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Abstract

Background

COVID-19 vaccine safety is of major interest worldwide, since there is no prior experience with it. Israel was one of the first countries to widely use the Comirnaty vaccine.

Aim

We aimed to assess the vaccine's short-term side effects directly from a large population and to predict influencing factors for self-reporting side effects.

Methods

In a retrospective cohort study, we investigated self-reported systemic vaccine side-effects using electronic surveys sent to vaccinated individuals between 20 December 2020 and 11 March 2021, within 3 days following administration of the first and second dose. We determined predictors for reporting systemic side effects by logistic regression.

Results

A total of 1,213,693 patients received at least one vaccine dose and 301,537 (24.8%) answered at least one survey. Among them, 68,162 (30.4%) and 89,854 (59.9%) individuals filled the first and the second dose surveys, respectively, and reported one or more side effects. Most common side effects were fatigue, headache and myalgia. Several respondents reported facial paraesthesia after first and second dose, respectively (n = 1,675; 0.7% and n = 1,601; 1.1%). Individuals younger than 40 years and women reported side effects more frequently than others, but pregnant women reported less. Pregnancy was a weak predictor for reporting any side effect in general and in particular fatigue, myalgia, headache, chills and fever.

Conclusions

We found further support for minor short-term side effects, within 3 days of receiving the Comirnaty vaccine. These findings from vaccine recipients in general and pregnant women in particular can improve vaccine acceptance.

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/content/10.2807/1560-7917.ES.2022.27.13.2100540
2022-03-31
2024-11-22
http://instance.metastore.ingenta.com/content/10.2807/1560-7917.ES.2022.27.13.2100540
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References

