Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Off label use, Product use in unapproved indication, Vaccination site pain
Clinical narrative: Caller states the ingredients that's in the Pfizer vaccine, it had some of her medication in it so that right there kind of helped her out a little bit so she felt a little better after she put a cold compress on her throat and her forehead and her; Caller states the ingredients that's in the Pfizer vaccine, it had some of her medication in it so that right there kind of helped her out a little bit so she felt a little better after she put a cold compress on her throat and her forehead and her; Caller states the ingredients that's in the Pfizer vaccine, it had some of her medication in it so that right there kind of helped her out a little bit so she felt a little better after she put a cold compress on her throat and her forehead and her; it stings, just has a little sting to it; she had some illness; nausea; vomiting; some lumps behind both ears/ kind of lumpy-like; tiredness; muscle pain; joint pain/ joint aches; pain from injection; headache / headache was reported as worsened; This is a spontaneous report from a contactable consumer. A contactable consumer (patient) reported for herself that the 65-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 30Mar2021 (Batch/Lot Number: ER8727) at single dose for covid-19 immunisation  .  Medical history included seizure from 2016 to an unknown date, cardiac failure congestive from 2009 to an unknown date (she had a stent put in), cerebrovascular accident from 2018 to an unknown date (stroke). The patient's concomitant medications were not reported. The patient experienced pain from injection on 30Mar2021 with outcome of recovering , headache / headache was reported as worsened on 30Mar2021 with outcome of not recovered, tiredness on 04Apr2021 with outcome of not recovered, muscle pain on 01Apr2021 with outcome of recovering, joint pain/ joint aches on 01Apr2021 with outcome of recovering, nausea on 05Apr2021 with outcome of recovering, vomiting on 05Apr2021 with outcome of recovered on 05Apr2021, some lumps behind both ears/ kind of lumpy-like on 05Apr2021 with outcome of recovering, caller states the ingredients that's in the pfizer vaccine, it had some of her medication in it so that right there kind of helped her out a little bit so she felt a little better after she put a cold compress on her throat and her forehead and her s on an unspecified date with outcome of unknown , it stings, just has a little sting to it on an unspecified date with outcome of unknown, she had some illness on an unspecified date with outcome of unknown.  The clinical course was reported as follows: She woke up with a little bit of surprises. She had reactions and it kind of took her by surprise. She's got 18 more days to go. She got it on 30Mar2021. So on the first roll of what she calls it, reactions, she had seemed like, she did not have chills, fever, she had all the other ones. She had pain from the injection, that was like say like three days after the injection, she had that, then she had the headache that night after the injection and the tiredness and then muscle pain came along with that and then the joint pain came this morning or last night, she knows old age can hit her too. It was a surprise, she has a little, some problems with reactions also because she has had a stroke, so that has been a while. She had a stroke in 2018, so and by the weather being a little cold, she kind of looked over joint aches and is trying to move in and get a little attention. Caller states the weather had changed, so she didn't pay it any attention with the joint aches and muscle pain. Then, she got some surprises this morning with nausea and after that she was a little coocoo from the coco pops and then back behind her ears, she had some lumps behind them, behind both ears. Caller states kind of lumpy-like so she felt like that maybe that was because she was vomiting a little bit too hard, it was going too hard, it kind of scared her. Caller states also vomiting and stuff. She also has congestive heart failure. Caller states the ingredients that's in the Pfizer vaccine, it had some of her medication in it so that right there kind of helped her out a little bit so she felt a little better after she put a cold compress on her throat and her forehead and her stomach. Caller states she felt a little better, what she had in her, got out of her. She drunk her some ginger ale and it did make her feel better, now she's drinking her some cold water. When she left the place where she was out there at she was about 4'10''. She's been eating like a little pig too. She was trying to give herself some, say some time periods, like she said the 30Mar2021, was on a Tuesday. When she was supposed to go get them, so they called and cancelled because of bad weather, so they re-scheduled her first dose on 30Mar2021. Caller states she goes back between 20Apr2021 or 21Apr2021 so she has to call them back on 15Apr2021 to make sure that she will be on the chart to get the second one. She doesn't know if they made that appointment, states she wants to make sure that she is on that schedule because she knows that is in  20 days, its between 20Apr2021 and 21 Apr2021. Pain from injection started around 600PM that night, well it didn't really stop. She took her some Tylenols every 4 hours and it stopped hurting around 02Apr2021. After she put some heat to that rascal. Caller states she can touch it and tell you that's where she did the damage. Caller states she put a band aid there so she won't touch it, it stings, just has a little sting to it. Caller clarifies the pain is still ongoing, it has improved. Caller states the headache started five minutes after getting the vaccine, and it keeps getting kind of heavy. Caller states she's a little tired, but she's been pushing herself to make herself do things. Caller states as long as she doesn't think about her tiredness, she's motivating herself. Caller states the weather that morning got real cold, that was Thursday, the weather hit 34 degrees. Caller states it's getting better. Caller states it's soothing down with the Tylenol, when she takes the Tylenol. She has been taking Tylenol every four hours. Caller states the Tylenol has been keeping it in control. Caller states that medication she is on, because she had some illness, because she had a stroke, states the medication that's also in this Pfizer vaccine, it's kind of keeping it under control. Caller states the medicines in the Pfizer vaccine and the medicines she takes, is keeping it on the down low. Caller attempts to clarify ingredient as like potassium- chlorine or something. It's a real long word, she doesn't know how to say it.  