Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Systemic scleroderma
Clinical narrative: systemic sclerosis; 'arachnoid' dermatitis; lichenoid dermatitis; I could not sleep at night it was so itchy; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID:.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Lot number: FH8841) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Seasonal allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism; FLUTICASONE PROPIONATE nasal taken for seasonal allergy; CLARITIN [LORATADINE] taken for seasonal allergy. Vaccination history included: BNT162b2 (DOSE 1, SINGLE., Anatomical location: Left arm; intramuscular, LOT#: EW0150), administration date: 06Apr2021, when the patient was 63-year-old, for COVID-19 immunization, reaction(s): "systemic sclerosis", "'arachnoid' dermatitis", "lichenoid dermatitis", "I could not sleep at night it was so itchy"; BNT162b2 (DOSE 2, SINGLE; LOT#: EW0173), administration date: 04May2021, when the patient was 63-year-old, for COVID-19 immunization, reaction(s): "systemic sclerosis", "'arachnoid' dermatitis", "lichenoid dermatitis", "I could not sleep at night it was so itchy"; Flu shot (got the flu shot (Name could not be specified) every fall), for immunization. The following information was reported: SYSTEMIC SCLERODERMA (medically significant), outcome "unknown", described as "systemic sclerosis"; ARACHNOIDITIS (medically significant), outcome "unknown", described as "'arachnoid' dermatitis"; LICHENOID KERATOSIS (non-serious), outcome "unknown", described as "lichenoid dermatitis"; SLEEP DISORDER (non-serious), outcome "unknown", described as "I could not sleep at night it was so itchy". The events "systemic sclerosis", "'arachnoid' dermatitis", "lichenoid dermatitis" and "i could not sleep at night it was so itchy" required physician office visit. The patient underwent the following laboratory tests and procedures: Antinuclear antibody: High, notes: I have been diagnosed with systemic sclerosis and the antibody that I have that shows that is RNA polymerase 3 and that came out high in test; Biopsy: eliminated like syphilis, notes: there were biopsies done and that eliminated like syphilis. Therapeutic measures were taken as a result of systemic scleroderma, arachnoiditis, lichenoid keratosis, sleep disorder.  Clinical Course: Patient has received 5 doses of the Pfizer COVID vaccines. She started developing reactions to each dose. Within 2 weeks from receiving a vaccine, she noticed isolated skin lumps in the trunk and arms, mainly. Then, the lumps came down to the point of going away after 3 months. She realized this pattern after the fourth shot. She has been diagnosed with lichenoid dermatitis and systemic sclerosis. Other Products: Yes; Patient wanted to talk to someone and let them know that she had certain reactions to the Pfizer COVID-19 Vaccine. She had the first four on the time of recommended by the CDC, but she had some reactions to it. She also did submit the information to the VAERS system, and she wanted to let us know that she had reactions to the Pfizer COVID-19 Vaccine."  When probed for the side effects/ reactions: Patient stated, "So, with the first vaccine (Pfizer COVID-19 Vaccine), at the site of the injection or little bit below it, I had a red spot like a raised red bump that was extremely itchy and that was a few days after I think and then I started to get a the same kind of things, isolated bumps on my arms and torso and all extremely itchy and I did not discover a pattern until like the third shot (Pfizer COVID-19 Vaccine) that I got and so what I was seeing the pattern seemed to be that within the first two weeks, mostly at about 2 weeks after the injection. I would start getting the rash and then it would last about 3 months and then it would start to go away, and it was not like, so the spots would come and then they go and sometimes it kind of got reactivated and they were eased by triamcinolone cream, that my dermatologist prescribed. So, there were biopsies done and that eliminated like syphilis, I am trying to remember what else but it is the diagnosis was like 'arachnoid' dermatitis and also a side from itchy bumps I noticed that like, if I crossed my ankles for a while or I lean against the end of the table with my arms, those areas would get red and itchy too but that would go away after like a half an hour. So, I did not do any cream or anything like that. I just tried to leave them alone, it was just like pressure, anything was like pressure I would get that and that had never happened before. So, it became consistent after each injection (Pfizer COVID-19 Vaccine) in about 2 weeks. I started getting itchy bumps and then after, at 3 months they would start to go away and it still would come back once in a while but not as bad, the first time, with the first shot (Pfizer COVID-19 Vaccine), that was the worst. I was trying everything to get rid of it. I could not sleep at night it was so itchy. I even tried like allergy eye drops (Name could not be specified), I am not supposed but anyway, so I decided to go ahead and get the 4th injection (Pfizer COVID-19 Vaccine because I felt that I could tolerate it by that time and so now what is happening and, I do not know if it is related and you know, my doctors, my allergist, my rheumatologist and my dermatologist, I will say, we just do not know enough about COVID yet and so what happening now is I have been diagnosed with systemic sclerosis and the antibody that I have that shows that is RNA polymerase 3 and that came out high in test. So, I do not know, at this point, if it is diffused or limited, I have no skin involvement, the hardening, or the stretching, I do not have any skin involvement. So, I wanted to let Pfizer know, I actually did have the same itchy reaction with COVID, I ended up getting COVID, I am out case and the same itchy reaction happened with that, so my allergist recommended after the 4th one, he recommended waiting to see when the Novavax, which is a different type of vaccine came out and to try that and actually got a worse reaction with that same thing but it was itchier and more prevalent, I had it more spots. So, I did report, I think after the 4th one, I reported everything to the VAERS system, but I wanted to let Pfizer know and I do not know if you can give me any information, that may be there is been other cases of systemic sclerosis turning up or my big question is. I am literally, I am 67 years old, (withheld) is my birthday and I am leery of getting more shots, I want to be able to protect myself from COVID, but I do not know if I should continue getting the Pfizer vaccine (Pfizer COVID-19 Vaccine)?"  When paraphrased the concern: patient stated, "Yes, the same but it was, the reaction it was more itchy and spots than, not as bad as the first time but it was worse than the last time that I had a shot. So, I do not want the Novavax again, it does not seem to matter what type, whether it was getting COVID or getting the mRNA, I do not know how to say it Pfizer or the more traditional vaccine, it was Novavax." . When probed for the product details for Novavax vaccine (LOT#, Expiration date, NDC# and UPC#): Consumer stated, "I do not have the one, they did not write the LOT# down. I actually may have it on the pharmacy sheet that they gave me. The date is 29Dec2023 and that was at (name withheld) pharmacy." Patient used: Triamcinolone Acetonide Cream as treatment of AE(s) - LOT#: V1212; Expiration date: Mar2025. When probed for the name of the eye drop that consumer has used for the adverse event: Consumer stated, "Which did not work by the way. I do not if I have, any of it because I stopped using them. It was an allergy eye drop. It was not for redness. I do not have it, I do not remember."  Stop date of eye drop: Consumer stated, "I only tried it a couple days, and that would have been soon after the first shot." Treatment: Consumer stated, "Just a Triamcinolone cream."  Consumer stated, "I have health conditions too, but I do not take medicine for them. I have seasonal allergies."  When asked any prior vaccination happened: Consumer stated, "I got the flu shot every fall but I do not have that information." Consumer stated, "I have one more allergy medicine: Name: Claritin (Loratadine); Dose: 10 milligrams, Frequency: Once a day for Indication: Seasonal allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400222927 since same patient/event, different dose;