Age: 26.0
Sex: M
Vaccine: RSV
Symptoms: Device issue, Eye pain, Occupational exposure to product, Wrong technique in device usage process
Clinical narrative: he inserted the needle into the stopper at a 45 degree angle and he withdrew approximately 0.3ml of air; a problem with over pressurized Abrysvo RSV vaccines; trying to reconstitute it and it sprayed him in the eye; soreness in the right eye; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 26-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 15Oct2024 at 10:00 as dose number unknown, single (Lot number: LN5460, Expiration Date: 30Jun2025) at the age of 26 years for immunisation. The patient's relevant medical history included: "he wears glasses" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious) with onset 15Oct2024 at 10:00, outcome "unknown", described as "a problem with over pressurized Abrysvo RSV vaccines"; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 15Oct2024 at 10:00, outcome "unknown", described as "he inserted the needle into the stopper at a 45 degree angle and he withdrew approximately 0.3ml of air"; EYE PAIN (non-serious) with onset 15Oct2024 at 10:00, outcome "recovered" (15Oct2024 at 13:30), described as "soreness in the right eye"; OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious) with onset 15Oct2024 at 10:00, outcome "unknown", described as "trying to reconstitute it and it sprayed him in the eye". Therapeutic measures were taken as a result of eye pain.  Additional information: The patient was trying to reconstitute it and it sprayed him in the eye and he doesn't know what to do. He states that in general all of the Abrysvo vials that he has worked with have been over pressurized. In order to mitigate this, he inserts a needle into the Act-o-vial to withdrawal some air before withdrawing the dose. When he was removing the needle from a vial this morning, the vaccine sprayed him in the eye.  He wants to know what to do about this.  He has been flushing his eye with water, but didn't know if there was further information regarding management of vaccine exposure to the eye. He states this happened to him and it occurred on 15Oct2024 at 10:00 AM. He begins to explain what happened to him and states he was preparing the Abrysvo vaccine when he pressed down on top to mix the lyophilized powder with the adjuvant, he removed the cover and wiped the rubber stopper with an alcohol wipe and he inserted the needle into the stopper at a 45 degree angle and he withdrew approximately 0.3ml of air. He states the reason that he removed the 0.3ml of air is because he has been noticing a problem with over pressurized Abrysvo RSV vaccines. He does not have lot, ndc, or expiration date to provide for any Abrysvo vaccine component where he has noticed the vaccine being overpressurized. This has been happening to the Abrysvo vaccines in the pharmacy but he does not have any product details to provide for the Abrysvo vaccines where the pharmacy has noticed it is overpressurized. He only has one lot, ndc, and expiration date to provide for the Abrysvo vaccine that sprayed in his eye today. He continues to explain that he took air out as a safety precaution this time, he removed the needle from the stopper with the base of the vial flat on the cabinet, as the needle was removed the needle was facing away from him slightly to the left side and the plunger was faced slightly towards his right eye. The stopper of the vial was pointed slightly away from him as a precaution in case it sprayed. Even after 0.3ml of air was removed, there was still sufficient pressure in the bottle for a stream of vaccine solution to spray from the hole created by the needle insertion, the spray was at a slight angle due to the needle insertion which caused a small volume of liquid to enter his right eye. When querying treatment, he states he immediately began rinsing his eye in the sink as he called Pfizer earlier. He rinsed his eye for 15 minutes since that is what he was instructed to do. He experienced soreness in the right eye for about 3 hours after this happened. There was no redness or vision changes. It appears to be completely resolved by around 130 in the afternoon which was about 3.5 hours after this happened. It got in his eye and he needed to know what to do very quickly. Attempted clarification on the presentation of the Abrysvo vaccine, states it is the one where it comes together and there is stopper to mix the lyophilized powder with adjuvant. He discarded it. There is only one component. He has only one lot, ndc, and expiration date to provide for this Abrysvo vaccine. It is 120mcg per 0.5 ml. He states the box is probably gone and lot, ndc, and expiration date cannot be provided. When querying other medical conditions, states he does not have an eye problem other than he wears glasses. He was not wearing his glasses at the time.