Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: VAERS REPORTING OCTOBER 2022 SUMMARY OF EVENT ADDITIONAL DISCOVERY FOUND IN JANUARY 2023  To whom it may concern: Employee Health discovered an additional 11 employees affected who were given the regular Moderna Booster and not the Moderna Bivalent Vaccine.  Regular Moderna CoVid 19 Vaccine Booster without the Omicron Strain was administered not the Moderna CoVid 19 Bivalent Booster medication/vaccine error.  No harm to employee reported by employee once Employee Health discovered same lot# AR5186C after mining data from Employee Health Program to transfer information to immunization registry. Notified employee of error who reports has had no concerns since vaccination and has not been infected with CoVid after this vaccination was administered. This was discovered when additional measures were taken to pull CoVid Bivalent Vaccine data from our Software for Employee Health due to the new immunization registry Regulations in which we had to enlist our IT Department to assist in getting this information to enter vaccines manually to meet compliance. In the pulling of this data it was discovered 11 more employees had the same Lot #AR5186C.  This was not the CoVid 19 Bivalent Booster but was the regular Moderna Booster in which previously we had thought only 4 employees were affected on 10/6/23 and were notified of the error immediately on the same day.  These additional 11 employees had received their vaccine at their off-site locations.  The consent forms with this lot number were not identified until the pulling of this recent data in January. Once the same lot #AR5186C was recognized by my Office Administrator in working with IT for the downloaded report to enter into immunization registry, Office Administrator notified this nurse manager. This nurse manager immediately notified their Medical Director, Director of Quality Risk Management, and Interim Infection Prevention/Quality Manager that 11 more employees had been discovered with the same lot # AR5186C. The same protocol was followed for all 11 employees have been contacted, notified of this recent discovery and disclosed error in vaccine administered.  All employees were made aware of the steps that were taken on October 6th for the 4 original known employees then and that the same steps are being taken now in discovering these 11 employees did not receive the Bivalent Vaccine and that this nurse was completing a VAERS report. All employees were made aware per Moderna Manufacturer (see rest of document what Moderna's facts were given with getting an extra booster non bivalent vaccines that they are eligible to receive the Bivalent Booster 2 months after their regular booster vaccination which was in October 2022, and therefore the employee is eligible now.  As previously reported the VAERS Report times out and boots you off when attempting to do the detailed documentation. I have constructed a word document to summarize these events. Employees at a Physical Medicine Off-site, and Homecare Offsite were the employees that were affected. Vaccine vials were sent to these off-sites to vaccinate, consent forms and documentation was completed at off-sites. SUMMARY OF EVENT ON 10/6/2022 ORIGINAL DISCOVERY Summary of event: Moderna Booster: given by mistake instead of Bivalent Vaccine in October 2022: This nurse on 10/6/2022 at 7 am drew up the wrong Moderna Booster Vaccine for Employee Health for herself and 2 staff nurses to give for Employee Health.  This nurse obtained the vaccine from the pharmacy looked at the label saw it said Moderna while drawing was the 5 dose vial but did not look at close enough to realize it did not say Bivalent.  When one of the other staff nurses realized we would need more drawn as we had 1 dose left she went to draw more and discovered the vaccine vial that was drawn from was Moderna but it did not say Bivalent and showed this to me after she had started to draw doses. Immediately we realized the error together and contacted the other nurse to R.N. to not give any more of the pre-drawn vaccine doses that I had drawn up for them to administer.  We determined that 4 employees had received the CoVid Moderna Booster and not the Bivalent Booster.  This was discussed with just the 3 of us and not in front of office worker personnel. Moderna Agent Encounter: We disposed of the rest of the incorrect vaccines and immediately. I immediately called the manufacturer of Moderna to report what had occurred.  This nurse gave all my information the hospital's address and contact information as requested. The agent of Moderna as requested the gender, age, and all dates of previous vaccinations for each employee that was given the wrong vaccine. I looked up this information already and gave it to the agent per the employee?s electronic health record. The agent of Moderna gave me a case # for reference of my phone call to report and seek guidance I was informed the new Bivalent Vaccine has all the same ingredients of the previous Moderna Booster so no risk of an undisclosed ingredient for a possible allergy concern. I was informed the Bivalent Booster is the same CoVid 19 Vaccine with just the Omicron Variant Strain added.  I was informed that the booster has been given as extra doses to immunocompromised patients for better protection. I was informed the ages of the employees were not the age or gender concern for Myocarditis after vaccination as this clinically has been reported in males in their teens and twenty?s so the ages of the employees were not a higher risk for myocarditis. I questioned whether or not the employee can receive the correct Bivalent Vaccine and if so when and I was informed that the employee if wishes to receive the Bivalent Vaccine must wait 2 months before receiving it as long as they have had no concerns with the previous vaccination.  I informed them I knew that I would need to complete a VAERS Incident to report and she said yes and that I would notify the Quality Risk Manager of the Hospital, Called the Pharmacy Director left voicemail, and later our Medical Director. I am informing the employees involved to report my mistake one on one and what measures have been taken for this not to occur again. I informed the agent that we would no longer pre-draw vaccine doses for others and that we would each draw up our own vaccine and that we will verify with another nurse to confirm. I was informed no adverse event should occur because of receiving another booster and that the time between boosters was not closer than 2 months but that it is an EAU Approved Vaccine and read me the disclosure and should an adverse reaction occur I would need to report this as well.  I informed this agent how awful I felt in realizing my mistake and that I would never let this happen again to me nor would I ever want this to happen to my associate staff nurses. I was then advised to call the CDC next and given the following phone.  I inquired about the New Monkey Pox Vaccine as an employee disclosed being vaccinated for Monkey Pox approximately 2 weeks ago and was advised that the employee should wait 4 weeks before receiving the Bivalent Vaccine. CDC Encounter I spoke with the CDC and reported the same as above who advised me the same as Moderna had advised and was instructed also that the VAERS should be completed and was sent emailed links to reference to the resources that the agent researched and shared with me. I was instructed again to complete a report in VAERS. This nurse spoke with the Medical Director of our hospital to inform him of my vaccine medication error and that I had been attempting to reach the Director of Pharmacy who was not on site. This nurse went to the pharmacy to speak with staff who was already made aware of the error and the Moderna Booster vaccines in the refrigerator were bagged up separately and labeled. The pharmacy vaccine refrigerator was checked as well as the Employee Health Bin in which we pick up vaccines to make sure no other Moderna Booster Vaccine was taken out by mistake. VAERS Report: This nurse attempted to complete the VAERS Report for the 1st employee and the online reporting timed me out after 20 minutes as this employee returned my call after I had called her to disclose my mistake and shared what I have described above all details with the employee. This nurse so not to have the VAERS time out again has completed this documentation on a word document to copy and paste for each of the 4 employee's VAERS that I am filing and reporting.    This documentation completed by: R.N. 10/6/2022