Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Pneumocystis jiroveci infection, Pneumonia, Respiratory distress, Respiratory syncytial virus infection, Respiratory syncytial virus test positive
Clinical narrative: Information has been received from a physician concerning a 2 month old male infant who was vaccinated with a dose of ROTATEQ at 2 months of age. It was reported that the child developed severe diarrhea and dehydration shortly after receive the vaccine. Presence of rotavirus vaccine strain in stool samples was confirmed by sequencing of the VP6 and NSP4 genes (which showed that the virus in the stool is indeed vaccine). Infant also developed pneumonia and P. jiroveci was identified. Child was diagnosed with severe combined immunodeficiency (RAG1 mutation). Child underwent bone marrow transplant and continue to have chronic diarrhea. At 9 months of age, the stool samples were still positive for rotavirus (unclear whether the virus detected in the stool was confirmed to be vaccine virus or wild type virus) and chronic diarrhea continued. Follow up information has been received from the authors of a published literature article. Patient was a full-term male infant who was born to consanguineous parents. He received ROTATEQ at 2 months of age in a pediatrician's office, after which he presented with severe diarrhea, failure to thrive (weight at less than the 3rd percentile), and respiratory distress. He did not attend day care. Severe lymphopenia (absolute lymphocyte count, 135 cells per cubic millimeter) was present on admission to hospital. Rotavirus was detected in stool specimens, by means of enzyme immunoassay. Bronchoscopy was performed, and silver staining of an aspirate specimen revealed P. jiroveci. The patient was treated with intravenous trimethoprimsulfamethoxazole. Respiratory syncytial virus was presented in a nasal-wash specimen, as detected with the use of enzyme immunoassay. Tests for red-cell adenosine deaminase and purine nucleoside phosphorylase levels were normal. A homozygous mutation was present in recombination activating gene 1 (RAGI), consistent with a diagnosis of SCID. At 8 months of age, the patient underwent transplantation of bone marrow from a haploidentical, related donor (without chemotherapy-induced bone marrow ablation beforehand), and at 10 months of age, underwent a second transplantation (preceded by a reduced-intensity conditioning regimen) of bone marrow from a matched, unrelated donor, followed by boost transplantation with both CD34+ stem cells and CD3+ donor lymphocytes at 14 months of age, because of nonengraftment. He received methotrexate and cyclosporine as prophylaxis against graft-versus host disease. At the most recent assessment, the diarrhea had improved, but the patient continued to require intravenous hyperalimentation. Stool specimens were positive for rotavirus before 14 months of age but were negative at 14 months of age (at the most recent evaluation). Severe combined immunodeficiency was considered by the reporter to be serious (Other important medical event). The reporter also described the experience of other two infants who had similar experiences after therapy with ROTATEQ (WAES No:0903USA02190 and 0903USA02889). No further information is available. It has been determined that WAES # 0907USA03428 is a duplicate of WAES # 0907USA02636. Therefore, WAES # 0907USA03428 is being deleted from our files and the reports consolidated into WAES # 0907USA02636.