PMID- 37641637
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230829
IS  - 2515-1355 (Print)
IS  - 2515-1363 (Electronic)
IS  - 2515-1355 (Linking)
VI  - 11
DP  - 2023
TI  - Active surveillance of adverse events following COVID-19 vaccines in a tertiary 
      care hospital.
PG  - 25151355231193975
LID - 10.1177/25151355231193975 [doi]
LID - 25151355231193975
AB  - BACKGROUND: Vaccination is a safe and effective way to prevent disease and save 
      lives, but it may also produce some undesirable adverse events (AEs)which may 
      affect healthy individuals. Therefore, the monitoring of AE following 
      immunization (AEFIs) is necessary. The objective of this study was to assess the 
      AEs following COVID-19 vaccinations in a tertiary care hospital. METHODOLOGY: The 
      study was conducted as active vaccine safety surveillance for a period of 
      6 months among the COVID-19 vaccine beneficiaries of the study site. Active 
      surveillance was conducted via initiating two telephone contacts. The first 
      surveillance was conducted in 8 days and the second surveillance after 28 days of 
      post-vaccination. All identified AEs following immunizations (AEFIs) were 
      reported and analysed by the AEFI investigation team at the study site. The 
      causality assessment of each identified AEFI was performed using the World Health 
      Organization's causality assessment algorithm. RESULTS: A total of 2927 enrolled 
      study population completed the study with a response rate of 80.85%. The study 
      identified 902 AEFIs from 614 study populations with an incidence rate of 20.97%. 
      Of which 794 and 79 AEFIs were associated with COVISHIELD and COVAXIN((R)), 
      respectively. The majority of the events were reported among the age group of 
      18-29 years. Overall, only three events were serious and no deaths were reported 
      among the study population. A total of 75.59% of events had a consistent causal 
      association with vaccination and were categorized as vaccine product-related 
      reactions. The study identified various factors such as gender (p = 0.019), age 
      (p < 0.05), co-morbid status (p = 0.032) and dose number (p = 0.001) as potential 
      predictors for development of AEFI. CONCLUSION: The study identified only 0.33% 
      of events as serious, and 99.67% of the study population recovered from the 
      AEFIs, which reveals that COVISHIELD and COVAXIN((R)) have a generally favourable 
      safety profile. However, close monitoring is required to identify the potential 
      signals, as the safety data from the clinical trials are limited.
CI  - (c) The Author(s), 2023.
FAU - Cherian, Naveena Mary
AU  - Cherian NM
AD  - Department of Pharmacy Practice, JSS College of Pharmacy, JSS Academy of Higher 
      Education and Research, Mysuru, India.
FAU - Durai, Dravya Anna
AU  - Durai DA
AD  - Department of Pharmacy Practice, JSS College of Pharmacy, JSS Academy of Higher 
      Education and Research, Mysuru, India.
FAU - Jaisel, Muhammed
AU  - Jaisel M
AD  - Department of Pharmacy Practice, JSS College of Pharmacy, JSS Academy of Higher 
      Education and Research, Mysuru, India.
FAU - Sharma, Divyansh
AU  - Sharma D
AD  - Department of Pharmacy Practice, JSS College of Pharmacy, JSS Academy of Higher 
      Education and Research, Mysuru, India.
FAU - Sebastian, Juny
AU  - Sebastian J
AUID- ORCID: 0000-0002-4626-8729
AD  - Department of Pharmacy Practice, JSS College of Pharmacy, JSS Academy of Higher 
      Education and Research, Mysuru, Karnataka 570015, India.
AD  - Department of Pharmacy Practice, College of Pharmacy, Gulf Medical University, 
      Ajman, United Arab Emirates.
FAU - Basavaraja, Chetak Kadabasal
AU  - Basavaraja CK
AD  - Department of Pediatrics, JSS Medical College and Hospital, JSS Academy of Higher 
      Education and Research, Mysuru, India.
FAU - Mathew, Merrin
AU  - Mathew M
AD  - Department of Pharmacy Practice, JSS College of Pharmacy, JSS Academy of Higher 
      Education and Research, Mysuru, India.
LA  - eng
PT  - Journal Article
DEP - 20230826
PL  - England
TA  - Ther Adv Vaccines Immunother
JT  - Therapeutic advances in vaccines and immunotherapy
JID - 101718382
PMC - PMC10460577
OTO - NOTNLM
OT  - active surveillance
OT  - adverse events following vaccination
OT  - causality assessment of AEFIs
OT  - vaccine safety
OT  - vaccine safety surveillance
COIS- The authors declare that there is no conflict of interest.
EDAT- 2023/08/29 06:43
MHDA- 2023/08/29 06:44
PMCR- 2023/08/26
CRDT- 2023/08/29 03:37
PHST- 2023/02/07 00:00 [received]
PHST- 2023/07/25 00:00 [accepted]
PHST- 2023/08/29 06:44 [medline]
PHST- 2023/08/29 06:43 [pubmed]
PHST- 2023/08/29 03:37 [entrez]
PHST- 2023/08/26 00:00 [pmc-release]
AID - 10.1177_25151355231193975 [pii]
AID - 10.1177/25151355231193975 [doi]
PST - epublish
SO  - Ther Adv Vaccines Immunother. 2023 Aug 26;11:25151355231193975. doi: 
      10.1177/25151355231193975. eCollection 2023.