Received Aug 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
diagnosed with COVID-19; diagnosed with COVID-19; broke out with "herpes simplex" virus all over her face; fever; threw up; This is a spontaneous report received from a Consumer or other non HCP. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (primary immunization series completed), for covid-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "diagnosed with COVID-19"; HERPES SIMPLEX (non-serious), outcome "unknown", described as "broke out with "herpes simplex" virus all over her face"; PYREXIA (non-serious), outcome "unknown", described as "fever"; VOMITING (non-serious), outcome "unknown", described as "threw up". Clinical course: Caller is a consumer, calling to report AE after receiving COVID-19 booster shots. After receiving booster shots she broke out with herpes simplex virus all over her face, had a fever, threw up and was diagnosed with COVID-19. Needs patient assistance for Paxlovid. Patients have government funded insurance. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.