Sex: U
Vaccine: DTAP, HEP, HIBV, IPV, RV5, DTAPH, HEP, IPV, RV5, DTAP, HEP, HIBV, IPV, RV5
Symptoms: Bronchospasm, Respiratory syncytial virus bronchiolitis
Clinical narrative: Information has been received from a literature article via Sanofi Pasteur. This case is about a patient of an unknown age and gender with DiGeorge's syndrome (DGS) who on an unspecified date, was vaccinated with rotavirus vaccine (manufacturer unknown) (dose, lot and route of administration not reported), hepatitis B vaccine (manufacturer unknown) (dose, lot and route of administration not reported), IPV, DTaP and Hib conj vaccine. After vaccination the patient experienced respiratory syncytial virus (RSV) bronchiolitis and bronchospasm and was hospitalized. The outcome for the events was not reported. The study included 194 individuals born between 1974 and 2008. The mean observation period was 8.3 years; subjects ranged in age between 0 and 31.5 years. All underwent fluorescence in situ hybridization (FISH) diagnostic confirmation, most (n = 120/194) before 1 year of age. Most (n = 121/194) had hemodynamically significant cardiac disease and underwent cardiac surgery. Many exhibited lymphocyte subsets below or in the low-normal range for healthy individuals. One-third of subjects with available CD4% results (n = 41/121) had evidence of immunosuppression (CD4% <25%); the proportion who were immunosuppressed did not differ based on timing of FISH confirmation. Among the 5% (n = 6/121) with documented severe immunosuppression (CD4% <15%), total lymphocyte counts ranged from low (n = 1) to normal (n = 3), CD3/CD3% ranged from low (n = 4) to normal (n = 1), and CDS/CDS% ranged from low (n = 5) to normal (n = 1). All subjects received at least 1 vaccine, 90% received at least 1 live vaccine, and 58% completed the 4:3:1:3:31 vaccination series by 19 to 35 months. Differences in vaccination coverage and/or timeliness were noted between select live and inactivated vaccines. Only 157 received IPV. All -IPV vaccination schedule was recommended (January 2000) received 3 IPV doses by that time (P < .01). One-quarter (27%) received a live vaccine before FISH confirmation (among those for whom FISH testing was available at birth, n = 160). Only 2 cases occurred before 1 year of age: 1 received rotavirus vaccine. Forty-four of 175 live-vaccine recipients experienced an Adverse Events Following Live Immunization (AEFLI). There were 91 events, resulting in 6 hospitalizations. All hospitalizations were secondary to respiratory illness. By using causality assessment tools, CISA investigators found sufficient evidence to support a causal relationship between live vaccinations. The 91 events occurred after 5% of rotavirus doses. Receipt of multiple vaccines preceding an event was common (30% received > 1 live vaccine; 66% also received an inactivated vaccine). AEFLIs were detected in 43 of 114 individuals (442 live-vaccine doses) at sites using the comprehensive abstraction procedure and in 1 of 80 subjects (198 live-vaccine doses) at sites using the targeted approach (p <001) ED visits and hospitalizations were detected only at sites using the comprehensive approach. Additional information has been requested.