Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; Itching; She had cracking creases with serous fluid coming out of both hands; She was covered big blisters; blotches; Her hands were so swollen after getting the dose of the vaccine that she couldn't get them closed; This is a spontaneous report from a contactable nurse, the patient.  A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration in the left arm on 05Feb2021 at 12:20 (at the age of 75-year-old) as a single dose for COVID-19 vaccination.  Medical history included reverse total shoulder replacement on 26Jan2021, cardiomyopathy from an unknown date, and type 2 diabetes mellitus from an unknown date.  There were no concomitant medications. The patient previously received her shingles shot (MANUFACTURER UNKNOWN) and flu shot (MANUFACTURER UNKNOWN); both in Oct2020 for immunization and had no reactions.  On 05Feb2021 at 16:00, the patient experienced hives and itching. On 05Feb2020, the patient had blotches, blistering, swollen hands, and cracked creases with serous fluid coming out of the hands. The clinical course was as follows: She had absolutely no problem at the time of the injection, no soreness with it she was fine and then she had welts starting with 2-3 then all over her body, that were itching terribly. They stared on the left wrist, both hands. The patient took diphenhydramine hydrochloride (BENADRYL); but it did not help. The patient then went to the emergency room (ER). By the time she got to the ER, the hives moved up to her abdomen and she was covered in big blistery looking raisings and few small raises on her trunk and arms. The hives were concentrated from her fingers to her elbow, and then there were other blotches on her elbows to her fingers that were real concentrated. She stayed at the hospital for 3 hours, but she was not admitted. At the ER, she received pantoprazole (PROTONIX), diphenhydramine hydrochloride, hydroxyzine (ATARAX) and prednisone (MANUFACTURER UNKNOWN). The patient also stated that her hands were so swollen after getting the dose of the vaccine that she couldn't get them closed and she had cracking creases with serous fluid coming out of both hands. The swelling went down a little bit the next day; but she still had the blotches. She said the itch was tolerated. However, the blistering started again. Her doctor put her on a sliding scale of prednisone and diphenhydramine at 25 mg every 6 hours. The clinical outcome of the swelling hands was recovering; while that of the blotches and blisters were not recovered. The clinical outcomes of the hives, itching, and cracked creases with serous fluid coming out of the hands were unknown. The patient assessed the events to be medically significant as she had never experienced anything like this.; Sender's Comments: Considering the temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of the reported events cannot be excluded. The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.