Received Aug 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
feel very ill; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) 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: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Immunization. The following information was reported: MALAISE (non-serious), 5 days after the suspect product(s) administration, outcome "unknown", described as "feel very ill". Additional information: Patient reported that just got 4th booster and after 5 days felt very ill. No Hospitalization Prolonged. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.