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Local and Systemic Adverse Reactions to mRNA COVID-19 Vaccines Comparing Two Vaccine Types and Occurrence of Previous COVID-19 Infection.

ABSTRACT: The aim of this study was to assess adverse reactions to COVID-19 vaccines, comparing the BNT162b2 or the mRNA-1273 COVID-19 vaccines and the presence and seriousness of a previous COVID-19 infection. We conducted a cross-sectional online survey of vaccinated healthcare workers at a tertiary hospital in Barcelona (Spain). Thirty-eight percent of vaccine recipients responded to the questionnaire. We compared the prevalence of adverse reactions by vaccine type and history of COVID-19 infections. A total of 2373 respondents had received the BNT162b2 vaccine, and 506 the mRNA-1273 vaccine. The prevalence of at least one adverse reaction with doses 1 and 2 was 41% and 70%, respectively, in the BNT162b2 group, and 60% and 92% in the mRNA-1273 group (p < 0.001). The BNT162b2 group reported less prevalence of all adverse reactions. Need for medical leave was significantly more frequent among the mRNA-1273 group (12% versus 4.6% p < 0.001). Interestingly, respondents with a history of allergies or chronic illnesses did not report more adverse reactions. The frequency of adverse reactions with dose 2 was 96% (95% CI 88-100%) for those with a history of COVID-19 related hospitalization, and 86% (95% CI 83-89%) for those with mild or moderate symptomatic COVID-19, significantly higher than for participants with no history of COVID-19 infections (67%, 95% CI 65-69%). Our results could help inform vaccine recipients of the probability of their having adverse reactions to COVID-19 vaccines.

SUBMITTER: Pares-Badell O

PROVIDER: S-EPMC8707814 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Cutaneous Adverse Reactions to COVID-19 Vaccines: Insights from an Immuno-Dermatological Perspective.

Project description:(1) Background: Numerous vaccines are under preclinical and clinical development for prevention of severe course and lethal outcome of coronavirus disease 2019 (COVID-19). In light of high efficacy rates and satisfactory safety profiles, some agents have already reached approval and are now distributed worldwide, with varying availability. Real-world data on cutaneous adverse drug reactions (ADRs) remain limited. (2) Methods: We performed a literature research concerning cutaneous ADRs to different COVID-19 vaccines, and incorporated our own experiences. (3) Results: Injection site reactions are the most frequent side effects arising from all vaccine types. Moreover, delayed cutaneous ADRs may occur after several days, either as a primary manifestation or as a flare of a pre-existing inflammatory dermatosis. Cutaneous ADRs may be divided according to their cytokine profile, based on the preponderance of specific T-cell subsets (i.e., Th1, Th2, Th17/22, Tregs). Specific cutaneous ADRs mimic immunogenic reactions to the natural infection with SARS-CoV-2, which is associated with an abundance of type I interferons. (4) Conclusions: Further studies are required in order to determine the best suitable vaccine type for individual groups of patients, including patients suffering from chronic inflammatory dermatoses.

| S-EPMC8470727 | biostudies-literature

Adverse reactions to the BNT162b2 and mRNA-1273 mRNA COVID-19 vaccines in Japan.

Project description:IntroductionThe BNT162b2 and mRNA-1273 COVID-19 vaccines are the main vaccines that have been used for mass vaccination in Japan. Information on adverse reactions to COVID-19 vaccines in the Japanese population is limited.MethodsWe conducted an online survey on self-reported adverse reactions in individuals who had received two doses of the BNT162b2 or mRNA-1273 vaccine. The incidence of adverse events after each dose of vaccine was investigated. Propensity score matching was used to compare the incidence of adverse reactions after the second dose of the BNT162b2 and mRNA-1273 vaccines.ResultsAfter the first and second doses of the BNT162b2 vaccine, and the first and second doses of the mRNA-1273 vaccine, 890, 853, 6401, and 3965 individuals, respectively, provided complete responses. Systemic reactions, including fever, fatigue, headache, muscle/joint pain, and nausea were significantly more common in females, individuals aged <50 years, and after the second dose. The incidence of injection site pain did not differ significantly according to the dose. The incidence of delayed injection site reactions after the first dose of mRNA-1273 vaccine was 3.9% and 0.8% among females and males, respectively, and 10.6% among females aged 40-69 years. Local and systemic reactions after the second dose, including fever, fatigue, headache, muscle/joint pain, nausea, and skin rash were more common in individuals who had received the mRNA-1273 vaccine.ConclusionsAdverse reactions were more frequently reported in females, younger individuals, and after the mRNA-1273 vaccine.

| S-EPMC8747950 | biostudies-literature

Acute Allergic Reactions to mRNA COVID-19 Vaccines.