Nausea; Vomiting happened real early this morning, it has settled. Her and the Lord had a conversation, he told her to drink some Ginger ale and put the cold compresses on her stomach, throat and head. She noticed Some lumps behind both ears around 300, she started noticing everything this morning. They are going down, because with that compresses that she put back there, she put one on the front and one on the back, and one on her stomach with alcohol. She was prepared. She had alcohol and compresses. Caller states she's not ready to go to the hospital, she wants to take care of herself. Caller also unsure of dose. Caller states she doesn't think the symptoms that she had are from this vaccine, she knows she didn't have those symptoms. Caller states and now and if she is off timing with her medication, they don't make her do all that, they don't send her to the coocoo nest, not all at one time. She has seizures, they don't have her running around like she's lost her mind. She was wondering what in the world was going on with her this morning. Her seizures started back when she had her stroke, back in, well she fell and split her head wide open, she's trying to think before it happened. Caller clarifies 2016 was her first seizure. Caller states a while back she went to the doctor, on 15Feb2021, she had some diarrhea going on, way before she got the vaccine. Caller states it was like a bug, she thought she had been around someone that had the virus, had a case of diarrhea. Caller states they couldn't figure out what caused her to having it, what it was is, she was real depressed, she was going through some issues, just had a nervous stomach, and she was depressed, then she took her some Pepto-Bismol and it took a while before it stopped, it was going on for like three weeks. She is drinking ginger ale and water to get electrolytes back in her system. Caller states it says 8 ounce fluid, 236 ML. Caller states it is from the Dollar General Store. Caller states well, she doesn't have her eyes on, she took 15 ML, took it as she needed and then when she did, she took the 15ML and took some water behind it to coat it, to soothe it. Caller states after she drunk, it left a nasty taste in her mouth. Caller states she didn't take the Tylenol until, because the Tylenol was just opened when she started this Covid shot. Caller states she doesn't have it with her. Caller states she's trying to get the liquids back in her system after that, because she was scared, she had to go run an errand and she had her Gatorade and all that with her. Caller states she's getting her exercise today girl, she was trying to stay still just in case she has an accident. Time the Vaccination was Given: 1430, and she waited and she asked if she could wait 30 minutes. No History of all previous immunizations with the Pfizer vaccine considered as suspect. No Additional Vaccines administered on SAME DATE of the Pfizer suspect. No AE(s) require a visit to: Emergency Room or Physician Office. Prior Vaccinations within 4 weeks (List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s)): No, caller states the only thing she had was she went to the doctor to get a test for Gastrology and the only thing they did was take some blood, this was before the vaccine. Caller states that's when she had, she was going to a depression stage and they took her blood at the hospital. Caller states they let her stay there for a while, they wanted to counsel her for a while, they wanted to calm her down then let her go home. She confirms this was before the covid vaccine. No AE(s) following prior vaccinations. No Family Medical History RELEVANT To AE. No Relevant Tests: the only blood work she has had was when she got her, when she was really depressed. They checked her blood to see if she was okay and they checked her urine, and everything was normal and that's when they let her come home. The only thing, only problem she had was her blood pressure, her blood pressure was out of this world. Caller states her blood pressure is kind of hard to control. Caller states she has a nurse that comes and sees her regularly. She has an in-house nurse that comes and checks on her monthly. Since she had this first allergies or whatever she wants to consider these things, she's  since she had this first reaction after the first one, she's pretty sure that that may be some more because this was the first dose. Now she had faith that she wasn't going to have any, she kept on saying she was going to be alright, she gave herself a positive outlook and since she got 18 more days to go she's gonna be alright with the second dose. Its just something, since she has a crazy body with her resistance, she has a crazy body, by her existence here, her immune system, is like kind of normal and she has a lot of allergies so besides penicillin and she has a list of allergies. Caller states with that she's pretty sure she has the faith that she has with the lord, something that is going in her body, that she is going to be alright. She had convulsions and she goes to acting a plum fool. She shakes all over the place and she just acts like a nut. The only one who knows them numbers are the good Lord. Caller reporting adverse events after first Pfizer Covid vaccine. She took some Tylenols every four hours after having pain at the injection site, but there is still burning at the injection site. Caller also states she had headaches and they are just getting heavier. She doesn't want to get up again, she needs a break. She started having diarrhea, just had a nervous stomach, and she was depressed, then she took her some Pepto-Bismol and it took a while before it stopped, it was going on for like three weeks. Caller states this occurred prior to receiving vaccine and visited the doctor for diarrhea on 15Feb2021. Caller states from the Dollar General Store. Caller states well, she doesn't have her eyes on- she took 15 ML, took it as she needed and then when she did she took the 15ML and took some water behind it to coat it, to soothe it. Caller states after she drunk it, it left a nasty taste in her mouth. No follow-up attempts are needed. No further information is expected.