Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus pain, Spinal pain, Tremor, Vaccination site swelling
Clinical narrative: Second dose: Tremors; Second dose: Dry skin; Second dose: Ear ache; Second dose: Throat hurts; Second dose: Nose hurts; Second dose: Sinuses hurt; Second dose: Muscle aches; Second dose: Chills; Second dose: Nausea; Second dose: Blood pressure high; Second dose: Rash; Second dose: Headache; Second dose: Heart rate went from 72 to 66 and stuttered; Second dose: Arm at injection site was all swollen and puffed up; Second dose: Sore arm; Second dose: Woke up having neurological event; Second dose: Lungs hurt; painful in her spine; Headache was reported as worsened/ Nausea was worsened /Ear ache was worsened /Nose hurts was reported as worsened /Sinuses hurt; This is a spontaneous report from a contactable consumer (patient herself). This 66-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0170 and expiration date was not reported), via right arm on 17APR2021 10:45 as dose 2, single for COVID-19 immunization. The patient medical history included in 2020 she had Pacemaker, heart rate went from 72 down to 66 then stuttered before her pacemaker kicked In, in 2009 she had traumatic brain injury, Dysautonomia, blood pressure stable, her traumatic brain injury was a brain stem injury, her heart and breathing were affected by the brain stem injury. thyroid, had to have her eyes operated on 3 times, brain injury was a brain stem injury. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number ER8727 and expiration date was not reported), via right arm on 24Mar2021 dose 1, single as single dose for COVID-19 immunization. After first dose on 24Mar2021 (At age of 66 years old) patient experienced Dizzy, felt really cold, heart rate went from 99 beats per minute to 47 beats/min, Flu symptoms, chills, and nausea. The concomitant medication included Hydrochlorothiazide, 25 mg once daily, in 2014 for she began taking hydrochlorothiazide after her traumatic brain injury due to dysautonomia. Clonidine, 0.1 mg once daily she began taken about a year ago for blood pressure stable. Methimazole, 2.5 mg daily she started taking methimazole years ago for Thyroid. On 17Apr2021 patient experienced Heart rate went from 72 to 66 and stuttered, Arm at injection site was all swollen and puffed up, Sore arm, on 18Apr2021 she had Muscle aches, Rash, Headache, Chills, Nausea and Blood pressure high, on 21Apr2021, experienced Earache, Nose hurts, Sinuses hurt, and throat hurt, on 29Apr2021 she had dry skin. On 30Apr2021 she had Tremors, on Apr2021, experienced woke up having neurological event, Lungs hurt. On an unknown date 2021 she had painful in her spine and condition was aggravated. Caller reported that her physician had the caller go to her cardiologist to check to make certain that the patient was ok to get the second dose of the Covid-19 vaccine. Caller reported that the cardiologist cleared her to get the second dose. Caller reported that she had her second dose of the Covid-19 vaccine on 17Apr2021. Caller reported that although her heart stayed fairly stable, her heart rate went from 72 down to 66 then stuttered before her pacemaker kicked in. Caller reported that by the time she got home on 17Apr2021, she felt really awful. Caller reported that she got progressively worse over the next 3 days. Arm at injection site all swollen and puffed up: Caller reported that she received the Covid-19 vaccine around 10:45 AM on 17Apr2021 and she thinks that she noticed her arm was swollen when she got undressed to go to bed. Caller reported that her arm was swollen for a couple of days and that it was still swollen on Monday, 19Apr2021. Caller reported that her arm was still sore and the soreness was in the muscle. Caller reported that the pain was pretty much the same. Caller reported that the level of pain hasn't increased but she is surprised that it was painful kind of a long way away from getting the injection. Caller reported that on the back of her shoulder she developed some kind of rash which has since gone away. Caller reported that the rash started to flake off on 20Apr2021 or 21Apr2021. Caller reported that she had an intense pressure feeling up her spine into the back of her head which caused a really bad headache. Caller reported that she didn't pass out but got to the point where she thought that she couldn't stand up anymore and had to lay down then immediately fell asleep. Caller reported that she noticed her skin was dry yesterday, 29Apr2021, when she woke up and noticed that her skin didn't look right. Caller reported that her skin seems rougher and drier and it was not normal. Caller reported that she put a ton