Received Dec 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT / RA |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT / RA |
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | UNK | — | OT / RA |
muscle weakness/loss of muscle control; muscle weakness/loss of muscle control; unable to stand; This is a spontaneous report received from an Other HCP and a Consumer or other non HCP, Program ID. A 77-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 12Oct2024 at 11:22 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years intramuscular, in right arm for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (ABRYSVO), on 12Oct2024 at 11:22 as dose number unknown, single (Batch/Lot number: unknown) at the age of 77 years intramuscular, in right arm for immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 12Oct2024 at 11:22 as dose number unknown, single intramuscular, in right arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULAR WEAKNESS (non-serious), MUSCLE DISORDER (non-serious) all with onset 12Oct2024, outcome "recovering" and all described as "muscle weakness/loss of muscle control"; BALANCE DISORDER (non-serious) with onset 12Oct2024, outcome "recovering", described as "unable to stand". Additional information: Patient reported muscle weakness/loss of muscle control to the point where he was unable to stand or use the bathroom. He required help of a caregiver to be transported from his bedroom to his bathroom and back. He reported these symptoms began the evening of vaccination and had begun to improve the following day. The information on the batch/lot number for BNT162b2 omicron (kp.2), rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.