Received Sep 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 3052549 | IM |
No adverse effect; a quarter of the way through the injection, it got stuck, and HCP was not able to administer the rest of it/patient only received maybe a quarter or so of the dose; a quarter of the way through the injection, it got stuck, and HCP was not able to administer the rest of it/HCP was administering a vaccine and had a malfunction with it; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (a quarter of the way through the injection, it got stuck, and HCP was not able to administer the rest of it/patient only received maybe a quarter or so of the dose), DEVICE MALFUNCTION (a quarter of the way through the injection, it got stuck, and HCP was not able to administer the rest of it/HCP was administering a vaccine and had a malfunction with it) and NO ADVERSE EVENT (No adverse effect) in a 78-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052549) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3052549) for COVID-19 prophylaxis. No Medical History information was reported. On 09-Sep-2025, 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 09-Sep-2025, the patient experienced UNDERDOSE (a quarter of the way through the injection, it got stuck, and HCP was not able to administer the rest of it/patient only received maybe a quarter or so of the dose) and DEVICE MALFUNCTION (a quarter of the way through the injection, it got stuck, and HCP was not able to administer the rest of it/HCP was administering a vaccine and had a malfunction with it). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse effect). At the time of the report, UNDERDOSE (a quarter of the way through the injection, it got stuck, and HCP was not able to administer the rest of it/patient only received maybe a quarter or so of the dose), DEVICE MALFUNCTION (a quarter of the way through the injection, it got stuck, and HCP was not able to administer the rest of it/HCP was administering a vaccine and had a malfunction with 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 patient did not receive full dose of vaccine. HCP administering a vaccine and had a malfunction with it. The quarter of the way through the injection, it got stuck, and HCP was not able to administer the rest of it. Patient only received maybe a quarter or so of the dose. 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. It was unknown if the patient experienced any additional symptoms/events.