of lotion so her skin looks better but she doesn't know if it's actually better. Caller reported that the chills come in waves and the last bunch were not as bad as they were the first time. Caller reported that the chills have been hanging on longer and when they come back they come back harder. Caller reported that the chills have lengthened in duration but are not as bad as they were. Caller reported that she has been trying to stay hydrated and trying to let her immune system do its thing. Caller reported that she has not been taking Tylenol or Ibuprofen. Caller reported that the nausea comes and goes in a wave like manner. Caller reported that the nausea suddenly came back this morning, 30Apr2021. Caller reported that she expected the nausea to go away after the first week. Caller reported that she had ugly flu symptoms of headache, nausea, and chills that seemed to go away and then came back with a vengeance on Sunday, 25Apr2021. Caller reported that the side effects went away, then came back yesterday 29Apr2021 and are worse today 30Apr2021. Caller reported that she was concerned because this is 10 to 13 days later. Caller reported that doesn't feel right. Caller reported that her side effects feel neurological. Caller reported that her hands began shaking when she went to put the toast in the toaster and that is not like her. Caller reported that she is not still having tremors at time of call on 30Apr2021. Caller reported that she is not sure if she has recovered and she will have to wait and see on that. Caller reported that she went and took Ibuprofen and laid down after the hand tremors. Caller reported that her hand wasn't voluntarily shaking. Caller reported that she picked up her toast and her hand was trembling as she was trying to get the toast into the toaster. Caller inquired if Pfizer has heard of neurological side effects before. Caller reported that her physician does not know anything about what happened to the caller with the increased heartrate after the second dose of the COVID-19 vaccine. Caller stated that she wondered what would have happened if she didn't have a pacemaker. Caller stated that she thought that she needed to report her adverse events. Caller reported that the literature she read said that it's not common to have side effects for so long. Caller reported that she has had to lay down twice today, 30Apr2021. Caller reported that she had a seminar this morning and had to go lay down afterward. Caller reported that the headache pressure was intense. Caller reported that she went and took her blood pressure medication that she never has to take and took the blood pressure medication just to make the pressure stop. Caller reported that she woke up not having seizure episodes but neurological events 2 nights this week. Caller reported that the neurological event is where you're not breathing as well as you could be and you wake up gasping. Caller reported that of the last 3 nights, the event didn't occur on the one night that she slept on her right side but happened twice when she was sleeping on her left side where her pacemaker was. Caller reported that she woke up and had a terrible headache. Caller reported that she thinks her headache woke her up. Caller reported that her side effects will go away for a day or two and then come back. Caller reported that each time her side effects come back, they are worse. Caller inquired if this is typical. Caller reported that she doesn't know why, but her rib cage felt like oh god what is that. Caller reported that it felt like she had taken a check in a hockey game. Caller reported that she rested and the pain sort of subsided. Caller reported that yesterday, 29Apr2021, and the day before, 28apr2021, the pain was really bad. Caller reported that her lungs still feel tight but she does not have horrible pain. Caller reported that she is making sure that she is doing deep breathing. Caller reported that the lung pain began this past week. Caller reported that when her lungs started to hurt and her other symptoms returned, she decided that she was not going to tough out her symptoms but was going to call Pfizer to report them. The outcome of event (Heart rate went from 72 to 66 and stuttered) was recovered on 17Apr2021, the event (Arm at injection site was all swollen and puffed up, Rash) was recovered on Apr2021, lungs hurt and chills was recovering, event of (Sore arm, Headache, Nausea, Muscle aches, Earache, Throat hurt, Nose hurts, Sinuses hurt) was not recovered and the event of (Dry skin, Blood pressure high, Woke up having neurological, painful spin, condition aggravated) was unknown.  No follow-up attempts are possible. No further information