Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Biopsy, Inappropriate schedule of product administration, Mass, Piloerection
Clinical narrative: Dose 1 on Jun2021 and Dose 2 on 07Sep2021; Hives; Raised bumps on his arms and front chest; These bumps are turning into hard skin cells; It first started as being itches/itching shortly after each dose and now his skin cells are all hardening up on his arm/hard skin lesions; It first started as being itches/itching shortly after each dose and now his skin cells are all hardening up on his arm; Red pimple; He stopped at a dermatologist and they are dumbfounded as to what it was and are concerned about the lumps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Sep2021 (Lot number: FF2588) at the age of 65 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single, Time of vaccination: around noon to 13:00, Administration site: injection in right arm), administration date: Jun2021, when the patient was 65 years old, for COVID-19 immunization, reaction(s): "These bumps are turning into hard skin cells", "kidney stone, last time he had one was in July or Aug 2021", "raised bumps on his arms and front chest", "It first started as being itches/itching shortly after each dose and now his skin cells are all hardening up on his arm.", "These bumps are turning into hard skin cells", "Hives". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 07Sep2021, outcome "unknown", described as "Dose 1 on Jun2021 and Dose 2 on 07Sep2021"; URTICARIA (non-serious) with onset 2021, outcome "unknown", described as "Hives"; PILOERECTION (non-serious) with onset 2021, outcome "unknown", described as "Raised bumps on his arms and front chest"; SKIN DISORDER (non-serious) with onset 2021, outcome "unknown", described as "These bumps are turning into hard skin cells"; SKIN LESION (non-serious) with onset 2021, outcome "unknown", described as "It first started as being itches/itching shortly after each dose and now his skin cells are all hardening up on his arm/hard skin lesions"; PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "It first started as being itches/itching shortly after each dose and now his skin cells are all hardening up on his arm"; ACNE (non-serious) with onset 2021, outcome "unknown", described as "Red pimple"; MASS (non-serious) with onset 2021, outcome "unknown", described as "He stopped at a dermatologist and they are dumbfounded as to what it was and are concerned about the lumps". The events "hives", "raised bumps on his arms and front chest", "these bumps are turning into hard skin cells", "it first started as being itches/itching shortly after each dose and now his skin cells are all hardening up on his arm/hard skin lesions", "it first started as being itches/itching shortly after each dose and now his skin cells are all hardening up on his arm", "red pimple" and "he stopped at a dermatologist and they are dumbfounded as to what it was and are concerned about the lumps" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria, piloerection, skin disorder, skin lesion, pruritus, acne, mass.  Additional information: No other products. No patient history. He got the Pfizer shot twice, first shot was in mid-June and the second shot was around Sep2021. He ended up with some type of hives or raised bumps on his arms and front chest after both doses. These bumps are turning into hard skin cells, does not know how to explain them. He went to the dermatologist, and they took biopsies of the ones on his arms. He does not know if it was covid vaccine related but both times it happened within a couple of days of getting the shots. It first started as being itches/itching shortly after each dose and now his skin cells are all hardening up on his arm. He went to urgent care to ask for something to stop the itches and he was given a prescription for Triamcinolone Cream. After second shot the bumps/itching/hives came back with a vengeance. His skin was turning hard. It looks like he has cancer things growing all over him, they are white hard skin lesions which are in the proximity of where the hives/itching/ red pimple like things are. He stopped at a dermatologist, and they are dumbfounded as to what it was and are concerned about the lumps. He asked if there was any connection with the bumps and the covid shot and dermatologist states she had not seen that before. However, he talked to the pharmacist when he went to pick up the ointment and they told him that they have heard of this happening. He was now on a tapered dose of prednisone, and he would try different ointments, he thinks one was called clobetasol. He just took his last prednisone. He was talking to pharmacist and was told to report this. First dose: He did not have his first card with him at time of second vaccination. So, he received a card only for his second dose. First dose was in Jun2021 around noon to 1300. He does not know the exact date and does not have lot, ndc, or expiration date for the first dose. He was left-handed. Vaccination facility type was pharmacy. Vaccine was not administered at private facility. Additional vaccines administered on same date of the Pfizer suspect was none. He may have gone to ER after the first dose since he was opening up his bill and it said he was in the ER in June. Confirms he was not admitted. He only goes to ER for kidney stone or something else and he was not having a kidney stone in June. Physician office was yes, dermatologist and urgent care. The patient was not hospitalized. Prior vaccinations (within 4 weeks) were none. Adverse events following prior vaccinations was none. Family medical history relevant to adverse events was no. Relevant tests were none. Does he have to worry about these hard skin lesions, states he was probably not using the correct term by calling them lesions, but his skin was scaly and hard and growing up and down his arm and are now up to his shoulder.   Follow-up attempts are completed. No further information is expected.