PMID- 37362835
OWN - NLM
STAT- Publisher
LR  - 20230701
IS  - 1576-9887 (Print)
IS  - 1578-8857 (Electronic)
IS  - 1576-9887 (Linking)
DP  - 2023 May 18
TI  - Adverse events following COVID-19 vaccination among pregnant women attending 
      primary health centers: An active-surveillance study.
LID - 10.1016/j.vacun.2023.05.003 [doi]
AB  - INTRODUCTION: Vaccine safety is a major barrier to the uptake of the COVID-19 
      vaccine by pregnant women. To bring confidence among pregnant women towards 
      vaccine intake, there is a need to synthesize evidence on safety profile of 
      vaccination. OBJECTIVE: To assess adverse events (AEs) following COVID-19 
      vaccination among pregnant women. MATERIALS AND METHODS: A vaccine safety 
      surveillance was conducted at 2 rural primary health centers (PHC) located in 
      Anantapur District, India. A total of 420 pregnant women were monitored for AEs 
      following COVID-19 vaccination for a period of 30 min and followed for 1 month 
      for late reactions through telephonic interviews. All AEs were subjected to 
      causality and severity assessment. Descriptive statistics were used to represent 
      adverse events. RESULTS: The COVID-19 vaccine acceptance rate among pregnant 
      women was 64.4%. A total of 420 pregnant women received 670 vaccine doses 
      (Covishield = 372, Covaxin = 298) against COVID-19. Majority of vaccine intake 
      was observed during the second trimester. The incidence rate of AEs following the 
      COVID-19 vaccine among pregnant women was 93.8%, and the majority include 
      injection site pain (28.4%, 29.6%), fever (25.5%, 19.0%), myalgia (8.21%, 12.3%), 
      and malaise (13.6%, 8.4%). Most AEs notified are probable and mild in nature. 
      CONCLUSION: The COVID-19 vaccine acceptance rate among pregnant women was 64.4%. 
      A 30 days incidence rate of AEs following COVID-19 vaccination among pregnant 
      women was 93.8%, with the most common mild events like injection site pain, and 
      fever. A further follow-up cohort study by taking an adequate sample size was 
      recommended to capture fetal-maternal outcomes.
CI  - (c) 2023 Elsevier Espana, S.L.U. All rights reserved.
FAU - Goruntla, Narayana
AU  - Goruntla N
AD  - Department of Clinical Pharmacy and Pharmacy Practice, School of Pharmacy, 
      Kampala International University, Western Campus, Uganda.
FAU - Karisetty, Basappa
AU  - Karisetty B
AD  - Department of Pharmacy Practice, Raghavendra Institute of Pharmaceutical 
      Education and Research (RIPER) - Autonomous, Anantapur, Andhra Pradesh, India.
FAU - Nandini, Nandini
AU  - Nandini N
AD  - Department of Pharmacy Practice, Raghavendra Institute of Pharmaceutical 
      Education and Research (RIPER) - Autonomous, Anantapur, Andhra Pradesh, India.
FAU - Bhupasamudram, Bharadwaj
AU  - Bhupasamudram B
AD  - Department of Pharmacy Practice, Raghavendra Institute of Pharmaceutical 
      Education and Research (RIPER) - Autonomous, Anantapur, Andhra Pradesh, India.
FAU - Gangireddy, Himaja Reddy
AU  - Gangireddy HR
AD  - Department of Pharmacy Practice, Raghavendra Institute of Pharmaceutical 
      Education and Research (RIPER) - Autonomous, Anantapur, Andhra Pradesh, India.
FAU - Veerabhadrappa, Kasturi Vishwanathasetty
AU  - Veerabhadrappa KV
AD  - Department of Pharmacognosy and Pharmaceutical Chemistry, School of Pharmacy, 
      Kampala International University, Western Campus, Uganda.
FAU - Ezeonwumelu, Joseph Obiezu Chukwujekwu
AU  - Ezeonwumelu JOC
AD  - Department of Clinical Pharmacy and Pharmacy Practice, School of Pharmacy, 
      Kampala International University, Western Campus, Uganda.
FAU - Bandaru, Vishnuvandana
AU  - Bandaru V
AD  - Department of Pharmaceutical Analysis, Balaji College of Pharmacy, Anantapur, 
      Andhra Pradesh, India.
LA  - eng
PT  - Journal Article
DEP - 20230518
PL  - Spain
TA  - Vacunas
JT  - Vacunas
JID - 101528857
PMC - PMC10192595
OTO - NOTNLM
OT  - Adverse events
OT  - Coronavirus disease 2019
OT  - Covaxin
OT  - Covishield
OT  - Pregnancy
COIS- The authors declare that they have no conflicts of interest.
EDAT- 2023/06/26 19:07
MHDA- 2023/06/26 19:07
PMCR- 2023/05/18
CRDT- 2023/06/26 13:10
PHST- 2023/04/24 00:00 [received]
PHST- 2023/05/02 00:00 [revised]
PHST- 2023/05/05 00:00 [accepted]
PHST- 2023/06/26 19:07 [medline]
PHST- 2023/06/26 19:07 [pubmed]
PHST- 2023/06/26 13:10 [entrez]
PHST- 2023/05/18 00:00 [pmc-release]
AID - S1576-9887(23)00037-7 [pii]
AID - 10.1016/j.vacun.2023.05.003 [doi]
PST - aheadofprint
SO  - Vacunas. 2023 May 18. doi: 10.1016/j.vacun.2023.05.003.