Administration of an excessive dosage of covid-19 pfizer vaccine in an infant: Case report of clinical and immune responses.

Introduction/Case report: We describe the case of a 6-month-old female infant who received the equivalent of 6 adult doses of the COVID-19 Pfizer vaccine due to an immunization error. The patient underwent clinical and laboratory evaluations from the time of vaccination error (January 2022) until November 2022. In the first three days after immunization, she presented with low-grade fever (38 °C) and mild pain and induration at the injection site. She showed no other symptoms afterwards. Laboratory tests were within normal limits for age, except for an elevated D-dimer (3.71 ug/mL; normal: up to 0.5 ug/mL) and as the echocardiogram and electrocardiogram were within normal limits as well, no interventions were instituted at that moment. On the tenth day, immune response evaluation showed a strong expression of cytokines related to the Th2 profile and a well-controlled inflammatory state. Forty-three days after the vaccine administration inflammation status remained, with a predominance of cellular immune response, IFN-γ expression increased compared to the previous evaluation, and a robust antiviral state was in place. After 90 days, immune response evaluation showed a significant reduction in the inflammatory state, still with a predominance of the cellular immune response. Clinically, the patient remained well, with no other noteworthy intercurrences, until the last appointment in November 2022. This child has had no evidence of a severe adverse effect associated to the vaccine overdose. Conclusion: The close follow-up of this case of vaccination error demonstrated that the COVID-19 Pfizer was safe and immunogenic in this individual, noting careful monitoring and followup of these vaccine administration errors is crucial.