Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Peripheral swelling, Pharyngeal mass, Presyncope, Wheezing
Clinical narrative: headache; dizziness; chest was tight; was not breathing very well for 3- 4 days; wheezing; bad pressure in the back of her head; felt like her heart was skipping beats; heart rate and blood pressure seem to be very erratic; erratic heartrate; arm swelled up and was sore; arm swelled up and was sore; lump in throat; unwell feeling all over like she was going to pass out.; unwell feeling all over like she was going to pass out.; She kept getting an icky feeling; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [26Mar2021], this case now contains serious adverse reaction(s). Information processed together.  This is a spontaneous report from contactable consumers (one is patient). A 64-year-old female patient received the first dose of BNT162B2 (BNT162B2, Lot Number: EN6204), intramuscular, administered in right arm on 08Mar2021 14:10 (at the age of 64-year-old) at single dose for Covid-19 immunization. Medical history included high cholesterol, osteoporosis, high blood pressure, arthritis, stenosis of neck and spine, allergies to dust and cleaners (when she cleans, the bottom of her neck swells up huge); all were ongoing. She has very high cholesterol, she believes it was close to 400 the last time it was checked and that's why she was given Repatha which brought it way down, but she doesn't know if she can take the Repatha again. She also has quite a few allergies - allergic to cats, sulfa, grass and Pre-diabetes. She has a fair amount of allergies. Her doctor thinks she has some asthma because she has had a little trouble breathing at different times, but she doesn't have an inhaler or anything. She mentions asthma and allergies run in her family. The patient also stated that a majority of her life, has had low blood pressure until about 9 years ago when her father passed. States that her blood pressure had been out of control for 6 months and was then put on a low dose of Carvedilol, and eventually evened out. Concomitant medications included ongoing carvedilol taken for blood pressure; ongoing loratadine (CLARITIN) taken for allergies from 1996 (has been taking for 25 years); ongoing lansoprazole taken for acid reflux; ongoing rosuvastatin calcium taken for cholesterol since Sep2020; ongoing calcium; carvedilol (COREG) taken for blood pressure. The patient had a previous reaction to a cholesterol medication evolocumab (REPATHA) from 23Oct2020 to 23Oct2020 - her neck swelled up pretty big and she had hives on her chest, which ended up going away. Therefore, she doesn't know if she can take that again or not. The patient also previously took rosuvastatin calcium (CRESTOR) 5-6 months ago and it made her legs ache really bad; esomeprazole sodium (NEXIUM) and had the problem; lansoprazole (PREVACID) for acid reflux. She took Nexium which was a different product with different ingredients and her blood pressure was still high the whole day. States that her doctor had prescribed another brand, which had the same main ingredient as the Nexium, and told her to double up on it one night, so she did that and about an hour later she just about hit the floor because her blood pressure shot up to about 200 over 100 and something, so she talked to the pharmacist who said that this was not a normal reaction to the ingredients in Nexium, but it happened to her every time she took it. She had been taking Prevacid for a long time but then started to get an allergic reaction. Clarified that feeling like she was having an allergic reaction after taking the Prevacid at night, was something that she has just started noticing within the last month. Wondering if the 2nd dose of the Prevacid is too much. States that she still takes this in the morning but not in the evening. States that she has started taking 15mg at night from an over the counter version of the same medicine (Lansoprazole). She explained that she hasn't had any vaccines as an adult, she never has had a flu shot. About 5 years ago, she had a bat in the house for 3 days and the bat ended up hitting her in the head and forehead as they were trying to get the bat out of the house, so she ended up getting a rabies vaccine. She was wondering and hoping there were no interactions with that. With the rabies vaccine, she did have a headache. She had to get 4 or 5 shots and she did not feel well most of the time. It took a long time to pass for her to feel normal again. The caller received the first dose of the vaccine last Monday on 08Mar2021, after the shot and while waiting those 30 minutes, she felt a lump in her throat which lasted all day and the next day, but it went away. She confirms by 10Mar2021, she recovered completely. Her arm swelled up and was sore for a day and half on 08Mar2021, but that went away. She isn't worried about that. She also has a really bad headache and was very dizzy on unspecified dates. She is concerned about the dizziness. She has been driving, but about the second day after getting the vaccine, she was leaning over talking to her mom and she felt like she going to pass out. She didn't, but she felt like she was. She has been using hot packs. It's like she has a headache around her temples and the back of her head seems to be hurting. In fact, she put a hot pack there while waiting to speak to this call handler. She doesn't know if its tension or what. She didn't have hives or none of that from COVID vaccine which she was excited about, but she is so dizzy she can hardly stand. She can't get rid of the headache and dizziness. She wants to know whether or not to go ahead with the next vaccination. This is the 5th day of having this dizziness. She was thinking the dizziness was going to last for a couple of days, but its going on 5 days. Even just sitting, She states it's kind of scaring her. She was thinking it would just go away, but it isn't. Her heart rate and blood pressure seemed to be very erratic on 12Mar2021. She woke up this morning (12Mar2021) and her blood pressure was very high, but she checked it within a few minutes and was dropping low. Her heart goes fast and then slows down, but she has had problems with this in the past. The dizziness has been bothering her a lot, she has been afraid to drive. The patient had a blood pressure of 150/102 on unspecified date.  