Received May 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | — | — |
rubber stopper is a little bit more thicker than normal that it causes the needle to be dulled; rubber stopper is a little bit more thicker than normal that it causes the needle to be dulled; causes a little bit more pain and discomfort than it should be; causes a little bit more pain and discomfort than it should be; This is a spontaneous report received from a Pharmacist. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown), in arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DEVICE ISSUE (non-serious), NEEDLE ISSUE (non-serious), outcome "unknown" and all described as "rubber stopper is a little bit more thicker than normal that it causes the needle to be dulled"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE DISCOMFORT (non-serious), outcome "unknown" and all described as "causes a little bit more pain and discomfort than it should be". Therapeutic measures were not taken as a result of device issue, needle issue, vaccination site pain, vaccination site discomfort. Additional information: The vaccine was clarified as Abrysvo Act-O-Vial. It had all in one dose that came in the vial. The pharmacist said, when they used the Act-O-Vial kit that they put the needle into the kit to withdraw the vaccine that they felt like the rubber stopper/plunger was thicker than normal. They felt the stopper/plunger was so thick that it caused the needle as it went through and when they withdraw and stuck it into the patient's arm, it caused the patient a little bit more pain and discomfort than it should be. In pharmacist's opinion the rubber stopper was a little bit more thicker than normal that it caused the needle to be dulled. That was the pharmacist opinion. There was no lab work in past two weeks. The packaging sealed and intact. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none