Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 3046731 | IM |
HCP stated that a few of her PFS have been having issues with the plunger; No adverse effect; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046731) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3046731) for COVID-19 prophylaxis. No Medical History information was reported. On 29-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. Not Provided For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. This case contains information for the 2nd patient out of 4 patients described by the reporter. Concomitant medication information was not reported. HCP stated that, whenever the needle is attached to the PFS, the plunger rod becomes stuck, almost like there was too much pressure. HCP stated that the nurse was able to push the plunger up and down before she attached the needle onto it. HCP stated that she did clarify with the nurse about the needle. She stated that the nurse tried taking off the needle to see if that was the issue and the plunger still would not move. HCP stated that the nurse encountered this issue upon administering the vaccine to the patient. She stated that it was administered in the patient's arm. This happened to 1 patient on 23-Apr-2025 and 3 patients on 29-Apr-2025. Treatment medication was not reported. The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which included Use of Device Problem. This case was linked to US-MODERNATX, INC.-MOD-2025-785794 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2025: Live follow up received that non-significant information. References added. On 29-Apr-2025: Live follow up received that non-significant information; reference ID added; Sender's Comments: US-MODERNATX, INC.-MOD-2025-785794:Patient 2 of 4