Sex: M
Vaccine: RV5, RV5
Symptoms: Weight decreased, White blood cell count decreased
Clinical narrative: Information has been received from the author of a literature article, that described two infants at two different sites who presented with failure to thrive, dehydration and diarrhea 7 and 30 days after the 2nd immunization with ROTATEQ (given at 2 and 4 months of age). Immunologic analysis revealed decreased numbers of circulating mature T lymphocytes with a depressed response to mitogens and hypogammaglobulinemia consistent with severe combined immunodcficiency (SCID). One patient had adenosine deaminase deficiency and another had interleukin-2 receptor gamma chain (IL2RC) deficiency. Rotavirus was detected in a stool specimens from both infants by reverse transcriptase polymerase chain reaction (RT-PCR) and either by electron microscopy or immunoassay. One infant (1L2RG deficient) developed coinfection with giardia and adenovirus. In both patients, sequence analysis demonstrated the presence of genes 6 and 10, both of bovine rotavirus origin as in the ROTATEQ. The sequences were identical (except for two different single nucleotide changes, in gene 6 in the viruses from both infants) to ROTATEQ vaccine sequences. Administration of live-attenuated rotavirus vaccine resulted in vaccine-acquired rotavirus infection in two patients with SCID. These infections raise concerns for serious adverse events with rotavirus vaccine, as can occur with other live viral vaccines, in severely immunocompromised hosts. Screening for immunodeficiency may be necessary to prevent rotavirus vaccine-acquired infection. Follow-up information received from an E-mail on 21-JUL-2009: The patient was male. The patient was at 2 and 4 months of age when he received 2 doses of ROTATEQ. Seven days after receipt of the second dose of ROTATEQ the patient developed severe diarrhea, dehydration and shock (6 days after onset of diarrhea). The patient also had concomitant infection with adenovirus and Giardia. At 8 months of age, the patient's stool samples were still positive for rotavirus. At the time of the report, it was unknown if diarrhea had resolved. It was unknown whether the virus detected in the stool was confirmed to be vaccine virus or wild type virus. Follow-up information has been received from a literature article concerning the full-term male infant who was born without complications after uneventful pregnancy. The patient had no adverse effects after the first dose of ROTATEQ at 2 months of age, but 6 days after receipt of a second dose at 4 months of age, he presented with shock, dehydration and watery diarrhea. The infant did not attend day care. The weight was in the 50th to 75th percentile. The peripheral-blood white-cell count on hospital admission was 9300 cells per cubic millimeter with 19% lymphocytes (absolute lymphocyte count, 1767 cells per cubic millimeter). Rotavirus was detected, with the use of enzyme immunoassay, in stool specimens, as was adenovirus and Giardia species. Tests for red-cell adenosine deaminase and purine nucleoside phosphorylase levels were normal. A mutation was present in the common gamma chain of the interleukin-2 receptor, consistent with X-linked SCID. Stem-cell transplantation (without chemotherapy-included bone marrow ablation beforehand or prophylaxis against graft-versus-host disease) was performed at age of 5 months with the use of haploidentical peripheral-blood stem cells. The diarrhea had resolved by this time, but the patient remained dependent on total parenteral nutrition for an additional 3 weeks. A second transplantation was performed at the age of 8 months, because of post-transplantation neutropenia. After the engraftment of donor lymphocytes, the infant was discharged. Stool specimens remained positive for rotavirus at 8.5 months of age but were negative for 9 to 12 months of age. The events were considered by the reporter to be serious (other important medical events). The reporter also described the experience of other two infants who had similar experiences after therapy with the ROTATEQ vaccine (WAES #0903USA02190 and 0907USA03428). No further information was provided.