Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Rash, Temperature intolerance, Urticaria, Vulvovaginal pain, Weight decreased
Clinical narrative: psychosis; cognitive decline; could not go out in heat; hives almost all my body/bad rash all over your body; bad rash all over your body; Vaginal pain; skin feels tingling all over her body; throat had pain and was dry and hot; waves of heat and hot spots/it was worse on her legs; she would be so cold she couldn't get warm again; butt was stinging and burning; butt was stinging and burning/burning in the back of her knees; couldn't sleep; Confusion; Constipation; Weight loss; throat had pain and was dry and hot; throat had pain and was dry and hot; noticed round raised bumps on same arm as the shot; This is a spontaneous report from a Contactable consumer. This 68-year-old female consumer (patient) reported that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534, Expiry Date, NDC Number: Unknown), via an unspecified route of administration, administered in left arm (on the arm but not the shoulder) on 05Apr2021 at 10:30 (at the age of 68 years) as dose 2, single for covid-19 immunization. Patient received prednisone on 15apr2021 at unknown dose, via an unspecified route of administration, on 16apr2021, 10 mg, tablet and orally, 18apr2021 at unknown dose, Intravenous, 19apr2021, 40 mg and on 26Apr2021, UNK, it was a 30,20,10 taper, via an unspecified route of administration for unknown indication. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (SYNTHROID) 88 mcg daily. It was reported that the patient took Synthroid but she did not have a thyroid. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266, Expiry Date, NDC Number: Unknown), via an unspecified route of administration, administered in left arm on 11Mar2021 (at the age of 68 years) as dose 1, single for covid-19 immunization. The vaccination facility was health department type and not military facility. The patient wanted to report her adverse event and severe reaction that she had after the second dose. The event happened 10 days after the second dose. On 15Apr2021, the patient noticed round raised bumps on the same arm as the shot, not pimples because they did not have a head. The patient applied calamine lotion but the bumps kept coming up more and more. The patient ended up being covered in hives on her whole body except her face, she was bright red and looked like a lobster. The patient was given a prednisone shot (unknown lot, NDC and expiration date) at the emergency room and the hives were better for about 12 hours, this was on 15Apr2021, but they came back. It was reported that she had this rash that would come up and go away. She went to an urgent care the following day and they gave her Prednisone (unknown lot, NDC and expiration date) 10 mg tablet and the next day she felt normal but then it rebounded. The patient went back to urgent care on the 17Apr2021 because the hives rebounded. Then on 18Apr2021, the patient went back to the emergency room and they gave her IV prednisone. The patient did not have any problems breathing. On 18Apr2021, the dermatologist took two biopsies and determined the rash was not lupus and it was from a drug but none of her normal medications. The doctor thought that this was from the covid shot. On 19Apr2021, the patient went into her dermatologist and got 40mg of Prednisone and was on that for a long period of time. The step down of that medicine started on 26Apr2021 and it was a 30,20,10 taper. The patient was scared that the hives would come back. She could not go out in the heat, her skin felt tingling all over her body. That had been going on since the hives was ongoing. If it was above 74 degrees outside, the patient could not go out because it got uncomfortable, it was really severe but had gotten less. On 05May2021, she was at the gynecologist with vaginal pain and they took her to the emergency room and was sent to the psych ward for a week because of psychosis from the Prednisone. She was admitted to the psychiatric hospital from 05May2021 to 12May2021. She had throat pain and was dry and hot. Cold water caused extreme pain if she drank it so she gurgled with lukewarm water. All of the patients symptoms were happening at the same time, starting with the hives, but varying intensities. She had waves of heat and hot spots that lasted 15-45 minutes then moved to another place, from her arms to her legs. Her butt was stinging and burning. This came back on the 04Jul2021 it was worse on her legs. She could not sleep, the bed would get really hot and would get pressure points lines from the sheets or if she crossed her legs it would leave a mark. She had cognitive decline, the doctor said that this was from the Prednisone and would take 4 months to get out of her system. She had confusion and constipation. She had weight loss, she had not tried to gain it back because if she ate too much she got an upset stomach. On 18Apr2021, her reaction was full blown. If she kept cold water on her skin it was okay, she would stand in front of fans but she would be so cold she could not get warm again. She did not remember all of this because of the steroids. On 04Jul2021, she had burning in the back of her knees until 08Jul2021. She was disappointed that all of this happened after the vaccine. The patient underwent lab tests and procedures which included biopsy skin: the reaction was from a drug and not lupus on 18Apr2021. The outcome of events hives, rash, skin feels tingling all over her body, waves of heat and hot spots, butt was stinging and burning, could not sleep, cognitive decline, confusion, constipation, she would be so cold she could not get warm again was not recovered while outcome of rest of events were unknown.