  1. Johns Hopkins Coronavirus Resource Center. COVID-19 Dashboard by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University (JHU). Baltimore: JHU; 2020. Available from: https://coronavirus.jhu.edu/map.html
  2. Rosen B, Waitzberg R, Israeli A. Israel’s rapid rollout of vaccinations for COVID-19. Isr J Health Policy Res. 2021;10(1):6.  https://doi.org/10.1186/s13584-021-00440-6  PMID: 33499905 
  3. Israeli Ministry of Health. The first ones to have the COVID-19 vaccine within the "Ten Katef" vaccine campaign. Jerusalem: Ministry of Health; 2020. Available from: https://www.gov.il/en/departments/news/16122020-01
  4. Raj N, Fernandes S, Charyulu NR, Dubey A, G S R, Hebbar S. Postmarket surveillance: a review on key aspects and measures on the effective functioning in the context of the United Kingdom and Canada. Ther Adv Drug Saf. 2019;10:2042098619865413.  https://doi.org/10.1177/2042098619865413  PMID: 31384423 
  5. Stefanizzi P, Stella P, Ancona D, Malcangi KN, Bianchi FP, De Nitto S, et al. Adverse events following measles-mumps-rubella-varicella vaccination and the case of seizures: a post marketing active surveillance in Puglia Italian region, 2017-2018. Vaccines (Basel). 2019;7(4):140.  https://doi.org/10.3390/vaccines7040140  PMID: 31591347 
  6. Shimabukuro TT, Kim SY, Myers TR, Moro PL, Oduyebo T, Panagiotakopoulos L, et al. Preliminary findings of mRNA Covid-19 vaccine safety in pregnant persons. N Engl J Med. 2021;384(24):2273-82.  https://doi.org/10.1056/NEJMoa2104983  PMID: 33882218 
  7. Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020;383(27):2603-15.  https://doi.org/10.1056/NEJMoa2034577  PMID: 33301246 
  8. Kumar D, Chandra R, Mathur M, Samdariya S, Kapoor N. Vaccine hesitancy: understanding better to address better. Isr J Health Policy Res. 2016;5(1):2.  https://doi.org/10.1186/s13584-016-0062-y  PMID: 26839681 
  9. Larson HJ, Schulz WS, Tucker JD, Smith DM. Measuring vaccine confidence: introducing a global vaccine confidence index. PLoS Curr. 2015;7:ecurrents.outbreaks.ce0f6177bc97332602a8e3fe7d7f7cc4.  https://doi.org/10.1371/currents.outbreaks.ce0f6177bc97332602a8e3fe7d7f7cc4  PMID: 25789200 
  10. Israeli Central Bureau of Statistics. Characterization and classification of geographical units by the socio-economic level of the population 2015. Jerusalem: Central Bureau of Statistics; 2019. Available from: https://din-online.info/pdf/lst92e.pdf
  11. Schoen C, Osborn R, Squires D, Doty MM. Access, affordability, and insurance complexity are often worse in the United States compared to ten other countries. Health Aff (Millwood). 2013;32(12):2205-15.  https://doi.org/10.1377/hlthaff.2013.0879  PMID: 24226092 
  12. Aslani P, Hamrosi K, Tong V, Chen TF, Cook J, Fois R, et al. Consumer opinions on adverse events associated with medicines and vaccines. Patient Prefer Adherence. 2018;12:1383-92.  https://doi.org/10.2147/PPA.S167396  PMID: 30104865 
  13. Israeli Ministry of Health. COVID-19 vaccine efficacy and safety follow up committee. Jerusalem: Ministry of Health; 2021. Hebrew. Available from: https://govextra.gov.il/ministry-of-health/covid19-vaccine/covid-19-vaccine-efficacy-safety-follow-up-committee
  14. Menni C, Klaser K, May A, Polidori L, Capdevila J, Louca P, et al. Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID Symptom Study app in the UK: a prospective observational study. Lancet Infect Dis. 2021;21(7):939-49.  https://doi.org/10.1016/S1473-3099(21)00224-3  PMID: 33930320 
  15. Wang J, Jing R, Lai X, Zhang H, Lyu Y, Knoll MD, et al. Acceptance of covid-19 vaccination during the covid-19 pandemic in CHINA. Vaccines (Basel). 2020;8(3):482.  https://doi.org/10.3390/vaccines8030482  PMID: 32867224 
  16. Reiter PL, Pennell ML, Katz ML. Acceptability of a COVID-19 vaccine among adults in the United States: How many people would get vaccinated? Vaccine. 2020;38(42):6500-7.  https://doi.org/10.1016/j.vaccine.2020.08.043  PMID: 32863069 
  17. Lin C, Tu P, Beitsch LM. Confidence and receptivity for COVID-19 vaccines: a rapid systematic review. Vaccines (Basel). 2020;9(1):16-41.  https://doi.org/10.3390/vaccines9010016  PMID: 33396832 
  18. Pfizer-Biontech COVID-19 Vaccine (BNT162, PF-07302048). Vaccines and related biological products advisory committee briefing document. Silver Spring: United States Food and Drug Administration; 2020. Available from: https://www.fda.gov/media/144246/download
  19. Potluri T, Fink AL, Sylvia KE, Dhakal S, Vermillion MS, Vom Steeg L, et al. Age-associated changes in the impact of sex steroids on influenza vaccine responses in males and females. NPJ Vaccines. 2019;4(1):29.  https://doi.org/10.1038/s41541-019-0124-6  PMID: 31312529 
  20. Furman D, Hejblum BP, Simon N, Jojic V, Dekker CL, Thiébaut R, et al. Systems analysis of sex differences reveals an immunosuppressive role for testosterone in the response to influenza vaccination. Proc Natl Acad Sci USA. 2014;111(2):869-74.  https://doi.org/10.1073/pnas.1321060111  PMID: 24367114 
  21. Bialek S, Boundy E, Bowen V, Chow N, Cohn A, Dowling N, et al. Severe outcomes among patients with coronavirus disease 2019 (COVID-19) - United States, February 12-March 16, 2020. MMWR Morb Mortal Wkly Rep. 2020;69(12):343-6.  https://doi.org/10.15585/mmwr.mm6912e2  PMID: 32214079 
  22. Shapiro Ben David S, Cohen D, Karplus R, Irony A, Ofer-Bialer G, Potasman I, et al. COVID-19 community care in Israel-a nationwide cohort study from a large health maintenance organization. J Public Health (Oxf). 2021;43(4):723-30.  https://doi.org/10.1093/pubmed/fdab055  PMID: 33690854 
  23. Smith LE, Weinman J, Amlôt R, Yiend J, Rubin GJ. Parental expectation of side effects following vaccination is self-fulfilling: a prospective cohort study. Ann Behav Med. 2019;53(3):267-82.  https://doi.org/10.1093/abm/kay040  PMID: 29868792 
  24. Skjefte M, Ngirbabul M, Akeju O, Escudero D, Hernandez-Diaz S, Wyszynski DF, et al. COVID-19 vaccine acceptance among pregnant women and mothers of young children: results of a survey in 16 countries. Eur J Epidemiol. 2021;36(2):197-211.  https://doi.org/10.1007/s10654-021-00728-6  PMID: 33649879 
  25. Dreier JW, Andersen AM, Berg-Beckhoff G. Systematic review and meta-analyses: fever in pregnancy and health impacts in the offspring. Pediatrics. 2014;133(3):e674-88.  https://doi.org/10.1542/peds.2013-3205  PMID: 24567014 
  26. Remillard ML, Mazor KM, Cutrona SL, Gurwitz JH, Tjia J. Systematic review of the use of online questionnaires of older adults. J Am Geriatr Soc. 2014;62(4):696-705.  https://doi.org/10.1111/jgs.12747  PMID: 24635138 
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