Received Oct 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | — |
Itching; Breast lumps; Dry skin; Other allergic reaction; positive ANA; This is a spontaneous report received from a Consumer or other non HCP from a sales representative. An adult female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2020 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown.), for Covid-19 immunization. The following information was reported: BREAST MASS (non-serious) with onset Jan2020, outcome "recovered with sequelae" (Aug2025), described as "Breast lumps"; DRY SKIN (non-serious) with onset Jan2020, outcome "recovered with sequelae" (Aug2025); PRURITUS (non-serious) with onset Jan2020, outcome "recovered with sequelae" (Aug2025), described as "Itching"; HYPERSENSITIVITY (non-serious) with onset Jan2020, outcome "recovered with sequelae" (Aug2025), described as "Other allergic reaction"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious) with onset Jan2020, outcome "recovered with sequelae" (Aug2025), described as "positive ANA". Additional information: The patient did not receive any other vaccines on the same date as the vaccine(s) for which you are reporting. Patient stated side effects such as itching, breast lumps, and dry skin, and other allergic reactions. Also stated the patient had a positive ANA. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.