Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
No adverse effect; a couple of drops leaked from the connection between the PFS and the needle; couple of drops leaked from the connection between the PFS and the needle; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (a couple of drops leaked from the connection between the PFS and the needle), UNDERDOSE (couple of drops leaked from the connection between the PFS and the needle) and NO ADVERSE EVENT (No adverse effect) in a 93-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 22-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 22-Oct-2025, the patient experienced DEVICE CONNECTION ISSUE (a couple of drops leaked from the connection between the PFS and the needle) and UNDERDOSE (couple of drops leaked from the connection between the PFS and the needle). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE CONNECTION ISSUE (a couple of drops leaked from the connection between the PFS and the needle), UNDERDOSE (couple of drops leaked from the connection between the PFS and the needle) 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 medication was reported. HCP reported that while administering the vaccine to the patient he saw that a couple of drops leaked from the connection between the PFS and the needle. These drops then fell on the patient's arm. The Device Problem Information included FDA code: 1250, Code: A050401, Device problem: Fluid Leak. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 23-Oct-2025: Live non-significant follow up received: reference number added.