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. Author manuscript; available in PMC: 2023 Aug 1.
Published in final edited form as: Pharmacoepidemiol Drug Saf. 2022 Apr 22;31(8):851–862. doi: 10.1002/pds.5435

TABLE 4.

Secondary analysis adjusted odds ratios (OR) and 95% confidence intervals (CI) for associations between influenza vaccination and non-cardiac birth defects, National Birth Defects Prevention Study 2006 to 2011

Birth defectd Case children with isolated defectsa
Singletons onlyb
First trimester overlapping with September–March Onlyc
Case children exposed/unexposedd Adjusted, limited modele,f OR (95% CI) Case children exposed/unexposedd Adjusted, limited modele,f OR (95% CI) Case children exposed/unexposedd Adjusted, limited modele,f OR (95% CI)
Central nervous system
 Any neural tube defectsg 7/793 0.74 (0.32, 1.72) 9/879 0.88 (0.42, 1.86) 8/752 0.81 (0.37, 1.80)
 Hydrocephaly 6/126 1.27 (0.54, 3.00) 7/177 0.91 (0.39, 2.13) 7/158 0.92 (0.40, 2.15)
Eye and ear
 Anophthalmia/microphthalmia 5/50 2.22 (0.84, 5.88) 5/81 1.82 (0.70, 4.72) 5/76 1.60 (0.62, 4.15)
 Cataracts 5/137 0.79 (0.32, 2.00) 4/150 NA 5/131 0.73 (0.29, 1.85)
 Anotia/microtia 6/175 0.84 (0.33, 2.10) 6/252 0.59 (0.24, 1.47) 7/222 0.68 (0.30, 1.58)
Orofacial
 Choanal atresia 3/35 NA 5/57 1.69 (0.65, 4.43) 5/55 1.65 (0.63, 4.30)
 Oral clefts 61/1598 0.97 (0.71, 1.31) 67/1774 0.94 (0.70, 1.26) 69/1545 0.98 (0.74, 1.32)
 Cleft lip w/wo cleft palate 41/1096 0.96 (0.67, 1.36) 45/1190 0.96 (0.68, 1.34) 45/1050 0.97 (0.69, 1.36)
 Cleft palate 20/502 0.98 (0.61, 1.59) 22/584 0.90 (0.56, 1.44) 24/495 1.02 (0.65, 1.60)
Gastrointestinal
 Esophageal atresia 7/137 1.19 (0.54, 2.63) 12/278 1.04 (0.56, 1.91) 15/256 1.20 (0.69, 2.10)
 Duodenal atresia/stenosis 6/71 2.30 (0.94, 5.61) 8/107 1.83 (0.85, 3.93) 8/96 1.76 (0.82, 3.80)
 Anorectal atresia/stenosis 7/168 1.13 (0.51, 2.49) 12/355 0.96 (0.53, 1.77) 12/322 0.86 (0.47, 1.57)
Genitourinary
 Hypospadias second/third degree 53/1027 1.16 (0.81, 1.67) 57/1079 1.18 (0.83, 1.68) 61/966 1.24 (0.87, 1.76)
 Bilateral renal agenesis or hypoplasia 4/49 NA 5/56 1.79 (0.61, 5.26) 5/51 1.61 (0.55, 4.70)
Musculoskeletal
 Limb deficiencyh 17/355 0.90 (0.51, 1.59) 22/447 0.99 (0.60, 1.65) 22/396 1.03 (0.63, 1.69)
  Longitudinal limb deficiency 6/96 1.60 (0.67, 3.81) 9/162 1.35 (0.64, 2.86) 10/145 1.47 (0.72, 3.01)
  Transverse limb deficiency 10/241 0.64 (0.29, 1.39) 11/269 0.69 (0.33, 1.44) 10/236 0.68 (0.33, 1.42)
 Craniosynostosis 42/683 1.25 (0.87, 1.77) 42/709 1.22 (0.85, 1.73) 44/613 1.30 (0.92, 1.85)
 Diaphragmatic hernia 10/244 1.23 (0.63, 2.41) 12/323 1.13 (0.61, 2.08) 14/281 1.28 (0.72, 2.28)
 Omphalocele 3/98 NA 5/128 0.41 (0.10, 1.68) 5/125 0.34 (0.08, 1.42)
 Gastroschisis 19/600 0.82 (0.48, 1.40) 18/660 0.72 (0.42, 1.23) 19/578 0.76 (0.45, 1.29)

Abbreviations: NA, not applicable as point estimates were not calculated when there were <5 exposed case children.

a

Neural tube defect analysis included 63 exposed and 4874 unexposed control children; hypospadias analysis included 87 exposed and 2457 unexposed control children; all other analyses included 197 exposed and 4740 unexposed control children.

b

Neural tube defect analysis included 62 exposed and 4728 unexposed control children; hypospadias analysis included 85 exposed and 2386 unexposed control children; all other analyses included 192 exposed and 4598 unexposed control children.

c

Neural tube defect analysis included 59 exposed and 4080 unexposed control children; hypospadias analysis included 85 exposed and 2043 unexposed control children; all other analyses included 189 exposed and 3950 unexposed control children.

d

Exposure window is 1 month before pregnancy through the first pregnancy month for neural tube defects and 1 month before pregnancy through the third pregnancy month for all other defects.

e

Counts in adjusted analyses were slightly lower than presented because of missing covariate values.

f

Adjusted for estimated date of delivery year and season, maternal age at delivery, maternal race/ethnicity, plurality, cigarette smoking, alcohol use, low folate intake, and, for neural tube defects, folate antagonist medication use.

g

Subtypes of neural tube defects with <5 exposed case children are not presented: anencephaly, encephalocele, spina bifida.

h

Subtypes of limb deficiency with <5 exposed case children are not presented: intercalary limb deficiency, NOS limb deficiency.