Received Feb 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052786 | IM |
hard to get off / had to like pull the rubber stopper out really hard separately from that other plastic piece; splash out a tiny bit and like the vaccine like touched the patient/ did not think that being on skin was an issue; splash out a tiny bit and like the vaccine like touched the patient/ a little drop of it flew out; just a weird design and that sometimes when it was pulled, it was kind of like a little drop of it flew out and had to pull the rubber stopper out really hard separately from that other plastic piece; No adverse effect; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE CONNECTION ISSUE (hard to get off / had to like pull the rubber stopper out really hard separately from that other plastic piece), ACCIDENTAL EXPOSURE TO PRODUCT (splash out a tiny bit and like the vaccine like touched the patient/ did not think that being on skin was an issue), PRODUCT LEAKAGE (splash out a tiny bit and like the vaccine like touched the patient/ a little drop of it flew out), PRODUCT DESIGN ISSUE (just a weird design and that sometimes when it was pulled, it was kind of like a little drop of it flew out and had to pull the rubber stopper out really hard separately from that other plastic piece) and NO ADVERSE EVENT (No adverse effect) in a female patient of an unknown age who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052786) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3052786) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (hard to get off / had to like pull the rubber stopper out really hard separately from that other plastic piece), ACCIDENTAL EXPOSURE TO PRODUCT (splash out a tiny bit and like the vaccine like touched the patient/ did not think that being on skin was an issue), PRODUCT LEAKAGE (splash out a tiny bit and like the vaccine like touched the patient/ a little drop of it flew out), PRODUCT DESIGN ISSUE (just a weird design and that sometimes when it was pulled, it was kind of like a little drop of it flew out and had to pull the rubber stopper out really hard separately from that other plastic piece) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE CONNECTION ISSUE (hard to get off / had to like pull the rubber stopper out really hard separately from that other plastic piece), ACCIDENTAL EXPOSURE TO PRODUCT (splash out a tiny bit and like the vaccine like touched the patient/ did not think that being on skin was an issue), PRODUCT LEAKAGE (splash out a tiny bit and like the vaccine like touched the patient/ a little drop of it flew out), PRODUCT DESIGN ISSUE (just a weird design and that sometimes when it was pulled, it was kind of like a little drop of it flew out and had to pull the rubber stopper out really hard separately from that other plastic piece) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. No concomitant medications were reported. The reporter was asking if the designs of the syringes could be changed with a different design, if possible, for ease of product usage. It was reported that, the product was being hard to get off, and the patient had it happen like a few times, like not quite as frequently as some other people, and it was like kind of splash out a tiny bit and like the vaccine touched the reporter who did not find that to be a problem. It was reported that, the reporter had the vaccine inside body but did not think that being on skin was an issue. It was reported to be just a weird design and that sometimes when it was pulled, it was kind of like a little drop of it flew out and had to pull the rubber stopper out really hard separately from that other plastic piece, so it was just from ease of use. The Device Problem Information included FDA code: 2900, IMDRF Code: A12, Device Problem: Connection Problem and FDA code: 1354, IMDRF Code: A0504, Device Problem: Leak / Splash. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided.