Received Oct 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 8146367 | IM |
HCP stated that she had 1 syringe with no plunger; No adverse effect; She inserted the vaccine into the patients arm and then realized there was no plunger, so she removed it from the arm as there was no way to administer it; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE ISSUE (HCP stated that she had 1 syringe with no plunger), PRODUCT DISPENSING ISSUE (She inserted the vaccine into the patients arm and then realized there was no plunger, so she removed it from the arm as there was no way to administer it) and NO ADVERSE EVENT (No adverse effect) in a 66-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 8146367) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 8146367) for COVID-19 prophylaxis. No Medical History information was reported. On 09-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 09-Oct-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced PRODUCT DISPENSING ISSUE (She inserted the vaccine into the patients arm and then realized there was no plunger, so she removed it from the arm as there was no way to administer it). On an unknown date, the patient experienced DEVICE ISSUE (HCP stated that she had 1 syringe with no plunger) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (HCP stated that she had 1 syringe with no plunger), PRODUCT DISPENSING ISSUE (She inserted the vaccine into the patients arm and then realized there was no plunger, so she removed it from the arm as there was no way to administer it) 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 were provided. The HCP stated that she had 1 syringe with no plunger. She inserted the vaccine into the patients arm and then realized there was no plunger, so she removed it from the arm as there was no way to administer it. The patient was then administered a vaccine with a functioning syringe/plumber. It was unknown if the patient experienced any additional symptoms/events. The Device problem code for pre-filled syringe include FDA code 1670, IMDRF code A23 which included Use of Device Problem. No treatment medication was provided. Most recent FOLLOW-UP information incorporated above includes: On 09-Oct-2025: Live follow-up received which contains non-significant information, reference numbers added. On 09-Oct-2025: Live follow-up received which contains non-significant information, reference numbers added. On 09-Oct-2025: Live follow-up received which contains significant information, reporter details, patient's demographic and reference number added.