Safety and use of tetanus-diphtheria-acellular pertussis-5 (Tdap5) vaccine during pregnancy: findings from 11 years of reporting to a pregnancy registry

Figures & data

Figure 1. Study flow diagram.

Figure 2. Age distribution of women enrolled in the Tdap5 pregnancy registry.

Table 1. Maternal adverse events reported following prenatal tetanus-diphtheria-acellular pertussis (Tdap5) vaccination*

	Count (n^†)	Frequency (%)	95% CI
Local reactions	31	2.6	1.8–3.7
Vaccination site inflammation	9	0.8	0.4–1.5
Erythema	6	0.5	0.2–1.1
Injection site pain	6	0.5	0.2–1.1
Injection site reaction	4	0.3	0.1–0.9
Injection site pruritus	3	0.3	0.0–0.8
Injection site mass	1	0.1	0.0–0.5
Localized edema	1	0.1	0.0–0.5
Vaccination site swelling	1	0.1	0.0–0.5
Blood and lymphatic system disorders	11	0.9	0.5–1.7
Anemia	6	0.5	0.2–1.1
Thrombocytopenia	5	0.4	0.2–1.0
Gastrointestinal events	9	0.8	0.4−1.5
Nausea	3	0.3	0.0–0.8
Diarrhea	2	0.2	0.0–0.7
Crohn’s disease	1	0.1	0.0–0.5
Gastroesophageal reflux disease	1	0.1	0.0–0.5
Superficial cholelithiasis	1	0.1	0.0–0.5
Upper abdominal pain	1	0.1	0.0–0.5
Respiratory events	9	0.8	0.4–1.5
Respiratory tract infection	3	0.3	0.0–0.8
Asthma	1	0.1	0.0–0.5
Cough	1	0.1	0.0–0.5
Influenza like illness	1	0.1	0.0–0.5
Nasopharyngitis	1	0.1	0.0–0.5
Respiratory tract congestion	1	0.1	0.0–0.5
Streptococcus test positive	1	0.1	0.0–0.5
Nervous system events	15	1.3	0.8–2.1
Headache	4	0.3	0.1–0.9
Depression	3	0.3	0.0–0.8
Fatigue	2	0.2	0.0–0.7
Hypoesthesia	1	0.1	0.0–0.5
Paresthesia	1	0.1	0.0–0.5
Nervous system disorders	1	0.1	0.0–0.5
Ageusia	1	0.1	0.0–0.5
Neuralgia	1	0.1	0.0–0.5
Migraine	1	0.1	0.0–0.5
Musculoskeletal events	13	1.1	0.6–1.9
Myalgia	4	0.3	0.1–0.9
Pain in extremity	3	0.3	0.0–0.8
Pain	2	0.2	0.0–0.7
Arthralgia	1	0.1	0.0–0.5
Hand fracture	1	0.1	0.0–0.5
Lethargy	1	0.1	0.0–0.5
Pain in jaw	1	0.1	0.0–0.5
Other events	26	2.2	1.5–3.2
Pyrexia	5	0.4	0.2–1.0
Urticaria	3	0.3	0.0–0.8
Chills	2	0.2	0.0–0.7
Hypothyroidism	2	0.2	0.0–0.7
Inflammation	2	0.2	0.0–0.7
Syncope	2	0.2	0.0–0.7
Urinary tract infection	2	0.2	0.0–0.7
Viral infection	2	0.2	0.0–0.7
Contusion	1	0.1	0.0–0.5
Dizziness	1	0.1	0.0–0.5
Ear Infection	1	0.1	0.0–0.5
Hyperhidrosis	1	0.1	0.0–0.5
Ovarian cancer	1	0.1	0.0–0.5
Peripheral swelling	1	0.1	0.0–0.5
Thrombophlebitis	1	0.1	0.0–0.5

CIs = confidence intervals.

*Maternal adverse events were assessed among all women in the pregnancy registry (n = 1,182).

^†Some women experienced >1 adverse event.

