Sex: F
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: their lot the Act-O-Vial is hard to press, very hard at the top, and once finally compressed the liquid squirts out; their lot the Act-O-Vial is hard to press, very hard at the top, and once finally compressed the liquid squirts out; hurt her hand so bad; This is a spontaneous report received from a Pharmacist from medical information team.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown, Expiration Date: Sep2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown" and all described as "their lot the Act-O-Vial is hard to press, very hard at the top, and once finally compressed the liquid squirts out"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "hurt her hand so bad ". Additional information: Act-O-Vial is hard to press, very hard at the top, and once finally compressed the liquid squirts out. Sometimes to get the product to compress, they turn it upside down with the cap on the table and press it that way and it will not push down and the caller asked the reporter if it was just a onetime  thing and they said no. The reporter's facility is right by a women's center so they have spill over from the vaccination side and their facility is inside a big doctor's building so they get a lot of age 60 plus patients and maternal patients and the reporter stated they have probably done multiple doses.Reporter states the that they still keep the other ones regarding the other presentation of the Abrysvo vaccine because they like that better and the caller said he thought the Actovial was a better mouse trap and thinks it is just the one or the last few they had of the Actovial that had this issue but the reporter said it is every one of the Actovials that have had this issue since they switched to the Actovial and it will squirt out every time and the reporter put a shirt over her hand and it was a long sleeve shirt to press down on the actovial and the reporter hurt her hand so bad and she is not a frail lady and she has done this a lot. The actovials were administered to patients and they were able to get the 0.5 dose out but did lose medication that was spewing out of the vial but there was still enough to get the 0.5mL dose; he has no patient specific information to provide. States initially that the lot number he has for the Actovial is PAA225394 and expiry date is Sep2025; caller clarified he has no additional number that could be the lot number and states the NDC is 0069-2465-19. He took photos of the actovial bottle and this information was from the photo of the actual little actovial itself and he took the photos all over the bottle and that is all he saw; has no additional lots, expiry dates, NDC numbers or manufacturer names to provide for any other Actovial or carton/box. For the other presentation they liked better, caller stated there were only two presentations and the one they were speaking of liking better that is the Abrysvo vaccine with the vial adaptor that they had last year so it had a syringe kit that had syringe diluent in it and vial adaptor and vial with lyophilized powder and you take the adaptor and put it down over the vial and take the syringe with Luer lock and lock in on it and push the solution in and they had zero problems with that presentation and this actovial is harder to do with the leakage for the actovial. Caller has no lots, expiry dates, NDC numbers or patient information or manufacturer names to provide for any of the components of the Abrysvo vaccine presentation with the vial adaptor, antigen vial, diluent syringe and carton/box and for that presentation, the caller states there were not any problems with that. He would say other pharmacists ordered it regarding the Actovial and liked it better as it is fairly new and just coming out and he found out they liked it better on probably Wednesday last week so had somebody who he can't remember the exact date of who or when he talked with people so maybe the 26Sep2024 is when he became aware of for people stating the Actovial is better than the diluent syringe presentation; states that was an in general comment and so far the general opinion as people are just now getting this and they overall like it and he is in pharmacies all day long and can't remember the pharmacies names or lot numbers; he has no reporter information, lots, expiry dates, NDC numbers, manufacturer names for any components of any other Abrysvo presentation to provide. Caller states he is assuming so and he did not ask the reporter this and for what came in the box, everything seemed ok and the reporter did not mention anything out of normal like that.  The information on the batch/lot number for [RSV VACCINE PROT.SUBUNIT PREF 2V] will be requested and submitted if and when received.