Received Nov 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | RA |
Large erythema went to 3 inches wide to 2 inches height, It became a lump was severely itchy; Large erythema/ itching and erythema started that same day/ told it might get red at injection site; Large erythema/ itching and erythema started that same day/ told it might get red at injection site; sore arm; This is a spontaneous report received from a Consumer or other non HCP. A 72-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 10Nov2025 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (ongoing); "thyroid condition" (ongoing). Concomitant medication(s) included: FLUAD taken for immunisation, in Oct2025 as dose number unknown, single. Vaccination history included: Moderna covid-19 vaccine (Dose number unknown, single, Location: left arm), administration date: 2021, for Covid-19 immunization, reaction(s): "neurological problems"; Shingles vaccine (Dose number unknown, single, right deltoid), for Immunization, reaction(s): "Adverse event NOS"; Sars covid 19 vaccine (Dose number unknown, single), for Covid-19 immunization; Tdap vaccine (right deltoid), for Immunization. The following information was reported: VACCINATION SITE MASS (non-serious) with onset 10Nov2025, outcome "recovering", described as "Large erythema went to 3 inches wide to 2 inches height, It became a lump was severely itchy"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 10Nov2025, outcome "recovering" and all described as "Large erythema/ itching and erythema started that same day/ told it might get red at injection site"; PAIN IN EXTREMITY (non-serious) with onset 10Nov2025, outcome "recovered" (Nov2025), described as "sore arm". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site pruritus, vaccination site mass, pain in extremity. Additional information: Patient stated that, the erythema and itching in right deltoid. Stated vaccine was administered, 10Nov2025, 2:30 PM, clarified, itching and erythema started that same day, about an hour to 2 hours it all began. Was told it might get red at injection site. She had large erythema, went to 3 inches wide to 2 inches height. It became a lump, was severely itchy. The severe itching was like, if she got 10 mosquito bites, is relentless itching. Got worse, then started to get better, about, maybe a day before it started looking mean and red. Lump started to go down, is barely there. Now, still has pink looking red, like a little erythema. Itching almost gone but, still slightly itching, has been 96 hours, since Monday, for 4 days. Never had this reaction. Has had a lot of vaccines in life. Treatment: she needed dose of Prednisone. Nothing worked, itching was internal, really severe. Only thing she could do is aloe, icing and, some lidocaine, that is about it. Only had sore arm, maybe first day, that went away. Took 1 Tylenol as soon as she got home. Drank 8 glasses of water. After that, was barely there, which is unusual because, usually has sore arm with other vaccines. The sore arm dissipated, maybe after 2 hours. Never had any reaction, fatigue, chills, headache, nothing but relentless itching. Patient took Fluad, Trivalent 2 weeks prior before latest Covid booster. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
Blood pressure abnormal; Thyroid disorder