after taking Synthroid or it could have been 5 years. There was nothing wrong with her bones before but if one looks at the Synthroid website, they say women can get osteoporosis if you get too much dosage. At first, her dose was experimental and it took over a year to get her dose, ongoing high cholesterol and she said her cholesterol was in the 340s. It was getting better before she took the vaccine, ongoing spinal stenosis, supraventricular tachycardia and osteoarthritis from an unknown date and unknown if ongoing. Concomitant medications included aspirin (ASPIRIN) taken for high blood pressure from an unspecified start date to 27Jun2021 and she stopped Aspirin since around Sunday because of taking the Pfizer vaccine. She had been taking Aspirin for a few years, metoprolol succinate ER taken for high Blood Pressure from Nov2016 to an unspecified stop date, vitamin b complex and vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID, calcium citrate (Citracal Petites 2 tablets per day), tocopheryl acetate, ubidecarenone (COQ10 [TOCOPHERYL ACETATE;UBIDECARENONE]) and levothyroxine sodium (SYNTHROID) taken for hypothyroidism, start and stop date were not reported. A minute or two after the vaccine, her blood pressure went sky high (upper number is over 200, bottom number is 135). Patient heart rate was 111. Pharmacist called EMT to come and get the caller. Patient also had continuous tremors and shaking that went with this. Patient mentioned she had a history of high blood pressure and is on Metoprolol but never had this issue. Patient mentioned her diastolic never goes to 135 and that she is much better this year so she is surprised when this happened. Patient mentioned that whenever her blood pressure goes to 180 to 200, she usually has tremors. Patient also mentioned that her left 2nd and 3rd toes (counting from the big toe) were with shooting pain right after the shot but have gone away right now. She also had spinal stenosis. She wanted to know if these had been reported side effects to the vaccine and what to do next. She wanted to know if she should still get the second dose of the Pfizer BioNTech COVID-19 vaccine 3 weeks from now. Can the Pfizer BioNTech COVID-19 vaccine be mixed with other COVID-19 vaccines like Johnson and Johnson and Moderna? She stated that yesterday she went to get the Pfizer Covid-19 vaccine and her blood pressure went sky high. She had tremors and shaking continuously. The drug store called the emergency medical, clarified as EMT. Eventually, slowly her blood pressure went down. The EMTs were afraid for her because of the shaking and all that. She explains these symptoms just came on. It was not long after she got the shot. The pharmacist at the drug store and both EMTs told her to call her doctor and to find out if she should use the Pfizer vaccine in 3 weeks as her second dose. She said because they kept saying she might not want that- the second dose and all of these vaccines make one feel sicker or get worse. She clarified that her doctor and EMT's were afraid of her getting the second shot because the second shot is worse and that her blood pressure might go above what it was. They kept mentioning Johnson and Johnson as a second way. Caller is thinking Johnson and Johnson is one whole shot for one whole year. She thought this might be too much taking that plus the first Pfizer COVID vaccine she received. She then thought of the Moderna vaccine, however the callers husband believes he heard you couldn't combine the Moderna with the Pfizer shot to take part 2 of the vaccine, but he wasn't sure. She clarifies her husband believes he heard that, but he wasn't sure, he was nervous to say. She explains they are in their 70s and she is not apart of the young group of young people that get heart conditions because of the COVID. Caller stated that she thought it was good to report this so Pifzer can learn from her experience. She said she had another thing that happen and went away fast and one of her toes was hurting a lot, intermittently, every once in awhile. She explained that this did not happen right after the shot, but soon after. The pain was not in the big toe on the left side, but the next toe after. There was like a shooting pain and then it would go away. It depends if she stood up, there was shooting pain. It hurt. She noticed this morning she was fine, but she did get a couple of small shooting pains in the middle of the night. She clarified she noticed the shooting pain more when she was standing or like when she was putting her sock on. It also happened when she was sitting as well, as she was trying to recover from the blood pressure. It happened in the middle of the night a couple of times, but it was no big deal, it wasn't as strong. She stated that she had a history of high blood pressure which was getting better before the vaccine. Her doctor was going to give her an additional medicine, but her doctor did not when she went to see him a couple of weeks ago at her appointment. She does have a history of high blood pressure and other stuff being