Received May 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | UNK | LL8391 | — |
Spilled it all over my hands and that are turning red and itching; Spilled it all over my hands and that are turning red and itching; Completely broke off of the thread; the syringe did off of the lower lock part; It went all over the place; did not even go in and it got all over me; Completely broke off of the thread; the syringe did off of the lower lock part; It went all over the place; did not even go in and it got all over me; This is a spontaneous report received from a Pharmacist. A 42-year-old female patient was exposed to rsv vaccine prot.subunit pref 2v (ABRYSVO), (Lot number: LL8391, Expiration Date: May2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "Spilled it all over my hands and that are turning red and itching"; SYRINGE ISSUE (non-serious), ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), outcome "unknown" and all described as "Completely broke off of the thread; the syringe did off of the lower lock part; It went all over the place; did not even go in and it got all over me". Additional information: reporter was preparing Abrysvo for a patient and when she attached the syringe to the vial adapter, it like completely broke off of the thread. The syringe did off of the lower lock part. The tip of the syringe separated from the lower lock of the syringe and it had never had that happened before her life. So, reporter thought well, she can always put on one of her own syringes. So, she put the syringe back on and pushed the liquid in. So, she could at least mix it but it went all over the place. It did not even go in and it got all over the reporter. Reporter had two questions: should she worry that the diluent all got over her and if there is a way for her to get a replacement from Pfizer. Reporter gave a different one to the patient, not the one that exploded all over her. Reporter was asking if she needs to go to the hospital since she spilled it all over her hands and that are turning red and itching. Causality for "spilled it all over my hands and that are turning red and itching" and "completely broke off of the thread; the syringe did off of the lower lock part; it went all over the place; did not even go in and it got all over me" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).