Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: No adverse effect; Incorrect dose administered; syringe was leaking and that the needle was not screwed on tightly so when the Pharmacist put pressure, it leaked; syringe was leaking and that the needle was not screwed on tightly so when the Pharmacist put pressure, it leaked; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT DOSE ADMINISTERED (Incorrect dose administered), DEVICE CONNECTION ISSUE (syringe was leaking and that the needle was not screwed on tightly so when the Pharmacist put pressure, it leaked), SYRINGE ISSUE (syringe was leaking and that the needle was not screwed on tightly so when the Pharmacist put pressure, it leaked) and NO ADVERSE EVENT (No adverse effect) in a 35-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis.    Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) from 30-Sep-2024 to 30-Sep-2024 for an unknown indication.   On 30-Sep-2024, the patient received fifth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 30-Sep-2024, the patient experienced INCORRECT DOSE ADMINISTERED (Incorrect dose administered), DEVICE CONNECTION ISSUE (syringe was leaking and that the needle was not screwed on tightly so when the Pharmacist put pressure, it leaked) and SYRINGE ISSUE (syringe was leaking and that the needle was not screwed on tightly so when the Pharmacist put pressure, it leaked). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse effect). At the time of the report, INCORRECT DOSE ADMINISTERED (Incorrect dose administered), DEVICE CONNECTION ISSUE (syringe was leaking and that the needle was not screwed on tightly so when the Pharmacist put pressure, it leaked), SYRINGE ISSUE (syringe was leaking and that the needle was not screwed on tightly so when the Pharmacist put pressure, it leaked) and NO ADVERSE EVENT (No adverse effect) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments.   The patient didn't receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The reporter stated that when the Pharmacist administered the dose, the vaccine was put it in the patient's arm and felt the vaccine run down on the arm. The reporter stated that it appeared that the syringe was leaking and that the needle was not screwed tightly, so when the pharmacist put pressure, it was leaked. The reporter stated that patient asked the pharmacist how much vaccine was administered, and pharmacist wasn't sure so used another syringe of Spikevax and administered about half the syringe to the patient. The reporter stated that patient was also received a dose of the flu vaccine on the same day. The reporter states that patient was not experienced any side effects. No other details were provided.  The Device problem code for Spikevax syringe include FDA code, code which include Use of Device Problem and FDA code, code which include Fluid Leak. Malfunction type was reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2024: Live non-significant follow-up received; reference numbers were added. On 03-Oct-2024: Live follow up received: No new information was updated.