Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | MY9550 | OT / LA |
developing hives; Non-severe allergic reaction; This is a spontaneous report received from an Other HCP from medical information team. A 28-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 11Sep2025 as dose 1, 0.3 single (Lot number: MY9550, Expiration Date: 12Jun2026) at the age of 28 intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "seizure disorder" (unspecified if ongoing); "Cerebral palsy" (unspecified if ongoing). The patient's concomitant medications were not reported.The following information was reported: HYPERSENSITIVITY (non-serious) with onset 12Sep2025, outcome "not recovered", described as "Non-severe allergic reaction"; URTICARIA (non-serious) with onset 12Sep2025, outcome "not recovered", described as "developing hives". Therapeutic measures were taken as a result of urticaria, hypersensitivity. Additional information: Patient reports she had hives that started within a few days after receiving the vaccine and then has persisted for about a week. Treatment: patient was taking Benadryl at home over the counter when hives started. She was put on a steroid pack and hydroxyzine HCL as of 23Sep2025.Outcome: caller is reading notes from the provider which states the hives rash persisted for approximately two weeks with episodes of disappearance and reemergence. This was clarified and documented as confirmed.
Medical History/Concurrent Conditions: Cerebral palsy; Seizure