Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052668 | IM |
after administering the vaccine to patient and upon removing the needle from the muscle the injected vaccine started "spilling out" of the patient arm; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE DISCHARGE (after administering the vaccine to patient and upon removing the needle from the muscle the injected vaccine started "spilling out" of the patient arm) in a 31-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052668) for COVID-19 prophylaxis. No Medical History information was reported. On 08-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On 08-Oct-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced INJECTION SITE DISCHARGE (after administering the vaccine to patient and upon removing the needle from the muscle the injected vaccine started "spilling out" of the patient arm). At the time of the report, INJECTION SITE DISCHARGE (after administering the vaccine to patient and upon removing the needle from the muscle the injected vaccine started "spilling out" of the patient arm) outcome was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter considered INJECTION SITE DISCHARGE (after administering the vaccine to patient and upon removing the needle from the muscle the injected vaccine started "spilling out" of the patient arm) to be related. Concomitant medication was not reported. HCP stated that after administering the vaccine to patient and upon removing the needle from the muscle the injected vaccine started spilling out of the patient arm. HCP confirmed that she was not exposed herself to the vaccine and that the vaccine leaked on the patient's arm. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.