Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropod sting, Off label use, Pain of skin, Rash, Rash erythematous
Clinical narrative: pressure on his skin; rash is red and covers his stomach and it is itchy; rash is red and covers his stomach and it is itchy; sting; Indication:Type 1 diabetes mellitus; he developed a rash; 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 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jan2021 10:00 (Lot number: EL9262, Expiration Date: 31May2021) at the age of 64 years as dose 1, single for covid-19 immunisation and Type I diabetes mellitus. Relevant medical history included: "Type I diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Type I diabetes mellitus, from the age of 29; "Rheumatoid arthritis" (unspecified if ongoing), notes: Verbatim: Rheumatoid arthritis, from two years ago; "Atrial fibrillation" (unspecified if ongoing), notes: Verbatim: Atrial fibrillation, from five years ago; "Allergic to shellfish" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA taken for rheumatoid arthritis (ongoing). The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "Indication:Type 1 diabetes mellitus"; RASH (non-serious) with onset Jan2021, outcome "recovering", described as "he developed a rash"; PAIN OF SKIN (non-serious), outcome "unknown", described as "pressure on his skin"; RASH ERYTHEMATOUS (non-serious), RASH PRURITIC (non-serious), outcome "unknown" and all described as "rash is red and covers his stomach and it is itchy"; ARTHROPOD STING (non-serious), outcome "unknown", described as "sting". The events "he developed a rash", "pressure on his skin", "rash is red and covers his stomach and it is itchy", "rash is red and covers his stomach and it is itchy" and "sting" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of rash, pain of skin, rash erythematous, rash pruritic, arthropod sting.  Additional information: The patient got his first dose of the Pfizer BioNTech Covid-19 vaccine in Jan, second dose in Feb. Within a week of the first dose, he developed a rash. That had been ongoing, and appears for about 10-15 minutes whenever there was pressure applied to his skin (e.g. lying on the floor for sit ups or bending over to tie his shoes. Adds what causes it was when he bends over to tie his shoe and his stomach was against his thigh; or if he does situps or anytime he had pressure on his skin. It doesn't happen when walking, it seems to be some type of pressure on his skin that causes the rash. Adds the rash was red and covers his stomach and it was itchy. It seems to be improving overall, but he was asking if it was safe to get the third dose of the vaccine, as his doctor told him to. He had Type I Diabetes, as well as rheumatoid arthritis, for which he took Humira, and a heart condition. He had seen his HCP, a cardiologist, and a dermatologist for this AE. He asked if people that got the third dose reported similar side effects as the first two doses. He was also allergic to shellfish, so wanted to know if that was useful information regarding the vaccine. There was no investigation assessment. Mentions he had told his heart doctor, his rheumatologist and his family doctor and none of them knows what it was; he also asked the dermatologist but he doesn't know either. Adds he wasn't concerned too much about it because he thought it would go away, and it seems a little less prevalent since it started. Adds now he had been told to get the booster shot; and he was concerned about it he should get the booster; and none of his doctors have any information. He was asking if we have any reports about this; and was it safe for him to get the booster. The patient had atrial fib although that went away because he had a procedure; and he was near the age to have the vaccine. The patient reported that within the first week after the first dose, he had the rash while exercising, like stretching on the floor; it had to be some kind of pressure. Adds the rash was only prompted by that type of activity and goes away in 15 minutes. At first it would sting, and he would get it on his stomach and inside of arms with sit ups. Adds but lately the last time he had it, he was doing sit ups or something it was a red rash all over his stomach that itches a little but less than in the beginning then still goes away in 10 or 15 minutes. Treatment: He saw all his doctors, but no one prescribed any treatment. The dermatologist ask him to send a picture but he had not done it. There was no history of all previous immunization with the Pfizer vaccine considered as suspect and had no additional vaccines administered on same date of the Pfizer suspect. Time of Onset Adverse Event: red, stinging, itching rash was a week after vaccine. The patient did not require any Emergency Room visit. The patient had a visit to Physician Office, have seen doctor for rash but no treatment was provided. There was no prior vaccinations (within 4 weeks). There was no AE(s) following prior vaccinations. The patient did not have family medical history relevant to AE(s). No relevant tests were done.  No follow-up attempts are possible. No further information is expected.