Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site warmth
Clinical narrative: a bump on injection site, describe mole-like with a diameter 1/2 inch/ still feel a little bit lumpy underneath/ it looks like it turned into a mole, obviously with mole you would think about cancer.; the injection site was gray, red and warm to the touch; noticed a bump on the injection site, describe mole-like with a diameter of 1/2 inch/ It still feel a little bit lumpy underneath; the injection site was gray, red and warm to the touch; the injection site was gray, red and warm to the touch; low grade fever; Little bit of chill; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose number unknown (booster), single (Lot number: GJ2524) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (Dose number unknown, single, Lot#EW0158), administration date: 2021, for Covid-19 immunization; Bnt162b2 (Dose number unknown, single, Lot#FG3527), administration date: 2021, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 2022, outcome "recovered", described as "Little bit of chill"; NEOPLASM MALIGNANT (medically significant) with onset 2022, outcome "unknown", described as "a bump on injection site, describe mole-like with a diameter 1/2 inch/ still feel a little bit lumpy underneath/ it looks like it turned into a mole, obviously with mole you would think about cancer."; PYREXIA (non-serious) with onset 2022, outcome "recovered" (2022), described as "low grade fever"; VACCINATION SITE MASS (non-serious) with onset 2022, outcome "not recovered", described as "noticed a bump on the injection site, describe mole-like with a diameter of 1/2 inch/ It still feel a little bit lumpy underneath"; VACCINATION SITE DISCOLOURATION (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 2022, outcome "unknown" and all described as "the injection site was gray, red and warm to the touch"; VACCINATION SITE WARMTH (non-serious) with onset 2022, outcome "not recovered". Therapeutic measures were taken as a result of vaccination site mass.  Clinical course: Caller, a patient, advised she received the Comirnaty vaccine 2 years ago and had the regular side effects which was low grade fever, chills and the injection site was gray, red and warm to the touch. 2 years later, she then noticed a bump on the injection site. She described it a mole-like with a diameter of 1/2 inch. She only brought it up today because the bump is still present, and she was advised by the vaccinator (she received flu and Covid vaccines today) to have it checked by her doctor. No investigations performed. Patient called about the Comirnaty vaccine. she said she received it 2 years ago and then so the injection site she mentioned was grey and red and then warm to the touch this was from 2 years ago and then 2 years later there was a bump on where the vaccine was injected so she was concerned about the bump. So, The bump was around half inch in diameter and when the healthcare professional who injecting her saw it looks like a mole in appearance and then patient thought that's pretty much as so. She was having the bump for 2 years and she just realized today when she got the new COVID vaccine. She already answered her question. so and she was just wanted to report this one. Her age by the way was 70." When paraphrased the concern: Consumer stated, "Yes, that's correct. She did not get the vaccine in her right arm. She chooses to get it in her left arm and that's what precipitated. This phone call was the technician as she said to (name withheld), she wasn't sure, she was training to be a Pharmacist or whether she was just technician but she did look at it and she said to her, this was from 2 years ago patient have this and patient said yes and she didn't take anything of it. It's just you know patient was now, patient know she emphatic that it was not there prior to her injection with COVID Vaccine and as she said she was not a penalty person, she was not an alarmist but she was concerned about it and which obviously precipitated this phone call. So, it's still there. She said it looks like it turned into a mole and obviously with mole you would think about cancer. She doesn't think that's what it was but okay that's what she was following. It's not just about her. It may be waiting in other people. She doesn't know." When probed to clarify about what was precipitated, consumer stated, "Okay, well Pfizer know as she said to Pfizer other safety associates, two other associates prior. Her vaccination in was right arm, her husband and she went to primary care. She had the typical immune response. She got a little fever, low grade fever, a little bit of chill blah blah, no big deal she thought it lasted for like a day and a half may be two at the most but at the injection site was raised and injection to the touch that lasted for more than a couple of days and she eventually it did dissipate that but the result of that raised warm to the touch observation was it never went away. It still feels a little bit lumpy underneath and now she tried putting cream on it. She showed the Pharmacist. they utilized Pharmacy, she was very good friendship with the Pharmacist. She said you know She don't know what that issue, just put cream on it. She put cream around it." Name of cream: Consumer stated, "she doesn't remember just some she did it once, it didn't do anything, but it did manifest some kind of, it didn't look. It was directly a result of the vaccine. It was not anything to do with the clinic because the cream did nothing and now it looks like a mole which was what the girl said today that she would go to her primary care doctor. Pfizer should have someone look at this because it doesn't, she have never seen anything this what she said. She has never seen anything like this before. So, she wanted to take a picture, she was going to take a picture of this, she wanted to email. She wanted Pfizer to put it in file and she wanted to know what to do because she doesn't know. When somebody said you should have a dermatologist look at it or primary care. Her primary care physician was two hours away and she do not have dermatology." Consumer stated, she was not a doctor, pharmacist or nurse." Age at the time of event, consumer stated, "she would have been 68, she just turned 70. Height and Weight: Consumer stated, she was 5 