her age. She said that the pharmacy called the EMTs after a while, after 40 minutes or something. They were trying to find a blood pressure machine and they could not find one. The caller heard one person say they did not use them anymore because of COVID. They had to open a new box and look for batteries so it took a while. Her blood pressure was around the 160s and 180s and then it went down. The second number was about 113 or 180, something like that. But her heart rate also went up to 111. She didn't see the other readings. She doesn't know for sure but she saw at the beginning that her heart rate was at 111. She clarifies she saw the first number (systolic) was over 200, but she doesn't know what it was. The second number was 135, she has never had the second number go that high or seen the number this high on a machine before. Her blood pressure had been doing really good until she went yesterday. She stated that she got the shot around 10:00, 10:15 or so. The toe thing happened when she got home around 11:00ish, she really doesn't remember the time. It happened throughout the day. It was intermittent. She clarified the toe hurting started directly after getting the vaccines, she could feel it. She told her husband she thought it was one of the effects. Then, she started getting the high blood pressure feeling which was like within minutes. She confirmed her toe has stopped hurting. She clarified when she woke up today, 01Jul2021, she was fine. She stated she was hopefully recovered. She just happened to go to her doctor, (withheld) but she turned out to be looking better. She was concerned about the different factors of what might happen. Then, she saw on TV, these nurses that were risking their lives, putting in all these hours, and people were not taking shots. After hearing that, she goes wow. Her brothers were in the military and (Withheld) and her husband and Dad were in the military, and here she is not doing her part. She figured she would risk it and get the shot. She felt it was her turn to do her part and not be selfish. She thought it was time. Her husband got his shot about a week or 2 ago. She was trying to gather information and then she decided to go for it. When she was asked where she got the shot on her body, she stated the left arm in the muscle then she said that her arm didn't hurt at all. She stopped Aspirin since around Sunday, 27Jun2021 because of the COVID-19 vaccine. She hasn't taken it since then. She knew that Aspirin was probably one of the bad things to take before going to get the Pfizer shot and she didn't want to take a chance. For Synthroid, her dose varies. Right now she takes 75mg four days a week and 50mg three days a week. She clarifies her dose varies because right now she was in the middle of changing it so the dose may be 5 days a week and the other dose 2 days a week, she is a little confused on that. She was seeing an Endocrinologist and she's been switching the caller dose. She had a blood test done the day before the COVID shot so that her doctor could get an idea of how her Thyroid was and all of that. Caller stated she had been on Synthroid over 10 years. Then she corrected it and said she thought it was about 20 years. She said that she got osteoporosis from the Synthroid. She tells the call handler that if she knows anybody that takes Synthroid to tell them to take calcium or talk to their doctor. She confirmed the Metoprolol Succinate ER seems to be helping a lot. She mentions she had to go to the hospital because she had Supraventricular Tachycardia (when the heart beats too fast) so she was started on this medication. They had to stop her heart for a moment (that was the only time she had that done). They stopped her heart, just like a flash, with the medicine, Adenosine, and then she felt bad after that event for months, but she recovered. When caller stated that she was taking vitamins, she said that she stopped Vitamin D a month or two ago. She said it was too much Vitamin D. It was almost like toxic. It was the only time her blood pressure went up, when she had that, so she stopped taking that separate. It's not that she can't take Vitamin D but not too much. She stated a lot of things affect her blood pressure a lot of medications and food she eats such as cinnamon and ginger, a lot of the pills she takes, if she takes certain brands. She was concerned about taking the COVID-19 vaccine or not because she has problems with her blood pressure at the drug store. When probed for when osteoporosis was diagnosed, the caller explains up to a certain age, it was when she was still allowed to take the DEXA Test. She said she just learned something about her spine that had nothing to do with the vaccine. She clarifies it is called spinal stenosis, it has to do with the nerves and stuff like that. She said that she went to the eye doctor a couple of years ago, she was told she was going to have macular degeneration of the eyes. At the time of this report event outcome was recovered on 01Jul2021.  Information on the lot/batch number is expected.