Received Dec 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052133 | IM |
No adverse effect; while the plunger was been pushed down "it squirted out the side" (between the needle and the syringe); the patient did not get the full dose; it was a very tough to get the tip out of it and put the needle on; it could have been user error as the tip may not have been on there completely; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT LEAKAGE (while the plunger was been pushed down "it squirted out the side" (between the needle and the syringe)), UNDERDOSE (the patient did not get the full dose), DEVICE CONNECTION ISSUE (it was a very tough to get the tip out of it and put the needle on), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (it could have been user error as the tip may not have been on there completely) and NO ADVERSE EVENT (No adverse effect) in a 54-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052133) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3052133) for COVID-19 prophylaxis. No Medical History information was reported. On 19-Dec-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 19-Dec-2025, the patient experienced PRODUCT LEAKAGE (while the plunger was been pushed down "it squirted out the side" (between the needle and the syringe)), UNDERDOSE (the patient did not get the full dose), DEVICE CONNECTION ISSUE (it was a very tough to get the tip out of it and put the needle on) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (it could have been user error as the tip may not have been on there completely). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse effect). At the time of the report, PRODUCT LEAKAGE (while the plunger was been pushed down "it squirted out the side" (between the needle and the syringe)), UNDERDOSE (the patient did not get the full dose), DEVICE CONNECTION ISSUE (it was a very tough to get the tip out of it and put the needle on), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (it could have been user error as the tip may not have been on there completely) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. For mRNA-1283 (MNEXSPIKE 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 medication was reported. On 19-Dec-2025, the patient had been administered the mNEXSPIKE and while the plunger had been pushed down, it squirted out the side (between the needle and the syringe). According to the reporter, it could have been user error as the tip might not have been on there completely. Therefore, the patient did not get the full dose as the amount that was given to the patient and the amount that squirted out was unknown. The reporter also stated it was very tough to get the tip out of it and put the needle on. Per reporter, possibly could not have screwed it on tight enough but it did not dislodge as it was still fully intact. The Device problem code for Spikevax syringe included FDA code, code which included Fluid Leak and FDA code, code which included Connection Problem. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported.