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Adverse effects of COVID-19 messenger RNA vaccines among pregnant women: a cross-sectional study on healthcare workers with detailed self-reported symptoms

      Objective

      Pregnant patients with COVID-19 are at an increased risk for severe illness when compared with nonpregnant patients.
      • Ellington S.
      • Strid P.
      • Tong V.T.
      • et al.
      Characteristics of women of reproductive age with laboratory-confirmed SARS-CoV-2 infection by pregnancy status–United States, January 22-June 7, 2020.
      None of the COVID-19 messenger RNA (mRNA) vaccines that were approved under the emergency use authorization have been tested in pregnant individuals during the initial vaccine trials despite the support offered by several agencies.
      • Stafford I.A.
      • Parchem J.G.
      • Sibai B.M.
      The coronavirus disease 2019 vaccine in pregnancy: risks, benefits, and recommendations.
      Although recent studies revealed more detailed side effects for both mRNA vaccines, there are limited data and literature that specifically focus on pregnant women.
      • Kadali R.A.K.
      • Janagama R.
      • Peruru S.
      • Malayala S.V.
      Side effects of BNT162b2 mRNA COVID-19 vaccine: a randomized, cross-sectional study with detailed self-reported symptoms from healthcare workers.
      ,
      • Kadali R.A.K.
      • Janagama R.
      • Peruru S.
      • et al.
      Non-life-threatening adverse effects with COVID-19 mRNA-1273 vaccine: a randomized, cross-sectional study on healthcare workers with detailed self-reported symptoms.
      The objective of this study was to analyze and compare the detailed side-effect profile of the mRNA vaccines among pregnant healthcare workers (HCWs) with that of nonpregnant HCWs using a self-reported online survey questionnaire consisting of a systematic review of organ systems independent of information collected through the Vaccine Adverse Event Reporting System (VAERS).
      • Shimabukuro T.T.
      • Kim S.Y.
      • Myers T.R.
      • et al.
      Preliminary findings of mRNA Covid-19 vaccine safety in pregnant persons.

      Study Design

      A cross-sectional study was conducted after obtaining institutional review board approval using an independent online survey questionnaire (Survey Monkey, San Mateo, CA). Anonymous responses about the side effects were collected from HCWs representing various parts of the country during the early phase of COVID-19 vaccination. Informed consent was obtained from the study participants. The responses were received from 1452 HCWs (who received 1 of the 2 mRNA-based COVID-19 vaccines) during the postvaccination period. Out of 1452 HCWs, 1029 were women and 38 were pregnant. Only the complete responses were included in the final analysis of this study. A statistical analysis was performed using Fisher exact tests to compare the side-effect profile between pregnant and nonpregnant groups.

