PMID- 34982462
OWN - NLM
STAT- MEDLINE
DCOM- 20220111
LR  - 20220111
IS  - 2284-0729 (Electronic)
IS  - 1128-3602 (Linking)
VI  - 25
IP  - 24
DP  - 2021 Dec
TI  - Host factors and history of SARS-CoV-2 infection impact the reactogenicity of 
      BNT162b2 mRNA vaccine: results from a cross-sectional survey on 7,014 workers in 
      healthcare.
PG  - 7985-7996
LID - 27649 [pii]
LID - 10.26355/eurrev_202112_27649 [doi]
AB  - OBJECTIVE: This study aimed to improve the post-marketing surveillance on mRNA 
      anti-SARS-CoV-2 vaccines, characterizing the adverse events (AEs) after the first 
      dose of mRNA BNT162b vaccine. The associations between the AEs and individuals' 
      characteristics were explored. PATIENTS AND METHODS: All adult healthcare workers 
      at Niguarda Hospital (Milan, Italy) who were referred for the first dose of 
      vaccine were offered to participate in a cross-sectional survey during the 
      second-dose administration, between 18 January and 7 February 2021. All 
      participants completed a questionnaire about age, gender, weight, height, medical 
      history, concurrent therapies, employment status, previous diagnosis/testing for 
      SARS-CoV-2 infection, and a list of 24 AEs (solicited AEs). The development of at 
      least one solicited AEs was the main outcome. AEs were stratified by the presence 
      of injection-site symptoms, systemic symptoms or both, and the differences 
      between strata were assessed as a secondary outcome. Biometric data and reports 
      of a previous diagnosis of SARS-CoV-2 infection were also explored, as predictors 
      of the main outcome. RESULTS: 7,014 healthcare workers were included. An 
      incidence of 3 per 10.000 persons for serious AEs following the first 
      administration of the mRNA BNT162b vaccine was found. An association between the 
      development of non-serious AEs with young age, female gender, low body mass 
      index, and previous history of SARS-CoV-2 was described. CONCLUSIONS: This 
      real-life study supported data on the safety profile of the BNT162b2 mRNA 
      vaccine. Our findings on the associations between the development of non-serious 
      AEs with some individual characteristics may help physicians and patients make 
      educated and informed medical decisions towards anti-COVID-19 vaccination.
FAU - Ughi, N
AU  - Ughi N
AD  - Multispecialist Medical Department, Division of Rheumatology, ASST Grande 
      Ospedale Metropolitano Niguarda, Milan, Italy. nicola.ughi@ospedaleniguarda.it.
FAU - Del Gaudio, F
AU  - Del Gaudio F
FAU - Dicuonzo, A
AU  - Dicuonzo A
FAU - Orso, M
AU  - Orso M
FAU - Micheloni, G
AU  - Micheloni G
FAU - Puoti, M
AU  - Puoti M
FAU - Pani, A
AU  - Pani A
FAU - Scaglione, F
AU  - Scaglione F
FAU - Zoppini, L
AU  - Zoppini L
FAU - Rossetti, C
AU  - Rossetti C
FAU - Epis, O M
AU  - Epis OM
FAU - Bellavia, G
AU  - Bellavia G
FAU - Giroldi, S
AU  - Giroldi S
FAU - Moreno, M
AU  - Moreno M
FAU - Bosio, M
AU  - Bosio M
LA  - eng
PT  - Journal Article
PL  - Italy
TA  - Eur Rev Med Pharmacol Sci
JT  - European review for medical and pharmacological sciences
JID - 9717360
RN  - N38TVC63NU (BNT162 Vaccine)
SB  - IM
MH  - Adult
MH  - Age Factors
MH  - BNT162 Vaccine/administration & dosage/*adverse effects
MH  - COVID-19/epidemiology/immunology/*prevention & control/virology
MH  - Cross-Sectional Studies
MH  - Female
MH  - Health Personnel/statistics & numerical data
MH  - Humans
MH  - Male
MH  - Medical History Taking/statistics & numerical data
MH  - Middle Aged
MH  - Product Surveillance, Postmarketing/statistics & numerical data
MH  - Risk Factors
MH  - SARS-CoV-2/immunology
MH  - Sex Factors
MH  - Vaccination/*adverse effects/statistics & numerical data
EDAT- 2022/01/05 06:00
MHDA- 2022/01/12 06:00
CRDT- 2022/01/04 12:42
PHST- 2022/01/04 12:42 [entrez]
PHST- 2022/01/05 06:00 [pubmed]
PHST- 2022/01/12 06:00 [medline]
AID - 27649 [pii]
AID - 10.26355/eurrev_202112_27649 [doi]
PST - ppublish
SO  - Eur Rev Med Pharmacol Sci. 2021 Dec;25(24):7985-7996. doi: 
      10.26355/eurrev_202112_27649.