Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: She said that when the shot was given to her that some of the fluid ran out.; No adverse event; The patient was nervous they didn't get the full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of SYRINGE ISSUE (She said that when the shot was given to her that some of the fluid ran out.), UNDERDOSE (The patient was nervous they didn't get the full dose) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 203G23A) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis.    Previously administered products included for Drug use for unknown indication: Patient got a flu shot the week before. (week before). Past adverse reactions to the above products included No adverse event with Patient got a flu shot the week before.   On 09-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 09-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced UNDERDOSE (The patient was nervous they didn't get the full dose). On an unknown date, the patient experienced SYRINGE ISSUE (She said that when the shot was given to her that some of the fluid ran out.) and NO ADVERSE EVENT (No adverse event). At the time of the report, SYRINGE ISSUE (She said that when the shot was given to her that some of the fluid ran out.), UNDERDOSE (The patient was nervous they didn't get the full dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  HCP reported that patient got a Covid shot last Thursday. She said that when the shot was given to her that some of the fluid ran out. The patient was nervous they didn't get the full dose.  HCP stated that some of the medication leaked out of the patient's arm post PFS administration. The PFS that was used in administration was discarded.  The Device problem code for Spikevax syringe include FDA code 1250, IMDRF code A050401 which include Fluid Leak.  The device was malfunctioned, and the malfunction type was CIRM.  Rationale for no investigation was reported as no additional investigation is recommended at this time as QA conducted follow up communication with the reporting HCP in which the reported event was clarified that the PFS (Pre-Filled Syringe), that was used for administration did not leak and that some of the medication leaked out of the patient's arm post PFS administration.  Treatment medication use information was not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2023: Non-significant follow up received and reference number added. On 20-Dec-2023: Closed PQC investigation report received contains significant information includes QC comment added and updated narrative.