      Results

      Among the 1029 HCW women, 38 were pregnant, 20 of whom received the Pfizer-BioNTech vaccine and the remaining 18 received the Moderna vaccine. About 81.58% (31 of 38) of the pregnant HCWs received both doses of the mRNA vaccine. The Table shows the detailed adverse events report among pregnant and nonpregnant women. No significant statistical differences were found between the groups for all of the symptoms reported for both groups (however, the participant with a report of seizure has a known history of seizure disorder and borderline low anticonvulsant blood levels). Most of the symptoms reported were within the early postvaccination phase of the vaccine and, consequently, the latent effects of these vaccines were not studied. No specific data about the initial timing of onset and duration of symptoms after vaccine administration were obtained during this study.
      TableComparison of the side-effect profile among pregnant and nonpregnant women
      Adverse event or side effectGroup that received the mRNA vaccineP value (Fisher exact test)
      Pregnant (n1=38)Nonpregnant (n2=991)
      Sore arm or pain37/38894/991.2517
      Fatigue22/38643/991.3905
      Headache19/38519/991.8689
      Chills18/38424/991.6183
      Myalgia13/38488/991.0714
      Nausea11/38211/991.313
      Fever6/38279/991.0999
      Sweating6/38135/991.6342
      Feelings of joy, relief, or gratitude4/3867/991.3265
      Rash4/3867/991.3265
      Joint pains3/38206/991.0625
      Swelling3/3894/9911
      Flushing3/3884/9911
      Brain fogging or reduced mental clarity3/3876/9911
      Itching2/3894/9911
      Decreased appetite2/3888/991.7669
      Decreased sleep quality2/3874/9911
      Palpitations or increased heart rate2/3864/9911
      Heat or cold intolerance2/3853/9911
      Anxiety2/3834/991.3876
      Heartburn2/3819/991.1799
      Muscle spasm1/38103/991.1676
      Nasal congestion1/3864/991.5073
      Increase in sleep1/3839/9911
      Vomiting1/3822/9911
      Seizures
      The participant with a report of seizure has a known history of seizure disorder and her anticonvulsant blood level was reported as borderline low
      The pregnancy-related adverse events were very rarely reported (gestational hypertension [1 in 38], threatened labor [1 in 38], miscarriage [1 in 38], and premature delivery [1 in 38]) from the Pfizer-BioNTech vaccine group and none were reported from the Moderna group.
      1/380/991.0369
      Diarrhea0/3861/991.1624
      Shortness of breath0/3823/9911
      Cough0/3820/9911
      Decrease in memory0/3814/9911
      Hives0/3811/9911
      Depression0/388/9911
      Psychological stress0/387/9911
      Swelling of lips or oral cavity0/385/9911
      Atopic eczema0/385/9911
      Hay fever0/383/9911
      Asthma exacerbation0/383/9911
      Behavioral changes0/381/9911
      mRNA, messenger RNA.
      Kadali. Adverse effects of COVID-19 messenger RNA vaccines among pregnant women. Am J Obstet Gynecol 2021.
      a The participant with a report of seizure has a known history of seizure disorder and her anticonvulsant blood level was reported as borderline low
      b The pregnancy-related adverse events were very rarely reported (gestational hypertension [1 in 38], threatened labor [1 in 38], miscarriage [1 in 38], and premature delivery [1 in 38]) from the Pfizer-BioNTech vaccine group and none were reported from the Moderna group.

      Conclusion

      The side-effect profile obtained from a detailed systematic review of organ systems among pregnant women who received either of the mRNA vaccines in the immediate or early postvaccination period were nonlife threatening and they appeared to be similar (with no significant statistical difference) when compared with nonpregnant women. The pregnancy-related adverse events were very rarely reported (see “b” below the Table). There is high acceptance of the second vaccine dose, which is an encouraging aspect for future pregnant vaccine recipients. Pregnant individuals should be educated to participate and be encouraged to be compliant with their report to VAERS after COVID-19 vaccination to a have more longitudinal follow-up for the evaluation of latent effects. As the vaccination continues among pregnant women, we recommend monitoring further reports from the Centers for Disease Control and Prevention.

      References

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        • Strid P.
        • Tong V.T.
        • et al.
        Characteristics of women of reproductive age with laboratory-confirmed SARS-CoV-2 infection by pregnancy status–United States, January 22-June 7, 2020.
        MMWR Morb Mortal Wkly Rep. 2020; 69: 769-775
        • Stafford I.A.
        • Parchem J.G.
        • Sibai B.M.
        The coronavirus disease 2019 vaccine in pregnancy: risks, benefits, and recommendations.
        Am J Obstet Gynecol. 2021; 224: 484-495
        • Kadali R.A.K.
        • Janagama R.
        • Peruru S.
        • Malayala S.V.
        Side effects of BNT162b2 mRNA COVID-19 vaccine: a randomized, cross-sectional study with detailed self-reported symptoms from healthcare workers.
        Int J Infect Dis. 2021; 106: 376-381
        • Kadali R.A.K.
        • Janagama R.
        • Peruru S.
        • et al.
        Non-life-threatening adverse effects with COVID-19 mRNA-1273 vaccine: a randomized, cross-sectional study on healthcare workers with detailed self-reported symptoms.
        J Med Virol. 2021; 93: 4420-4429
        • Shimabukuro T.T.
        • Kim S.Y.
        • Myers T.R.
        • et al.
        Preliminary findings of mRNA Covid-19 vaccine safety in pregnant persons.
        N Engl J Med. 2021; ([Epub ahead of print])