Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Urticaria
Clinical narrative: whelps on her arms; This kept getting worse/ itching so bad; itching on random spots if my body/ kept getting worse/ white and red bumps; itching on random spots if my body/ kept getting worse/ itching so bad all over her legs/ burning itch that it came up with white and red bumps; This is a spontaneous report from a contactable consumer (patient). A 65-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6204; NDC number and expiry date: unknown) via an unspecified route of administration on 10Mar2021 at 12:00 (at the age of 65-years-old) in upper right arm in the muscle as a single dose for covid-19 immunization. Medical history included allergy to Sulfa, dust, mold, grass and cats, arthritis, asthma, high blood pressure (controlled with medication), high cholesterol, depression, acid reflux, aneurysm in heart, and anxiety all from an unknown date and unknown if ongoing. She had allergies and used to take allergy shots and the staff said it didn't matter whenever she went to get the vaccine. Years ago, she had an antibiotic (unknown lot, expiration) and started itching. She had a urinary tract infection or something but then started to itch after taking the antibiotic. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient had not been tested for covid-19. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect, prior vaccinations (within 4 weeks), adverse events following prior vaccinations, family medical history relevant to adverse events were reported as none. Concomitant medication received within 2 weeks of vaccination included rosuvastatin calcium (CRESTOR) taken for high cholesterol, unspecified inhaler for asthma, unspecified blood pressure medication for blood pressure high, all start and stop date were not reported. Her husband had the vaccine and was fine. On 11Mar2021 after vaccination she came home and felt fine, at 07:00 the patient experienced itching in random spots, it kept getting worse. Broke out in whelps, it would pop up sporadically, it was on her back, legs, stomach, and her arms. On 12Mar2021. She thought it was dry skin, it became intense so she took 3 Benadryl's and put cortisone cream on the whelps that would come up. It was this past Thursday, she wouldn't quit itching it was 18Mar2021, that night before on 17Mar2021, she was itching so bad all over her legs she had to go see her primary care provider team. The physician's assistant said it was a reaction to the vaccine and saw the whelps on her arms at that time. The physician's assistant gave her a strong steroid shot and told her to continue taking 3 Benadryl's a day and Pepcid. After the shots the next morning the itching and everything was a whole lot better. She filled out a case number, she was due for her second shot on 31Mar2021. The itching was bad until the steroid shot. The severe itching was ongoing. When it started itching severely, she knew it wasn't just dry skin. She knew people were scared of the vaccine since it is not fully FDA approved. She tried not to scratch but it was a burning itch that it came up with white and red bumps. She reported that she took the same medication every day and she did not had itching and whelps until the next day, following the vaccine. She also reported that several family members got their vaccine and not one thing happened and then she got, and she looked like a pin cushion the next day, it was strange. The events resulted in doctor or other healthcare professional office/clinic visit. She was worried because she won't have the full immunity but doesn't know if she should get the second shot. She heard that she cannot go out and get another vaccine like Johnson and Johnson, and she also heard that you shouldn't get the second shot if you have had a reaction. She wanted to know if she should get the second dose of the vaccine. The caller filed a safety report online, but she deleted it, her main email address wouldn't let her print it. She wanted to know if there's any way she can get a copy of the adverse event for her files. She wanted to file another safety report on the same event to make sure it went through. Report reference number: F843A308-OE66-4B7D-B347-9C2358635602. The physician's assistant that the caller saw told her to report. Treatment medication included Benadryl- regular over the counter 25mg. She took it 3 times a day, every 4-6 hours, lot number AAF092, expiration Oct2022. It was the real brand. Cortisone 10 maximum strength with aloe topical cream- lot number unknown, she did not keep the box and could not find it on the tube. expiration date 01Apr2022. The outcome of all the events was not resolved.  No follow-up attempts are needed. No further information is expected.