Short-Term Adverse Events and Antibody Response to the BNT162b2 SARS-CoV-2 Vaccine in 4156 Health Care Professionals

Azzolini, Elena; Canziani, Lorenzo Maria; Voza, Antonio; Desai, Antonio; Pepys, J.; Santis, Maria De; Ceribelli, Angela; Pozzi, Chiara; Turato, M; Badalamenti, Salvatore; Germagnoli, Luca; Mantovani, Alberto; Rescigno, María; Selmi, Carlo

doi:10.3390/vaccines10030439

Cited by 7 publications

(4 citation statements)

References 31 publications

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“…This finding may assure individuals hesitant of subsequent doses because an ISR is implicative of improved vaccine immunogenicity. Contrary to Azzolini et al ( 11 ) who observed increased antibodies with adverse events after 2 doses, our study determined nonsignificant associations between anti-S concentration and ISR after the first, second, and third doses.…”

Section: Discussioncontrasting

confidence: 99%

Adverse Events and Serological Responses After SARS-CoV-2 Vaccination in Individuals With Inflammatory Bowel Disease

et al. 2023

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We determined adverse events after 4 doses of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccine in those with inflammatory bowel disease (IBD), associations between antibodies and injection site reactions (ISR), and risk of IBD flare. METHODS:Individuals with IBD were interviewed for adverse events to SARS-CoV-2 vaccine. Multivariable linear regression assessed the association between antibody titers and ISR. RESULTS:Severe adverse events occurred in 0.03%. ISR were significantly associated with antibody levels after the fourth dose (geometric mean ratio 5 2.56; 95% confidence interval 1.18-5.57). No cases of IBD flare occurred. DISCUSSION:SARS-CoV-2 vaccines are safe for those with IBD. ISR after the fourth dose may indicate increased antibodies.

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Section: Discussioncontrasting

confidence: 99%

Adverse Events and Serological Responses After SARS-CoV-2 Vaccination in Individuals With Inflammatory Bowel Disease

et al. 2023

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“…Nearly all articles reported a higher incidence of AEFIs in females compared to males with the exception of four articles which found an opposite outcome, for most of which no clear reason could be identified other than a possible skewed distribution of the sexes and age groups in the studies ( 17 , 18 , 80 , 85 ). Of the 21 articles which reported a OR of any adverse reaction for sex, the median OR was 1.93 (range: 0.85-3.45, IQR 1.49-2.50) using males as reference group ( Supplementary Table S8 ) ( 2 , 6 , 13 , 22 , 24 , 25 , 34 , 43 , 45 – 47 , 52 , 54 , 56 , 61 , 63 , 66 , 68 , 79 , 81 , 85 ). Similarly, females had a median 1.96 times higher odds of reporting a local reaction compared to males (range: 1.02-2.90, IQR1.85-2.54) ( 22 , 32 , 42 , 54 , 76 ).…”

Section: Resultsmentioning

confidence: 99%

Sex-disaggregated outcomes of adverse events after COVID-19 vaccination: A Dutch cohort study and review of the literature

et al. 2023

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BackgroundAlbeit the need for sex-disaggregated results of adverse events after immunization (AEFIs) is gaining attention since the COVID-19 pandemic, studies with emphasis on sexual dimorphism in response to COVID-19 vaccination are relatively scarce. This prospective cohort study aimed to assess differences in the incidence and course of reported AEFIs after COVID-19 vaccination between males and females in the Netherlands and provides a summary of sex-disaggregated outcomes in published literature.MethodsPatient reported outcomes of AEFIs over a six month period following the first vaccination with BioNTech-Pfizer, AstraZeneca, Moderna or the Johnson&Johnson vaccine were collected in a Cohort Event Monitoring study. Logistic regression was used to assess differences in incidence of ‘any AEFI’, local reactions and the top ten most reported AEFIs between the sexes. Effects of age, vaccine brand, comorbidities, prior COVID-19 infection and the use of antipyretic drugs were analyzed as well. Also, time-to-onset, time-to-recovery and perceived burden of AEFIs was compared between the sexes. Third, a literature review was done to retrieve sex-disaggregated outcomes of COVID-19 vaccination.ResultsThe cohort included 27,540 vaccinees (38.5% males). Females showed around two-fold higher odds of having any AEFI as compared to males with most pronounced differences after the first dose and for nausea and injection site inflammation. Age was inversely associated with AEFI incidence, whereas a prior COVID-19 infection, the use of antipyretic drugs and several comorbidities were positively associated. The perceived burden of AEFIs and time-to-recovery were slightly higher in females.DiscussionThe results of this large cohort study correspond to existing evidence and contribute to the knowledge gain necessary to disentangle the magnitude of the effect sex in response to vaccination. Whilst females have a significant higher probability of experiencing an AEFI than males, we observed that the course and burden is only to a minor extent different between the sexes.

