Age: 0.3
Sex: F
Vaccine: RVX
Symptoms: Cough, Diarrhoea, Gene mutation, Rotavirus infection, Rotavirus test positive
Clinical narrative: This case was reported in a literature article and described the occurrence of scid (severe combined immune deficiency) in a 4-month-old female subject who was vaccinated with Rotavirus vaccine (manufacturer unspecified). On an unspecified date the subject received 2nd dose of Rotavirus vaccine (unknown). At an unspecified time after vaccination with Rotavirus vaccine, the subject experienced gastroenteritis, cough and diarrhea and later was diagnosed with scid (severe combined immune deficiency ADA mutation). The subject was hospitalised. Relevant test results included stool testing positive rotavirus for vaccine strain. At the time of reporting the outcome of the events were unspecified. Stem cell transplant was pending. The Food and Drug Administration (FDA) has licensed two rotavirus vaccines: ROTATEQ, licensed in February 2006, and ROTARIX (GlaxoSmithKline), licensed in April 2008. VAERS report dates from February 3, 2006 (the licensing date of ROTATEQ) through January 15, 2010; MedDRA (Medical Dictionary for Regulatory Activities) preferred term (PT) " combined immunodeficiency" (which included the lower level term "severe combined immunodeficiency") and/or any report text field (including fields for symptoms, laboratory/diagnostic tests, pre-existing conditions and illness at time of vaccination) with the term "SCID" or "combined immunodeficiency". Additionally, exploratory queries for other immunodeficiencies were performed to ascertain whether individuals with these conditions might be at risk from rotavirus vaccine. The research was expanded to include all MedDRA PTs available in the database for acquired and congenital immunodeficiency nine reports of SCID and rotavirus vaccination in five female and four male infants, with ages at presentation ranging from 3 to 9 months. Seven had received ROTATEQ, one ROTARIX and one an unspecified rotavirus vaccine; two reports originated outside of country. All cases required hospitalization that ultimately led to a diagnosis of SCID after at least one dose of rotavirus vaccine. Of the seven infants, none completed the vaccine series prior to the SCID diagnosis. All reports documented stool testing positive for rotavirus (EIA antigen, viral RT-PCR, or unspecified method), and vaccine strain rotavirus was specifically identified in a six cases. Seven reports also described prolonged rotavirus shedding, lasting from 1 month to at least 7.5 months (median of at least 5.5 months). Bone marrow transplantation was reported as completed in four cases and pending in four additional cases. One report listed the outcome as unknown. No deaths were reported. The author's conclusion stated: The aforementioned labelling changes were warranted given the risk posed by live rotavirus vaccine to individuals with SCID, as illustrated by these VARES cases. Although congenital, SCID was not diagnosed in these infants until after rotavirus vaccination. Earlier identification of SCID (e.g., from expanded newborn screening of heightened clinical vigilance) could prevent inadvertent live rotavirus vaccine administration and also potentially result in earlier life-saving stem cell transplants.