Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus, Urticaria
Clinical narrative: Soreness of joint; Caller stated that she got the booster shot last 19Oct2021 and 4 days after her lupus relapsed; Broke out all over, chest broke out red hives; Skin blood red and blistered; Skin blood red and blistered; Burns like fire and itches like Poison ivy; Burns like fire and itches like Poison ivy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Oct2021 (Lot number: FC3184) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Colitis" (unspecified if ongoing). Family history included: "Lupus" (unspecified if ongoing), notes: Mother had Lupus. She has been gone for 15-18 years. Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]; FLU. Vaccination history included: Bnt162b2 (Dose: 2, Lot number: EN6208, Injected in left arm. , Primary Immunization series complete but unknown manufacturer), administration date: 19Mar2021, when the patient was 66 years old, for COVID-19 immunization; Bnt162b2 (Dose: 1, Lot number: EN6200, Injected in left arm. , Primary Immunization series complete but unknown manufacturer), administration date: 26Feb2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant) with onset 23Oct2021, outcome "not recovered", described as "Caller stated that she got the booster shot last 19Oct2021 and 4 days after her lupus relapsed"; URTICARIA (non-serious) with onset 23Oct2021, outcome "not recovered", described as "Broke out all over, chest broke out red hives"; ERYTHEMA (non-serious), BLISTER (non-serious) all with onset 23Oct2021, outcome "not recovered" and all described as "Skin blood red and blistered"; SKIN BURNING SENSATION (non-serious), PRURITUS (non-serious) all with onset 23Oct2021, outcome "not recovered" and all described as "Burns like fire and itches like Poison ivy"; ARTHRALGIA (non-serious) with onset 17Jan2022, outcome "not recovered", described as "Soreness of joint". The events "caller stated that she got the booster shot last 19oct2021 and 4 days after her lupus relapsed", "broke out all over, chest broke out red hives", "skin blood red and blistered", "skin blood red and blistered", "burns like fire and itches like poison ivy", "burns like fire and itches like poison ivy" and "soreness of joint" were evaluated at the physician office visit. Therapeutic measures were taken as a result of systemic lupus erythematosus.  Clinical comment: Patient stated the inquiry is regarding the Pfizer Covid 19 Vaccine boosters. Patient stated that she got the booster shot last 19Oct2021 and 4 days after her lupus relapsed. Patient was asking if there is any difference between the booster shot and the previous vaccines she got on Jan2021 and Feb2021. Four days after took it, her Lupus came back full force. She has lupus and it was under control, and she was on Plaquenil for 2 years. She was doing good. The Lupus came back full force and is horrendous.She broke out all over. Her skin is blood red and looks like she has been out in sun. It looks like when you go to the beach and lay out in and sun and has blistered. It itches like the worst poison ivy ever. It burns like Fire and itches like Poison Ivy. This was a severe case. She decided she did not want to provide the doctor she goes to for wellness. She provided the Lupus doctor.  She has been sitting, thinking and when she first got Lupus, the sun was not her friend and she break out in the sun. She has not been out and wears long sleeves. She realized it came 4 days after the booster and it dawned on her that made the autoimmune start attacking. The hives are on her arms, nose, face, hair, and down her legs. It did not do that the first time. It was only on her chest and arms. She clarified she meant the first time she was ever diagnosed with Lupus, it was only on her chest and arms. It was full force after the booster, and has not gotten any better. It is different now. She said her joints are swollen and muscles are sore like you gave shot in arm. Her muscles are like that now. She cannot hardly raise her arm. On 23Oct2021, she noticed it was coming back and it got worse as the day went by. It stayed same for redness now though. It felt like ants were biting her. She just noticed soreness when she was cleaning last Monday and realized it was hard to put clothes on. She asked herself why are her arms, legs and joints so sore. She has not told her doctor about that. She kept hearing people say if she had autoimmune to get booster too. She has been on Plaquenil for almost 2 years and it got rid of her Lupus and had been clear ever since. She was clear in Feb2021-Oct2021, until she had shot. She did not provide lot or expiration for Plaquenil. She has Colitis and does not take anything for it. She learned to control it with food. She was diagnosed way before the vaccines. She was about at her wits end about the Lupus. She goes back to doctor on 08Mar2022. They all happened at the same time.Her arms got red and burning. It is from 6:00-10:30, so it was before lunch before she started noticing. Her arms and chest were burning. Patient did not visit emergency room but visited physician office. She visited her Rheumatologist. It was (withheld) that told her it was coming back, so she needed to see her first. She inferred that she worked with her Rheumatologist. Her Plaquenil was going to run out and she renewed it. She takes 400mg a day to keep the Lupus at bay. Treatment provided was to prescribe a type of Chemo pill Methotrexate once a week, 6 pills of 2.5mg, along with Folic Acid to keep toxins out of her body. It was in a 2.5mg pill form and lot and expiration are unknown. She takes 1mg of Folic acid every morning. The first one made her feel like she had a flu and it only lasted a day, but no side effects with the second one. Lot and expiration above. She was going to have blood work ran at her next visit to see if it is harming anything. Lupus attacks kidneys and they will do test. She would like to know if the booster dose is different than the other two.