Mix-Ups Between the Influenza (Flu) Vaccine and COVID-19 Vaccines
Now that the 2021-2022 influenza (flu) vaccine is available, the Centers for Disease Control and Prevention (CDC) stated that both the flu and coronavirus disease 2019 (COVID-19) vaccines can be administered during the same visit, without regard to timing. In fact, the CDC encourages healthcare providers to offer both vaccines at the same visit to increase the probability that people will become fully vaccinated. Additionally, under an Emergency Use Authorization (EUA), the US Food and Drug Administration (FDA) has recommended a third COVID-19 vaccine for patients 12 and older who are moderately to severely immunocompromised. Recently, FDA amended the EUA to include a Pfizer-BioNTech COVID-19 vaccine booster for Pfizer-BioNTech vaccine recipients who completed their initial series at least 6 months ago and are 65 years or older, or 18 years or older if they are living in long-term care settings, have underlying medical conditions, or if they are living or working in high-risk settings.
Mix-ups Between the Flu and COVID-19 Vaccines
Unfortunately, since the availability of the flu vaccine in September 2021, ISMP has received multiple reports, mostly from consumers, of mix-ups between the flu vaccine and COVID-19 vaccines. Most of the mix-ups occurred in patients who consented to a flu vaccine but received one of the COVID-19 vaccines instead; however, in two cases, patients received the flu vaccine instead of the intended COVID-19 vaccine. All of the events happened in community/ambulatory care pharmacies. The reported cases are highlighted below, and a discussion about possible causative factors and recommended strategies follows.
A 23-year-old patient received the Pfizer-BioNTech COVID-19 vaccine instead of the flu vaccine. Afterwards, the patient was asked when she had received the first two COVID-19 vaccines, and the error was recognized. While the vaccine provider disclosed the error and apologized to the patient, the patient’s request to get a flu vaccine was crossed out and replaced with “COVID (3rd)” in the documentation provided to the patient.
A 17-year-old visited a community pharmacy for a flu vaccine and was given a COVID-19 vaccine in error. The patient was called that evening and the error was disclosed; however, the patient’s parents were upset because they were opposed to the COVID-19 vaccine.
A 26-year-old made an appointment at a local pharmacy for the flu vaccine. Upon arrival, the patient was given a screening form, consent form, and a Vaccine Information Statement (VIS) for the flu vaccine. However, a COVID-19 vaccine was administered in error. The error was immediately discovered, and the patient was given the flu vaccine. However, the pharmacy did not provide the patient with a record of the third COVID-19 vaccine.
A mother, son (10 years old), and daughter (6 years old) received the Moderna COVID-19 vaccine instead of the flu vaccine. When the mother experienced symptoms similar to those she experienced after receiving the Moderna COVID-19 vaccines, she called the pharmacist. After watching a video of the vaccination clinic, the pharmacist called the mother to report that she had received the Moderna COVID-19 vaccine in error, but her children had received the flu vaccine. After her daughter developed a local reaction at the vaccination site, the mother called the pharmacist and asked him to watch the video again. A few days later, the pharmacist called the mother to say that both of her children had also received the COVID-19 vaccine instead of the flu vaccine.
A vaccinated 70-year-old patient received the Pfizer-BioNTech COVID-19 vaccine instead of the flu vaccine. He completed a consent form for the flu vaccine, but was told after administration that he now had his “COVID-19 booster.” He was then also given the flu vaccine and asked to provide consent for the COVID-19 vaccine he had received in error.
A 4-year-old child received the Pfizer-BioNTech COVID-19 vaccine instead of the flu vaccine. The Pfizer-BioNTech COVID-19 vaccine is not approved for EUA in a 4-year-old child. While the FDA is currently reviewing data submitted by Pfizer-BioNTech from a COVID-19 vaccine study in children 5-11, the dose is much smaller than that used for patients 12 years and older. Fortunately, the child suffered no ill effects from the vaccine.
A 22-year-old patient was scheduled to receive his first COVID-19 vaccine dose. The vaccinator assumed the patient was there to receive the flu vaccine and administered that instead. About 20 minutes after the patient left the pharmacy, he received a call informing him about the error. It is unclear if the patient returned to the pharmacy to receive the COVID-19 vaccine.
A 21-year-old patient was scheduled to receive a COVID-19 vaccine but was given the flu vaccine instead. Before the error was recognized, the patient had been given a COVID-19 vaccination card. The patient later noticed that the forms she had received from the pharmacy suggested that she had received the flu vaccine. She returned to the pharmacy, where the error was confirmed. The patient received her COVID-19 vaccine but no apology for the error.
A patient, who happened to be a pharmacist, scheduled an appointment at a local pharmacy to receive the flu vaccine, and his wife scheduled an appointment at the same time to receive both the flu vaccine and the Pfizer-BioNTech COVID-19 booster. Because there was a high-volume of patients receiving the COVID-19 booster, the pharmacist asked the vaccine provider to double check that he was only getting the flu vaccine (he had previously received a series of two Moderna COVID-19 vaccines, for which a booster has not yet been approved for EUA). After the vaccine provider confirmed that he was administering the flu vaccine, he grabbed the wrong syringe and gave the patient the Pfizer-BioNTech COVID-19 vaccine booster in error.
