Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Investigation, Magnetic resonance imaging, Palpitations, Paraesthesia
Clinical narrative: mini-stroke; weird heart pounding sensations/Heart started pounding; numbness on the side of her head/numbness in face from eyebrow down face; her blood pressure and it was really high, like 180; tingling in one arm; cold hands off; weird chills; This is a spontaneous report from a contactable consumer (patient).  A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left at the age of 68-year-old on 26Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included high blood pressure from Dec2020, neck injury from 2001 (had an neck injury from a chiropractor from 20 years ago), nerve damage (had some nerve damage on the face under the eye and cheek and the side of her head and back, but it mostly cleared ), heart pounding from Dec2020 (She did have heart pounding the week before 2nd shot ), abdominal stomach pain from Dec2020, cramping from Dec2020, nauseated from Dec2020, chills from Dec2020, shaking from Dec2020, rash, memory issues, car accident, irregular heartbeat, anxiety. Concomitant medicationincluded nebivolol hydrochloride (BYSTOLIC) taken for high blood pressure from an unspecified start date and ongoing; unspcified anti-anxiety pill. The patient previously took bnt162b2 (left arm around 9am in the morning. lot number of EN5318) at the age of 68-year-old on 30Jan2021for COVID-19 immunisation and experienced pain, chest pain, tired, stomach aches, loose stools, slight angina; rabies vaccine at the age of 67-year-old in Aug2020 for immunisation, antibiotics and experienced sensitive to antibiotics, bnt162b2 for COVID-19 immunisation and experienced chest pain. Her symptoms have resolved, but she experienced a weird heart pounding sensations and numbness on the side of her head in 2021. She was diagnosed with a mini-stroke in 2021. The doctor at the hospital said the only cause he could think of was the covid vaccination because all of her tests came back normal. Caller reports the first vaccine was ok, it was the second vaccine. reporting she was later admitted to the hospital stating I went to the ER that Friday night, then back to the ER Monday and Tuesday where I was in the hospital and they ran every test they could think of and thats when they decided they didnt see anything else so it must have been the vaccine. She reports that before the first vaccine patient took half of a blood pressure pill not because of that, for something else. Then the second patient didnt do that and thinks this may have something to do with her symptoms after the second dose because she had a pounding heart. Have there been reports of people experiencing the same symptoms that she did after her second dose. Caller is just now getting to report an apparent reaction to the vaccine she had at the end of February. Is hoping to be able to get a booster and she does not know what she didn't try back then and she couldnt get through. She just called the number from Pfizer and was told she should report. Got the first shot and then got the second one about 3 weeks after the first one, but she ended up getting it 1 more week afterwards because of a snow storm, so a month later. The second shot she looked back and maybe it made a difference, but she is not sure, but at the time she had been on blood pressure medicine off and on and at that time she was currently not on it. She guesses it was doing something and when her doctor found out he told her she was not supposed to be doing that. She took blood pressures every day and it has been on occasion been reading high and so she would be taking one half of a pill she had. It was Bystolic and that would always bring it down. This also happened before the first vaccine that she was taking half a dose because the blood pressure was high and it was high the day before the vaccine. Maybe that is why nothing happened with the first dose. A week later after the second dose, immediately afterwards her heart started pounding. When she looked at her notes she had some slight pounding before this, but it was not as hard as this one. Had slight palpitations, but she wasnt worried about it and she noticed she was having them and not had them before the second dose. It really started pounding and on the sheet they gave her it said to watch out for that and report it she you do. After getting the second dose she waited the 15 minutes in the sitting room and then it got to like 20 minutes and it was still pounding. They had paramedics there who were giving the shots and they told her they were concerned and it was about 4 of them with her. She is guessing about 30 minutes later with them still standing there they monitored her blood pressure and it was really high, like 180 in 2021 and the pulse monitor was high. It didnt slow or stop or anything. They told her they thought she needed to go to the ER and she declined stating she wanted to go home and she can take half of the blood pressure pill she has there and maybe it would stop and they had her sign a waiver and she went home. They made her promise that if it didn't get better after about an hour to call 911. It didnt get better after the half a pill and she didnt call withheld. Thought to call her friend to take her to the ER and after getting settled in the ER bed and they hooked her up and all that and within the next hour or two she seemed to be getting better, but they kept her until 1am and kept doing tests on her. They reran everything to make sure everything was okay and then they released  her and that was on a Friday. Was fine on Saturday and Sunday. That following Monday she did fine, but my mid-morning was on the phone and then all of a sudden her heart started pounding again just as it had when she first got the second vaccine for no apparent reason. Called withheld again and they didnt go right away and the paramedics came out and she told them what had happened a few days earlier with the same things with the blood pressure and heart rate and pounding and they recommended to take her to the emergency room. She asked them to wait and so they continued to monitor her about another 20 minutes and it was going down and they told her they can still take her to the emergency room, but she declined