DOI: 10.5061/dryad.cnp5hqc6d
title: Adverse drug reactions to the three doses of the SARS-COV-2 mRNA-1273 vaccine in a cohort of cancer patients of a tertiary hospital

description: Introduction: SARS-CoV-2 vaccines efficacy and safety have been tested in
 phase 3 studies in which cancer patients were not included or
 underrepresented. Information is scarce regarding safety in this
 population.  Methods: The objective of this study is to evaluate
 the safety profile of the mRNA-1273 vaccine across cancer 
 patients and its relationship to patients’ demographics. This cross
 sectional study included patients 18-years or older with solid
 malignancies receiving active treatment in our hospital who had received
 the three dose schedule of the mRNA9 1273 vaccine and whose side effects
 after each dose were recorded. Patient electronic medical records were
 reviewed retrospectively to collect tha available information in 2021.
 Patients with documented previous infection by SARS-Cov-2 were excluded
 from the study. Results: 93 patients met inclusion criteria. Local adverse
 drug reactions (ADRs) were reported more frequently after the first and
 second dose than after the third (41.9%, 43% and 31.1% of the patients
 respectively), while systemic ADRs were reported less frequently after the
 first and second dose than after the third (16.1%, 34.4% and 52.6% of the
 patients respectively). We found  a statistically significant
 association between sex and systemic ADRs after the third dose. 
 Cochran-Armitage test showed a statistically significant linear trend, p =
 0.012, with higher ECOG score associated with a lower proportion of
 patients suffering from systemic side effects. A logistic regression
 showed that females had 5.79 times higher odds to exhibit systemic ADRs
 after the third dose (p=0.01)  compared to males. Increasing age
 was associated with a decreased likelihood of exhibiting ADRs (p=0.016).
 Conclusion: mRNA-1273 vaccine shows a tolerable safety profile. The
 likelihood of ADRs appears to be associated with gender and age. Its
 association with ECOG scores is less evident. Further studies are needed
 to elucidate this data in cancer patients.
description: <strong>Study Design, Eligibility and
 Study Procedures.</strong> This observational retrospective study included
 patients with solid tumors receiving anticancer treatment at the
 outpatient facility of the Hospital Clínico San Carlos Medical Oncology
 service in Madrid, Spain. We included all the patients vaccinated with 
 mRNA-1273 vaccine that were on active anticancer therapy and had complete
 available information about the date of each vaccination dose and side
 effects for each of the three doses in electronic medical records.
 Patients who had a documented SARS-CoV-2 infection or a positive
 SARS-CoV-2 serology test collected during routine clinical practice in the
 7 days prior to the first mRNA-1273 vaccine dose were excluded. 
 Additional clinical information was
 abstracted from the electronic medical record, including age, sex,
 performance status (PS) cancer type, cancer history, cancer stage, cancer
 therapy before enrollment. Patient
 electronic medical records were reviewed retrospectively to collect
 available information in 2021. The
 Comité de Ética del Medicamento e Investigación Clínica (Ethics Committee)
 of Hospital Clínico San Carlos approved the project with the code:
 22/033-E. <strong>Data
 Analysis</strong> The primary
 end point of this study was ADRs after each dose of mRNA-1273 VACCINE.
 ADRs were categorized as local adverse reactions which included pain,
 swelling, rash and itchiness at the site of infection and systemic adverse
 reactions. Systemic adverse reactions reported by patients were fever
 (defined as body temperature equal or above 38ºC), headache, myalgia,
 malaise, nausea, arthralgia, chills, adenopathies, urticaria, asthenia and
 cough. Data was analyzed with IBM
 SPSS v.25. For descriptive purposes, categorical variables were
 represented by absolute and relative frequencies and quantitative
 variables were represented by central and dispersion measures. In order to
 ascertain the relationship between nominal independent variables (sex,
 heavily trated status and past story of systemic adverse drug reactions)
 we performed a Chi-squared test (all expected cell frequencies were
 greater than five) followed by a Cramer’s V test. For ordinal variables
 (Eastern Cooperative Oncology Group performance status) we performed a
 Cochran-Armitage Test of trend. Significance was tested with an alpha
 value of 0,05. No multiplicity correction was applied. In order to test
 the value as predictors of true baseline variables (age, sex and Eastern
 Cooperative Oncology Group performance status) we fitted a binomial
 logistic regression to ascertain the effects of age, sex and ECOG score on
 the likelihood that participants have systemic adverse events after the
 third dose (hereinabove described). Linearity of the continuous variables
 with respect to the logit of the dependent variable was assessed via the
 Box-Tidwell procedure. A Bonferroni correction was applied using all seven
 terms in the model resulting in statistical significance being accepted
 when <em>p</em> &lt; 0.0071. Age was included as a
 continuous variable, sex as a dichotomous variable, being male considered
 as reference, and ECOG score was included as categorical variables, being
 considered a score of 0 the reference.