Failure to warn about vaccine complications

by Laura Hale Brockway, ELS, Vice President, Marketing, and 
Susie Edwards, Senior Risk Management Representative
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‍Presentation

‍On September 13, a 14-year-old girl came with her mother to her pediatrician’s office for a well-child visit. The advanced practice registered nurse (APRN) treated the patient. 
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‍Physician action

‍The patient reported that she was performing well in school and that she was involved in several extracurricular activities. A PHQ-9 depression screen was administered, and the results were recorded as normal. The APRN ordered the second dose of the HPV vaccine. (The first dose had been given to the patient nine months earlier with no complications noted.)

At the end of the visit, the medical assistant (MA) administered the vaccine. While in the waiting room checking out with her mother, the patient fainted, fell to the floor, and hit her head.

The APRN took the patient back to the exam room. He noted that the patient felt lightheaded before the fall and was a “little dazed” immediately afterward. The APRN documented a bump on the back of the patient’s head that was painful and that the patient was tearful but answering questions appropriately. He further noted discussing signs and symptoms of concussion with the patient and her mother, and that he would call that afternoon to check on the patient.

The patient and her mother returned the next day, September 14. She was seen by Pediatrician A, who noted the patient had fainted in the waiting room and “was out for 5-10 seconds.” Pediatrician A documented that the patient was “still a little shaken up about what happened and a little out of it but doesn’t really think she has been foggy.” The patient did not have a headache, was not irritable, but did vomit once when she arrived home the day before.

Pediatrician A examined the patient and administered a SCAT 3 to evaluate for concussion. The exam was reassuring, and the patient seemed to be feeling back to her normal self. The patient asked about volleyball tryouts and Pediatrician A noted it was okay to participate if she was feeling well. If she was not feeling well, she was told to sit out and call back to discuss the “back to play protocol.”

On September 19, the patient was seen in the office by Pediatrician B. She noted that the patient reported neck pain for the last five days and had vomited twice after leaving the office on the 14th. (Pediatrician A had noted only one vomiting episode.) Pediatrician B documented that the patient had been “a little off” and had been more sensitive to emotions.

She performed another SCAT and documented that it was “very good in physical and memory testing.” Pediatrician B discussed with the patient and her mother that the patient might have a concussion because she had some head pressure and vomiting and felt more emotional. Pediatrician B also noted the pressure could be from neck muscle spasms. She advised the patient to go to school, but to hold off on physical activity until after she was re-checked in four days.

After the visit, Pediatrician B documented the following:

“I apologized to the mom that she was not informed of the HPV fainting issue. We endeavor to continue to educate our patients on vaccines. She had done fine [with] the first HPV. I reassured mom that we would have office wide discussion regarding HPV side effects. Mom to call me if there are any issues.”

Neither the patient nor her siblings returned to the pediatric practice.

The patient was seen on September 20 by a sports medicine physician. This physician administered a SCAT 5 and diagnosed “concussion with increased symptoms of Vestibular Ocular Reflex Horizontal and Vertical.” He placed the patient on a return to school protocol, but restricted sports until her symptoms resolved.

Four months later, the patient sought treatment with a neurologist. She reported fatigue, memory deficits, and moodiness. Her PHQ-9 and GAD7 scores were abnormal, and the patient and her mother acknowledged that she was having symptoms of depression. The neurologist diagnosed “current moderate episode of major depressive disorder without prior episode and post concussive syndrome.” She encouraged the patient to seek counseling.

The patient received counseling over the next seven months. She was also prescribed escitalopram and rizatriptan by the neurologist.

At her last documented visit with the neurologist — one year after she started counseling and 21 months after she sustained the concussion — the patient was doing well. Her mood was improved, and she no longer had headaches. She had resumed full activity in sports.
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‍Allegations

‍A lawsuit was filed against the pediatric practice. The plaintiffs alleged that the APRN and MA violated the standard of care by failing to warn the patient and her mother of the risk of fainting after receiving the HPV vaccine and failing to instruct the patient to wait 15 minutes before standing.

It was also alleged that the pediatric practice failed to train/supervise their employees and failed to disclose the risk of the HPV vaccine to the patient. Pediatricians A and B were not named in the lawsuit.

Legal implications

‍The plaintiff’s pediatric expert claimed that had staff from the pediatric practice told the patient and her mother about the risk of syncope following the HPV vaccine and had the patient been seated for 15 minutes of observation, she would not have fallen and hit her head. This fall caused the patient’s concussion, post-concussion syndrome, anxiety, and post-concussion depression. These actions constituted a deviation from the standard of care.

The defense pediatric expert stated that although the CDC makes recommendations for the administration of vaccines, it — like other organizations —does not define practice standards. A 15-minute wait policy across the board for adolescent vaccinations is not the standard of care.

However, defense experts were critical that there was no mention in the medical record that the patient was notified about the risk of fainting after HPV. Another area of concern for the defense was Pediatrician B’s note about an “office wide discussion regarding HPV side effects.” The plaintiffs would likely use this to prove that all staff members at the pediatric practice should have known about the side effects of the vaccine and had a duty to warn the patient.

Regarding the actions of the defendant APRN, an APRN reviewing the case for the defense stated that the common practice of warning patients about potential vaccine side effects falls to the provider who orders the vaccine and not the medical assistant who administers it. Therefore, this expert would have expected the defendant APRN to have this discussion with the patient and her mother. Additionally, it is not expected that a medical assistant would know about potential vaccine side effects, much less warn the patient about them.

Regarding causation, the defense APRN expert stated that it is hard to predict who will faint after receiving a vaccine. Anxiety, age, and whether the patient has eaten can all contribute to a syncope episode.

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Disposition

‍This case was settled on behalf of the pediatric practice.

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‍More on communication errors.

Risk management for pediatricians.‍