Project description: Not available

| S-EPMC7941251 | biostudies-literature

Delayed Large Local Reactions to mRNA Covid-19 Vaccines in Blacks, Indigenous Persons, and People of Color.

Project description: Not available

| S-EPMC8219056 | biostudies-literature

Adverse reactions following COVID-19 vaccination: An Ecuadorian experience.

Project description:BackgroundLimited large-scale studies have been conducted to investigate the adverse effects of COVID-19 vaccine in Latin America, particularly among the healthcare worker (HCW) population in Ecuador. The objective of this study was to assess a cohort of Ecuadorian healthcare workers for adverse reactions following vaccination with the Pfizer-BioNTech vaccine.MethodsWe conducted an observational cross-sectional study to assess the potential adverse reactions to the Pfizer-BioNTech COVID-19 vaccine among a sample of healthcare workers (HCWs) in the city of Guayaquil, Ecuador, from March to May 2021.ResultsThe sample comprised 1291 patients, with a mean age of 39.3 years (SD, 13.5). In general, 79% (N = 1020) of participants presented an adverse effect of any type at first dose, while 75.1% (N = 969) did so at the second dose. Pain at the puncture site was the most common adverse effect overall after either the first (68.4%) and second (55.6%) dose. Regarding anaphylaxis, no participant developed the condition after the first dose, and only 0.2% (N = 2) developing it at the second dose. No fatalities were reported.ConclusionOur findings suggest that adverse reactions following COVID-19 vaccination with the Pfizer-BioNTech vaccine are relatively common, albeit often mild and self-limited. Consistent with the literature there were few cases of anaphylaxis, and no deaths that could be attributed to the inoculation with the vaccine. We hope our findings can help to reassure the public that benefits of vaccination highly outweigh the risks and contribute to the effort of reducing vaccine hesitancy among those who are concerned about the safety and potential side effects.

| S-EPMC8598282 | biostudies-literature

Adverse Events After XBB.1.5-Containing COVID-19 mRNA Vaccines.

Project description: Not available

| S-EPMC10897819 | biostudies-literature

Reported orofacial adverse effects of COVID-19 vaccines: The knowns and the unknowns.

Project description:IntroductionAdverse events associated with vaccine administration can manifest in the oral cavity and orofacial region. Hence, the aim of this study was to compare the orofacial adverse effects of two recently authorised COVID-19 vaccines, namely BNT162b2 and mRNA-1273.MethodsPublicly available data on BNT162b2 and mRNA-1273 vaccines were accessed from the relevant regulatory authorities in the United States, Canada, European Union and United Kingdom. Both patient/recipient information and healthcare professional fact sheets for each of these drugs were manually searched to find their orofacial adverse effects.ResultsAdverse events affecting the orofacial region were reported for both vaccines. These were rare and included acute peripheral facial paralysis (Bell's palsy), facial swelling, and swelling of the lips, face or tongue associated with anaphylaxis. There was heterogeneity in the acknowledgement of vaccine-related adverse events in North America compared with Europe.ConclusionGlobally, there are inconsistencies in the description of adverse effects presenting in the orofacial region of the COVID-19 vaccines BNT162b2 and mRNA-1273. We believe that awareness of these orofacial manifestations will improve recognition, management and reporting of vaccine-related adverse effects.

| S-EPMC8013400 | biostudies-literature

Clinical and histopathological spectrum of delayed adverse cutaneous reactions following COVID-19 vaccination.

