Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Fatigue, Head discomfort, Headache, Mammogram
Clinical narrative: She felt dizzy, weak, and tired.; She felt dizzy, weak, and tired.; She felt dizzy, weak, and tired.; Drop in her blood pressure; Right arm pain; headache; fever; she felt pressure on the top of her head, eyes, and nose; dizzy/states that if she stays in bed she is okay. If she gets up, it comes back; She felt like her ear was going to burst/Caller asks if it is okay to feel pressure going into her head from both ears like it is going to blow out; she felt pressure on the top of her head, eyes, and nose; she felt pressure on the top of her head, eyes, and nose; This is a spontaneous report from a contactable patient (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0172), parenteral, administered in Arm Right on 10May2021 at around 12 or 12:30 (at the age of 46-year-old) as single dose for COVID-19 immunization. Medical history included cyst on her breast, it had been diagnosed since probably like 3 to 4 years. She thinks when she turned 40, or it was longer than that, she did not pay attention. Twice a year she gets a mammogram. She believes when she turned 40 it was her first mammogram and they found it. Her pap smears and everything have been good and she had a cyst on her breast that had been under control, it is not cancer or anything. When she was pregnant her last pregnancy her blood pressure went high. She ended up into a C-section. She had headache that time. She confirmed the high blood pressure with pregnancy was 12 years ago. She felt like her blood pressure went high up, up, up and she could not get it down and ended up having a C-section. She did not end up having problems and was on blood pressure medications for years, but everything was normal. The patient had no family medical history relevant to AEs, but her sister had a history of seizures. Concomitant medication(s) included ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS) taken for an unspecified indication, start and stop date were not reported. She had been taking since more than 10 years or more. There was no history of previous immunization with the Pfizer vaccine considered as suspect and no vaccines administered on same date with the Pfizer vaccine considered as suspect. The patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) and had no AEs following prior vaccinations. After she received the 1st dose, the patient felt dizzy, weak, and tired. When she sat on the chair, she said she noticed a drop in her blood pressure. In addition to this, she said she felt weak, and dizzy again, and this time it was accompanied by headache which she noticed when she went to work. She also said that between half an hour and an hour, she felt pressure on the top of her head, eyes, and nose. She felt like her ear was going to burst. She ended up going to the emergency room because she can no longer stand the dizziness. She mentioned that they were ruling out a blood clot so she had to see a neurologist. Later on confirmed that there was no blood clot. She also mentioned that she was afraid to get the 2nd dose but her doctor advised her to proceed with it. She did mention that she was feeling a little better today (11May2021). The patient reported that she got the shot last day (10May2021) and as soon as she got the shot she read the paper that they gave her that says what reactions are. She had to sit down because she got dizzy and a headache. She thought it was her blood pressure. She drove and went to work. She got back home and was feeling so tired and had a headache. She did not work on 11May2021 because she was still tired and had dizziness. She still had dizziness, was still tired, and still had headache. She had been in bed most the day. If she gets up or something, her head started going back. She felt so dizzy. She also had right arm pain, no redness or swelling. She did not know if there was swelling, there might be swelling now - she just feels like everything, like if she touches it or rubs it it hurts. The sore arm started after, 2 to 3 hours after she got the shot. The sore arm was still there. Not as much today as last day. It was still hurting. It did not hurt as much. Patient added that she did not read the paper yesterday as soon as she got the shot. She stood up, went to sit down, and felt dizzy. There was a doctor right there and she was going to ask the doctor to take her blood pressure. She felt like her body was shutting down and she was like damn, she never thought this was because of the vaccine. She did not read the paper they gave her until work. Then she realized that was what it was - she was so super tired and dizzy. Dizzy was the same. If she knew she was going to stay in bed - patient interrupts sentence and states that if she stays in bed she was okay. If she gets up, it comes back. She was going to get something to ate and she just did not want to get up. Patient added first came the dizziness and tiredness and headache right away. Tiredness started right away when she went down. Patient clarifies that she meant that when she sat down, like when she was going to sit down, she felt like she was getting sick like a fever that was icky. She felt like how it feels before someone gets a fever, icky, and that's how she felt. Patient added that the dizziness, tired, and headache all started the same. She did not know how to say it was a headache because it was like a pressure. Her ears were like when she was going to have an infection, it was pressure in her ears. The pressure in her head was on top of her head. Last day, when she got a headache, she believes when she was pregnant her last pregnancy her blood pressure went high. Patient cannot think of what it is called. She ended up into a C-section. That headache that time, she has never had it before, until yesterday. It was the same as years ago. But now it was just the top of her head. She did not end up having problems and was on blood pressure medications for years, but everything is normal. Now it was like, she felt the same pain in her head as she did before. Patient stated she received vaccination because it was a requirement, that it was required now and also she was going to see a doctor for pap smears and other things and they say she had to be fully vaccinated. She was not scared or afraid of the vaccine like other people were. She was not expecting to have those issues. Her pap smears and everything had been good and she had a cyst on her breast that had been under control, it was not cancer or anything. Other than that, she was going to see her doctor on 01Jun2021 to do, as far as she knows, she had no issues she knows of. Patient states that she only took Tylenol. Her coworker said take Tylenol and she had been taking it. She got a paper that she read and that was when she called and it said signs of allergy reaction. The word allergy reaction said hard breathing, swelling face and throat, and something with the heart, weakness which is what she feels, and dizziness. Patient confirmed she did not have these, just the weakness and the dizziness. No rash. No swelling. She felt dizzy and weak and her head. She had pressure that if she did not move she was fine. She did not know, maybe it was because she laying down. If she started doing stuff like she usually does, it comes back when she gets up as pressure. She just did not want to go to the hospital, she will just be so depressed if she does go to the hospital. She felt bad but she thinks she will feel good if she stays in bed. The patient may not get second vaccine: she states whatever right now, she just cannot stand it. She was scared of the second shot. If this happened now, she did not want to get the second shot. She did not feel well at all. She enquired if it was okay to feel pressure going into her head from both ears like it was going to blow out. She felt pressure again. The patient was informed that there is no information on low blood pressure, and pressure in the head, eyes, nose, and ears associated with the Pfizer-BioNTech Covid-19 Vaccine. Outcome of the event fever was unknown; other events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.