Received May 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (INFANRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | YC239 | IM / LL |
Patient is a 2 year old male who presented to our office on 4/22/25 for his two year physical. While here, Dr. noticed that he had not received his 18 month vaccinations at his 18 month check up due to being under the weather and ordered those to be administered. While attempting to administer the first vaccination, Infanrix, CMA had explained to mom that it was important for her to hold patient's hands so he did not interfere with the administration. Mom had let go of his hands as the needle entered his left thigh. Patient grabbed the needle and rolled, causing the needle to exit his thigh and create a minor, inch-long scratch. The scratch was cleaned and a band-aid was placed on the scratch. Upon examination of the syringe, it was noted that roughly one third of the vaccine was administered to the child. The ordering provider was notified of the error. Mom refused to attempt to revaccinate that day as she stated that this situation was "traumatic" for patient and he was "too worked up". Mom stated she understood the risks of leaving unvaccinated but would be willing to come back in to fully vaccinate patient. I called GSK and spoke with the Medical Information Team. The situation was relayed and I asked for the recommendation for revaccination. This information was emailed to me, which I have attached. They also referred me to the CDC website where the "Clinical Implications of Nonstandard Vaccination Practices" citation reads as follows: "Administering volumes smaller than recommended (e.g., inappropriately divided doses) might result in inadequate protection. Using reduced doses administered at multiple vaccination visits that equal a full dose or using smaller divided doses is not recommended (4). Any vaccination using less than the standard dose should not be counted, and the person should be revaccinated according to age unless serologic testing indicates that an adequate response has developed. However, if 2 half-volume formulations of vaccine have already been administered on the same clinic day to a patient recommended for the full volume formulation, these 2 doses can count as one full dose. If less than a full General Best Practice Guidelines for Immunization: Vaccine Administration 100 recommended dose of a vaccine is administered because of syringe, applicator, or needle leakage, the dose should be repeated (5)." I have attached the CDC link to the bottom of this description. I spoke with mom on 4/23/25 to check on patient and overview the risks of not vaccinating with Infanrix again. Mom said that she understood and he was fine but was pointing out his scratch. I offered to move her vaccine appointment up from 4/30/25 to 4/24/25 at any time that would work best for her schedule to monitor the scratch to make sure it was healing properly and to also vaccinate patient. Mom agreed and was happy to schedule an appointment at 4/24/25 at 16:00. I verbally explained to Dr. that patient would be coming in to discuss the vaccinations and receive them as well as double check on the scratch. Dr. agreed with this and is prepared to see patient and his mother on 4/24/25. Patient was seen in our office 4/30/25 to check on his scratch and get the rest of his vaccinations. His scratch has fully healed. Dr. again explained the benefits of administering the full dose of Infanrix and mom agreed. Patient was fully vaccinated with Infanrix, Hiberix and Hepatitis A. CMA administered the vaccinations while mom and an additional CMA held him down appropriately. After today's visit, patient is fully vaccinated for his age and will not be due for additional vaccinations until he is four years of age. We did apologize again to mom for what happened last week; she was happy with today's visit.
Acute suppurative otitis media of right ear without spontaneous rupture of tympanic membrane 23 days prior.
Speech delay, expressive
Taking Cetirizine HCl 1 MG/ML Solution 2.5 mL Orally Once daily
N.K.A.
N/A