Received Jul 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | LL8394 | — |
the plunger stopped and kept pushing, pulled the needle out and malfunctioned/Administered; the plunger stopped and kept pushing, pulled the needle out and malfunctioned/Administered; that there was half of the vaccine left in the syringe.; This is a spontaneous report received from a Pharmacist from medical information team, Program ID: 004756. An 85-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Lot number: LL8394, Expiration Date: Feb2026) for immunisation, Device Lot Number: LH6570, Device Expiration Date: Apr2027. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MECHANICAL ISSUE (non-serious), POOR QUALITY DEVICE USED (non-serious), outcome "unknown" and all described as "the plunger stopped and kept pushing, pulled the needle out and malfunctioned/Administered"; UNDERDOSE (non-serious), outcome "unknown", described as "that there was half of the vaccine left in the syringe.". Additional information: The pharmacist called in with regard to a dosage and administration question on Abrysvo. So, what she said, happened was when she was giving the vaccine to the patient the plunger stop as if it was done like it is normally does. So, when she went to throw it, she felt like there was more vaccine. So, she looked into the sharps container to confirm it and she saw that there was still vaccine left. She estimated that the patient got half of the vaccine. Then she was not able to fully confirm the presentation of the Abrysvo but she said, it is the one with the vial, adaptor." When paraphrased the concern, reporter stated, "I was giving the vaccine the plunger stop as if the vaccine had all been given. The times seemed like it was correct as well. I guess per usual and then as I was throwing it away, you know how like those like, instinctive thing, just kick in. I thought, as it was going in the sharp, saw liquid in there. I confirmed that later, I could see it in the sharp's container that there seemed to be a half a vial or half dose, still there." Causality for "the plunger stopped and kept pushing, pulled the needle out and malfunctioned/administered" and "that there was half of the vaccine left in the syringe." was determined associated to device constituent of rsv vaccine prot.subunit pref 2v.