Received Oct 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | NA0739 | OT / LA |
patient felt pain; Patient did not get full dose; Plunger was hard as a rock at the last 1/3 of injection; plunger failed approximately 2/3rds of the way through; This is a spontaneous report received from an Other HCP from medical information team. A 33-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 20Oct2025 as dose 1, single (Lot number: NA0739, Expiration Date: 02Jul2026) at the age of 33 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INCORRECT DOSE ADMINISTERED BY DEVICE (non-serious) with onset 20Oct2025, outcome "unknown", described as "Patient did not get full dose"; DEVICE MECHANICAL ISSUE (non-serious) with onset 20Oct2025, outcome "unknown", described as "Plunger was hard as a rock at the last 1/3 of injection"; VACCINATION SITE PAIN (non-serious) with onset 20Oct2025, outcome "unknown", described as "patient felt pain"; DEVICE OCCLUSION (non-serious) with onset 20Oct2025, outcome "unknown", described as "plunger failed approximately 2/3rds of the way through". Causality for "patient did not get full dose", "plunger was hard as a rock at the last 1/3 of injection" and "plunger failed approximately 2/3rds of the way through" was determined associated to device constituent of BNT162b2 omicron (lp.8.1). Additional information: Pharmacy technician queried asking "Is 2/3 dose enough for coverage or need to give her another one. Reporter was administering the Comirnaty covid shot to a patient but the plunger failed approximately 2/3rds of the way through and was hard as a rock. The patient did not get a full dose; she got just about 2/3rds of dose into her body. Around 2/3s of the dose, the plunger hardened to like a rock, like pressing a rock on it, and the lady felt pain. They removed the syringe from the patient. When took it out, pressed the plunger harder and had to put full force and the last third of the injection was wasted in the waste bin. Caller has done a couple of hundred shots so far, and these were the only ones that had this issue, so caller got weirded out. First time going through something like that. Caller was the injecting immunization technician, caller was the one doing the plunger.