Age: 0.6
Sex: F
Vaccine: RV5, RV5
Symptoms: Acidosis, Adenovirus infection, Bronchoscopy abnormal, Combined immunodeficiency, Condition aggravated
Clinical narrative: Information has been received from the author of a literature article, title stated above, 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 immunodeficiency (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 rotavinls origin as in the ROTATEQ. The sequences were identical (except for two different single nucleotides changes, in gene 6 in the viruses from both infants) to ROTATEQ 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 imniunodeficiency may be necessary to prevent rotavirus vaccine-acquired infection. Follow-up information has been received from the author of a literature article, title stated above, concerning about the full term female patient with adenosine deaminase deficiency, had pneumonia and respiratory failure complications from two weeks of age to two months of age. The patient received two doses of ROTATEQ at two and four months of age, respectively. As noted earlier, onset of diarrhea occurred thirty days after the second dose of ROTATEQ. At five months of age, the child had severe diarrhea, became dehydrated, exhibited failure to thrive and had acidosis. At nine months of age, despite resolution of diarrhea, the stool samples were still positive for rotavirus (unclear whether the virus detected in the stool was confirmed to be vaccine virus of wildtype virus). Follow-up information has been received from the author of another literature article, title stated above. Patient was a full-term female infant who presented to an outside hospital at 2 weeks of age with respiratory failure and pneumonia. At that time, the peripheral-blood white-cell count was 4300 cells per cubic millimeter with 11% lymphocytes (absolute lymphocyte count, 473 cells per cubic millimeter [normal range for age, 3400 to 7600]). She was discharged home at 2 months of age and received the ROTATEQ at 2 and 4 months of age at her pediatrician's office. She did not attend day care. She was rehospitalized at 5 months of age with dehydration, severe diarrhea, metabolic acidosis, failure to thrive (weight at less than the third percentile), and pneumonia. The peripheral-blood white-cell count was 1120 cells per cubic millimeter with 3% lymphocytes (absolute lymphocyte count, 38 cells per cubic millimeter [normal range for age, 3900 to 9000]). A bronchoscopy specimen grew Pseudomonas aeruginosa, and silver staining for Pneumocystis jiroveci and fungal organisms was negative. Stool specimens were positive for rotavirus by means of enzyme immunoassay. Adenosine deaminase was undetectable in white cells, and a diagnosis of Severe Combined Immunodeficiency (SCID) was made. There were multiple severe, persistent episodes of diarrhea until the age of 8 months, associated with intermittent fever, weight loss, dependence on total parenteral nutrition, and electrolyte disturbance, including marked metabolic acidosis requiring electrolyte replacement and periodic fluid resuscitation. The infant was discharged and received pegylated adenosine deaminase-replacement therapy, pending curative treatment through stem-cell transplantation. A stool specimen for rotavirus was positive at the age of 9 months, despite resolution of the diarrhea, and negative at the age of 10 months. The patient continues to receive pegylated adenosine deaminase-replacement therapy. The events were considered to be serious by the reporter (other important medical events). The reporter also described the experience of another two infants who had a similar experience after therapy with the ROTATEQ (WAES #0903USA02889 and 0907USA03428). It has been determined that WAES 0903USA02190 is a duplicate of WAES 0811USA03477. Therefore, WAES 0903USA02190 is being deleted from our files and the reports consolidated into WAES 0811USA03477. No further information was provided.