PMID- 37230943
OWN - NLM
STAT- MEDLINE
DCOM- 20230615
LR  - 20230627
IS  - 2049-632X (Electronic)
IS  - 2049-632X (Linking)
VI  - 81
DP  - 2023 Jan 17
TI  - Assessment of long-term adverse events regarding different COVID-19 vaccine 
      regimens within an 18-month follow-up study.
LID - ftad010 [pii]
LID - 10.1093/femspd/ftad010 [doi]
AB  - Early reports on coronavirus disease 2019 (COVID-19) vaccines presented the 
      short-term adverse events (AEs). This follow-up study investigated a standard 
      regimen based on protein subunit vaccines, PastoCovac and PastoCovac Plus, and 
      the combinational vaccine regimens including AstraZeneca/PastoCovac Plus and 
      Sinopharm/PastoCovac Plus. The participants were followed up to 6 months post the 
      booster shot. All the AEs were collected through in-depth interviews using a 
      valid researcher-made questionnaire and were evaluated regarding the association 
      with the vaccines. Of the 509 individuals, 6.2% of the combinational vaccine 
      participants had late AEs, of whom 3.3% suffered from cutaneous manifestations, 
      followed by 1.1% arthralgia complaints, 1.1% with neurologic disorders, 0.3% 
      ocular problems and 0.3% metabolic complications, with no significant difference 
      between the vaccine regimens. For the standard regimen, 2% of the individuals 
      experienced late AEs as (1%), neurological disorders (0.3%), metabolic problems 
      (0.3%) and involvement of joints (0.3%). Notably, 75% of the AEs were persistent 
      up to the end of the study. A low number of late AEs were captured in 18 months 
      as 12 improbable, 5 unclassifiable, 4 possible and 3 probable associated AEs with 
      the vaccine regimens. The benefits of COVID-19 vaccination far exceed the 
      potential risks and late AEs seem to be uncommon.
CI  - (c) The Author(s) 2023. Published by Oxford University Press on behalf of FEMS.
FAU - Sadat Larijani, Mona
AU  - Sadat Larijani M
AD  - Clinical Research Department, Pasteur Institute of Iran, Tehran 1316943551, Iran.
FAU - Sorouri, Rahim
AU  - Sorouri R
AD  - IPI Directorate, Pasteur Institute of Iran, Tehran 1316943551, Iran.
FAU - Eybpoosh, Sana
AU  - Eybpoosh S
AD  - Quality Control Department, Production and research Complex, Pasteur Institute of 
      Iran, Tehran-Karaj 3159915111, Iran.
FAU - Doroud, Delaram
AU  - Doroud D
AD  - Department of Epidemiology and Biostatics, Research Centre for Emerging and 
      Reemerging Infectious Diseases, Pasteur Institute of Iran, Tehran 1316943551, 
      Iran.
FAU - Moradi, Ladan
AU  - Moradi L
AD  - Clinical Research Department, Pasteur Institute of Iran, Tehran 1316943551, Iran.
FAU - Ahmadinezhad, Mozhgan
AU  - Ahmadinezhad M
AD  - Quality Control Department, Production and research Complex, Pasteur Institute of 
      Iran, Tehran-Karaj 3159915111, Iran.
FAU - Bavand, Anahita
AU  - Bavand A
AD  - Clinical Research Department, Pasteur Institute of Iran, Tehran 1316943551, Iran.
FAU - Ashrafian, Fatemeh
AU  - Ashrafian F
AD  - Clinical Research Department, Pasteur Institute of Iran, Tehran 1316943551, Iran.
FAU - Tajmehrabi Namini, Parinaz
AU  - Tajmehrabi Namini P
AD  - Clinical Research Department, Pasteur Institute of Iran, Tehran 1316943551, Iran.
FAU - Zali, Mahsan
AU  - Zali M
AD  - Clinical Research Department, Pasteur Institute of Iran, Tehran 1316943551, Iran.
FAU - Ramezani, Amitis
AU  - Ramezani A
AUID- ORCID: 0000-0003-3502-8524
AD  - Clinical Research Department, Pasteur Institute of Iran, Tehran 1316943551, Iran.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Pathog Dis
JT  - Pathogens and disease
JID - 101595366
RN  - 0 (COVID-19 Vaccines)
SB  - IM
MH  - Humans
MH  - *COVID-19 Vaccines/adverse effects
MH  - Follow-Up Studies
MH  - *COVID-19/prevention & control
MH  - Vaccination/adverse effects
OTO - NOTNLM
OT  - COVID-19
OT  - late adverse events
OT  - long-term AEs
OT  - safety
OT  - vaccine
EDAT- 2023/05/26 01:05
MHDA- 2023/06/15 06:42
CRDT- 2023/05/25 22:52
PHST- 2023/04/19 00:00 [received]
PHST- 2023/05/10 00:00 [revised]
PHST- 2023/05/23 00:00 [accepted]
PHST- 2023/06/15 06:42 [medline]
PHST- 2023/05/26 01:05 [pubmed]
PHST- 2023/05/25 22:52 [entrez]
AID - 7179983 [pii]
AID - 10.1093/femspd/ftad010 [doi]
PST - ppublish
SO  - Pathog Dis. 2023 Jan 17;81:ftad010. doi: 10.1093/femspd/ftad010.