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Observational Study
. 2023 Jul 1;142(1):125-129.
doi: 10.1097/AOG.0000000000005241. Epub 2023 May 9.

Medically Attended Acute Adverse Events in Pregnant People After Coronavirus Disease 2019 (COVID-19) Booster Vaccination

Malini B DeSilva  1 , Jacob Haapala, Gabriela Vazquez-Benitez, Thomas G Boyce, Candace C Fuller, Matthew F Daley, Darios Getahun, Simon J Hambidge, Heather S Lipkind, Allison L Naleway, Jennifer C Nelson, Kimberly K Vesco, Eric S Weintraub, Joshua T B Williams, Ousseny Zerbo, Elyse O Kharbanda
Affiliations
Observational Study

Medically Attended Acute Adverse Events in Pregnant People After Coronavirus Disease 2019 (COVID-19) Booster Vaccination

Malini B DeSilva et al. Obstet Gynecol. .

Abstract

In this multisite, observational, matched cohort study of more than 80,000 pregnant people, receipt of an mRNA monovalent coronavirus disease 2019 (COVID-19) booster vaccination in pregnancy was not associated with increased risk for thrombocytopenia, myocarditis, venous thromboembolism, ischemic stroke, or other serious adverse events within 21 or 42 days after booster vaccination. The mRNA monovalent COVID-19 booster in pregnancy was associated with an increased risk for medically attended malaise or fatigue within 7 days of vaccination (adjusted rate ratio [aRR] 3.64, 95% CI 2.42-5.48) and lymphadenopathy or lymphadenitis within 21 days (aRR 3.25, 95% CI 1.67-6.30) or 42 days (aRR 2.18, 95% CI 1.33-3.58) of vaccination. Our findings are consistent with prior evaluations of the primary COVID-19 vaccine series and are reassuring with respect to COVID-19 booster vaccination in pregnancy.

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Conflict of interest statement

Financial Disclosure Gabriela Vazquez-Benitez reports money was paid to her institution from AbbVie and Sanofi Pasteur, both for research not related to this work. Candace C. Fuller's institution has received research funding from Pfizer and Johnson & Johnson for unrelated studies. Darios Getahun reports money was paid to their institution from Hologic Inc. and Johnson & Johnson. Simon J. Hambidge reports receiving payment through his employment from Denver Health. He sits on the board for the Colorado Community Health Network and the Denver Health Medical Plan (all unpaid). Heather S. Lipkind received payment from the Data Safety and Monitoring Board for Pfizer for the COVID-19 vaccination. Allison L. Naleway reports money was paid to her institution from Pfizer and Vir Biotechnology. Jennifer Nelson reports receiving payment from Harvard Pilgrim Health Care for statistical consulting and from Elsevier Publishing for service as an Associate Editor for the journal Vaccine. Kimberly K. Vesco's institution received Pfizer Independent Grants for Learning and Change. The other authors did not report any potential conflicts of interest.

Figures

Fig. 1.
Fig. 1.. Number of events, incidence rates per 10,000, and adjusted rate ratios (aRR) with 95% CIs for medically attended acute adverse events occurring 1–7, 1–21, or 1–42 days after mRNA monovalent coronavirus disease 2019 (COVID-19) booster vaccination in pregnant people at eight Vaccine Safety Datalink sites, September 23, 2021–June 30, 2022. Rates of medically attended acute adverse events in pregnant people receiving a COVID-19 booster vaccine in the 28 days before pregnancy start date or during pregnancy were compared with those of an unexposed pregnant cohort who did not receive a COVID-19 vaccine in the 28 days before pregnancy start date or during the matched exposure window during pregnancy. Outcomes evaluated but for which there were no cases in the COVID-19 booster–vaccinated or unexposed groups include acute disseminated encephalomyelitis, cerebral venous sinus thrombosis, Guillain-Barré syndrome, Stevens-Johnson syndrome or toxic epidermal necrolysis, thrombosis with thrombocytopenia syndrome, transverse myelitis, and thrombotic thrombocytopenic purpura.
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