Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Hives; itching scalp; This is a spontaneous report received from a Consumer or other non HCP. A 63-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 07Oct2025 at 11:45 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "shellfish allergy" (unspecified if ongoing); "Iodine allergy" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 24Sep2025 as dose number unknown, single; LOSARTIN, start date: 01Aug2023. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 10Oct2025 at 14:00, outcome "not recovered", described as "Hives"; PRURITUS (non-serious) with onset 10Oct2025 at 14:00, outcome "not recovered", described as "itching scalp". Therapeutic measures were taken as a result of urticaria, pruritus. Additional information: The patient did not receive any other vaccines on the same date. Doctor told him to take Zyrtec for hives daily. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Blood pressure high; Iodine allergy; Shellfish allergy
LOSARTIN