Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm swelling up a lot; It just keeps bleeding; It was red muddled and then every time it became red just over an area; Hematoma / it started turning black; It's extremely painful just something slightly touching it; Slowly the swelling and soreness has been going down; Slowly the swelling and soreness has been going down; aching even my mouth; My blood pressure way up; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 02Sep2024 at 18:46 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure way up" (unspecified if ongoing). Concomitant medications included: CHLOROPHYLL; HYDROCHLOROTHIAZIDE taken for hypertension; LISINOPRIL taken for hypertension; METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID]; OMEGA 369 [BORAGO OFFICINALIS OIL;FISH OIL;OLEA EUROPAEA OIL]; VITAMIN C ACID; VITAMIN D3. Past drug history included: Relafen, reaction: "Allergic reaction"; Tylenol. Vaccination history included: Pneumococcal vaccine (done on October 31st at annual physical with the same PCP), for Immunization; Fluad (Fluad 65 plus, Tivpfs 24-25, NDC# 70461-0024-03, manufacturing Seqirus), for Immunization. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 2024, outcome "recovered", described as "My blood pressure way up"; PAIN (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 2024, outcome "unknown" and all described as "Slowly the swelling and soreness has been going down"; ORAL PAIN (non-serious) with onset 2024, outcome "unknown", described as "aching even my mouth"; VACCINATION SITE SWELLING (non-serious) with onset 02Sep2024, outcome "unknown", described as "Arm swelling up a lot"; VACCINATION SITE HAEMATOMA (non-serious) with onset 02Sep2024, outcome "unknown", described as "Hematoma / it started turning black"; VACCINATION SITE HAEMORRHAGE (non-serious) with onset 02Sep2024, outcome "unknown", described as "It just keeps bleeding"; VACCINATION SITE ERYTHEMA (non-serious) with onset 02Sep2024, outcome "unknown", described as "It was red muddled and then every time it became red just over an area"; VACCINATION SITE PAIN (non-serious) with onset 02Sep2024, outcome "unknown", described as "It's extremely painful just something slightly touching it". The events "arm swelling up a lot", "it just keeps bleeding", "it was red muddled and then every time it became red just over an area", "hematoma / it started turning black", "it's extremely painful just something slightly touching it", "slowly the swelling and soreness has been going down", "aching even my mouth" and "my blood pressure way up" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site swelling, vaccination site haemorrhage, vaccination site erythema, vaccination site haematoma, vaccination site pain, pain, peripheral swelling, blood pressure increased. Additional information: The patient reported that right away the nurse who gave her vaccine could see her arm swelling up a lot. The nurse said it's bleeding and asked the patient if she's taking any blood thinner or anything. The patient was not. The nurse said it just kept bleeding and she doesn't know if she will be able to stop it. She said it might have hit a "vessel". The nurse ended up putting pressure on it, three bandage and the patient saw it when she got home how far it was sticking out from the side of her arm. The patient said it was about half inch to more and more. Compared to the other arm it was red muddled and then every time it became red just over an area and stayed that way by about maybe the third day it started turning black and slowly the swelling and soreness went down but it's extremely painful just something slightly touching it. The patient had to go to the doctor because she was reading on the internet of what can happen, hematomas or the abscess. It could go to gangrene. She called her PCP, they got her right in, and she thought that it was probably a hematoma and quite hot, you know, the temperature of it and she was given a prescription for something she can't take but she was desperate to get some help for this. So, she took one of them. It was 800 mg Ibuprofen. The NSAIDs (unspecified medications) she has a problem with. she thought it was only one of them, she thinks all of them except Aspirin. Years ago, she had an allergic reaction to Relafen, so she doesn't ever use that, don't use any of them. She just uses Tylenol or whatever, but in that case a lot of inflammation, Tylenol really could not touch this which was another reason she went to PCP. So, that did actually help but along with it, it drove her blood pressure way up and she took anti-hypertensive Lisinopril and Hydrochlorothiazide but it was still up too high and the PCP had her keeping a log on that and by the day it started turning black and the swelling started going down and it was about 50% as painful, the blood pressure normalized into the 120 over the 80 like they usually were but heart rate had stayed decent. Anyway, so she only had to take one 800 mg tablet just because she chose no matter what she wasn't going to take any more of that stuff. Now, the patient had a prior, for the first time in her life had a pneumococcal vaccine done on October 31st at her annual physical with the same PCP and she had no problem with that whatsoever. Not one single symptom, nothing hurt, no discoloration, nothing and the flu vaccine in between the two was done at a different pharmacy and again no problem with that. The patient clarified that it was a terrible pain. It's still aching even her mouth. The patient tried Tylenol and when that would not touch it she was kind of worried and it was very painful. She was told to use, the nurse who give the vaccine to put ice packs on it and she did but then it was close to. This was an evening vaccine, it was 6:46 at night. So, by the time, she went home. It was not that long so, she went to sleep, and she cannot use the ice packs when she's sleeping, it would keep her up so, she had to stop.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.