Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swollen tongue, Throat tightness, Urticaria
Clinical narrative: Swelling in one of her eye/one eye was a little swollen; Sore throat/throat was sore; Swollen tongue/tongue swelled up; rash; allergic reactions; Break out with hives/hives under her armpit; Still itch; Probably throat closing up/feeling tight; swelling of her tongue and throat; This is a spontaneous report from a contactable consumer (patient). This 69-year-old female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in arm right on 24Aug2021 10:00 (Batch/Lot Number: FD8448) as dose 2, single at the age of 69-year-old for covid-19 immunisation. First dose was received on 03Aug2021 11:00 am (LOT: EW0198) injection in right arm at the age of 69-year-old for covid-19 immunisation. There were no medical history and concomitant medications and investigation assessment. No AE following prior vaccinations. Vaccination facility type: pharmacy. No additional vaccines administered on same date of the Pfizer suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient got her 2nd dose of the bnt162b2 vaccine on 24Aug2021. Following that night, she broke out with hives. Subsequently she reported being treated with Prednisone and Benadryl. Following that, it went away. But when she started weaning off prednisone, the hives and rash keep coming back on all different parts of her body. She also reported experiencing on Sunday, 29Aug2021, waking up with hives under her armpit, swelling in one of her eye, sore throat and swollen tongue. In line with this, patient would like to know if these are reported AEs post vaccination? If so, she also wanted to know how long these lasts and if she had to be aware of anything that may happen aside from having hives (probably throat closing up). Patient stated she had the second Pfizer vaccine on 24Aug2021 and right after that, that night she started breaking out in hives, and they got so severe, had to go to the doctors and be put on prednisone and diphenhydramine hydrochloride (BENADRYL), she went through the course of that and started weaning down off the prednisone and the hives came back with a vengeance all over her body, in the groin area, all over. She stated the questions she had, she knew with clinical trials, they did say people got hives and rashes, but are these very extreme, like where the throat closed up and tongue swelled up? She was concerned because was there a length of time that these allergic reactions go away after the shot? Is the experience through the trials or something else she should be looking for? She stated as of right now, she was on prednisone, and they have gone away, but as soon as she started weaning down they come back on different parts of the body. She stated when she first got them, they started in the back of her neck on the day of the shot, at the crown of the neck. Then by the next day, 25Aug2021, her groin and top part of her legs were covered with these large hives and the back of her left knee and left ankle. She stated that Sunday, 29Aug2021, was when she weaning off prednisone, she woke up that morning, had hives all underneath armpits, one eye was a little swollen, throat was sore, tongue swelled up could feel hard hives on it. She was put back on prednisone, diphenhydramine hydrochloride and she doesn't know the name, cetirizine hydrochloride (ZYRTEC ALLERGY) tabs, it's celutine, or something, that she needed to take still. Treatment included prednisone: She stated she started with 60mg, cut down to one tablet a day, by mouth; diphenhydramine hydrochloride: 25mg, she stated she can't read it, the dosage, it's too small, she doesn't have her glasses with her. Stated she took it every 4-6 hours, 25 mg tablet. The doctor also still wanted her to take it with the prednisone. Lot: ABF082, expiry Date: Nov2022. She stated the hives are not as bad as the initial hives, but they are in a different part of her body, it's not as raised, but they still itch. She stated the only thing more severe was the swelling of her tongue and throat, it started to feeling tight. Hives: stated began again on 29Aug2021, it went away after she started prednisone and diphenhydramine hydrochloride, well higher dose, and it did go away. She stated she had recovered completely for now, it actually went down the next day, 30Aug2021. She stated she didn't have any medical problems, that's one reason about why she called, because she wasn't sure if through the trials maybe they found out something that somebody gets, like after the adverse event if there is something else after that or in connection with it that may happen so she can be prepared so she can get medical attention right away. No emergency room visit. Physician office visit on Thursday after the shot. The outcome of event break out with hives/hives under her armpit was recovered on 30Aug2021. The outcome of event still itch was not recovered.  The outcome of other event was unknown.  Follow-up attempts are completed. No further information is expected.