Received Mar 5, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3053258 | IM |
No adverse effect; Having to remove the needle because it wasn't budging/It wasn't letting me; More than half of the medication or the vaccine that went into the patient, but there was maybe less than 25% left in the vaccine itself; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE ISSUE (Having to remove the needle because it wasn't budging/It wasn't letting me), UNDERDOSE (More than half of the medication or the vaccine that went into the patient, but there was maybe less than 25% left in the vaccine itself) and NO ADVERSE EVENT (No adverse effect) in a male patient of an unknown age who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3053258) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3053258) for COVID-19 prophylaxis. No Medical History information was reported. On 25-Feb-2026, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 25-Feb-2026, the patient experienced DEVICE ISSUE (Having to remove the needle because it wasn't budging/It wasn't letting me) and UNDERDOSE (More than half of the medication or the vaccine that went into the patient, but there was maybe less than 25% left in the vaccine itself). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (Having to remove the needle because it wasn't budging/It wasn't letting me), UNDERDOSE (More than half of the medication or the vaccine that went into the patient, but there was maybe less than 25% left in the vaccine itself) 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 provided by the reporter. It was reported that the dosage given to the male patient was not the full vial but more than half. This amount was expected to completely cover the patient, but the reporter had to remove the needle because it was not budging. It was noted that less than a quarter of the vaccine remained, but the reporter wanted to ensure that the patient was still fully covered even though that portion did not fully go in. The reporter added that more than half of the medication had gone into the patient, with approximately less than 25% remaining in the syringe. The reporter decided to discard the PFS rather than continue attempting to inject material that would not come out. They did not re-poke the patient, but the reporter wanted to ensure the patient was fully covered. The PFS was fully thawed, but less than a quarter of the vaccine remained in it. The reporter decided to discard the PFS rather than continue attempting to inject material that would not dispense. The Device Problem Information included FDA code:, Code:, Device problem: Use of Device Problem. It was unknown whether the patient experienced any additional symptoms or events. No treatment medications provided by the reporter.