Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Ear pain, Electrocardiogram
Clinical narrative: ear hurt on the left side and her throat on one side was really red; ear hurt on the left side and her throat on one side was really red; cough; chills; speeded up her heart rate; fever 101; Eyes hurt real bad; Left shoulder could not move arm because of pain; she went to swallow she would get a pain where her eyebrows are; was like she could not breathe/ had a hard time breathing when she went to talk and felt like she didn't have enough breath to talk on.; arm was on fire; The left arm and into her chest hurt/Chest pain; had a 101 temperature and was sweating like crazy/ sweating like a race horse; nausea/Nauseated; diarrhea; Her head hurt so bad she couldn't stand it/ head hurt so bad it was unreal; The left arm and into her chest hurt; throat was sore on one side but not the other/ had a sore throat on the left side; Got weak and had to sit down after getting injection; Right arm felt like it was on fire at injection site after getting injection but it was not sore; was so bad she had to have someone help her get out of bed; Heart felt like it was out of rhythm; dizzy/ felt a little light headed/light headed and came close to blacking out 3 times; had a 101 temperature and was sweating like crazy; heart palpitations; This is a spontaneous report from a contactable consumer (patient) via information team. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, NDC number and Expiry Date of Covid shot: Not Provided) intramuscular, administered in Arm Right on 15Mar2021 13:00 (at the age of 61-year-old) (Lot Number: EN6208) as dose 1, single for COVID-19 immunization. Medical history included open heart surgery (2 years ago), COPD from 2009 (COPD with chronic bronchitis), chronic bronchitis from 2009, allergic to penicillin (allergic to injectable penicillin), other allergies to medicine, partial epilepsy with seizures, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes), diabetes, obesity, heart attacks, diagnosed allergies. The patient previously took lidocaine, morphine, dilaudid and was allergic to these drugs, methylprednisolone acetate [MEDROL] and can't take Medrol steroid. Historical Vaccine included pneumonia shots and flu (has taken pneumonia and flu shots). The patient's concomitant medications included blood thinner for unspecified indication, start and stop date not reported. The patient experienced heart felt like it was out of rhythm (medically significant), dizzy/ felt a little light headed/light headed and came close to blacking out 3 times on 15Mar2021; arm was on fire and the left arm, was like she could not breathe/ had a hard time breathing when she went to talk and felt like she didn't have enough breath to talk on and into her chest hurt/chest pain, had a 101 temperature and was sweating like crazy/ sweating like a race horse, nausea/nauseated, diarrhea, her head hurt so bad she couldn't stand it/ head hurt so bad it was unreal, she went to swallow she would get a pain where her eyebrows are, fever 101; all on 16Mar2021 17:00; the left arm and into her chest hurt, throat was sore on one side but not the other/ had a sore throat on the left side; all on 16Mar2021; heart palpitations and had a 101 temperature and was sweating like crazy on Mar2021; ear hurt on the left side and her throat on one side was really red, cough, chills, speeded up her heart rate on an unspecified date. Caller stated she had some reactions to the first shot on 15Mar2021 at 01:00. Her primary care provider was supposed to call and she did not. Caller stated she had some bad reaction. She stated when she got the shot she explained to the lady that she is on blood thinner and has had open heart surgery, has COPD, chronic bronchitis, and is allergic to penicillin, lidocaine and morphine, and Dilaudid. The minute she gave it to her, her arm was on fire and the HCP told her that shouldn't happen. So she sat there for quite a while to be monitored. At 05:00 on the 16Mar2021, the next day, everything hit like a bomb. She stated she took the shot in the right arm. The left arm and into her chest hurt, she could not move the arm without getting chest pains. She also had heart palpitations. It was like she could not breathe, she was having a real hard time with that. She has a monitor that goes to her pulmonary doctor and they called her everyday. She had every symptom on the paper. She had a 101 temperature and was sweating like crazy. Not long after that she started with the nausea and it felt like she was going to black out. She had diarrhea. The pain was so bad in her left arm and in her chest only on the left side that she had to get someone to help her out of bed. Her head hurt so bad she couldn't stand it. She had a sore throat on the left side, her ear hurt on the left side and her throat on one side was really red. She also had a cough. She ended up with the chills, nausea and diarrhea. When she went to swallow she would get a pain where her eyebrows are. She stated cardiac is not mentioned on any of these papers. She contacted the heart doctor and he said that should not