Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Immunisation, Off label use, Pain in extremity
Clinical narrative: she took the third one; she took the third one; it was dry skin; sore left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), administration date 16Sep2021 (Lot number: FC3184) at the age of 82 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis", start date: 1997 (ongoing); "osteoarthritis" (ongoing). Concomitant medication(s) included: METHOTREXATE taken for rheumatoid arthritis, start date: 1997 (ongoing). Vaccination history included: Bnt162b2 (Dose: 01, Batch/lot number: EW0150, Anatomical location: Left arm, put lotion on it and the bumps rubbed off and turned, pink.), administration date: 06Apr2021, when the patient was 81 years old, for Covid-19 immunization, reaction(s): "blood red spot on arm size of a dime", "blood red spot on arm size of a dime and bumps came on that spot"; Bnt162b2 (Dose: 02, Lot number: EW017), administration date: 27Apr2021, when the patient was 81 years old, for Covid-19 immunization, reaction(s): "now has osteoarthritis", "blood red again", "bumps". The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 16Sep2021, outcome "unknown" and all described as "she took the third one"; DRY SKIN (non-serious) with onset 2021, outcome "unknown", described as "it was dry skin"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore left arm". Therapeutic measures were taken as a result of dry skin.  Additional information: Caller stated that she called because she has a problem from the time that she got her first vaccine in April. Stated that when the pharmacist gave it to her at withheld that it left a blood red spot on arm size of a dime and bumps came on that spot. Stated that she would rub it with water and put lotion on it and the bumps rubbed off and turned pink. Stated that she showed it to several doctors and they said that they had never seen it and that it would go away. Stated that in September that it was blood red again and the bumps came back. Stated that the dermatologist in October told her the he had never seen it and gave her a tube of cream. Stated that she went back in two weeks and it is the same thing again. Stated that it did not look like the cream did anything. Stated that she went back to withheld when she was told to go back for her second one. Stated that she has had rheumatoid arthritis since 1997 and now has osteoarthritis. Stated that she takes Methotrexate once a week which is all the medication that she takes. Is a vegetarian and gave up meat for rheumatoid arthritis. Stated that a few times a year that she takes medication for acid reflux. No further details provided. Stated that she gave a list of medications to the nurse and she told her that nothing would interfere with the vaccine. Stated that she told her to go home and get some rest. Stated that she did not have any reaction. Stated that she sat down for a couple of hours. Stated that she did a little gardening. Stated that she had soreness of the arm. Stated that she took the third one. Stated that they made her sit for one hour before she could leave. Stated that 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 is. Stated that she called to see if the medical staff can advise her of what to do and how to get rid of the spot. Stated that she saw a friend that is an internist and saw her own internist. Stated that she is a lay person and works in medical as an accountant. Stated that the unknown is what she worries about. Stated that this has been since April and it is still there. Stated that she saw ophthalmologist/internist and plastic surgeon and several internists. Clarified that the spot was on the left arm. Stated that the soreness was on the left arm. Unable to clarify details despite trying to redirect caller. Stated that she massaged arm with water and the bumps fell off and put lotion there because thought that it was dry skin. Is for the Pfizer Covid 19. Unable to clarify details despite trying to redirect caller. Later clarified that she had a sore left arm with all doses. Description of complaint: PC#1: Halog: Stated that the 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. Stated that it is hard to read the expiration date. PC#2:Methotrexate: Stated that she has flare ups. Product strength and count size dispensed: PC#1: 1mg/g; two tubes PC#2: 2.5mg; 72 in her current bottle. Does not have previous bottles to provide. A sample of the product is available to be returned, if requested.  Informed caller to please retain their product and its packaging as it may be required if an investigation is 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.