Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: left a blood red spot on her arm the size of a dime and bumping on that spot; left a blood red spot on her arm the size of a dime and bumping on that spot; had a sore left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 81-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 (Lot number: EW0150) at the age of 81 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis", start date: 1997 (ongoing), notes: Stated that it was 10 years after she got rheumatoid arthritis; "osteoarthritis" (ongoing); "Acid reflux" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE taken for rheumatoid arthritis, start date: 1997 (ongoing). The following information was reported: ERYTHEMA (non-serious) with onset 06Apr2021, outcome "not recovered", RASH PAPULAR (non-serious) with onset 06Apr2021, outcome "recovering" and all described as "left a blood red spot on her arm the size of a dime and bumping on that spot"; PAIN IN EXTREMITY (non-serious) with onset 06Apr2021, outcome "recovered" (2021), described as "had a sore left arm". The event "left a blood red spot on her arm the size of a dime and bumping on that spot" and "left a blood red spot on her arm the size of a dime and bumping on that spot" was evaluated at the physician office visit. Therapeutic measures were taken as a result of erythema, rash papular. Additional information: patient stated that there was blood red spot the size of a dime on the left arm at the site of the Pfizer BioNTech Covid-19 injection with little bumps on top of the red. Thought it was dry skin at first, reminded her of a wart. It took about a month to get rid of the bumps, after the bumps left the blood red spot began to fade and became more like a pink. It came back again in September with the blood red spot with less bumps, specifically 4 to 5 maybe 6 dried bumps that have nothing in them. She massages the bumps with water and applies Eucerin cream which allowed the bumps to fall off. She saw her dermatologist and she did not know what it was, dermatologist gave her two tubes of cream to use, she only used one tube and it did not help. She also saw a plastic surgeon, 3 interns, an ophthalmologist, a GI doctor and no doctor knows what it was. She also had soreness on the left arm. She stated that she had no other side effects after receiving the vaccine, no headache and no chills except the discoloration and bumps at the injection site. She took Halog, 1mg/g; two tubes cream looked like it did not do anything. Stated that she used the cream and could tell that nothing was happening. Stated that it is hard to read the expiration date. She takes medication for acid reflux a few times a year. She took Methotrexate once a week (six (2.5mg) pills every Saturday), 72 in her current bottle and gave up meat for rheumatoid arthritis. Stated that she has flare ups. Does not have previous bottles to provide. A sample of the product is available to be returned, if requested. Informed her to retain their product and its packaging as it may be required if an investigation was required. It normally takes 3-10 business days to send out a prepaid (mailer name) mailer to return a sample. No for Methotrexate. Packaging sealed and intact Yes for both. She gave a list of medications to the nurse and she told her that nothing would interfere with the vaccine. Nurse told her to go home and get some rest. She sat down for a couple of hours and did a little gardening, after which she had soreness of the arm. She took the third one and they made her sit for one hour before she could leave. She had about five look at her arm. Stated that she has seen 5-6 doctors who say that they have not seen it and do not know what it was. She called to see if the medical staff can advise her of what to do and how to get rid of the spot. She received 2nd dose of the Covid-19 vaccine on 27Apr2021 with a lot number of EW017 and the 3rd dose on 16Sep2021 with a lot number of FC3184. Later clarified that she had a sore left arm with all doses. No follow-up attempts are possible. No further information is expected.