have happened because it is not listed anywhere that there is cardiac issues. She had every symptom of covid and the rapid test was negative. The other test that takes 3-5 days to get back did not come and when she called the boy said well it is negative for the one on the 23rd, but she said she did not know where the results were for the one that was sent away. She stated she had too many side effects that were not listed on the paper. She felt like she was suffocating and could not breathe. She was really weak and it was like she was really dizzy and had to sit down and this is totally bad side effects that she had. She didn't start to feel better until this past Saturday, 27Mar2021. Still feels like she has some of the effects but not as bad. She asked, knowing the shot caused all of that, is it safe to get the second dose? She is scheduled for the second dose on 05Apr2021. Additional AE details: Her brother got the Moderna vaccine and could not get out of bed after his second dose. His head hurt, he was throwing up and had diarrhea. He got sick. Her sister got the first dose of the Pfizer vaccine and she thought she was going to die. She stated she is not sure if she is going to get the second dose. Reporter seriousness for everything hit on the left side which caused severe pain in that arm and in her chest, speeded up her heart rate, right at the moment she gave the shot callers arm was on fire where she got the shot in her right shoulder, felt a little light headed, she hurt so bad and when she tried to move her arm and it caused chest pain, Nauseated, fever 101, sweating like a race horse, Diarrhea, light headed and came close to blacking out 3 times, was so bad she had to have someone help her get out of bed, head hurt so bad it was unreal, throat was sore on one side but not the other, whenever she tried to swallow, between her eyes on her forehead she would have pain there whenever she tried to swallow, Chills, had a hard time breathing when she went to talk and felt like she didn't have enough breath to talk on: Unspecified. Dates for was so bad she had to have someone help her get out of bed: (From: Unspecified To: Unspecified). Other Products: Yes. Investigation: Covid test rapid (Date: Unspecified, Result/Units: negative) and Covid test sent out (Date: Unspecified, Result/Units: unknown). Caller states she took the Pfizer shot on 15Mar2021 and caller states that two of her doctors told her to call and report this to Pfizer. Caller states they gave her the shot in her right arm and the next morning when she got up on 16Mar2021, it was not bothering her and then everything hit on the left side which caused severe pain in that arm and in her chest. Caller states it speeded up her heart rate. Caller states she didn't start to feel better, and had to get a Covid test, and she hasn't gotten the second half of that result yet. States she told the person doing the shot everything she is allergic to. States she is on a blood thinner and has had open heart surgery. States she told the lady, she is allergic to injectable penicillin, morphine and dilaudid and that she can't take Medrol steroid and has other allergies to medicines. Caller states she told the lady everything before she gave caller the shot and that lady told caller that she had not found anything yet as to why caller couldn't take the vaccine. States right at the moment the lady gave the shot, callers arm was on fire where she got the shot in her right shoulder. Caller states she had no symptoms but felt a little light headed and the next morning and everything hit on the left side and her heart sped up. Caller relays that she hurt so bad and when she tried to move her arm and it caused chest pain. Caller states she started feeling better yesterday and clarifies it was on Saturday that she was feeling better. States the 1st shot did cause quite a few more side effects. Caller provided that she was nauseated, had a fever of 101, was sweating like a race horse, ended up with diarrhea, and was light headed and came close to blacking out 3 times. Caller states if she passes out she will get a seizure as she has partial epilepsy with seizures. Caller states the woman, who administered caller the shot, knew everything. Caller states she had the fever of 101 on 16Mar2021, which was the day after she got the shot. Caller states she contacted her cardiologist about her arm, shoulder and her chest because she has had open heart surgery. States it got worse over time. States it was so bad she had to have someone help her get out of bed. States her head hurt so bad it was unreal. Caller relays that her throat was sore on one side but not the other. States whenever she tried to swallow, between her eyes on her forehead she would have pain there whenever she tried to swallow. Caller provides that she had chills and diarrhea and everything. Caller states her PCP told her to get a Covid test and the rapid test was negative, and they sent the other test away and there are no results yet. States she told them to call her when the test results were back if it was positive or negative and doesn't know what is going