Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pruritus, Rash, SARS-CoV-2 test, Urticaria
Clinical narrative: whole body super itchy/ every time she would itch/ itch continued to flare up; her skin would get raised welts, red and rashy; her skin would get raised welts, red and rashy; felt heated up inside; palm, and fingers became red and inflamed; palm, and fingers became red and inflamed; could be GERD/ it sounds like GERD or hiatal hernia; bad pain in her stomach/ sharp pain in waves/ felt in upper part of her stomach, diaphragm; could be GERD/ it sounds like GERD or hiatal hernia; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6199, Expiry date: Unknown) via an unspecified route of administration, administered in left arm on 08Mar2021 19:30 (at the age of 54-year-old) as dose 1, single for covid-19 immunization. Medical history included high Blood pressure, high cholesterol. Patient had ongoing allergies, pet and seasonal allergies. Concomitant medications included levocetirizine dihydrochloride (XYZAL, Lot Number: 20E137, expiration: 23May) taken daily for Allergy, olmesartan, rosuvastatin calcium (CRESTOR) taken within 2 weeks of vaccination and diphenhydramine hydrochloride (BENADRYL, Lot Number: 1800411, Expiration Date: Aug2022) taken few minutes before first injection for an unspecified indication, start and stop date were not reported. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient been tested for COVID-19 on 22Mar2021 with unknown results. The patient reported that she had the vaccine on 08Mar2021 at 19:30. It was stated that on 12Mar2021, the patient whole body super itchy. That night, her palm, and fingers became red and inflamed. The patient stated that every time she would itch, her skin would get raised welts, red and rashy. She stated that she felt heated up inside, but had no fever, She would take two Benadryl and go to sleep. She did take a Benadryl about a few minutes before the vaccine. Benadryl: no NDC, Lot: #, and expiration looks like 22Aug, she thinks, it looks faded on the box. The itch continued to flare up at certain points during the day, and at times was manageable, like when she went swimming, it would feel better. She took a Xyzal every day because she has allergies, and stated this was before she received the vaccine. Described Xyzal as a common over the counter, daily allergy medication. No NDC, Lot: #, and expiration: 23May. The patient stated she was late for an appointment, that was 15 minutes ago. She wanted to report all of the things together, she thought in case they were related. On 10Mar2021 at 03:00, the patient continues to report that she woke up, in the middle of the night with a bad pain in her stomach. She thought it could be GERD, and she never had that before. She describes as irritating, sharp pain in waves. She states she got up, felt in upper part of her stomach, diaphragm, and took an antacid. Later clarified in report: Prilosec, no NDC, Lot, or expiration. Caller states stomach pain subsided, thought it was one and done and on Thursday, it happened again, only when she slept. She took the antacid, clarified. Caller states she went to the doctor for the abdominal pain and he said that it sounds like GERD or hiatal hernia, but she would have to have endoscopy and has to make an appointment. She was taking Prilosec, no NDC, Lot, or expiration provided. She was not sure it was relevant the night before, when she had the itchiness on her body. She doesn't know, maybe it was related. She wanted to report it and states the possible itch and GERD could be histamine in the body. The outcome of the events of could be GERD/ it sounds like GERD or hiatal hernia, Abdominal pain upper was recovered on an unknown date in Mar2021 and other events was not recovered. Follow up attempts are completed. No further information is expected.