Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Thrombosis, Vaccination site haemorrhage, Vaccination site pain, Vaccination site swelling
Clinical narrative: large knot right above the injection site/size of a half dollar/size of a silver dollar and where the needle went in was right at the base of that knot/like egg under the skin or clot; felt like she got a flu shot and could tell her arm was very sore; swelling started almost immediately after the shot/swelling was exactly underneath the injection site, just in the pronounced area/about 4 inches wide and about 2 inches high; thought maybe someone has hit a vein because it did bleed and ran down her arm; This is a spontaneous report from a contactable consumer.  A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EN6201, unknown expiration), via an unspecified route of administration on 18Feb2021 at 04:30 at a single dose for COVID-19 immunization. Medical history reported as none. Concomitant medications included tolterodine and adalimumab (HUMIRA). The patient reported that she received the COVID vaccine on 18Feb2021 at around 4:30. Firstly it was fine, she felt like she got a flu shot and could tell her arm was very sore. What concerned her was the swelling started almost immediately after the shot on 18Feb2021. She knew that was one of the symptoms. This morning and yesterday though (18Feb2021), she noticed some of the symptoms. She got a large knot that was right above the injection site. Yesterday, it was about the size of a half dollar, today it is about the size of a silver dollar and where the needle went in was right at the base of that knot. It feels like an egg under the skin or a clot. Like a knot (a hard spot underneath the skin). The patient was wondering if it was something she should be concerned about because the swelling was exactly underneath the injection site, just in the pronounced area. It was a rectangle and is about 4 inches wide and about 2 inches high and then right above that was where the needle went in. The large circle or knot was right above that and she was thinking possibly when she was given the injection she has never really bleed before. So, she thought maybe someone has hit a vein because it did bleed and ran down her arm. She got no problem. That happens at times, but she started thinking if this was a clot or it was something that is right above there because it is so pronounced, and it really hurts. The patient stated that she took some Aspirin last night and is going to take an ibuprofen in a little while. She mentioned that she takes this one pill and it has nothing to do with anything.  The patient had lab work done (unknown results) that was about 3 weeks ago (2021). She also stated that she also take Humira which is a shot every 2 weeks and it said in the fact sheet that she should be concerned or be sure that she did not take any medicine that affects the immune system and Humira does weaken the immune system but she was not ask that prior to. The patient wanted to know if is that something she should be concerned about. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.