Comparison of Immediate Adverse Effects of COVID-19 Vaccine (COVAXIN BBV152) in Pregnant vs Nonpregnant Women
Journal of SAFOG
; 15(1):57-60, 2023.
Article
in English
| EMBASE | ID: covidwho-20237631
ABSTRACT
Aims and objectives:
The aim of this study was to compare the immediate adverse effects of the coronavirus disease 2019 (COVID-19) vaccine (COVAXIN) in a pregnant woman with that of a nonpregnant woman. Material(s) and Method(s) It is a prospective observational study done at Vanivilas Hospital, Bangalore Medical College & Research Institute (BMCRI) for 2 months. The sample size was 100 pregnant and 100 nonpregnant women. Telephonically, patients were followed-up, and details of the side/adverse effects were collected in a proforma after 2 and 14 days. Data collected from both groups were analyzed using the Chi-square test or Fisher's exact test. Result(s) The majority of women were in the age group of <=25 years (64.0% and 36.0%, respectively) with a mean age of 25.01 +/- 3.71 years among the pregnant and 28.52 +/- 6.00 years among nonpregnant women. About 25.0% of pregnant women and 38.0% of nonpregnant women reported side effects. About 15.0% and 22.0% had taken treatment for side effects among pregnant women and nonpregnant women, respectively. Among the pregnant women, the common side effects reported were injection site pain (17) followed by fever (5), fatigue (4), and myalgia (03). Whereas among the nonpregnant women, the common side effects reported were injection site pain (28) followed by fever (6), myalgia (3), headache (2), and fatigue (1). Conclusion(s) Side effects reported following the administration of Covaxin in pregnant and nonpregnant women are fever, fatigue, injection site pain, myalgia, and headache. The proportion of side effects was not significantly different in the pregnant and nonpregnant women following Covaxin administration. Clinicalsignificance:
Covaxin is an inactivated killed vaccine against COVID-19 by Bharat Biotech. The vaccine has been recommended for pregnant women by the Government of India during corona pandemic. Studies are lacking regarding the difference in adverse events in pregnant versus nonpregnant women, after vaccine administration.Copyright © The Author(s).
Adverse events; sars cov 2; Vaccination; abdominal pain/si [Side Effect]; adult; article; cardiovascular disease; cesarean section; clinical significance; controlled study; coronavirus disease 2019/dt [Drug Therapy]; diabetes mellitus; dizziness/si [Side Effect]; epilepsy; fatigue/si [Side Effect]; female; fever/si [Side Effect]; groups by age; headache/si [Side Effect]; health insurance; hospitalization; human; hypotension; injection site pain/si [Side Effect]; major clinical study; malaise/si [Side Effect]; maternal hypertension; medical school; monotherapy; myalgia/si [Side Effect]; neuromuscular disease; observational study; pandemic; preeclampsia; pregnancy; pregnancy outcome; pregnancy rate; pregnant woman; premature labor; questionnaire; sample size; Severe acute respiratory syndrome coronavirus 2; sweating; tertiary care center; vomiting/si [Side Effect]; covaxin/ae [Adverse Drug Reaction]; covaxin/do [Drug Dose]; covaxin/dt [Drug Therapy]; inactivated vaccine
Full text:
Available
Collection:
Databases of international organizations
Database:
EMBASE
Type of study:
Experimental Studies
/
Observational study
/
Prognostic study
/
Randomized controlled trials
Topics:
Vaccines
Language:
English
Journal:
Journal of SAFOG
Year:
2023
Document Type:
Article
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