Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test abnormal, Balance disorder, Chest pain, Dizziness, Fatigue
Clinical narrative: lips were tingly and swollen; lips were tingly and swollen; fatigued; allergic reaction; passed out; breathing fast; her brain felt like a rock, like she was there but not there; head was so heavy,wouldn't open her eyes; her throat started to tighten up; chest pain; nauseous; headache; felt a little lightheaded, a little wobbly; palpitations; sweaty; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sponsored Program. A 48-year-old female patient (no pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899) via an unspecified route of administrationon 22Dec2020 on left shoulder at single dose for COVID-19 immunization. The patient's medical history included pernicious anemia and She had problems with B12 and Vitamin D like 10 years ago, she had none in her body, everyone said she was deficient and this year with her new primary care, they sent her to do some antibody tests, and found out she has pernicious anemia, allery to MRI and CT contrast. MRI and CT contrast NDC, lot, expiry unknown. Her CT contrast allergy happened when she was 9 and 12 years old. It turns out to be her dad has an allergy the same way, his airways close. Whenever she needs a CT, they do without contrast, if she does need, they prep and give her Benadryl and keep an eye on her. This only happened once, that she needed with contrast, and with prep she was ok. With the MRI, this happened 4 or more years ago, maybe like 5 years ago. She needed an MRI, they said she would be fine, they injected contrast, she felt pretty hot, then she doesn't know, 20 minutes into it, she couldn't handle her gown, she looked at her chest, her whole chest was red like a burn. They gave her the IV Benadryl, she guesses, and it went away, now she knows, she doesn't know if her dad is allergic to MRI dye, but she knows she got the allergy from him for the CT contrast. The concomitant drugs was not reported. The patient was taken to ER with a severe allergic reaction. She had an allergic reaction on 22Dec2020: she passed out, said her brain felt like a rock, like she was there but not there, she then received an Epi Pen shot, when she got to the ER, her throat started to tighten up, lips were tingly and swollen, she was breathing fast, she had chest pain, she scaled it from a scale of 1-10, as about a 3 to 4 for chest pain, she felt nauseous, sweaty, and had a headache. She went to bed last night, and woke up, feeling better but a little fatigued on 23Dec2020. She is wondering if she should take the second dose, and wants to be in the clinical trial for this type of reaction. She needs transfer to Regulatory Authority. Caller confirmed details. Caller states she works in a hospital, and all this happened at the hospital, and her doctor was not involved. Outcome of allergic reaction: asks what does lasting effects mean? Right now she has a little fatigue and headache, but she knows they are regular symptoms she can have with the vaccine, are those lasting effects? She was discharged from the ER to home. She mentioned to the nurse she has, she went to get the shot, she told the registration nurse, she said she has a severe allergic reaction to CT contrast, her airway closes and she has a severe reaction to MRI contrast, her skin burns, it turns red and feels like a horrible burn, she cannot handle anything to contact her skin, it burns, and she mentioned that to the nurse, she said, instead of staying 15 minutes, said to stay 30 minutes there to observe just in case. She got the vaccine, and 10 minutes after the vaccine, she felt a little lightheaded, a little wobbly, but she didn't think much, it was mild, and on the mark at 30 minutes, the nurse asked her to stand, and that is when she started feeling, like her head was so heavy, the only way to describe, was like her brain was like a rock, she had to lay down, and when they laid her down, she wasn't there, she was there but wasn't, and they didn't wait at all to give her the Epi Pen, she had a feeling of heaviness that got worse, she wouldn't open her eyes, she was able to answer questions, but it was not her there, it was weird, then she didn't have. she breathed fast, had palpitations, chest pain, so they called a Rapid Response team, they were keeping an eye on her breathing, which was super fast, and they rushed her to the ED, and the doctor did what they were doing, giving her IV of whatever medication, and she was also very nauseous, then at one point in the ED, she started feeling, like imagine if fists were on throat, pushing her throat, a  little bit, and she tried to tell to the ED doctor, but guessed she was calling everyone to give her things, and didn't catch it, but it didn't last long, at the same time, she started to feel her lips tingly, so she thinks that, because they gave the Epi Pen so quickly, they wasted no time, she didn't have the airways closing like she does when she gets the CT contrast, they were quick. NDC/lot/expiry: She reads from the card they gave her: states first dose COVID-19 EH9899, states it doesn't specify lot, but she can find that out, they just gave her a vaccine record card. EPi Pen: NDC, lot, expiry unknown, states everything happened so quickly, she didn't think to get this information before calling, but she can get it. There at the hospital, she went to see the occupational health doctor, and based on guidelines from the CDC, he read supposedly she cannot get the second dose, but the doctor said because it is so new, and she has to wait the 3 weeks she guesses, things can change, and she wanted to be proactive. The outcome of the events, allergic reaction, passed out, throat started to tighten up, lips were tingly and swollen, chest pain, nauseous, headache, lightheaded, palpitations, sweaty was recovering. The outcome of other events was unknown.