2 and 3 quarters, and she may don't even know 212 pounds and something like that. Date of vaccination: Consumer stated, "patient thought, she has two dates here on. It was the second not the first so she has only card here she has it could have been Nov2021 or she was going to give another date here, She thought it was on 11Nov2021 or 18Sep2022. It definitely two years ago so according to the card that's the best she can help you with." Lot#: Consumer stated, "she doesn't know what that would be but she gave some documentation. It says Pfizer this number. Okay, what would facility that was (facility name abbreviations) or (facility name abbreviations)." Vaccination card: Consumer stated, "she doesn't provide any other information here other than EW0158 or FG3527 that's for November one for September was GJ2524. she suggested that Pfizer can call or somebody call out (primary care) they have, they (patient) know the owner of the company there. Pharmacist he would be more than happy to give Pfizer whatever Pfizer needed. She doesn't have that information. She doesn't why she would, it just us. Vaccination record card and those are the only two parameters that they have here on this card." Expiration Date: Consumer stated, "No, don't have it. When you go for a vaccination, she doesn't think any of that was let her look here. Checked if help she have anything else. If you can be patient make the she will try to answer your question. The other best way to track this down would be contact Privacy he is the owner director of primary care at that time. Yes, she doesn't have any of that." Vaccination facility privacy, this was not the Pharmacy, this was her primary care physician office. He gave her and they gave her the injection in the office at the time still doing them many more. That's her primary care. They were doing inoculations in the office and they stopped that, that they gave her this injection. "Consumer stated, "she doesn't mean to disparage but Pfizer colleague keep saying Pharmacy it's not the Pharmacy this was her Primary care physician office. It was not a Pharmacy." Dose: Consumer stated, "she doesn't know the dose of the vaccine that whatever the normal parameters were for the dosing at that time. She doesn't know anything about that." Indication: Consumer stated, "Well, she took the vaccine as a preventative for Covid-19 and answer the first question. she like everywhere else nobody wanted to punish from Covid-19 or give it to anybody else and knowingly. So, they did their due diligence and figured out that, they are vaccine people. She has got vaccines since she was child so she don't know." Treatment: Consumer stated, "No, she didn't pay attention to it. she didn't, she just saw that it changed, and it's not thought it was anything. She hopes it's not anything, somebody brought it to her attention today. So, yes it has changed every time and she described this looking like a mole." Name of the cream that didn't work, consumer stated, "she thought she just put she said cream but she doesn't use many things that are over the counter. She thought she put coconut like extra virgin coconut oil, like compressed coconut oil. She did say some cream but she told her to use cream patient used coconut oil." When probed consumer do have product handy, consumer stated, "No, that was two years ago." When probed to clarify that do not have to product so unable to provide details, consumer stated, "No, she didn't use it because or even frequently. She thought she put it on and then see if it as an observation. She saw that it didn't do anything. So, she was like all right well she was not going to keep putting this stuff on because this did nothing and like as she said she never look she was not an alarmist. She doesn't think anything about it. It's like that's what happened but as she said this moment today at the Pharmacy said need to have that looked at. So, that's what precipitated this whole call." Vaccination anatomical location: Consumer stated, "Right arm upper bicep and interior." Any vaccine administered on the same date: Consumer stated, "No other vaccine on that day, absolutely not." When probed vaccine administered four weeks prior to the Comirnaty, consumer stated, "No, if anything she was more reticent about safety." Got covid vaccine today: consumer stated, "correct." Covid-19 Vaccine: Lot#: Consumer stated, "Well she was looking here. She doesn't see a LOT number. She doesn't know. She has a documentation here that says Covid 2024-25, 3 milliliters where it was administered, Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula). It does not do with LOT number precautions, general facts, side effect so people are." Expiration date: Consumer stated, "she doesn't, she will be glad to send a picture of this. Pfizer can figure it out." Was it Pfizer COVID-19 vaccine: Consumer stated, "Yes, it was." Consumer stated, "Yes, she needs to know what she can expect. She needs a confirmation# for this call please. She needs to know what kind of due diligence will be done and how she was going to be notified and if she was supposed to go to primary care physician. She doesn't feel or dermatologist, she doesn't feel that. She should be financially responsible for this to be quite honest. So, that's going to help in work." Requested for hold, consumer stated, "she just listen to be prudent and not to she thought that she could take a photo of this. She requested that she takes a photo and someone provide her with a viable email address with which to send a photo. She would take as many photos wanted but she wanted this recorded for Pfizer documentation that this was indeed. What was on her right arm? That's in there formulating something or other okay." Consumer stated, "she doesn't get a response. She doesn't get a reply. She was just left here to figure out what to do. She mean she need some direction. This isn't just a Pfizer know this was not just a how do Pfizer do conversation? This was like what do Pfizer want her to do. She wanted to speak to the legal department. She would be more than happy to accept a phone call from somebody in your legal department to discuss this but when somebody tells you, you should go see your doctor, a dermatologist because this is a direct result in by an emphatic about this from the vaccine period."