Medication vial and syringe 849 x 566

Vaccine administration is usually regarded as a simple office procedure, often performed without the direct supervision of the physician or a licensed professional.

Although vaccinations are a routine procedure, physicians and staff should remain vigilant about patient safety considerations. Whether you are seeing children for back-to-school immunizations or adults for travel abroad or general disease prevention, take time now to assess the vaccine administration protocol in your practice.

Related content:  The Critical Ingredient to the Success of Vaccination Programs

As with any medical intervention, the risks, benefits, and alternatives of the vaccination must be discussed and documented in the medical record, as well as ensuring that safety protocols are followed.

Could this happen in your office?

The Doctors Company, the nation’s largest physician-owned medical malpractice insurer, performed a closed claims analysis of vaccine-related events in the medical office setting. Could similar situations occur in your office?

Missed vaccination

A 4.5-month-old male infant received the pneumococcal conjugate vaccine (PCV) Prevnar 7, which provided protection against seven serotypes of pneumococcus. The following year, the FDA approved the use of Prevnar 13, which provided protection against an additional 6 serotypes of the disease. The American Academy of Pediatrics recommended that those vaccinated with Prevnar 7 also receive Prevnar 13. The physician did not update the recommended immunization protocols in her office. Even though the child returned for three additional well visits, the child never received Prevnar 13. At age 39 months, the child developed serotype 6A pneumococcal meningitis, which resulted in left hemiparesis, seizures, and vision and hearing impairment. This disease could have been prevented if the child had received Prevnar 13.

Dental injury

A 13-year-old female received a Gardasil vaccine. Even though her mother was monitoring her in the exam room, the patient fainted and fell off the exam table, resulting in a tooth avulsion, another tooth luxation, a fractured wrist, and a laceration to her hand.

Injection site reaction

A 35-year-old female complained of redness and swelling at the injection site for a flu vaccine, interfering with her ability to perform her job over the course of several months and resulting in several weeks of physical therapy. No informed consent was obtained. She stated she would never have had the injection had she known of the potential complications.

Vaccination overdose

A 41-year-old female with a history of ankylosing spondylitis requested a Pneumovax vaccination. No informed consent was obtained. The patient was queried regarding whether she had previously received pneumovax, which the patient denied. Actual vaccination status was never verified by the physician; however, the patient had actually received the vaccine two years earlier. The patient developed inflammatory response syndrome, including the amputation of a toe, which was alleged to have resulted from administering the vaccine without checking her immunization history and because the vaccine was not indicated for patients younger than 65 years old.

Take these steps for safety

To help avoid these types of issues:

  • Ensure that immunization tracking is up-to-date and well-documented in the medical record so that patients remain on schedule. Obtain copies of vaccination records from previous providers or state registries. Create easy-to-read office forms for documenting administration.
  • Educate patients and parents regarding vaccination schedules.
  • Designate a staff member to monitor for revisions/new recommendations of FDA/CDC vaccination schedules. Ensure that new vaccination schedules are incorporated with office procedures and are included on office vaccination forms.
  • Provide accurate information to patients. Conduct and document a thorough informed consent discussion; use Vaccine Information Statements prior to vaccine administration.
  • Obtain patient or parent signatures on an informed consent form that includes potential side effects and complications.
  • Document the discussion in the progress notes when the immunization is refused. Consider using an informed refusal form, which includes the patient or parent signature.
  • Check state laws regarding exemptions and educate patients. Be aware that religious and philosophical exemptions vary by state.
  • Monitor patients closely post-administration for anaphylaxis, vasovagal response, and reaction at the injection site. Document any reactions, suspected side effects, and complications in the medical record.
  • Educate staff and conduct skills verification on accepted procedures, new standards, and risk prevention methods. Document these efforts in administrative training files.
  • Store and handle vaccinations in accordance with Vaccines for Children/CDC guidelines. Monitor these practices with staff—don’t just assume they are being followed correctly.
  • Follow basic medication administration safety protocols for vaccine administration. Be aware of the most common vaccine-related errors by reviewing “Confusion Abounds! 2-Year Summary of the ISMP National Vaccine Errors Reporting Program” Part I and Part II.
  • Be responsive to patients who express concerns about reactions from their vaccines. Document these discussions in the medical record.
  • Report errors or hazards (anonymously) to the ISMP National Vaccine Errors Reporting Program.

What to do when a patient declines vaccines

It is a physician’s obligation to talk with all patients (or their guardians) about what could happen if they decline vaccination. This discussion should include these points:

  • Not vaccinating can result in disease or even death.
  • Unvaccinated children and adults pose a threat to the population of people unable to receive vaccinations due to weakened immune systems, such as those with leukemia, who rely on the general public being vaccinated to reduce their risk of exposure.
  • Social implications may include exclusion and quarantine. If there is an outbreak in a community, parents may be asked to remove their unvaccinated child from organized events and activities due to the threat of transmission.
  • Females of childbearing age who are unvaccinated and who become pregnant are vulnerable to diseases such as rubella, which can cause congenital rubella syndrome with congenital fetal anomalies.

Parents should be reminded to alert medical personnel of their child’s immunization status each time the child seeks healthcare in case distinctive care is needed.

You can also help raise awareness of the benefits of immunizations:

  • Encourage parents of young children to get immunizations by age two.
  • Help parents make sure older children have received vaccinations by the time they return to school.
  • Remind college students to get vaccinations before moving into dormitories.
  • Educate adults, including healthcare workers, about vaccines and boosters they may need.

Inform pregnant women about getting vaccinated to protect newborns from disease such as whooping cough.

This post was sponsored by The Doctors Company, the nation’s largest physician-owned medical malpractice insurer.

Debbie Hill, RN, MBA, CPHRM and Lisa McCorkle, MSN, CPHRM
Debbie Hill, RN, MBA, CPHRM (Left) is the Patient Safety Risk Manager at The Doctors Company. She has worked in the insurance industry, in consulting, in practice management, and in various clinical settings as a registered nurse. She has more than 20 years of experience as a health care risk manager and previously worked as Director of Risk Management in a multispecialty group practice and managed care plan. Prior to joining The Doctors Company, Ms. Hill worked as a consultant in risk management in New England and Florida, with a focus on AAAHC accreditation, compliance training, and practice management. For several years, she was a faculty member at Florida Tech in the School of Business where she taught coursework in organizational behavior, leadership, ethics, and stakeholder management. Lisa McCorkle, MSN, CPHRM (Right)is also the Patient Safety Risk Manager at The Doctors Company. In addition to patient safety and risk management experience, she has reviewed hundreds of medical negligence claims as a patient safety analyst, served as a legal nurse consultant for several law firms, and spent more than a dozen years implementing electronic health record systems in university and community hospitals prior to joining the staff of The Doctors Company.


  1. As a professional nurse I am baffled as to why you would use a photo of an inappropriate sized needle for a population that is already fearful of vaccines and injections. This is a disservice and should be stopped


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