Received Sep 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 3052030 | IM |
administered mNEXSPIKE to a patient but some of the liquid dribbled out of the injection site after the needle was withdrawn; administered mNEXSPIKE to a patient but some of the liquid dribbled out of the injection site after the needle was withdrawn; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE DISCHARGE (administered mNEXSPIKE to a patient but some of the liquid dribbled out of the injection site after the needle was withdrawn) and INCORRECT DOSE ADMINISTERED (administered mNEXSPIKE to a patient but some of the liquid dribbled out of the injection site after the needle was withdrawn) in a 24-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052030) for COVID-19 prophylaxis. Concurrent medical conditions included Asthma and Arthritis. Concomitant products included Influenza vaccine (Flu) for an unknown indication. On 17-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On 17-Sep-2025, the patient experienced VACCINATION SITE DISCHARGE (administered mNEXSPIKE to a patient but some of the liquid dribbled out of the injection site after the needle was withdrawn) and INCORRECT DOSE ADMINISTERED (administered mNEXSPIKE to a patient but some of the liquid dribbled out of the injection site after the needle was withdrawn). At the time of the report, VACCINATION SITE DISCHARGE (administered mNEXSPIKE to a patient but some of the liquid dribbled out of the injection site after the needle was withdrawn) and INCORRECT DOSE ADMINISTERED (administered mNEXSPIKE to a patient but some of the liquid dribbled out of the injection site after the needle was withdrawn) outcome was unknown. For mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use), the reporter did not provide any causality assessments. It was reported that the Flu shot was administered at the same time after the mNEXSPIKE was administered. HCP had reported that a colleague had administered mNEXSPIKE to a patient but some of the liquid dribbled out of the injection site after the needle was withdrawn. HCP confirmed through the colleague who administered that the plunger was fully depressed during the administration. HCP confirmed that his colleague did not notice anything different with what he normally does during the process of administration. HCP guessed would be perhaps that they did not use the appropriate size needle. HCP confirmed they have used a gauge 25 luer-style needle by 1-inch. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided.
Arthritis; Asthma
Flu