COVID-19 Vaccinations in Pregnancy: Comparative Evaluation of Acute Side Effects and Self-Reported Impact on Quality of Life between Pregnant and Nonpregnant Women in the United States

Abstract

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. Key Points

Comparison of clinical characteristics of COVID-19 in pregnant women between the Delta and Omicron variants of concern predominant periods

“…There have been many studies that showed efficacy in preventing SARS-CoV-2 infection, hospitalization, and death due to COVID-19 including the Delta or Omicron VOC periods [ 14 , 15 , [23] , [24] , [25] ]. The favorable safety and efficacy of SARS-CoV-2 vaccines in pregnant women have also been reported [ [26] , [27] , [28] , [29] ] and SARS-CoV-2 vaccination in pregnant women at any stage of pregnancy has been recommended worldwide, including in Japan [ [30] , [31] , [32] ]. Our study results in the total cohort were consistent with previous reports and demonstrated the benefits of SARS-CoV-2 vaccination in pregnant women even in the Delta and Omicron VOC periods.…”

COVID-19 Pharmacotherapy in Pregnancy: A Literature Review of Current Therapeutic Choices

“…Rare side effects include thrombosis with thrombocytopenia syndrome, myocarditis, and pericarditis, Guillain–Barré syndrome, as in nonpregnant individuals; however, no infertility issues have been reported [ 78 , 79 , 80 , 81 ]. Pregnancy by itself does not represent a cause for increased risks of any adverse outcome, following COVID-19 vaccination [ 82 ], while the overall risk of the occurrence of an acute adverse event requiring medical attention is low (<1%) and similar in pregnant and unvaccinated pregnant patients [ 83 ]. Direct or indirect harmful effects on fertility, embryo/fetal development, pregnancy outcome, parturition, or short-term postnatal development of offspring were not detected [ 75 , 84 , 85 , 86 , 87 , 88 , 89 , 90 , 91 , 92 , 93 , 94 , 95 , 96 , 97 ].…”

Coronavirus and Pregnancy: The Challenges of the 21st Century: A Review

“…No harmful effects on fertility, embryo/fetal development, pregnancy outcome, parturition, or short-term postnatal development of offspring has been reported in association with vaccines. Side effects are similar in pregnant and non-pregnant females ( Brinkley et al, 2022 ).…”

“…None of the recommended COVID-19 vaccines [Pfizer/BioNTech (Comirnaty) by Fosun Pharma, Pfizer; Moderna (Spikevax); Janssen/Johnson & Johnson by Janssen Pharmaceutical Companies] contain virus that replicates. Thus, they do not cause disease, but non-specific side-effects from activation of the immune system may occur ( Brinkley et al, 2022 ). Women can be assured that data supports the safety of vaccine in pregnancy and lactation.…”

“…Women can be assured that data supports the safety of vaccine in pregnancy and lactation. Benefits of vaccination include reductions in maternal SARS-CoV-2 infection, severity of maternal COVID-19, perinatal death, COVID-19-related hospitalization among infants up to 6 months of age ( American College of Obstetricians and Gynecologists, 2022 ; Brinkley et al, 2022 ; Fu et al, 2022 ). No harmful effects on fertility, embryo/fetal development, pregnancy outcome, parturition, or short-term postnatal development of offspring has been reported in association with vaccines.…”