Received Jun 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
weakness; not being able to perform normal tasks; This is a spontaneous report received from a Consumer or other non HCP. An elderly male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jun2025 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: ASTHENIA (non-serious), outcome "recovering", described as "weakness"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "recovering", described as "not being able to perform normal tasks". Therapeutic measures were not taken as a result of asthenia, loss of personal independence in daily activities. Additional Information: the patient did not receive any other vaccines on the same date as the suspect vaccine and he was taking other medications within 2 weeks of the event starting. The patient reported weakness to the extent of not being able to perform normal tasks after receiving the vaccine. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.