Table 2.

Reported adverse events (AEs)^† in pregnant women following receipt of inactivated influenza vaccines in pregnant women, VAERS, 2010 – 2016 (N=544)

Adverse Events ǂ	N (%)
Pregnancy-specific AEs	102 (18.8)
Spontaneous abortion (< 20 weeks gestation)	62 (11.4)
Stillbirth (≥ 20 weeks gestation)	10 (1.8)
Fetal death (gestational age unknown)	2 (0.4)
Preterm delivery (< 37 weeks)	6 (1.1)
Preeclampsia/pregnancy induced hypertension	6 (1.1)
Vaginal bleeding	5 (0.9)
Other a	11 (2.0)
Non-pregnancy specific AEsb	252 (46.3)
General disorders and administration site conditions	106 (19.5)
Injection site reactions	55
Immune system disorders	39 (7.2)
Anaphylaxis	5
Non-anaphylaxis allergic reactions	34
Respiratory, thoracic and mediastinal disorders	38 (6.9)
Nervous system disorders	24 (4.4)
Bell’s palsy	8
Guillain-Barré syndrome	8
Musculoskeletal and connective tissue disorders	20 (3.7)
Infections and infestations	8 (1.5)
Gastrointestinal disorders	8 (1.5)
Other c	9 (1.7)
Infant outcomes	22 (4.0)
Intrauterine growth restriction	1
Neonatal hypoxia	1
Low birth weight	1
Laryngomalacia	1
Ventricular septal defect	1
Patent foramen ovale	1
Vascular malformation (Port wine stain)	1
Jaundice	1
Lack of respiratory effort	1
Left foot ligament laxity	1
Hydronephrosis	1
Aplasia cutis congenital	1
Hooded foreskin/hemophilia A	1
Autism spectrum disorder	1
Fetal pyelectasis	1
Major birth defects d	7
Polydactyly	2
Ectopic kidney in newborn	1
Cleft lip and palate	1
Cleft palate (incomplete)	1
Trisomy 18	1
Multiple birth defects (complex congenital heart disease, microtia, cleft lip)	1
No adverse event reported e	168 (30.9)

^†Adverse events are based on primary reported diagnoses identified during clinical review. One diagnosis assigned to one report. Proportions calculated using all IIV reports as denominator (N=544)

^ǂSixty-one (11.2%)were serious reports

^aOther pregnancy specific adverse events included two reports of gestational diabetes, and one report each of placental abruption, threatened abortion, gestational trophoblastic disease, preterm labor, placenta previa, excessive labor bleeding and injection site reaction, chorioamnionitis, increased fetal movement, and aborted pregnancy due to Guillain-Barré syndrome

^bSelected adverse event shown under each system organ class

^cOther non-pregnancy specific adverse events included one report each of diabetes type 1 uncontrolled, increased blood pressure/dizziness/flushed skin, acute myeloblastic leukemia, anemia, thrombocytopenia, pyelonephritis, tachycardia, and two reports of an unspecified adverse event

^dGestational age in weeks (in parentheses) at the time of vaccination for birth defects were: polydactyly (8, 29), ectopic kidney (18), cleft lip and palate (9), cleft palate/incomplete (10), trisomy 18 (2), and multiple birth defects (8)

^eReports with no AE comprised vaccination errors and/or reports submitted to the manufacturer pregnancy registry