on. Caller states with all of these her doctor told her she has every symptom of Covid and she has breathing issues as it is, she has COPD with chronic bronchitis and she had a hard time breathing, when she went to talk, she felt like she didn't have enough breath to talk on. Caller states her endocrinologist today said those are bad side effects that caller had with the 1st shot and she said she was wanting to know what does Pfizer think as far as recommendations for her to get the second shot, which is scheduled for 05Apr2021. Caller reports that she knows which batch and number for the shot that she got, but something did not go right. Caller is questioning if something is not right with the batch, because the product is not supposed to do anything cardiac related, in terms of side effects. Caller states she is wondering about reported side effects. States some side effects are not normal, the part about cardiac is a new one and it doesn't say anything cardiac anywhere. Caller states she told the lady who was administering the product, that she was on a blood thinner and when that lady gave the shot, caller was told it should not have burnt the way it did. Caller relays that because cardio is not on the paper and tells about diarrhea and chills and all that but not listed is cardio. Caller states she needs to know and her doctor said to find out. Caller relays that her second shot is coming and with the side effects that she had, should she take it and how protected would she be with just the 1st shot. Caller states she had 2 of her doctors tell her to contact Pfizer to tell Pfizer what went on with her, as the stuff she read doesn't state that information. States she got the shot in her right arm and everything happened on her left side. Caller clarifies it as the Pfizer BioNTech Covid shot. Description of complaint: Caller is a patient who is calling regarding the COVID vaccine. Caller had quite a few side effects that were not listed on her information sheet, to include some cardiac issues, so caller is wondering if she got a bad batch of the product, because something did not go right. Reporter seriousness for Eyes hurt real bad, Throat sore on left side and when she swallowed there was a pain between eyebrows, Really hard time breathing, Nauseated, Diarrhea, Left shoulder could not move arm because of pain, Chest pain, Headache, Dizzy, Right arm felt like it was on fire at injection site after getting injection but it was not sore, Fever, Sweating like crazy, Got weak and had to sit down after getting injection, Heart felt like it was out of rhythm: Unspecified. Dates for Right arm felt like it was on fire at injection site after getting injection but it was not sore.: (From: 15Mar2021 To: Unspecified). Dates for Heart felt like it was out of rhythm: (From: 15Mar2021 To: Unspecified). Why was the patient taking Pfizer COVID vaccine: Prevention and High Risk. Received call from consumer regarding the Pfizer COVID vaccine.  She has talked with CDC and they did say she had some of the more severe effects from that shot.  They sent her to Pfizer to find out how much percentage there is as far as protection in the first shot. CDC has everything that happened. She does not think it is safe to take second shot.  She had two doctors say not to take it. Then two recommend she does but contact CDC and Pfizer. She did not have an email.  Her primary care doctor advised her to get the shot. She tried to do report a week ago and they sent her back to her primary care doctor who sent her back to CDC and back to Pfizer. She doesn't understand why she has to do. She then clarified that she had not spoken with anyone in Pfizer Drug Safety to report this. She took the first dose at 13:00 and was fine that day and on 16Mar2021, was fine until 17:00, and then she doesn't know what happened. Her eyes hurt read bad. She took the shot on the right and everything that happened was on the left. Her throat was sore on left side and when she swallowed there was a pain between her eyebrows. She had a really hard time breathing because she has COPD with Chronic Bronchitis, which was diagnosed prior to getting the vaccine. They are monitoring her breathing with a machine. It had gotten worse since she got the shot and it is kind of getting better. She was having left arm pain and could not move because it hurt so bad.  It was like she wanted to scream and caused chest pain.  She already had open heart surgery.  She thought she was having a heart attack.  Her doctor said it was not, but that it was the vaccine. She had three heart attacks and had open heart surgery.  All were prior to getting the vaccine. The open heart surgery was 2 years ago. When the person gave her the shot, it set her right arm on fire. They told her that should not have happened when it did. The right arm did not bother her, it was everything on the left side. When she contacted her primary care doctor, she was running a fever of 101 and was sweating like crazy. She said a lot of her symptoms are like she has already come in contact with COVID and she sent her for COVID test.  