Received Jun 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 3046734 | IM |
No adverse effect; Complained about the plunger of a vaccine from lot #3046734/having to push the plunger very hard while giving the vaccine to the patient.; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE ISSUE (Complained about the plunger of a vaccine from lot #3046734/having to push the plunger very hard while giving the vaccine to the patient.) and NO ADVERSE EVENT (No adverse effect) in a 73-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046734) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3046734) for COVID-19 prophylaxis. No Medical History information was reported. On 12-Jun-2025, 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 12-Jun-2025, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced DEVICE ISSUE (Complained about the plunger of a vaccine from lot #3046734/having to push the plunger very hard while giving the vaccine to the patient.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (Complained about the plunger of a vaccine from lot #3046734/having to push the plunger very hard while giving the vaccine to the patient.) and 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. It was reported that HCP had to push the plunger very hard while giving the vaccine to the patient. It was unknown if the patient experienced any additional symptoms or events. Treatment information was not reported. 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 12-Jun-2025: Live follow-up received contains non-significant information: reference number added.