Received Mar 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | — |
pulmonary embolism (PE); she was accidentally given 2 doses; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), 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: Comirnaty (2024-2025 formula) (DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: PULMONARY EMBOLISM (hospitalization), 2 months after the suspect product(s) administration, outcome "unknown", described as "pulmonary embolism (PE)"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "she was accidentally given 2 doses". A patient had an adverse event to the BNT162b2 omicron (kp.2) immunization (she was accidentally given 2 doses by the pharmacist and subsequently (2 months later) developed PE/hospitalization. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.