It was negative. She was sitting in a chair when she got the injection and she told the lady when she put it in, that it was automatically burning like crazy and she said it shouldn't have happened. She got weak and had to sit down. It took up until that Saturday to really come around to being kind of normal. She was a high risk for getting it and she really did not want to and she got pushed into it. This is on the first shot.  If it did this on the first one, she doesn't have any idea what it would do on the second one.  A couple of her doctors say it might not be safe to get second dose.  They wanted her to find out on the first shot, how much percentage does it protect her for. She has always taken the medications she has taken and has taken pneumonia and flu shots with them and never had any problems. No further details provided. Vaccine supplemental form. Anatomical Location of Administration of Pfizer vaccine considered as suspect: Injected intramuscularly in right arm. Vaccination facility information available. 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). No previous. Additional Vaccines Administered on Same Date of the Pfizer Suspect. None. AE Details and time of onset: Eyes hurt real bad - 17:00-17:30. Throat sore on left side and when she swallowed there was a pain between eyebrows. 17:00-17:30. Really hard time breathing 17:00-17:30. Nauseated 17:00-17:30. Diarrhea 17:00-17:30. Left shoulder could not move because of pain 17:00-17:30. Chest pain 17:00-17:30. Headache 17:00-17:30. Dizzy not provided. Right arm felt like it was on fire at injection site after getting injection, but it was not sore. 13:00. Fever 17:00-17:30. Sweating like crazy 17:00-17:30. Got weak and had to sit down after injection 13:00. Heart felt like it was out of rhythm - not provided. ER or physician's office required- She called her Primary care doctor and she sent her to get a COVID test. She contacted her cardiologist by phone and did not contact pulmonary doctor but they were already monitoring her breathing. Her pulmonologist office called her three times because they could tell her breathing was faster and she told them she had the COVID shot. Her breathing was elevated and her heart was a little out of rhythm. Prior Vaccinations (within 4 weeks): none. AE following prior vaccinations: None. Patient medical history: Provide 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: COPD was diagnosed in 2009 somewhere around there and Chronic Bronchitis around 2009.  They are monitoring her respiratory home hub that you plug in and she has these little tabs she hooks up to her underwear and it picks up breathing rate. IT shows like a little EKG for breathing. Family medical history: none. Relevant test: COVID test done on 17Mar2021 and it was negative. Caller was a 61 year female consumer, asking Since she had all of these weird side effects with the first shot, should she get the second shot Caller reportedly spoke with her doctor and the CDC about her severe reaction, who both referred her to Pfizer for recommendations for getting the second shot. Caller reports that she had several side effects, but also reports that she forgot to tell DSU that on 17th she couldn't get out of bed by myself and had to get someone to help me. She reports that she received the shot on right side, but everything on my left side hurt. She had left side pain in my arm. Moving my arm it would hurt so bad with pain in my chest Caller reports that she called her cardiologist who said it was not cardiac related. Caller reports she have had open heart surgery and have COPD with chronic bronchitis When she got the shot it burnt like crazy and the lady that gave me the shot said that shouldn't happen. Caller reports that after getting the shot I got really weak and dizzy and stayed dizzy the rest of the day Caller also reported her hesitation to getting the second dose because she don't know anyone who had side effects from the first dose but my brother had the second dose and felt like he was run over by a truck, his muscles hurt so bad. Reporting that if her side effects were bad with the first dose, she doesn't know how the second would be. Caller is a 61 year female consumer asking What percent of protection do she have after getting the first covid vaccine dose. Response: Disclaimer provided. Confirmed Pfizer covid vaccine. Lot #EN6208. For events, arm was on fire, the left arm and into her chest hurt, had a 101 temperature, she went to swallow she would get a pain where her eyebrows are and was sweating like crazy/ sweating like a race horse and the left arm and into her chest hurt/chest pain, fever 101, outcome was recovered on an unspecified date; nausea/nauseated; diarrhea; her head hurt so bad she couldn't stand it/ head hurt so bad it was unreal; ear hurt on the left side and her throat on one side was really red; cough; chills; dizzy/ felt a little light headed/light headed and came close to blacking out 3 times; throat was sore on one side but not the other/ had a sore throat on the left side outcome of recovering and for all other events, outcome was unknown.  No follow-up attempts are needed. No further information is expected.