Sex: U
Vaccine: COVID19
Symptoms: Device issue, No adverse event, Product colour issue
Clinical narrative: try to pull it off, it's very difficult to remove. We did finally get it removed and then we tried another one because I thought this doesn't sound right and then the stopper got stuck; It's kind of brown like inside of those, inside of that area/The pen was discolored. I don't recall it being discolored before.; No adverse effect; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE ISSUE (try to pull it off, it's very difficult to remove. We did finally get it removed and then we tried another one because I thought this doesn't sound right and then the stopper got stuck), PRODUCT COLOUR ISSUE (It's kind of brown like inside of those, inside of that area/The pen was discolored. I don't recall it being discolored before.) and NO ADVERSE EVENT (No adverse effect) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 208H23A) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection (batch no. 208H23A) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (try to pull it off, it's very difficult to remove. We did finally get it removed and then we tried another one because I thought this doesn't sound right and then the stopper got stuck), PRODUCT COLOUR ISSUE (It's kind of brown like inside of those, inside of that area/The pen was discolored. I don't recall it being discolored before.) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (try to pull it off, it's very difficult to remove. We did finally get it removed and then we tried another one because I thought this doesn't sound right and then the stopper got stuck), PRODUCT COLOUR ISSUE (It's kind of brown like inside of those, inside of that area/The pen was discolored. I don't recall it being discolored before.) and NO ADVERSE EVENT (No adverse effect) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which include Use of Device Problem and FDA code 1170, IMDRF code A0407 which include Material Discolored.   The suspect product dosage text was reported as unknown. The reporter had some Moderna product pre-filled syringes, and they were having some issues with them. The last time they tried to use them, it would be where, the top screws off, where one can put the syringe, the needle tip on. It's kind of brown like inside of those, inside of that area. And then when they tried to pull it off, it's very difficult to remove. They did finally get it removed and then tried another one because the reporter thought this doesn't sound right and then the stopper got stuck.  The HCP stated that the issue was discovered while they were going to administer. HCP confirmed that no patient was involved. The technician was going to do it and they were having trouble getting the top off. Then another technician tried another pen, and this was discolored. The reporter doesn't recall it being discolored before.  Treatment information was not provided.