Sex: U
Vaccine: UNK
Symptoms: Device issue, No adverse event, Wrong technique in device usage process
Clinical narrative: Have you been receiving any complaints about how difficult is has been to take off the cap of the pre-filled syringe?; It took pliers to take the cap off of a syringe. He states that he doesn't want it reported that he had to use pliers; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE ISSUE (Have you been receiving any complaints about how difficult is has been to take off the cap of the pre-filled syringe?), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (It took pliers to take the cap off of a syringe. He states that he doesn't want it reported that he had to use pliers) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.    The suspect product included Pre-filled Syringe injection 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 (Have you been receiving any complaints about how difficult is has been to take off the cap of the pre-filled syringe?), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (It took pliers to take the cap off of a syringe. He states that he doesn't want it reported that he had to use pliers) and NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE ISSUE (Have you been receiving any complaints about how difficult is has been to take off the cap of the pre-filled syringe?), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (It took pliers to take the cap off of a syringe. He states that he doesn't want it reported that he had to use pliers) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for DEVICE ISSUE (Have you been receiving any complaints about how difficult is has been to take off the cap of the pre-filled syringe?) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (It took pliers to take the cap off of a syringe. He states that he doesn't want it reported that he had to use pliers).  For Pre-filled Syringe, the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for DEVICE ISSUE (Have you been receiving any complaints about how difficult is has been to take off the cap of the pre-filled syringe?) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (It took pliers to take the cap off of a syringe. He states that he doesn't want it reported that he had to use pliers).    No concomitant or treatment medications were provided. The caller reported that when they received the shipment, some boxes were damaged. The vaccine itself inside the boxes were fine. The boxes were taped together like they fell off a truck. The patient reported that they were scotch taped together, and it was only some boxes, not all of them. The patient asked that if any complaints about how difficult it has been to take off the cap of the pre-filled syringe received before. The patient told it took pliers to take the cap off of a syringe which was so aggravating. The patient just wanted to report that it was very difficult to remove the cap off the syringes. The Device problem code for Spikevax syringe include FDA code 2588, IMDRF code A0203 which include Defective Device. The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which include Use of Device Problem.