Table 2. Complications of pregnancy, labor, delivery and puerperium reported following prenatal tetanus-diphtheria-acellular pertussis (Tdap5) vaccination

	Count (n*)	Frequency (%)	95% CI
Complications of pregnancy
Hypertension and preeclampsia	15	5.5	3.3–8.9
Gestational diabetes	7	2.5	1.1–5.3
Amniotic cavity infection ^†	4	1.5	0.4–3.8
Fetal growth restriction	4	1.5	0.4–3.8
Oligohydramnios	3	1.1	0.2–3.3
Placental abruption	3	1.1	0.2–3.3
Hemorrhage in pregnancy	2	0.7	0.0–2.8
Bacterial toxemia	1	0.4	0.0–2.2
Fetal hypokinesia	1	0.4	0.0–2.2
Hemorrhage	1	0.4	0.0–2.2
Circumvallate placenta	1	0.4	0.0–2.2
Placenta previa	1	0.4	0.0–2.2
Polyhydramnios	1	0.4	0.0–2.2
Single umbilical artery	1	0.4	0.0–2.2
Vaginal hemorrhage	1	0.4	0.0–2.2
Complications of labor, delivery and puerperium
Premature labor	8	2.9	1.4–5.7
Premature rupture of membranes	4	1.5	0.4–3.8
Labor complication	2	0.7	0.0–2.8
Breech presentation	1	0.4	0.0–2.2
Cervical cerclage procedure	1	0.4	0.0–2.2
Cervical incompetence	1	0.4	0.0–2.2
Shoulder dystocia	1	0.4	0.0–2.2
Threatened labor	1	0.4	0.0–2.2
Postpartum hemorrhage	1	0.4	0.0–2.2
Postoperative wound complication	1	0.4	0.0–2.2

*Among pregnancies with a known outcome (n = 275); some women experienced >1 complication.

^†Did not include any cases reported as chorioamnionitis.

Figure 3. Pregnancy birth outcomes following prenatal tetanus-diphtheria-acellular pertussis (Tdap5) vaccination; Legend: blue = Ectopic Pregnancy, red = Stillbirth/Death in Utero, green = Spontaneous Abortion, and purple = Live Birth.

Table 3. Neonatal outcomes following prenatal tetanus-diphtheria-acellular pertussis (Tdap5) vaccination

	Count (n)	Frequency (%)	95% CI
APGAR scores
Normal (>7 after 5 minutes)	105^a	98.1	93.0–99.9
Low (5–7 after 5 minutes)	2^a	1.9	0.1–7.0
Birth weight
Normal (5.5–8.8 lbs)	99^b	95.0	89.0–98.2
Low birthweight (3.3–<5.5 lbs)	5^b	4.8	1.8–11.0
Very low birthweight (<3.3 lbs)	0	0.0	0.0–2.4*
Congenital Anomalies
Congenital deafness	1^c	0.4	0.0–2.3
Patent foramen ovale with peripheral pulmonic stenosis	1^c	0.4	0.0–2.3

CI = confidence interval.

*Calculated using the equal-tailed Jeffreys interval method⁹.

^aAmong 107 births with a known APGAR score.

^bAmong 104 births with known birth weight.

^cAmong 270 births with known birth outcome.

Figure 4. Prenatal Tdap5 vaccination by year and trimester of exposure; Legend: purple = Exposure during 3rd trimester, green = Exposure during 2nd trimester, red = Exposure during 1st trimester, and blue = Exposure during conception period.

Table

Date Report Received • Spontaneous/nonspontaneous • Product received/product code • Reporter/source

Reporter Information

Patient Information • Age • Significant medical conditions including smoking and alcohol history, hypertension, diabetes, epilepsy, and others • Serological information Also includes information on race, ethnicity, consanguinity, education level, occupation or environmental exposures, if considered to contribute significantly to the investigation and evaluation of certain adverse findings in the pregnancy or its outcome or on the health of the fetus/child; per local privacy law

Immunization/Gynecology • Maternal immunization history • Contraception history

Pregnancy Information • Date of last menstrual period, estimated date of delivery • Medical assistance or hospitalization during pregnancy • Parity/gravidity/obstetrical historyCongenital disease or malformation history

Adverse Event Information (if applicable)

Medications (Concomitant and History)

Pertinent Medical Data

Prenatal Testing • Including amniocentesis, alpha fetal protein, chorionic villi sampling, fetal stress test, uterine ultrasound (please describe), genetic screening

Pregnancy Outcome • Date of delivery • Pregnancy outcome • Weeks of gestation • Sex, birth weight and length, APGAR scores at 1 and 5 minutes • Delivery mode • Congenital anomaly • Complications of labor and delivery (if applicable) • additional information about the newborn condition, such as breastfeeding, neonatal illness, need for resuscitation, developmental delay or immaturity, intensive care or transfer to intensive care/pediatric department

Medical Dictionary for Regulatory Activities (MedDRA). [accessed 2018 Aug 28]. http://www.meddra.org.

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