Age: 0.3
Sex: F
Vaccine: RV1
Symptoms: Combined immunodeficiency, Diarrhoea, Rotavirus test positive, Stool analysis abnormal
Clinical narrative: This case was reported in a literature article and described the occurrence of scid (severe combined immune deficiency) in a female subject of 3 month-old who was vaccinated with ROTARIX (GlaxoSmithKline). The occurrence of this case was outside the country (non specification given). On an unspecified date the subject received 2nd dose of ROTARIX (unknown). Thirty three days after vaccination with ROTARIX, the subject experienced severe gastroenteritis with diarrhea and later was diagnosed with scid (severe combined immune deficiency, unspecified genotype). The subject was hospitalised. Relevant test results included stool testing positive rotavirus (unspecified strain). At the time of reporting the outcome of the events was unspecified. Stem cell transplant was pending. The Food and Drug Administration (FDA) had licensed two rotavirus vaccines: ROTATEQ (Merck and Co, Inc), 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 test, 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 live 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 the 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 was specifically identified in six cases. Seven reports also described prolonged rotavirus shedding, lasting from 1month to at lease 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 the VAERS cases. Although congenital, SCID was not diagnosed in these infants until after rotavirus vaccination. Earlier identification of SCID (e.g. from expanded newborn screening or heightened clinical vigilance) could prevent inadvertent live rotavirus vaccine administration and also potentially result in earlier life-saving stem cell transplants.