Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052731 | IM |
No adverse effect; very tight caps, resulting in the loss of the doses. The vaccine spilled from the syringes; The vaccine spilled from the syringes, and one of the technicians touched the areas; We had two vaccines which spilled when trying to remove the top / Problem: vaccine cap excessively tight, difficulty removing cap without using excessive force resulting in vaccine loss; This spontaneous case was reported by a physician and describes the occurrence of DEVICE LEAKAGE (very tight caps, resulting in the loss of the doses. The vaccine spilled from the syringes), OCCUPATIONAL EXPOSURE TO PRODUCT (The vaccine spilled from the syringes, and one of the technicians touched the areas), PRODUCT CLOSURE REMOVAL DIFFICULT (We had two vaccines which spilled when trying to remove the top / Problem: vaccine cap excessively tight, difficulty removing cap without using excessive force resulting in vaccine loss) and NO ADVERSE EVENT (No adverse effect) in an adult female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052731) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3052731) for COVID-19 prophylaxis. No Medical History information was reported. In October 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. In October 2025, the patient experienced DEVICE LEAKAGE (very tight caps, resulting in the loss of the doses. The vaccine spilled from the syringes), OCCUPATIONAL EXPOSURE TO PRODUCT (The vaccine spilled from the syringes, and one of the technicians touched the areas) and PRODUCT CLOSURE REMOVAL DIFFICULT (We had two vaccines which spilled when trying to remove the top / Problem: vaccine cap excessively tight, difficulty removing cap without using excessive force resulting in vaccine loss). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE LEAKAGE (very tight caps, resulting in the loss of the doses. The vaccine spilled from the syringes), OCCUPATIONAL EXPOSURE TO PRODUCT (The vaccine spilled from the syringes, and one of the technicians touched the areas), PRODUCT CLOSURE REMOVAL DIFFICULT (We had two vaccines which spilled when trying to remove the top / Problem: vaccine cap excessively tight, difficulty removing cap without using excessive force resulting in vaccine loss) 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 medications provided by the reporter. It was reported an issue with two vaccine doses that had very tight caps, which resulted in the loss of the doses. It was also reported that the vaccine spilled from the syringes, and one of the technicians touched the areas and it caused contamination to the vaccine. The vaccine was not administrated to any patient. No treatment medications provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 24-Oct-2025: Live non-significant follow-up received in which new reference number was added. On 25-Oct-2025: Live non-significant follow-up received in which reporter details were updated and new reference number was added.