Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Device operational issue, No adverse event, Product colour issue, Product physical issue, Product preparation error
Clinical narrative: No adverse event; the vaccine inside the syringe turned into a jelly like consistency. It was cloudy almost white in color; the vaccine inside the syringe turned into a jelly like consistency. It was cloudy almost white in color; The needle was already stuck to the patient but they were not able to push the vaccine; HCP will send a picture of the product and the data log in the freezer where the product was stored before thawing at room temperature for about 20 minutes.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT PHYSICAL ISSUE (the vaccine inside the syringe turned into a jelly like consistency. It was cloudy almost white in color), PRODUCT COLOUR ISSUE (the vaccine inside the syringe turned into a jelly like consistency. It was cloudy almost white in color), DEVICE OPERATIONAL ISSUE (The needle was already stuck to the patient but they were not able to push the vaccine), PRODUCT PREPARATION ERROR (HCP will send a picture of the product and the data log in the freezer where the product was stored before thawing at room temperature for about 20 minutes.) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030372) for COVID-19 prophylaxis.   The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis.    No Medical History information was reported.   On 10-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 10-Nov-2023, the patient experienced PRODUCT PHYSICAL ISSUE (the vaccine inside the syringe turned into a jelly like consistency. It was cloudy almost white in color), PRODUCT COLOUR ISSUE (the vaccine inside the syringe turned into a jelly like consistency. It was cloudy almost white in color), DEVICE OPERATIONAL ISSUE (The needle was already stuck to the patient but they were not able to push the vaccine) and PRODUCT PREPARATION ERROR (HCP will send a picture of the product and the data log in the freezer where the product was stored before thawing at room temperature for about 20 minutes.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT PHYSICAL ISSUE (the vaccine inside the syringe turned into a jelly like consistency. It was cloudy almost white in color), PRODUCT COLOUR ISSUE (the vaccine inside the syringe turned into a jelly like consistency. It was cloudy almost white in color), DEVICE OPERATIONAL ISSUE (The needle was already stuck to the patient but they were not able to push the vaccine), PRODUCT PREPARATION ERROR (HCP will send a picture of the product and the data log in the freezer where the product was stored before thawing at room temperature for about 20 minutes.) 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 PHYSICAL ISSUE (the vaccine inside the syringe turned into a jelly like consistency. It was cloudy almost white in color), PRODUCT COLOUR ISSUE (the vaccine inside the syringe turned into a jelly like consistency. It was cloudy almost white in color), DEVICE OPERATIONAL ISSUE (The needle was already stuck to the patient but they were not able to push the vaccine) and PRODUCT PREPARATION ERROR (HCP will send a picture of the product and the data log in the freezer where the product was stored before thawing at room temperature for about 20 minutes.).  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 PHYSICAL ISSUE (the vaccine inside the syringe turned into a jelly like consistency. It was cloudy almost white in color), PRODUCT COLOUR ISSUE (the vaccine inside the syringe turned into a jelly like consistency. It was cloudy almost white in color), DEVICE OPERATIONAL ISSUE (The needle was already stuck to the patient but they were not able to push the vaccine) and PRODUCT PREPARATION ERROR (HCP will send a picture of the product and the data log in the freezer where the product was stored before thawing at room temperature for about 20 minutes.).    Concomitant medication was not reported.  It was reported that the vaccine inside the syringe turned into a jelly like consistency and was cloudy almost white in color. The needle got stuck into the patient and was not able to push the vaccine. HCP will send a picture of the product and the data log in the freezer where the product was stored before thawing at room temperature for about 20 minutes. The product was stored at the recommended storage conditions and handled appropriately.  Treatment medication was not reported.  The Device problem code for Spikevax syringe include FDA code which include Device Difficult to Operate. The device was malfunctioned, and the malfunction type.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2023: Live-Significant follow-up received and updated patient details.