Received Jul 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Lymph node enlargement; This is a spontaneous report received from a healthcare professional from a sales representative. An adult female patient (unknown if pregnant) 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. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Lymph node enlargement". It was unknown if therapeutic measures were taken as a result of lymphadenopathy. Additional Information: It was unknown if the patient was taking any other medication within 2 weeks of the event starting. It was unknown if the patient received any other vaccines within 4 weeks prior or on the same date as the suspect vaccine. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.