Age: 1.4
Sex: M
Vaccine: PNC
Symptoms: Abscess, Culture positive, Pneumococcal infection, Vaccination failure
Clinical narrative: Information regarding PREVNAR was received from a literature source. This individual case safety report was collected from a review of cases reported to the Centers of Disease Control and Prevention's Active Bacterial Core surveillance systems from October 2001 through February 2004 and may therefore be a duplicate report. Case 1 of 27 involved a 17-month-old male who received 4 doses (at ages 4, 6, 8 and 12 months) of PREVNAR and experienced deep thigh abscess/pneumococcal infection serotype 19F. The patient received the fourth dose on an unspecified date. On an unspecified date between Oct-2001 and Feb-2004, at 12 months of age, the patient completed a primary series of PREVNAR (4 doses). The reporter defined a "vaccination failure" case as an invasive pneumococcal infection (isolated from normally sterile body site), in a child who had completed the vaccine series (fully vaccinated) according to the Advisory Committee on Immunization Practices (ACIP) recommended routine infant or catch-up schedule, and for which the pneumococcal isolate was a PREVNAR serotype (4, 6B, 9V, 14, 18C, 19F, or 23F). Each vaccine dose had to have been received at least 2 weeks before illness onset. On an unspecified date, between Oct-2001 and Feb-2004, at 17 months of age, the patient (number 1 of 27) experienced deep thigh abscess/pneumococcal infection serotype 19F, confirmed by culture. The patient was hospitalized. The outcome was unknown. The author's noted that "the proportion of breakthrough cases decreased with the increasing number of PREVNAR doses received" and in conclusion noted that "invasive pneumococcal infections identified in vaccinated children were primarily caused by diseases resulting from serotypes not covered with PREVNAR, rather than failure of the vaccine. Incomplete vaccination and co-morbid conditions likely contributed to breakthrough vaccine-type pneumococcal infections." The investigator(s) considered abscess bacterial, pneumococcal infection and vaccination failure possibly related to the study product. No additional information was available at the time of this report. See related case(s): US-WYE-H14225110 (adverse event, expedited); US-WYE-H14225210 (adverse event, expedited); US-WYE-H14224510 (adverse event, expedited); US-WYE-H14224610 (adverse event, expedited); US-WYE-H14224710 (adverse event, expedited); US-WYE-H14224810 (adverse event, expedited); US-WYE-H14224910 (adverse event, expedited); US-WYE-H14225010 (adverse event, expedited); US-WYE-H14223910 (adverse event, expedited); US-WYE-H14224010 (adverse event, expedited); US-WYE-H14224110 (adverse event, expedited); US-WYE-H14224210 (adverse event, expedited); US-WYE-H14224310 (adverse event, expedited); US-WYE-H14224410 (adverse event, expedited); US-WYE-H14223610 (adverse event, expedited); US-WYE-H14223710 (adverse event, expedited); US-WYE-H14223810 (adverse event, expedited); US-WYE-H14223310 (adverse event, expedited); US-WYE-H14223410 (adverse event, expedited); US-WYE-H14223510 (adverse event, expedited); US-WYE-H14214710 (adverse event, expedited); US-WYE-H14214810 (adverse event, expedited); US-WYE-H14214910 (adverse event, expedited); US-WYE-H14215010 (adverse event, expedited); US-WYE-H14215110 (adverse event, expedited); and US-WYE-H14215210 (adverse event, expedited). No additional information was available at the time of this report.