Project description:BackgroundAs more people become vaccinated against the SARS-CoV-2 virus, reports of delayed cutaneous hypersensitivity reactions are beginning to emerge.MethodsIn this IRB-approved retrospective case series, biopsy specimens of potential cutaneous adverse reactions from the Pfizer-BioNTech or Moderna mRNA vaccine were identified and reviewed. Clinical information was obtained through the requisition form, referring clinician, or medical chart review.ResultsTwelve cases were included. Histopathological features from two injection-site reactions showed a mixed-cell infiltrate with eosinophils and a spongiotic dermatitis with eosinophils. Three biopsy specimens came from generalized eruptions that showed interface changes consistent with an exanthematous drug reaction. Three biopsy specimens revealed a predominantly spongiotic pattern, consistent with eczematous dermatitis. Small-vessel vascular injury was seen in two specimens, which were diagnosed as urticarial vasculitis and leukocytoclastic vasculitis, respectively. There were two cases of new-onset bullous pemphigoid supported by histopathological examination and direct immunofluorescence studies. Eosinophils were seen in 10 cases.ConclusionsDermatopathologists should be aware of potential cutaneous adverse reactions to mRNA-based COVID-19 vaccines. Histopathological patterns include mixed-cell infiltrates, epidermal spongiosis, and interface changes. Eosinophils are a common finding but are not always present. Direct immunofluorescence studies may be helpful for immune-mediated cutaneous presentations such as vasculitis or bullous pemphigoid.

| S-EPMC8444807 | biostudies-literature

Case Report: Associated Ocular Adverse Reactions With Inactivated COVID-19 Vaccine in China.

Project description:The vaccine is still the best clinical measure for effective prevention and control of coronavirus disease 2019 (COVID-19). The vaccine-associated ocular adverse reactions should be noted in detail among the medical community. We reported twelve eyes of 9 patients presented at the Department of Ophthalmology, Qilu Hospital of Shandong University from March to August 2021 with ocular complaints following COVID-19 vaccination. The main inclusion criterion was the development of ocular symptoms within 14 days after receiving a dose of an inactivated COVID-19 vaccine. The mean (SD) age was 44.7 ± 16.5 years (range, 19-78 years), among which seven (77.8%) cases were women. The mean time of ocular adverse events was 7.1 days (range, 1-14 days) after receiving the inactivated COVID-19 vaccine. One patient was diagnosed with choroiditis, 1 with uveitis, 4 with keratitis, 1 with scleritis, 1 with acute retinal necrosis, and 1 with iridocyclitis. Although the causal relationship between vaccines and ocular adverse events cannot be established from this case series report, physicians should pay attention to the ocular adverse reactions following the COVID-19 vaccine administration.

| S-EPMC8801805 | biostudies-literature

The prevalence of adverse reactions among individuals with three-dose COVID-19 vaccination.

Project description:BackgroundConsidering the adverse reactions to vaccination against coronavirus disease 2019 (COVID-19), some people, particularly the elderly and those with underlying medical conditions, are hesitant to be vaccinated. This study aimed to explore the prevalence of adverse reactions and provide direct evidence of vaccine safety, mainly for the elderly and people with underlying medical conditions, to receive COVID-19 vaccination.MethodsFrom 1st March to 30th April 2022, we conducted an online survey of people who had completed three doses of COVID-19 vaccination by convenience sampling. Adverse reaction rates and 95% confidence intervals were calculated. In addition, conditional logistic regression was used to compare the differences in adverse reactions among the elderly and those with underlying medical conditions with the general population.ResultsA total of 3339 individuals were included in this study, of which 2335 (69.9%) were female, with an average age of 32.1 ± 11.4 years. The prevalence of adverse reactions after the first dose of inactivated vaccine was 24.6% (23.1-26.2%), 19.2% (17.8-20.7%) for the second dose, and 19.1% (17.7-20.6%) for the booster dose; among individuals using messenger RNA vaccines, the prevalence was 42.7% (32.3-53.6%) for the first dose, 47.2% (36.5-58.1%) for the second dose, and 46.1% (35.4-57.0%) for the booster dose. Compared with the general population, the prevalence of adverse events did not differ in individuals with underlying medical conditions and those aged 60 and above.ConclusionsFor individuals with underlying medical conditions and those aged 60 and above, the prevalence of adverse reactions is similar to that of the general population, which provides a scientific basis regarding vaccination safety for these populations.

| S-EPMC9724502 | biostudies-literature

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