From July 19 to July 20, 1982, a cluster of severe local reactions with prolonged fever occurred among children immunized with diphtheria-tetanus-pertussis (DTP) vaccine at a private pediatric office in Atlanta, Georgia. Twelve children developed abscesses at the injection site within 2 weeks of vaccination; four of these were hospitalized because of the severity of symptoms or for incision and drainage of their abscesses.

Group A streptococci were cultured from the abscesses of nine of the 12 children. The remaining three had been on antibiotics for at least 5 days before being cultured. In addition, two of the hospitalized children had blood cultures positive for Group A streptococcus. All 11 isolates were of the same type: T-28, M-nontypeable, serum opacity reaction (SOR) positive.

Eleven children had temperatures 102 F (38.9 C) lasting 2 or more days; eleven had irritability and four had vomiting. Three had generalized rash, which in one patient clinically resembled scarlatina. Eight children were 6 months old; two were 6 to 11 months old; and two were

1 year old. All 12 children had received DTP vaccine from the same lot between 2:00 p.m. July 19 and 12:00 noon July 20. Two additional children who received DTP vaccine during this interval did not develop abscesses; one developed a moderate to severe local reaction that resolved spontaneously without therapy or abscess formation; the other had no fever or local reaction. The attack rate for abscess development during this time was 12 of 14 or 86%. Seventy-seven children, seen at the same office, had received other vaccines during this period or had received DTP vaccine on the 2 days before or the 2 days after this period; their parents were interviewed and reported no abscesses among any of the children.

The pediatric office has five pediatricians and eight nurses. The pediatricians do not give vaccinations. During the period of risk, six of the nurses were known to have given vaccinations. A single 7.5-ml vial of DTP vaccine was probably used for all patients; normal disinfection procedure consisted of wiping vaccine vials with cotton balls saturated with 70% ethanol. The vaccine was left out of the refrigerator between immunizations. At the end of the day, any unused vaccine was returned to the refrigerator and used the next day. On July 30, throat, ear, scalp, vaginal, rectal, and appropriate skin cultures were taken from all nurses and from one child's mother who claimed to be a "strep carrier." Cultures were also taken of unused disposable syringes, vaccine preparation areas, vaccine storage area of the refrigerator, and laboratory incubator. None of the cultures of the staff or environment were positive for Group A streptococcus.

The vaccine was packaged in 7.5-ml vials, which in this practice usually yield 13 or 14, 0.5-ml doses of DTP vaccine. Approximately one-half million doses of this lot had been released for distribution in December 1981. Active surveillance has been established in Milwaukee, Wisconsin, Atlanta, Georgia, and South Carolina, where this lot is actively being used. No cases of abscesses due to Group A streptococcus have been reported from South Carolina or Wisconsin; no further cases have been reported from Georgia.

The pediatric office discontinued use of the particular vaccine lot on Thursday, July 22. Eight unopened vials remaining from this lot were recovered for testing and yielded no bacteria on culture. Thimerosal, the preservative, was present within accepted limits.

Laboratory studies were conducted at CDC to determine the survival of the isolated strain of streptococcus in DTP vaccine from the implicated lot. A varying number of colony-forming units (140 CFU up to 10,000 CFU) of this strain were inoculated into previously unused DTP vaccine vials. Vials were sampled on a regular basis. At 3 days, 29 of 30 vials contained viable streptococci in substantially reduced numbers; at 15 days, one of 30 vials contained one colony of viable streptococci. Initial testing of the lot in 1981, both by the manufacturer and the Office of Biologics, National Center for Drugs and Biologics (NCDB), indicated that the vaccine satisfied requirements for sterility. Additional testing for sterility and Thimerosal content was performed on other vials of the same lot by both the NCDB and the manufacturer after the episode occurred. These results were similarly satisfactory. Reported by WR Elsea, MD, Fulton County Public Health Dept, JD Lockridge, CC Turner, JW Alley, MD, RK Sikes, DVM, State Epidemiologist, Georgia Dept of Human Resources; Respiratory and Special Pathogens Br, Bacterial Disease Div, Center for Infectious Diseases, Surveillance, Investigations, and Research Br, Immunization Div, Center for Prevention Svcs, CDC.

Editorial Note

Editorial Note: Sterile abscesses are known to occur after administration of DTP vaccine, especially when the injection is given subcutaneously (1). However, the occurrence of pyogenic abscesses, especially in clusters, appears to be rare following DTP vaccination. The investigation of this group of abscesses suggests that one multi-dose vial of the lot had become contaminated with Group A streptococci. The source of contamination could not be determined.

Bacterial contamination of multi-dose vials has resulted in cases of serious infections. This is the second cluster of abscesses caused by Group A streptococcus following DTP immunization reported to CDC during the past 18 months. In the other outbreak, seven children developed abscesses after vaccination with DTP vaccine from a different manufacturer (2). The strain isolated from these cases and from the remaining vaccine in the multi-dose vial was Group A, T-1, M-1. Neither the nurse nor the physician who had administered this vaccine yielded Group A streptococci when cultured. As in the present outbreak, no source of contamination could be identified.

The choice of a preservative for inclusion in a vaccine is limited on the one hand by possible deleterious effects on the vaccine's antigenicity, and on the other by the vaccine's safety for humans. Thimerosal, the preservative used in the production of DTP, is bacteriostatic, but only weakly bactericidal. The laboratory experiments in this investigation have shown prolonged survival of at least one strain of Group A streptococcus in multi-dose DTP vials.

Use of sterile technique in withdrawing medications and vaccines is critical to preventing contamination of multi-dose vials. Reports of pyogenic abscesses after vaccination should be followed up to determine if vaccine-vial contamination may have occurred; such episodes should be reported to local public health authorities for inclusion in the existing system for monitoring illnesses following immunization so that the risk of contamination of multi-dose vaccine vials can be evaluated.

References

1. Bernier RH, Frank JA Jr, Nolan TF Jr. Abscesses complicating DTP vaccination. Am J Dis Child 1981;135:826-8.

2. Greaves WL, Hinman AR, Facklam RR, Allman KC, Barrett CL, Stetler HC. Streptococcal abscesses following DTP vaccination. Pediatric Infectious Disease. (In press)

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