Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error, Pyrexia, Vaccination site mass
Clinical narrative: noticed a little bump on the site where the vaccine was given (left deltoid); Syringe that was not defrosted properly The Nurse defrosted the vaccine by holding the vaccine in her hands/applying heat to  the frozen vaccine with her hands for up to 15-20 minutes until it turned into liquid; fever for less than 2 days; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever for less than 2 days), VACCINATION SITE MASS (noticed a little bump on the site where the vaccine was given (left deltoid)) and PRODUCT PREPARATION ERROR (Syringe that was not defrosted properly The Nurse defrosted the vaccine by holding the vaccine in her hands/applying heat to  the frozen vaccine with her hands for up to 15-20 minutes until it turned into liquid) in a 42-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031897) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Oct-2023 at 10:43 AM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 30-Oct-2023 at 10:43 AM, the patient experienced PRODUCT PREPARATION ERROR (Syringe that was not defrosted properly The Nurse defrosted the vaccine by holding the vaccine in her hands/applying heat to  the frozen vaccine with her hands for up to 15-20 minutes until it turned into liquid). On an unknown date, the patient experienced PYREXIA (fever for less than 2 days) and VACCINATION SITE MASS (noticed a little bump on the site where the vaccine was given (left deltoid)). At the time of the report, PYREXIA (fever for less than 2 days) and VACCINATION SITE MASS (noticed a little bump on the site where the vaccine was given (left deltoid)) had resolved and PRODUCT PREPARATION ERROR (Syringe that was not defrosted properly The Nurse defrosted the vaccine by holding the vaccine in her hands/applying heat to  the frozen vaccine with her hands for up to 15-20 minutes until it turned into liquid) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that 6 patients who received Spikevax PFS after removing from the freezer. A Nurse took vaccine out and held it in her hand for 15 to 20 minutes and then gave the vaccine. It was reported that Medical Assistant was applying heat to the frozen vaccine with her hands for up to 15-20 minutes until it turned into liquid. Patient had fever for less than 2 days and noticed a little bump on the site where the vaccine was given (left deltoid). Patient did not go to urgent care/ hospital/ emergency room. Patient was informed about the administration error of the vaccine. Patient was feeling very well and no other concerns.   No treatment medications were reported.  This case contains information for the 03 of 06 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-748638 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2023: Live follow-up received: reference numbers and patient age group was added. On 21-Nov-2023: Significant information received. Reporter details added. Patient age, initials and demographics were added. Suspect start date, dose, route of administration and site of administration added. Event onset date update. Added events of Fever and Vaccination site lump. I narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748638:Master Case (Patient 1)