Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
full blown hives on trunk, waist up to bottom of breasts, whole front sides and back all the way around; hot spots, and it itches; hot spots, and it itches; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 81-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (ongoing), notes: has had ulcerative colitis for 32 years and was is in remission for the past 2 to 3 years.; "blood pressure" (ongoing), notes: Been on low dose Lisinopril (started probably 3 or 4 years ago) and on amlodipine currently.; "started itching on outer thighs up to the hip, hip down to about 3/4 of the thigh, the leg", start date: Jul2024 (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL oral taken for blood pressure abnormal, stop date: Dec2024; AMLODIPINE taken for blood pressure abnormal, start date: 27Dec2024 (ongoing). Vaccination history included: BNT162b2 (Dose 1, single, Lot: EN5318), administration date: 29Jan2021, when the patient was 77-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, single), administration date: 26Feb2021, when the patient was 77-year-old, for Covid-19 immunization; BNT162b2 (Dose 3 (booster), single), administration date: 01Oct2021, when the patient was 78-year-old, for Covid-19 immunization; BNT162b2 (Dose 4 (Booster), single, Lot number: FM9992), administration date: 17May2022, when the patient was 78-year-old, for Covid-19 immunization; BNT162b2, BNT162b2 omi ba.4-5 (Dose 5 (Booster), single, lot number: GJ2524), administration date: 09Sep2022, when the patient was 79-year-old, for Covid-19 immunization; BNT162b2, BNT162b2 omi ba.4-5 (Dose 6 (Booster, single),), administration date: 20May2023, when the patient was 79-year-old, for Covid-19 immunization; comirnaty (2023-2024 formula) (Dose 1, single,, Lot number: HG4629), administration date: 22Sep2023, when the patient was 80-year-old, for Covid-19 immunization; comirnaty (2023-2024 formula) (Dose 2, single), administration date: 22Mar2024, when the patient was 80-year-old, for Covid-19 immunization. The following information was reported: URTICARIA (non-serious) with onset Sep2024, outcome "not recovered", described as "full blown hives on trunk, waist up to bottom of breasts, whole front sides and back all the way around"; FEELING HOT (non-serious) with onset Sep2024, outcome "unknown", PRURITUS (non-serious) with onset Sep2024, outcome "not recovered" and all described as "hot spots, and it itches". Therapeutic measures were taken as a result of urticaria, feeling hot, pruritus. Additional information: Patient has had a total of 9 shots of the Pfizer COVID vaccination starting 29Jan2021 and the last one was 06Sep2024. Had no symptoms, none of the shots gave her any symptoms. Patient's theory, why calling about this, is that sometime in July2024 started itching on outer thighs up to the hip, hip down to about 3/4 of the thigh, the leg, outside of legs, confirmed both legs, but especially right leg. Was scratching, scratching in July, but continued, didn't go away. Was not drawing blood at that time from scratching. Didn't think of it, didn't connect to COVID shot in her head. Hives: Start date: On 06Sep2024, got the 9th shot, that was Comirnaty also, that was her last shot. Within 3 to 4 days had full blown hives on her trunk, waist up to bottom of breasts, whole front sides and back all the way around, and that's when really started scratching. Went to MD in September, MD sent her to dermatologist, saw dermatologist twice, couldn't help her, sent her to immunologist, quit that immunologist because wanted to give her allergy shots for a year, once a week, and her share would have been $12,000. Patient has been to two immunologists. Patient had never been to allergic to anything she knows of, didn't go back to first immunologist. Patient got, found another immunologist, and she was on antihistamines. Patient was going to immunologist. HCP in formal fields was MD and was the first one that looked at her and sent to dermatologist, but MD did not know that much about it. Hives: Stop date, outcome: Doesn't look the same, has now what patient would call hot spots, and it itches, and patient scratches, ends up with small scabs, has small scabs all over in scalp, back, torso, itches on butt cheeks, hips, especially the outer leg area, been moving, increasing, increasing, so now has from knee down to ankle, arms also, but not real bad. Arms are probably, of the extremities, the least worrisome. Batch/lot number is not provided, and it cannot be obtained.
Blood pressure abnormal (Been on low dose Lisinopril (started probably 3 or 4 years ago) and on amlodipine currently.); Ulcerative colitis (has had ulcerative colitis for 32 years and was is in remission for the past 2 to 3 years.)
Medical History/Concurrent Conditions: Itching
LISINOPRIL; AMLODIPINE