Table 2.
Risks for acute adverse events, 0–3 and 0–42 days following maternal Tdap, for the full matched cohort and those vaccinated at 20 weeks gestation or later.
| Tdap during pregnancy N = 53,885 Rate per 10,000 (N) | Unvaccinated N = 109,253 Rate per 10,000 (N) | Adjustedrate ratioa (95% CI) | |
|---|---|---|---|
| Any 0–3 day eventb | 8.1 (43) | 6.8 (74) | 1.19 (0.81–1.73) |
| Allergic reaction | 1.3 (7) | 1.3 (14) | |
| Malaise | <1 (3) | 1.2 (13) | |
| Fever | 2.8 (15) | <1(6) | |
| Seizures | <1 (1) | <1(1) | |
| Altered mental status | − (0) | <1(3) | |
| Local and other reactions | 3.4 (18) | 3.9 (42) | |
| Any 0–42 day neurologic eventb | 9.6 (51) | 9.6 (104) | 0.98 (0.70–1.37) |
| Autonomic disorders | <1 (2) | <1 (7) | |
| Cranial nerve disorders | 3.5 (19) | 3.5 (38) | |
| CNS degeneration/demyelinating | 0 (0) | <1 (3) | |
| Peripheral neuropathy | 3.4 (18) | 2.5 (27) | |
| Guillain-Barrésyndrome | 0 (0) | 0 (0) | |
| Meningoencephalitides | <1 (3) | <1 (9) | |
| Movement disorders | 2.4 (13) | 2.9 (32) | |
| Paralytic syndromes | <1 (1) | 0 (0) | |
| Spinocerebellar disease | 0 (0) | <1 (6) | |
| Proteinuria | 17.9 (84) | 21.9 (207) | 0.81 (0.6–1.05) |
| Venous thromboembolism | 4.1 (22) | 6.3 (69) | 0.65 (0.40–1.05) |
| Tdap ≥20 weeks gestation N = 44,063 | Unvaccinated N = 86,057 | Adjustedrate ratioa (95% CI) | |
| Gestational diabetes | 275 (1101) | 287 (2263) | 0.96 (0.89–1.03) |
| Thrombocytopenia | 57 (249) | 68 (579) | 0.85 (0.73–0.98) |
| VenousThromboembolism | 4.3 (19) | 7.6 (65) | 0.58 (0.35–0.97) |
| Cardiac events | 20.4 (90) | 23.0 (198) | 0.90 (0.70–1.15) |
| Pericarditis | <1 (2) | 0 (0) | |
| Myocarditis | <1 (1) | 1 (9) | |
| Cardiomyopathy | 17.5 (77) | 21.5 (185) | |
| Heart failure | 7.7 (34) | 6.4 (55) | |
a
Adjusted for Kotelchuck Adequacy of Prenatal Care Utilization Index (APNCU), hospitalization prior to vaccination/index date, mean percent of families in census tract with income below 150% of the federal poverty level.
b
Events occurring on the day of vaccination (Day 0) were required to be emergency department or inpatient diagnoses.