Received Dec 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Benign Fasciculation Syndrome; This is a spontaneous report received from an Other HCP. A 47-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 21Nov2025 at 12:30 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: BENIGN FASCICULATION SYNDROME (non-serious) with onset 22Nov2025 at 16:00, outcome "not recovered". Therapeutic measures were taken as a result of benign fasciculation syndrome. Additional information: The patient did not receive any other vaccines on the same date as the vaccine, not received any other vaccines within 4 weeks PRIOR to the vaccine. Patient was not taking any other medications within 2 weeks of the event starting. 24 hours after the vaccine his lower legs started Fasciculation. Treatment received for the adverse event, Diagnosed with Benign Fasciculation Syndrome. No known allergies and other medical history reported as none. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.