Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Device issue, No adverse event
Clinical narrative: No adverse effect; A different pharmacist went to give the shot and the plunger would not move. The Pharmacist looked at it and the rubber stopper was swollen/That one stopper would not move/~plunger was slightly swollen and did not the pharmacist to inject the medicat; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE ISSUE (A different pharmacist went to give the shot and the plunger would not move. The Pharmacist looked at it and the rubber stopper was swollen/That one stopper would not move/~plunger was slightly swollen and did not the pharmacist to inject the medicat) and NO ADVERSE EVENT (No adverse effect) in an 82-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043835) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection (batch no. 3043835) for COVID-19 prophylaxis.    No Medical History information was reported.   On 23-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 23-Nov-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced DEVICE ISSUE (A different pharmacist went to give the shot and the plunger would not move. The Pharmacist looked at it and the rubber stopper was swollen/That one stopper would not move/~plunger was slightly swollen and did not the pharmacist to inject the medicat). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse effect). On 23-Nov-2024, DEVICE ISSUE (A different pharmacist went to give the shot and the plunger would not move. The Pharmacist looked at it and the rubber stopper was swollen/That one stopper would not move/~plunger was slightly swollen and did not the pharmacist to inject the medicat) had resolved. At the time of the report, NO ADVERSE EVENT (No adverse effect) outcome was unknown.        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.   Concomitant medication was not provided. A different pharmacist went to give the shot, and the plunger would not move. The Pharmacist looked at it and the rubber stopper was swollen, so the pharmacist had to take it out and give another one. The pharmacist took it out of the arm and tried to move it, finally when the rubber stopper did move, it almost all came out in one fell swoop. It was not moving well. Could see a line in the middle of the rubber stopper and it was pretty swollen where it looks solid. It came to them frozen, and HCP was not aware of any temperature excursions so she was not sure what would have caused it. That one stopper would not move. Pharmacist had to stick the patient twice. Patient did not get any vaccine out of the first syringe with the issue. HCP confirmed that a pharmacist tried to administer the vaccine, and while it was in the patient's arm, the syringe would not plunge, so the pharmacist had to use a different syringe after to administer Spikevax to the patient. The stopper in syringe jammed, obstructing medication from being delivered to patient deltoid muscle. Needle removed from patient's arm and new syringe was then used to deliver medication.  The event did not cause patient to seek medical care. Treatment information was not provided.  The Device Problem Information include FDA code: 1670, IMDRF Code: A23, Device problem: Use of Device Problem.   Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2024: Live follow-up received that contains non-significant information: Reference ids added. On 03-Dec-2024: Live Non-significant Follow-up added. LRN added. On 04-Dec-2024: Live Non significant information updated LRN number added. On 19-Dec-2024: Significant follow-up received and added reporter details, added patient details, added suspect administration date, added event onset date, updated outcome of event and updated narrative.