Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Device difficult to use, No adverse event, Product administration error, Syringe issue
Clinical narrative: she removed the needle from the syringe and tried with a new needle but it was the same, seemed like the syringe was blocked/Outside of the patient, they were able to pull the product drop by drop but it definitely does not work as usual; the plunger did not depressed even after a lot of strength was applied into the plunger rod (HCP got a mark into her finger due to strength applied)/when they tried to take out the rubber tip cap it was difficult; No Adverse Event; she injected the needles in the arm of the patient 3 times; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (she injected the needles in the arm of the patient 3 times), SYRINGE ISSUE (she removed the needle from the syringe and tried with a new needle but it was the same, seemed like the syringe was blocked/Outside of the patient, they were able to pull the product drop by drop but it definitely does not work as usual), DEVICE DIFFICULT TO USE (the plunger did not depressed even after a lot of strength was applied into the plunger rod (HCP got a mark into her finger due to strength applied)/when they tried to take out the rubber tip cap it was difficult) and NO ADVERSE EVENT (No Adverse Event) in an 89-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030337) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis.    Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 (Dose 1) on 13-Jan-2021, Moderna COVID-19 (Dose 2) on 10-Feb-2021, Moderna COVID-19 (Dose 3) on 28-Oct-2021, Moderna COVID-19 (Dose 4, partial dose, unknown dosage) on 05-Jul-2022 and Moderna COVID-19 (Dose 5) on 19-Oct-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19, Moderna COVID-19, Moderna COVID-19, Moderna COVID-19 and Moderna COVID-19.   On 05-Dec-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 05-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced PRODUCT ADMINISTRATION ERROR (she injected the needles in the arm of the patient 3 times). On an unknown date, the patient experienced SYRINGE ISSUE (she removed the needle from the syringe and tried with a new needle but it was the same, seemed like the syringe was blocked/Outside of the patient, they were able to pull the product drop by drop but it definitely does not work as usual), DEVICE DIFFICULT TO USE (the plunger did not depressed even after a lot of strength was applied into the plunger rod (HCP got a mark into her finger due to strength applied)/when they tried to take out the rubber tip cap it was difficult) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT ADMINISTRATION ERROR (she injected the needles in the arm of the patient 3 times), SYRINGE ISSUE (she removed the needle from the syringe and tried with a new needle but it was the same, seemed like the syringe was blocked/Outside of the patient, they were able to pull the product drop by drop but it definitely does not work as usual), DEVICE DIFFICULT TO USE (the plunger did not depressed even after a lot of strength was applied into the plunger rod (HCP got a mark into her finger due to strength applied)/when they tried to take out the rubber tip cap it was difficult) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT ADMINISTRATION ERROR (she injected the needles in the arm of the patient 3 times), SYRINGE ISSUE (she removed the needle from the syringe and tried with a new needle but it was the same, seemed like the syringe was blocked/Outside of the patient, they were able to pull the product drop by drop but it definitely does not work as usual) and DEVICE DIFFICULT TO USE (the plunger did not depressed even after a lot of strength was applied into the plunger rod (HCP got a mark into her finger due to strength applied)/when they tried to take out the rubber tip cap it was difficult).  For Pre-filled Syringe, the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT ADMINISTRATION ERROR (she injected the needles in the arm of the patient 3 times), SYRINGE ISSUE (she removed the needle from the syringe and tried with a new needle but it was the same, seemed like the syringe was blocked/Outside of the patient, they were able to pull the product drop by drop but it definitely does not work as usual) and DEVICE DIFFICULT TO USE (the plunger did not depressed even after a lot of strength was applied into the plunger rod (HCP got a mark into her finger due to strength applied)/when they tried to take out the rubber tip cap it was difficult).    No relevant concomitant medications were reported.  The Device problem code for Spikevax syringe include code 1670, IMDRF code A23 which include Use of Device Problem and FDA code 2588, IMDRF code A0203 which include Defective Device. Malfunction type was reported as CIRM.  On 5 DEC 2023 they received a shipment of 2 boxes of Spikevax for 12 years and older PFS in blister packs. and put the vaccines in the fridge. On the same date they opened 1 box to get a PFS since a patient needed to be administrated, when they tried to take out the rubber tip cap it was difficult but then she was able to do it and put a needle in the syringe, and when she tried to administer the product, the plunger did not depressed even after a lot of strength was applied into the plunger rod (HCP got a mark into her finger due to strength applied), she removed the needle from the syringe and tried with a new needle but it was the same, seemed like the syringe was blocked. HCP tried with a second new PFS from the same box but once again she was not able to push the plunger. Outside of the patient, they were able to pull the product drop by drop but it definitely does not work as usual, it was not fluid but the vaccine was completely liquid inside of the syringe. Reporter mentioned they only tried with 2 different PFS but they assume all the vaccines have the same defect, and if possible they would like to return the 2 full boxes. No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Dec-2023: Live follow-up received on 06-Dec-2023, containing non-significant information and references updated.