PMID- 35649591
OWN - NLM
STAT- MEDLINE
DCOM- 20220603
LR  - 20220716
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 12
IP  - 6
DP  - 2022 Jun 1
TI  - Adverse events and overall health and well-being after COVID-19 vaccination: 
      interim results from the VAC4COVID cohort safety study.
PG  - e060583
LID - 10.1136/bmjopen-2021-060583 [doi]
LID - e060583
AB  - OBJECTIVES: To describe the incidence of adverse events (AEs), reactogenicity 
      symptoms, menstrual changes and overall self-rated improvement in health and 
      well-being after COVID-19 vaccination. DESIGN: VAC4COVID is an ongoing 
      prospective, active observational, post-authorisation cohort safety study (PASS) 
      of UK-approved vaccines for COVID-19 disease. SETTING: The study is conducted 
      through a secure website (www.vac4covid.com) by MEMO Research, University of 
      Dundee, UK. PARTICIPANTS: 16 265 adult (18 years or older) UK residents with a 
      valid email address and internet access. INTERVENTIONS: Any UK-authorised 
      COVID-19 vaccination. MAIN OUTCOME MEASURES: The outcomes reported in this 
      interim analysis include AEs, reactogenicity-type AEs (headache, fatigue, muscle 
      or joint pain, fever, nausea, dizziness or local vaccine reaction), menstrual 
      changes and reported improvement in overall health and well-being. RESULTS: 
      11 475 consented participants (mean age 54.8 years) provided follow-up data 
      between 2 February and 5 October 2021 (mean follow-up duration 184 days), by 
      which date 89.2% of participants had received two vaccine doses. 89.8% of 5222 
      participants who completed a follow-up questionnaire in the 7 days after any 
      COVID-19 vaccination reported no AEs. The risk of experiencing any event (not 
      necessarily vaccine-related) requiring hospitalisation was less than 0.2%. 43.7% 
      of post-vaccination follow-up records reported improvement in health and 
      well-being. Reactogenicity-type reactions were more common in the week after the 
      first dose of ChAdOx1 than BNT162b2 (7.8% vs 1.6%), but this relationship was 
      reversed after the second dose (1.3% vs 3.1%). 0.3% of women reported menstrual 
      symptoms after vaccination; no differences between vaccine type or dose order 
      were detected. CONCLUSIONS: The study provides reassuring data on low rates of 
      AEs after COVID-19 vaccination. Differences in reactogenicity-type AE profiles 
      between ChAdOx1 and BNT162b2 and between first and second doses of these vaccines 
      were observed. TRIAL REGISTRATION NUMBER: ISRCTN95881792; Pre-results.
CI  - (c) Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Rogers, Amy
AU  - Rogers A
AUID- ORCID: 0000-0001-5207-7032
AD  - MEMO Research, University of Dundee, Dundee, UK a.rogers@dundee.ac.uk.
FAU - Rooke, Evelien
AU  - Rooke E
AUID- ORCID: 0000-0002-9174-777X
AD  - MEMO Research, University of Dundee, Dundee, UK.
FAU - Morant, Steve
AU  - Morant S
AUID- ORCID: 0000-0001-5674-3784
AD  - MEMO Research, University of Dundee, Dundee, UK.
FAU - Guthrie, Greg
AU  - Guthrie G
AUID- ORCID: 0000-0002-9207-1118
AD  - MEMO Research, University of Dundee, Dundee, UK.
FAU - Doney, Alex
AU  - Doney A
AUID- ORCID: 0000-0002-6210-5620
AD  - MEMO Research, University of Dundee, Dundee, UK.
FAU - Duncan, Andrew
AU  - Duncan A
AUID- ORCID: 0000-0002-7767-472X
AD  - Clinical Infection Research Group, NHS Lothian, Edinburgh, UK.
FAU - Mackenzie, Isla
AU  - Mackenzie I
AUID- ORCID: 0000-0002-3680-7127
AD  - MEMO Research, University of Dundee, Dundee, UK.
FAU - Barr, Rebecca
AU  - Barr R
AUID- ORCID: 0000-0003-4820-4240
AD  - MEMO Research, University of Dundee, Dundee, UK.
FAU - Pigazzani, Filippo
AU  - Pigazzani F
AUID- ORCID: 0000-0002-8726-306X
AD  - MEMO Research, University of Dundee, Dundee, UK.
FAU - Zutis, Krists
AU  - Zutis K
AD  - MEMO Research, University of Dundee, Dundee, UK.
FAU - MacDonald, Thomas M
AU  - MacDonald TM
AUID- ORCID: 0000-0001-5189-6669
AD  - MEMO Research, University of Dundee, Dundee, UK.
LA  - eng
SI  - ISRCTN/ISRCTN95881792
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220601
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
RN  - 0 (COVID-19 Vaccines)
RN  - N38TVC63NU (BNT162 Vaccine)
SB  - IM
MH  - Adult
MH  - BNT162 Vaccine
MH  - *COVID-19/epidemiology/prevention & control
MH  - *COVID-19 Vaccines/adverse effects
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - Prospective Studies
MH  - Vaccination/adverse effects
PMC - PMC9160588
OTO - NOTNLM
OT  - COVID-19
OT  - adverse events
OT  - clinical pharmacology
COIS- Competing interests: TM, IM and A Doney have received consultancy fees to their 
      university from AstraZeneca not relating to this work. IM has received personal 
      consultancy fees from AstraZeneca not pertaining to this work. A Duncan has 
      previously worked as an NHS study physician on COVID-19 vaccine trials sponsored 
      by Oxford University, Valneva, BioNTech and AstraZeneca. The authors declare no 
      other relationships or activities that could appear to have influenced the 
      submitted work.
EDAT- 2022/06/02 06:00
MHDA- 2022/06/07 06:00
PMCR- 2022/06/01
CRDT- 2022/06/01 20:52
PHST- 2022/06/01 20:52 [entrez]
PHST- 2022/06/02 06:00 [pubmed]
PHST- 2022/06/07 06:00 [medline]
PHST- 2022/06/01 00:00 [pmc-release]
AID - bmjopen-2021-060583 [pii]
AID - 10.1136/bmjopen-2021-060583 [doi]
PST - epublish
SO  - BMJ Open. 2022 Jun 1;12(6):e060583. doi: 10.1136/bmjopen-2021-060583.