and didnt want to go since she had already just been. That was that Monday morning and then 2 hours later around noon time she was sitting at the table about to eat and all of a sudden felt this sensation going down the right side of her head like near the hairline and it started and kind of moved down. It was kind of unrolling down the right side of her face. What then came to her mind was  she thought it was possibly a stroke/symptoms of stroke. States she has a back story where she had an neck injury from a chiropractor from 20 years ago and clarifies this was prior to the covid vaccines where she had some nerve damage on the face under the eye and cheek and the side of her head and back, but it mostly cleared. States the unrolling feeling she had was kind of like this, but she never had experienced numbness not since a long time, the numbness feeling rolling down the side of the face, this was new. Wondered if this was a stroke symptom and she called withheld again and let them take her to the ER. They stated it sounded like it could be a stroke and she was admitted to hospital and they did further tests. The ER doctor thought it probably could have been a stroke and she told the provider about what she experienced earlier with the pounding and thought it was somehow connected. After the provider did his tests they wanted to admit her to run all other tests like MRI and other things. They thought it was probably a stroke and was looking for signs of a mini or big stroke. They ran all of the tests and couldnt find anything else and the hospital floor doctor (the second doctor) deduced that it was a vaccine reaction. It is located across from that and they did like 4000 shots at that city, it was a city wide event. States the blood pressure medication she was taking was Bystolic. Had been taken it a long time ago and has thrown away the bottle and unable to provide the NDC, lot, or expiry. States she thinks it was 10mg so she would have possibly been taking 5mg. Again, states her doctor got mad at her when she found out she was not taking it as directed, but the pharmacist told her it was okay and her blood pressure was mostly normal. Every since then she has had other problems and now back on Bystolic. Was taking blood pressure medication, Bystolic off and on for high blood pressure and believed it was 10mg, and that she probably was taking 5mg. Would check blood pressure and if it was high would take half pill (5mg). Doctor was made when found out she was not taking it as directed. Has since had other problems and put back on Bystolic. Got the first shot and then got the second one about 3 weeks after the first one, but ended up getting it 1 more week afterwards because of a snow storm, so a month later. 3 days later pounding started again, numbness in face from eyebrow down face, She said she did have heart pounding before 2nd shot. She went to ER tested for stroke and was told probably a covid shot reaction. Caller says that she was on the phone with somebody with Pfizer and she kind of gave her whole story already about how she ended up in the hospital and they concluded that it was a possible reaction to the second Pfizer COVID vaccine. She says that she got her COVID vaccines in Feb2021 and according to what she has been reading the efficacy of the COVID vaccine is weaning and it may a good idea to get the booster but should she dare get the booster when with the 2nd COVID vaccine she had those effect and if she doesn't get it what could that look like for her?Inquired if caller received a report number from the previous agent and she states that she doesnt think so. She says they were getting close to the end of the report, they were talking for 45 minutes, and the previous agent had gotten the whole story down and then when the caller had something else that she was about to tell her the call disconnected.The caller had told the previous agent about how she had ended up in the emergency room twice. She got sent to the emergency room after the COVID vaccine because it had made her heart pound and the first time this happened she was okay two days later. She told the previous agent all of that. She had some kind of weird things going on, too, before she even got the 2nd COVID vaccine and she is wondering if maybe she just had these all even before she got the 1st COVID vaccine, now that she is thinking in retrospect. After her 2nd dose she had severe heart pounding twice within a few days and she had something down the side of her head that had felt like a stroke. However back in Dec2020 she was starting to have not really bad heart pounding but an occasional heart pounding to where she would make a note of it but she was not worried about that. Also this may or may not have an effect but she had a bat land on her in the summer and she took a rabies shot, it was a strong vaccine, maybe that had something to do with this. She says that she had to get like 5 to 6 shots and wait in the emergency room and only their emergency room was giving them and she had to wait like 6 hours during COVID for this. Her 1st dose was on 30Jan2021 and her 2nd dose was a week later than it should have been because they had a snow storm, it was on 26Feb2021.  History/ Investigations: When caller was probed for relevant test results, medical conditions orconcomitant products she states well she needs to check her blood pressure log because she had a weird Dec2020. Then she started having some heart pounding then, but it was not as bad as it was with her COVID vaccine but she did make a note of it. She had an endoscopy because her doctor thought that maybe it was worse than just a colon impaction which is what it turned out to be. She went to see a neurologist on 22Jan2021 and the neurologist tapped on the side of her head as she was checking for things. The caller has gone to her with memory issues before and for other things that have happened. The caller had car accident years back and had some off and on numbness of her face since then, this was earlier to this time, but when the neurologist tapped on her head it kind of triggered that and also she had numbness in her legs and the bottoms of her feet following that. She made note also of having heart palpitations. Then in Jan2021 she had her 1st COVID vaccine, 30Jan2021. Now