PMID- 37914862
OWN - NLM
STAT- MEDLINE
DCOM- 20231103
LR  - 20231108
IS  - 2045-2322 (Electronic)
IS  - 2045-2322 (Linking)
VI  - 13
IP  - 1
DP  - 2023 Nov 1
TI  - Impact of the COVID-19 pandemic on the spontaneous reporting and signal detection 
      of adverse drug events.
PG  - 18817
LID - 10.1038/s41598-023-46275-w [doi]
LID - 18817
AB  - External factors severely affecting in a short period of time the spontaneous 
      reporting of adverse events (AEs) can significantly impact drug safety signal 
      detection. Coronavirus disease 2019 (COVID-19) represented an enormous challenge 
      for health systems, with over 767 million cases and massive vaccination campaigns 
      involving over 70% of the worldwide population. This study investigates the 
      potential masking effect on certain AEs caused by the substantial increase in 
      reports solely related to COVID-19 vaccines within various spontaneous reporting 
      systems (SRSs). Three SRSs were used to monitor AEs reporting before and during 
      the pandemic, namely, the World Health Organisation (WHO) global individual case 
      safety reports database (VigiBase(R)), the United States Food and Drug 
      Administration Adverse Event Reporting System (FAERS) and the Japanese Adverse 
      Drug Event Report database (JADER). Findings revealed a sudden over-reporting of 
      35 AEs (>/= 200%) during the pandemic, with an increment of the RRF value in 2021 
      of at least double the RRF reported in 2020. This translates into a substantial 
      reduction in signals of disproportionate reporting (SDR) due to the massive 
      inclusion of COVID-19 vaccine reports. To mitigate the masking effect of COVID-19 
      vaccines in post-marketing SRS analyses, we recommend utilizing 
      COVID-19-corrected versions for a more accurate assessment.
CI  - (c) 2023. The Author(s).
FAU - Montes-Grajales, Diana
AU  - Montes-Grajales D
AD  - Chemotargets SL, Parc Cientific de Barcelona, Baldiri Reixac 4 (TR-03), 08028, 
      Barcelona, Catalonia, Spain.
FAU - Garcia-Serna, Ricard
AU  - Garcia-Serna R
AD  - Chemotargets SL, Parc Cientific de Barcelona, Baldiri Reixac 4 (TR-03), 08028, 
      Barcelona, Catalonia, Spain.
FAU - Mestres, Jordi
AU  - Mestres J
AD  - Chemotargets SL, Parc Cientific de Barcelona, Baldiri Reixac 4 (TR-03), 08028, 
      Barcelona, Catalonia, Spain. jordi.mestres@chemotargets.com.
AD  - Institut de Quimica Computacional i Catalisi, Facultat de Ciencies, Universitat 
      de Girona, Maria Aurelia Capmany 69, 17003, Girona, Catalonia, Spain. 
      jordi.mestres@chemotargets.com.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20231101
PL  - England
TA  - Sci Rep
JT  - Scientific reports
JID - 101563288
RN  - 0 (COVID-19 Vaccines)
SB  - IM
MH  - United States/epidemiology
MH  - Humans
MH  - COVID-19 Vaccines
MH  - Pandemics
MH  - *COVID-19/epidemiology
MH  - Adverse Drug Reaction Reporting Systems
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology
PMC - PMC10620227
COIS- The authors declare no competing interests.
EDAT- 2023/11/02 06:42
MHDA- 2023/11/03 06:43
PMCR- 2023/11/01
CRDT- 2023/11/02 00:37
PHST- 2023/07/26 00:00 [received]
PHST- 2023/10/30 00:00 [accepted]
PHST- 2023/11/03 06:43 [medline]
PHST- 2023/11/02 06:42 [pubmed]
PHST- 2023/11/02 00:37 [entrez]
PHST- 2023/11/01 00:00 [pmc-release]
AID - 10.1038/s41598-023-46275-w [pii]
AID - 46275 [pii]
AID - 10.1038/s41598-023-46275-w [doi]
PST - epublish
SO  - Sci Rep. 2023 Nov 1;13(1):18817. doi: 10.1038/s41598-023-46275-w.