New COVID-19 Vaccine Errors Or Hazards

After the US Food and Drug Administration (FDA) granted emergency use authorization (EUA) to both the Pfizer-BioNTech and Moderna coronavirus disease 2019 (COVID-19) vaccines, ISMP has received numerous voluntary reports of COVID-19 vaccine errors or hazards through the ISMP National Vaccine Errors Reporting Program (VERP), the ISMP National Consumer Medication Errors Reporting Program (C-MERP), and via email correspondence from professional colleagues.

Institute of Safe Medication Practices (ISMP) warns customers about the most common mistakes.

The Most Common COVID-19 Vaccine Errors And Mistakes

1) Four dilution errors were reported with the Pfizer-BioNTech COVID-19 vaccine, which was granted EUA for immunization to prevent COVID-19 in individuals 16 years and older. After thawing, each Pfizer-BioNTech multiple-dose vaccine vial contains 0.45 mL, which must be diluted using 1.8 mL of preservative-free (not bacteriostatic) 0.9% sodium chloride injection.

Once properly diluted, each vial contains 6, perhaps even 7, doses when using low dead-volume syringes/needles to extract each 0.3 mL (30 mcg) dose. The vaccine is administered intramuscularly (IM) as a series of 2 doses 3 weeks apart.

Dilution errors result in administering too much or too little vaccine. If you add too much diluent, doses may be ineffective; if you add too little diluent, doses may invoke stronger adverse effects (if one happens).

2) Vaccine and monoclonal antibody mix-up mistake was in that, that instead of receiving the first dose of the Moderna COVID-19 vaccine, 44 adults (77 years and older) at a West Virginia (WV) clinic received IM injections of casirivimab, one of two new Regeneron monoclonal antibodies recently granted EUA in the US to treat adults and children (12 years or older weighing at least 40 kg) with mild to moderate COVID-19 who are at risk for progressing to severe COVID-19 and/or hospitalization.

3) ISMP received one report of vaccine contamination and several emails about concerns associated with unnecessary waste of the COVID-19 vaccines. In the reported event, a vaccinator found that one of the pharmacy-prepared syringes of the Pfizer-BioNTech COVID-19 vaccine dispensed that morning did not have a cap over the needle, and that the safety shield was locked over the needle. The vaccine dose was appropriately discarded. 

4) Administration to the wrong age group and error with scheduling the second dose. A 17-year-old at one clinic received the Moderna vaccine instead of the Pfizer-BioNTech vaccine, and a 15-year-old at another clinic inappropriately received the Moderna vaccine. According to the EUAs, the Pfizer-BioNTech vaccine is intended for individuals 16 years and older, and the Moderna vaccine is intended for individuals 18 years and older. An elderly patient who had received his initial Moderna COVID-19 vaccination reported that he had misspelled his email address on a registration form, which was needed for registration and confirmation of his appointment for his second dose 1 month later.

Safety Rules

Verify the competency of vaccinators. Educate vaccination staff regarding the storage, preparation, and administration of the COVID-19 vaccines, as well as the common types of errors that may occur, including those described above. Provide vaccinators with an up-to-date Fact Sheet for Healthcare Providers for the vaccine(s) being used, and verify their competency regarding:

• Proper vaccine storage and temperature monitoring
• Patient assessment prior to vaccination
• Age indications for each vaccine (16 years and older for Pfizer-BioNTech, 18 years and older for Moderna)
• Providing patients with a Fact Sheet for Recipients and Caregivers before vaccination
• Proper dilution of only the Pfizer-BioNTech vaccine
• Withdrawal of the correct dose for each vaccine from multiple-dose vials using strict aseptic technique and low dead-volume syringes/needles
• Identification of the appropriate IM injection site 
• Administration of the IM vaccine(s)
• Recognition of the signs and symptoms of an allergic reaction
• Emergency treatment of anaphylaxis (e.g., immediate IM injection of EPINEPHrine, transport for further medical care)
• Timing and scheduling of a second vaccine dose

Report all COVID-19 vaccine errors and adverse reactions to the Vaccine Adverse Event Reporting System (VAERS), which is mandatory for healthcare providers.