On 17Mar2021, She mentioned she will see her HCP at 2:00 PM. She has already filed a report regarding the side effects she had. She filed a report and asked if she should get the second dose shot. However, she was informed if her HCP called, they may be able to provide her with more information. She was informed her HCP could call the medical line. On 26Mar2021, she stated that the first report was filed the first week and that during the second week, more not good things have been happening. She wrote down the report number from the first report but does not have it now. Since the vaccine, she has been having different symptoms; she is not sure if it is related to the vaccine but wanted to report it. She was a little concerned because she has allergies, stating she had just tried an injectable cholesterol drug and she did break out hives and her neck had swelled. States that she has not had any vaccines as an adult, so she was a little bit cautious anyway. She clarified that she did not have hives and did not have any breathing problems when she left. Stated that later that evening and the next day had a really bad headache and bad pressure in the back of her head, which she knew was typical. States that 3 or four times she felt a rush over her body and felt like she was going to pass out. That night and the next day (unspecified date), she was having breathing problems (was not breathing very well for 3- 4 days) and her chest was tight and she was starting to wheeze, and continued for about 3 or 4 days. She kept getting an icky feeling Monday and Friday when she got up and had unwell feeling all over like she was going to pass out on unspecified date in Mar2021. States she had real bad pressure in her head and high blood pressure and felt like her heart was skipping beats on unspecified date. States her blood pressure was around 152/100 on 09Mar2021. One-day blood pressure was real low, 88 over something but that kind of went away. States all that information was already reported. The next week, she thought she was feeling better and that Monday and Tuesday felt back to normal. Stated that on Thursday night (Mar2021), she was just sitting and around 8 o'clock her blood pressure spiked within a few minutes to around 184/105 and she wasn't doing anything; she couldn't get it to go down. States that she went to the ER to check everything out last Thursday.  Every night since then, somewhere around 8 o'clock, her blood pressure spikes really high.  Stated she then called her doctor. Stated she was on a really low dose of blood pressure medication, stating that she had occasional problems with her blood pressure in the past but it never went that high. Her blood pressure was usually in the 140's or 150's over 90 something. States that now it is much higher and happening every night. Caller stated that Wednesday night (24Mar2021) her blood pressure started to spike every 5 to 6 hours, stating it first started at 830 at night and again at 230 in the morning. She has been feeling unwell since that shot. Her doctor thinks it may be causing inflammation. States that they doubled her medication last night and her blood pressure is still going up and up, but usually goes down after a couple of hours. It is totally uncontrolled and her doctors are trying to figure it out. States that meds have been added, including Xanax and will be going to see a heart doctor. States that this has all been since the vaccine. Caller would like to know if people are reporting these symptoms. States that it is pretty terrible, and that she feels normal and then it rushes over her. States that it is exhausting and that she almost went to the ER last night. States that she does not want to go back if she does not have to. When she filed the first report she did not have issues with blood pressure yet. Again, she had the vaccine on Monday 08Mar2021 and that the next Thursday she felt like her heart rate was really high. During that first week, she felt out of rhythm, like missing beats. Her blood pressure dropped low the first week and that just one time was around 152/100 but it didn't sustain. It then dropped pretty low one day. The next Thursday, it was uncontrollable. It was around 180 over 104 or 105 and that it kept going up, but then back down to 160/90 something. Took Xanax and went to bed, when she woke up this morning it was low, but went right back up within 5 minutes. In the first couple of days, they increased her blood pressure medicine and it seemed to be bringing her blood pressure down and she was able to go to bed. The caller stated that Monday, it will be three weeks. States that a day and a half after the vaccine, her arm was not hurting but was still puffy, but not bad. States that when she runs her hands over it, it is still sore to the touch and a little swollen but nothing extreme. She was concerned that her blood pressure keeps going up and then down. States that the blood pressure started spiking on the 18Mar2021, in the evening very quickly and was very high. Stated that this was happening every night since then until the 24th, when it started spiking every 5-6 hours; and her blood pressure medicine wasn't controlling it like it was earlier in the week, even though the dose was doubled. For one day it worked good and brought it down low but then, it wasn't controlling it anymore. She stated no relevant tests, related to this event but states that in her last 2 labs her cholesterol was high. States that it was over 300 and her bad cholesterol double or more triple. States this has been going on for many years. States that she changed her calcium to calcium with vitamin D and her vitamin has come back up. When she was in the ER they did a Metabolic panel and everything looked okay. The adverse events require and emergency room visit. The patient recovered from the event lump in throat on 10Mar2021; the events arm swelled up and was sore recovered in Mar2021; the events erratic heart rate, chest was tight, was not breathing very well for 3- 4 days, wheezing resolved on unspecified date. The outcome of dizziness, blood pressure seem to be very erratic was not recovered and the outcome of the remaining events was unknown.