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COVID-19 Vaccinations in Pregnancy: Comparative Evaluation of Acute Side Effects and Self-Reported Impact on Quality of Life between Pregnant and Non-pregnant Women in the United States.Funding IQVIA provided financial support for the CARE Registry and supported IQVIA authors time to design the study and write this publication. The Food and Drug Administration contributed small support to IQVIA for this work.
Objective The objective of this study was to describe the acute side effects experienced by pregnant women who received a coronavirus disease 2019 (COVID-19) vaccine in the United States and to compare their experience to non-pregnant women of similar age.
Study Design Adults who received a COVID-19 vaccine in the United States were invited via social media to enroll in an online, longitudinal, community-based registry (www.helpstopCOVID19.com). Participants self-reported pregnancy status, vaccination dates, manufacturer, acute side effects, impact on work and self-care, medical consultation, and hospitalization. This analysis was restricted to women aged 20 to 39 at the time of vaccination. Side effects reported by pregnant women were compared to those reported by non-pregnant women.
Results This analysis included 946 pregnant women, with 572 (60%) receiving at least one dose of Pfizer, 321 (34%) Moderna, and 53 (6%) J&J, and 1,178 non-pregnant women. Demographic and medical history were similar across manufacturers for both cohorts.
Overall, pregnant women reported similar side effects as non-pregnant women, with the most common being injection site reactions (83 vs. 87%), fatigue (72 vs.78%), and headache (45 vs. 59%). Pregnant women reported fewer side effects (median: 3 vs. 4, respectively) ([Table 2]). In both cohorts, very few reported seeking medical care (<5%) or being hospitalized (<0.3%) after vaccination. Fewer pregnant women reported working less after vaccination than non-pregnant women (32 vs. 40%) or trouble with self-care (32 vs. 46%), respectively ([Table 2]).
Conclusion Pregnant women reported similar COVID-19 vaccine side effects as non-pregnant women, although fewer total side effects; pregnant women judged these side effects to have less impact on work and self-care. While these results do not address pregnancy outcomes or long-term effects, findings about acute side effects and impact offer reassurance for all three vaccines in terms of tolerability.
COVID vaccines were well tolerated by pregnant women.
Pregnant women reported fewer total side effects.
Pregnant women reported less impact on work and self-care.
Received: 24 November 2021
Accepted: 17 February 2022
Article published online:
06 May 2022
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