Possible Causative Factors
Because most of the errors were reported by consumers, details about the contributing factors were not provided in many cases. However, the possible causative factors we have gleaned from the reports include the following:
Increased demand and coadministration of the vaccines. Flu season is already a busy vaccination time for community pharmacies. And, with the approval of the Pfizer-BioNTech vaccine booster and the surge in COVID-19, pharmacies are stretched even more to accommodate the demand in vaccination services. Also, the ability to administer the flu and COVID-19 vaccines during the same visit may be a causative factor.
Syringes near each other. Two vaccine providers indicated that they had picked up a COVID-19 vaccine syringe instead of the flu vaccine syringe, which were right next to each other in the vaccination area. Bringing both vaccines into a patient vaccination area when they are not needed sets the vaccine provider up for a possible mix-up.
Unlabeled syringes. While many vaccine providers purchase the flu vaccine in manufacturer prefilled syringes, which are labeled, COVID-19 vaccines are available in multiple-dose vials and must be prepared in a syringe for administration to patients. It is possible that these prepared COVID-19 vaccine syringes were not labeled. Also, COVID-19 vaccine doses may be prepared in an unlabeled syringe by one healthcare provider and administered by another; as a result, the person who administers the vaccine may not visually verify the empty vial if it remains with the person who prepared the dose.
Distractions. After a vaccine mix-up, one vaccine provider told the patient that he had become distracted by their conversation. Interruptions and other distractions in a busy pharmacy could also lead to mix-ups.
Staffing shortages. Because most healthcare providers are experiencing staffing shortages, it is possible that current vaccine providers are multi-tasking and hurried/rushed, even when patients are scheduled for vaccinations. For example, a pharmacist who was working alone in a busy pharmacy recently told us that she needed to administer more than 50 vaccinations during her shift, in addition to dispensing prescriptions.
Safe Practice Recommendations
Implement these safety strategies during the multistep vaccination process to avoid errors, particularly mix-ups between the flu and COVID-19 vaccines:
Provide staffing support. Schedule vaccines for a dedicated block of time each day and ensure adequate staffing. Ideally, staff should not be expected to accomplish both vaccine administration and regular dispensing functions simultaneously. Explore the use of qualified and trained volunteers to assist in the vaccination process (as was done initially when the COVID-19 vaccines first became available) to relieve some of the stress associated with professional staffing shortages.
Separate vaccination areas. Provide a separate area for vaccine administration, away from distractions and interruptions.
Label the syringes. All individual syringes containing vaccines should be clearly labeled, by the manufacturer if prefilled syringes are used, or by the vaccine dose preparer if single- or multiple-dose vials are used. Be sure to provide vaccine preparers with any necessary labels to affix to the syringes to facilitate proper labeling.
Separate the vaccines. Only bring the intended and labeled vaccine syringe(s) for one patient into the vaccination area.
Identify the patient and requested vaccine. When the patient approaches the pharmacy counter to request a vaccination and immediately prior to vaccination, ask the patient to provide at least two patient identifiers—their full name and date of birth. Access to an electronic patient profile to assist with verifying the patient’s identity is recommended. Also, be sure to ask the patient which vaccine(s) they have requested. Talking with the patient about their vaccines ahead of administration can reduce the risk of errors. Be sure to verify the vaccine(s) the patient requests with the patient’s signed consent form(s).
Involve the patient/parent in the checking process. Ask the patient/parent to read the syringe label (and vial if present) to confirm that it is the correct vaccine. Have the patient/parent and the vaccine provider read the label and expiration date aloud. At a minimum, the vaccine provider should tell the patient exactly which vaccine is being given before administration.
Document lot number/expiration date. Document the vaccine lot number and expiration date prior to administration. (The vaccine lot number may signal a mix-up has occurred and prevent it from reaching a patient.) Then document vaccine administration afterward in the patient’s profile, on vaccination records, and via state or other immunization registries.
Scan the barcode. During the production and/or pharmacist verification phase of the dispensing process, scan the vaccine barcode to verify that the correct product has been retrieved from the refrigerator or freezer. Ideally, barcode scanning should be available at the point of administration, even in outpatient vaccine clinics, to once again confirm that the correct vaccine had been retrieved and prepared.
Provide the intended vaccine. If a mix-up occurs, apologize to the patient and provide the intended vaccine (since both the flu and COVID-19 vaccines can be given at the same visit), either before they leave the vaccination area or by asking the patient to return to the vaccination site.
Report vaccine errors. Report all vaccine errors internally as well as to the FDA Vaccine Adverse Event Reporting System (VAERS), which is mandatory for errors with the COVID-19 vaccines available under an EUA. ISMP also asks providers to report vaccine errors to the ISMP National Vaccine Errors Reporting Program (ISMP VERP).