Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin lesion, Systemic lupus erythematosus, Upper limb fracture, Weight
Clinical narrative: Diagnosed with lupus; she had lupus syndrome; She has been debilitated from last 6 months; she has been incapacitated for 6 months; she can not work; She is developing fracture in her left elbow. She has had 5 surgeries on her left elbow; Lost her finger nails, her toe nails, her finger prints; Developed skin lesions which were red and purple blotches on her skin; After the vaccine she got febrile, it is called fever the next day; she had flu like symptoms for about a week; looked like burns; Wrong vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.1 (BNT162B2, BNT162B2 OMI BA.1). The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "Diagnosed with lupus; she had lupus syndrome"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (disability), outcome "unknown", described as "She has been debilitated from last 6 months; she has been incapacitated for 6 months; she can not work"; UPPER LIMB FRACTURE (medically significant), outcome "unknown", described as "She is developing fracture in her left elbow. She has had 5 surgeries on her left elbow"; ONYCHOMADESIS (non-serious), outcome "unknown", described as "Lost her finger nails, her toe nails, her finger prints"; SKIN LESION (non-serious), outcome "unknown", described as "Developed skin lesions which were red and purple blotches on her skin"; PYREXIA (non-serious), outcome "unknown", described as "After the vaccine she got febrile, it is called fever the next day"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "she had flu like symptoms for about a week"; BURNS SECOND DEGREE (non-serious), outcome "unknown", described as "looked like burns"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Wrong vaccine administered". The events "diagnosed with lupus; she had lupus syndrome", "she has been debilitated from last 6 months; she has been incapacitated for 6 months; she can not work", "she is developing fracture in her left elbow. she has had 5 surgeries on her left elbow", "lost her finger nails, her toe nails, her finger prints", "developed skin lesions which were red and purple blotches on her skin", "after the vaccine she got febrile, it is called fever the next day", "she had flu like symptoms for about a week" and "looked like burns" required physician office visit. The patient underwent the following laboratory tests and procedures: Body height: Probably 5 (feet) 5 (inches); Weight: 116 lbs.  Clinical course: Reporter stated, "Well, you know what, am going online because of his wife and am looking at all the adverse reactions with the COVID vaccines. She had been debilitated from last 6 months. She had had few surgeries on her left elbow. Hope you are recording this. She was diagnosed with lupus while she previously had no health problems. All this started after the booster and she think you guys are in trouble cause she see something on the horizon. It was not going to be in your favor because she was not the only one who had these adverse reactions and hers was not unique. There are several adverse reactions because these vaccines were never really tested and shotgun to the market. So, this is a, her going to follow requests on other place as well (Further clarification unknown. Hence, split case not made) but she had your number. She pulled up your number and she wants you to know that she had been out of work for 6 months. She has had 5 surgeries on her left elbow. She has been diagnosed with lupus, previously not had. She had lost her finger nails, her toe nails, her finger prints and she believe you guys are responsible for that. Your turn." When paraphrased the concern, reporter stated, "Yes, after the boosters. She was fine until then. The next day she was febrile, she had lupus syndrome, she developed skin lesions which were red and purple blotches on her skin, her legs, her back, her chest and they opened up to me like, looked like burns. She went to several doctors and they diagnosed the same, you have lupus which is, you know it is pretty characteristic, you know looks to me as lupus but she never had it before but it was coincident with getting the boosters. Reporter stated, "Yes, you can. After the vaccine she got febrile, it was called fever the next day, she had flu like symptoms for about a week. She started breaking out in these blotches of red and purple skin lesions on her legs, her arms, her back and they opened up into looked just like burns. she had seen burns before. she was medical professional, I have seen burns. She went to several doctors and they said you have lupus and she was a healthy person before this. Now, at this point of time she is developing fracture in her left elbow. She has had 5 surgeries on her left elbow and they were related all back to your vaccine which you know that was the way it was . That was my opinion, my professional opinion. We are not alone go on the website, look under adverse reactions to COVID vaccine and you will see a number of people with different symptoms like this (Further clarification unknown. Hence, split case not made.) And you guys are going to be in big trouble down the road because you did not adequately test this. It was rushed into the market because it was pushed by the federal government and you know what she has been out, she has been incapacitated for 6 months, she lost her job, she can not work. These are all the things that have happened since she got that booster and that was, she had the booster the same day and she was doing fine but you know she crashed".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded. 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.