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“…However, as with all vaccines, there can be potential side effects. The most common symptoms include fatigue and soreness near the injection site, typically lasting only a few days, while serious adverse reactions are rare occurrences [ 2 ].…”

Section: Introductionmentioning

confidence: 99%

“…The first vaccine against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (the virus responsible for COVID-19) used on a large scale was BNT162b2 [ 4 ], which has been reported to be associated with common adverse effects including pain, swelling and redness at the injection site, fatigue, headache, muscle pain, chills, joint pain, fever, nausea, malaise, and lymphadenopathy [ 2 ]. Rarely have hypersensitivity reactions to BNT162b2, including delayed reactions suggesting cellular hypersensitivity, been reported [ 5 ]; the vaccine component that has been hypothesized to be involved as the potential eliciting allergen in patients with BNT162b2-induced hypersensitivity reactions is the excipient polyethylene glycol (PEG), a hydrophilic polymer that is frequently used as an excipient in everyday products including medicines, cosmetics, and foods [ 6 , 7 , 8 ].…”

Section: Introductionmentioning

confidence: 99%

The Prevalence of Immediate Hypersensitivity Reactions to the BNT162b2 mRNA Vaccine against SARS-CoV-2: Data from the Vaccination Campaign in a Large Academic Hospital

et al. 2023

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The anti-SARS-CoV-2 vaccination has probably been the most effective tool for preventing the infection and negative outcomes of the COVID-19 disease, and therefore for interrupting the pandemic state. The first licensed SARS-CoV-2 vaccine was BNT162b2, an mRNA vaccine that has been widely used since the earliest stages of the global vaccination campaign. Since the beginning of the vaccination campaign, some cases of suspected allergic reactions to BNT162b2 have been described. Epidemiological data, however, have provided reassuring results of an extremely low prevalence of these hypersensitivity reactions to anti-SARS-CoV-2 vaccines. In this article, we describe the results of a survey carried out through the use of a questionnaire, administered to all the health personnel of our university hospital after the first two doses of the BNT162b2 vaccine, which investigated the development of adverse reactions after a vaccination. We analyzed the responses of 3112 subjects subjected to the first dose of the vaccine; among these, 1.8% developed symptoms compatible with allergic reactions and 0.9% with clinical manifestations of possible anaphylaxis. Only 10.3% of the subjects who had allergic reactions after the first injection experienced similar reactions after the second dose and none of them experienced anaphylaxis. In conclusion, the anti-SARS-CoV-2 vaccination is rarely associated with severe allergic reactions and the second dose of vaccine is safe for this group of patients.

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Short-Term Adverse Events and Antibody Response to the BNT162b2 SARS-CoV-2 Vaccine in 4156 Health Care Professionals

Cited by 7 publications

References 31 publications

Adverse Events and Serological Responses After SARS-CoV-2 Vaccination in Individuals With Inflammatory Bowel Disease

Adverse Events and Serological Responses After SARS-CoV-2 Vaccination in Individuals With Inflammatory Bowel Disease

Sex-disaggregated outcomes of adverse events after COVID-19 vaccination: A Dutch cohort study and review of the literature

The Prevalence of Immediate Hypersensitivity Reactions to the BNT162b2 mRNA Vaccine against SARS-CoV-2: Data from the Vaccination Campaign in a Large Academic Hospital

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