this is important she thinks, she used to take her blood pressure every day but for the past few years she hasnt. She asked a doctor or a pharmacist about this and her blood pressure has never been real bad but she asked if it was okay for her to take only half of her blood pressure medication and whoever she had asked said yes. When she later told her cardiologist he said that she should of never done that. The morning before she had went to get her first COVID vaccine she had a high blood pressure and so she took half of her Bystolic, so that would of been 5 mg, and she didnt have any side effects except she did have some pain under her breast bone. She adds that she doesnt know if that was before or after the COVID vaccine, maybe it was before the COVID vaccine. Then on 02Feb2021 she still had pain around her heart, she was tired, had stomach aches, loose stools and she still had some heart pain and her stomach hurt on that Wednesday and Thursday. Then that continued for the next few days, the tiredness did, and she was still having the stomach pain and numbness in her legs, that was around 07Feb2021 and then on 12Feb2021 she noted that she was having stomach pain that was moving around and she had fatigue. On 25Feb2021 she noted slight angina in her upper abdomen and then on 26Feb2021 she got the 2nd COVID vaccine. That evening is when she had the stuff with her heart. She had noted this occasionally in months prior to having the 1st COVID vaccine that her heart would of pounded. She was born with an irregular heartbeat and after the COVID vaccine it really started pounding like it never had done before. She went to the emergency room because the first responders were sitting with her and they had their blood pressure and heartbeat recorder and said that she needed to go. She ended up going but she was okay. That night and Friday morning were the worst when she started pounding again for no particular reason. She ended up calling 911 and they came out and were there and then they left. Then legit just a few hours later, she already told the other agent all of this, but she felt the numbness feeling down the right side of her face and that hadnt happened before. She remembered that it could be a stoke symptom so they took her to the hospital and at the emergency room they did a bunch of tests and decided that it was more than likely a mini stroke or a stoke. They admitted her overnight and she stayed unitl the next day. While she was there they did every test, MRI and x-ray and they couldn't find anything. The doctor over her case said that they are going to have to assume that it was some kind of COVID vaccine reaction, and thats kind of the end of all of that. After she came home from the hospital she started having tingling in one arm and cold hands off and on and a numbness on the side of her face in 2021. She also took one anti-anxiety pill that could also cause those symptoms, but she never took another one. The reason she was anxious is because they wanted her to start a blood pressure medication but she needed to see her heart doctor and she couldnt see him until a week later. She got something to take in the event that her blood pressure sky rocket. She asked for an anti-anxiety pill since she had to wait a week to see her doctor. She doesnt know if this is either from the anxiety pills or another after effect of the COVID vaccine but she had weird chills in 2021, numbness and this and that. When she started on her beta blocker, 10 mg, a week or so later she kind of slowly got better until she finally really didn't have any of those symptoms, they all went away. Probed for further information on the anti-anxiety medication and she says the doctor that declared that her problems are from the COVID vaccine, or that it was the culprit, is the one who came up with it and when she had told her primary care provider and her cardiologist about that anti-anxiety medication they said that shouldnt have that medication because it is the worst thing. She said she was looking for the medication but she may of thrown it out. She only has something else that she was prescribed. She doesnt really like anxiety medications but she had it just in case, but what she has in front of her is not the same one that she had taken. She confirmed that she has had no new events. She adds that as time went on, now she is on a regular blood pressure medicine and she doesn't think she has been having anything that was similar to what she was experiencing during that time and around the time that she was in the hospital and in the weeks after that to some extent. They all kind of teetered out. The numbness in her arms and the tingling and weakness all just stopped which could of been triggered by the left over COVID vaccine or that one anti-anxiety pill that she took. According to what she has been reading the efficacy of the COVID vaccine is weaning and it may a good idea to get the booster. The patient underwent lab tests and procedures which included blood pressure measurement: high  on  unknown date, blood pressure measurement: 180  in 2021 (paramedics monitored her blood pressure and it was really high, like 180 ), blood pressure measurement: high  in 2021 , endoscopy: unknown results   on  unknown date , investigation: normal   in 2021, magnetic resonance imaging: unknown results  on  unknown date (had the MRI and got a rash ), magnetic resonance imaging: unknown results  in 2021 (did tests and they wanted to admit her to run all other tests like MRI and things), magnetic resonance imaging: couldn't find anything  in 2021, x-ray: couldn't find anything   in 2021.Therapeutic measures were taken as a result of her blood pressure and it was really high, like 180. The outcome of event mini-stroke was not recovered. The outcome of event numbness on the side of her head/numbness in face from eyebrow down face and tingling in one arm, weird chills was recovered in 2021. The outcome of other events was unknown. As of 25Aug2021,Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN5318 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN5318, fill lot EN5317, and the formulated drug product lot EN5316. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  The lot number for BNT162b2 was not provided and will be requested during follow up.