Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure inadequately controlled, Blood test, Hypersensitivity, Pruritus, Skin discolouration
Clinical narrative: itching in her whole body; allergic reaction; Severe itching/hives; black and blue from itching; I am so stressed out with this itching that it has made my blood pressure go up; stressed; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 07Oct2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162b2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in the left arm on 25Feb2021 (Lot Number: EN6198) as a single dose for COVID-19 immunization and an unspecified medication. Medical history included Blood pressure high which was under control. Concomitant medications included metoprolol tartrate taken for Blood pressure high; vitamin D in the morning and amoxicillin taken for dental operation from 16Feb2021 to 24Feb2021. Past drug included BNT162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in the left arm on 06Feb2021 (Lot Number: EL9269) as a single dose for COVID-19 immunization and an unspecified medication. The patient did not take an prior vaccinations within 4 weeks. The patient received the second dose on 25Feb2021 and 10 days later (also reported as 7 to 10 days later), on 07Mar2021, the itching in her whole body began then waited for a few days for it to subside. She went to her family doctor who told her to go to a dermatologist in which they performed some blood work and gave her creams and prescription but nothing worked. She was suggested to go to a hematologist in where they performed more blood work and there was nothing in the blood work. She also went to the ER because the itching was so bad that it was black and blue from the itching. They have also searched for a gene that could mutate and found nothing as well. She went to another dermatologist but they could not help her either. She was still experiencing it after visit with 5 doctors and described her symptom as terrible itching with hives in which nothing takes it away. She added that the hives always come back. She said that prior to this, she was very healthy. She stated that it had to be the shot. She was an extremely healthy person and she had never had anything. All 5 doctors told her it had to be a reaction to the shot. It didn't happen until after she got the second one. She had seen her family doctor, her spouse's doctor, 2 dermatologists and allergologist, with no relief. All say there was nothing in blood work and must be allergic reaction to vaccine. She tried Zyzal and it did give her some relief, but had to stop it as it made her blood pressure go very high. As of 01Sep2021, she he was still itching and she get hives every once in a while, big hives that hurt and then finally go away. Since she had this itching, the heart doctor gave her Olmesartan 25 milligrams. The heart doctor said that the itching was because she was so stressed out with this itching that it had made my blood pressure go up. So he gave additional medicine to keep the blood pressure down. The medication (Olmesartan) was keeping the blood pressure down which it was supposed to do but she was still itching. The itching never stopped. She had been given prescription and non prescription creams, etc, that work some what but itching remains. The patient had all kinds of lab work. She even went to the Emergency Room once and had lab work done and they couldn't help her either with the itching. Nothing showed up on the lab work. The outcome of itching, hives and allergic reaction was not recovered. The outcome of blood pressure went up was recovered. The outcome of black and blue from itching and stressed was unknown. The patient considered the event as serious due to Persistent/significant disability/incapacity.  No follow-up attempts are needed. No further information is expected.